Study of (Mirapex) Pramipexole for the Early Treatment of Parkinsons Disease (PD)

Parkinson Disease Clinical Trial

Official title:

A Randomized, Double-blind, Placebo-controlled, Parallel-group Clinical Trial to Examine the Efficacy and Safety of Early Pramipexole (PPX) Treatment Versus Delayed Pramipexole Treatment in Patients With New Onset Parkinson's Disease.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00321854
• Other study ID #: 248.595
• Status: Completed
• Phase: Phase 4
• First received: May 3, 2006
• Last updated: May 7, 2014
• Start date: May 2006

Study information

• Verified date: March 2014
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Bundesamt für Sicherheit im Gesundheitswesen, A-1030 Vienna, AustriaFinland: Finnish Medicines AgencyFrance: AFFSAPSGermany: Federal Institute for Drugs and Medical DevicesGreat Britain: MHRAItaly: Comitato Etico dell'Az. USL 12 di Viareggio - VIAREGGIOJapan: Ministry of Health, Labor and WelfareSpain: Spanish Agency for Medicines and Health ProductsSweden: Regional Ethics Committee of Stockholm, PO Box 289, SE-17177 Stockholm, Sweden. Medical Products Agency, PO Box 26, SE-751 03 Uppsala, SwedenUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This is a double blind, placebo-controlled clinical trial of 15 months duration designed to examine early Mirapex (pramipexole) treatment vs. delayed Mirapex (pramipexole) treatment in patients with new onset Parkinsons disease

Recruitment information / eligibility

• Status: Completed
• Enrollment: 535
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 79 Years

Eligibility

Inclusion Criteria:

• Ability to provide written informed consent in accordance with Good Clinical Practice (GCP) and local legislation;

• Male or female patient with idiopathic Parkinson Disease (PD) confirmed by at least three of the following signs: resting tremor, bradykinesia, rigidity, and asymmetry (must have bradykinesia);

• Parkinsons disease newly diagnosed within the past 2 years;

• Patients with idiopathic PD characterized as Stage I-II by the Modified Hoehn and Yahr Scale who do not require PD medication and will not likely need PD medication for at least 6 months in the opinion of the investigator; Age 30 to 75 years at screening (Visit 1);

• Women of childbearing potential must have a negative serum Beta-HumanChorionGonadotropin (Beta-HCG) pregnancy test at the Screening (Baseline) visit unless surgically sterile or post-menopausal (last menstruation 12 months prior to signing Informed Consent). Women of childbearing potential must be using a medically accepted contraceptive method. Acceptable methods of birth control are limited to: Intra-Uterine Device (IUD), oral, implantable, or injectable contraceptives, estrogen patch, and double barrier method (spermicide + diaphragm); and Patients who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.

Exclusion Criteria:

• Previous history of allergic response or complications with pramipexole (PPX) or its excipients;

• Atypical PD syndromes due to either drugs (e.g., metoclopramide, flunarizine) or metabolic disorders (e.g., Wilsons Disease), encephalitis, or degenerative diseases (e.g., progressive supranuclear palsy);

• The patient is currently on L-dopa, dopamine agonists or other PD medication at baseline;

• The patient has been on L-dopa, dopamine agonists or other PD medications for greater than 14 consecutive days prior to baseline;

• If on L-dopa, dopamine agonists or other PD medications prior to baseline, the patient stopped treatment less than 30 days prior to baseline;

• The patient has clinically significant abnormal laboratory values, and/or medical or psychiatric illness other than as seen in Parkinsons disease;

• The patient has a clinically significant deviation from normal in the physical examination other than as seen in Parkinsons disease;

• The patient has any disorder that may interfere with drug absorption, distribution, metabolism, or excretion (including gastrointestinal surgery);

• History of stereotactic brain surgery;

• Surgery within 6 months of randomization, which in the opinion of the investigator, would negatively impact the patients participation in the study;

• History of active epilepsy (i.e., occurrence of a seizure) within the past year;

• Symptomatic orthostatic hypotension prior to randomization;

• Malignant melanoma or history of previously treated malignant melanoma;

• Patients who have received any of the following drugs (all time periods are calculated from randomization): Amantadine;

• Electroconvulsive therapy during 180 days preceding the screening visit (Visit 1);

• Patients who are currently pregnant or planning pregnancy during the study, or lactating;

• Participation in other investigational drug studies or use of other investigational drugs within the previous 30 days prior to randomization;

• History of psychosis;

• A diagnosis of dementia

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Drug:
• pramipexole

Locations

Country	Name	City	State
Austria	248.595.43005 Boehringer Ingelheim Investigational Site	Bruck a. d. Mur
Austria	248.595.43003 Boehringer Ingelheim Investigational Site	Graz
Austria	248.595.43001 Boehringer Ingelheim Investigational Site	Innsbruck
Austria	248.595.43002 Boehringer Ingelheim Investigational Site	Wien
Austria	248.595.43004 Boehringer Ingelheim Investigational Site	Wien
Finland	248.595.35803 Boehringer Ingelheim Investigational Site	Helsinki
Finland	248.595.35804 Boehringer Ingelheim Investigational Site	Lahti
Finland	248.595.35801 Boehringer Ingelheim Investigational Site	Oulu
France	248.595.3306A Centre Hospitalier du Pays d'Aix	Aix en Provence
France	248.595.3306B Centre Hospitalier du Pays d'Aix	Aix en Provence
France	248.595.3306C Centre Hospitalier du Pays d'Aix	Aix en Provence
France	248.595.3301A Hôpital Gabriel Montpied	Clermont Ferrand
France	248.595.3301B Hôpital Gabriel Montpied	Clermont Ferrand
France	248.595.3303A Cabinet Médical	Evreux
France	248.595.3307A Hôpital Roger Salengro	Lille cedex
France	248.595.3307B Hôpital Roger Salengro	Lille cedex
France	248.595.3302A Hôpital La Timone	Marseille cedex 05
France	248.595.3302B Hôpital La Timone	Marseille cedex 05
France	248.595.3305A Hôpital Purpan	Toulouse cedex 9
France	248.595.3305C Hôpital Purpan	Toulouse cedex 9
Germany	248.595.49006 Boehringer Ingelheim Investigational Site	Augsburg
Germany	248.595.49008 Boehringer Ingelheim Investigational Site	Berlin
Germany	248.595.49007 Boehringer Ingelheim Investigational Site	Bochum
Germany	248.595.49011 Boehringer Ingelheim Investigational Site	Bonn
Germany	248.595.49016 Boehringer Ingelheim Investigational Site	Gera
Germany	248.595.49009 Boehringer Ingelheim Investigational Site	Göttingen
Germany	248.595.49004 Boehringer Ingelheim Investigational Site	Hamburg
Germany	248.595.49010 Boehringer Ingelheim Investigational Site	Hanau
Germany	248.595.49005 Boehringer Ingelheim Investigational Site	Hannover
Germany	248.595.49012 Boehringer Ingelheim Investigational Site	Leipzig
Germany	248.595.49001 Boehringer Ingelheim Investigational Site	Marburg
Germany	248.595.49015 Boehringer Ingelheim Investigational Site	München
Germany	248.595.49014 Boehringer Ingelheim Investigational Site	Tübingen
Italy	248.595.39004 Università degli Studi di Bari	Bari
Italy	248.595.39009 Ospedale di Bellaria	Bologna
Italy	248.595.39005 Ospedale della Misericordia	Grosseto
Italy	248.595.39001 Azienda Ospedaliera Istituti Clinici di Perfezionamento	Milano
Italy	248.595.39010 Ospedale Maggiore Policlinico Mangigalli e Regina Elena	Milano
Italy	248.595.39011 Ospedale S. Raffaele - IRCCS	Milano
Italy	248.595.39002 Università Federico II	Napoli
Italy	248.595.39012 Azienda Ospedaliera Pisana- Università degli Studi di Pisa	Pisa
Italy	248.595.39014 Boehringer Ingelheim Investigational Site	Roma
Italy	248.595.39006 Policlinico Universitario Molinette	Torino
Italy	248.595.39007 Ospedale Evangelico Valdese	Torino
Italy	248.595.39013 Ospedale Umberto I	Venezia Mestre
Italy	248.595.39003 Ospedale di Viareggio	Viareggio
Japan	248.595.81001 Juntendo University Hospital	Bunkyo-ku, Tokyo
Japan	248.595.81002 Kagawa Prefectural Central Hospital	Takamatsu, Kagawa
Spain	248.595.34003 Hospital de Alcorcon	Alcorcon (Madrid)
Spain	248.595.34001 Hospital Clinic i Provincial of Barcelona	Barcelona
Spain	248.595.34002 Nuevo Hospital de Sant Pau	Barcelona
Spain	248.595.34004 Hospital 12 de Octubre	Madrid
Spain	248.595.34005 Hospital Mutua de Terrassa	Tarrasa (Barcelona)
Sweden	248.595.46004 Boehringer Ingelheim Investigational Site	Jönköping
Sweden	248.595.46006 Boehringer Ingelheim Investigational Site	Linköping
Sweden	248.595.46005 Boehringer Ingelheim Investigational Site	Norrköping
Sweden	248.595.46002 Boehringer Ingelheim Investigational Site	Örebro
Sweden	248.595.46001 Boehringer Ingelheim Investigational Site	Stockholm
Sweden	248.595.46007 Boehringer Ingelheim Investigational Site	Stockholm
United Kingdom	248.595.44003 Boehringer Ingelheim Investigational Site	Birmingham
United Kingdom	248.595.44008 Boehringer Ingelheim Investigational Site	Glasgow
United Kingdom	248.595.44004 Boehringer Ingelheim Investigational Site	London
United Kingdom	248.595.44002 Boehringer Ingelheim Investigational Site	Newark
United Kingdom	248.595.44001 Boehringer Ingelheim Investigational Site	Newcastle upon Tyne
United Kingdom	248.595.44010 Boehringer Ingelheim Investigational Site	North Shields
United Kingdom	248.595.44011 Boehringer Ingelheim Investigational Site	Romford
United Kingdom	248.595.44005 Boehringer Ingelheim Investigational Site	Stoke-on-Trent
United States	248.595.0103 Boehringer Ingelheim Investigational Site	Atlanta	Georgia
United States	248.595.0127 Boehringer Ingelheim Investigational Site	Augusta	Georgia
United States	248.595.0134 Boehringer Ingelheim Investigational Site	Baltimore	Maryland
United States	248.595.0113 Boehringer Ingelheim Investigational Site	Bradenton	Florida
United States	248.595.0122 Boehringer Ingelheim Investigational Site	Brimingham	Alabama
United States	248.595.0101 Boehringer Ingelheim Investigational Site	Chicago	Illinois
United States	248.595.0120 Boehringer Ingelheim Investigational Site	Cleveland	Ohio
United States	248.595.0137 Boehringer Ingelheim Investigational Site	Columbus	Georgia
United States	248.595.0107 Boehringer Ingelheim Investigational Site	Dayton	Ohio
United States	248.595.0111 Boehringer Ingelheim Investigational Site	Elk Grove Village	Illinois
United States	248.595.0105 Boehringer Ingelheim Investigational Site	Gainesville	Florida
United States	248.595.0119 Boehringer Ingelheim Investigational Site	Hollywood	Florida
United States	248.595.0108 Boehringer Ingelheim Investigational Site	Houston	Texas
United States	248.595.0121 Boehringer Ingelheim Investigational Site	Kirkland	Washington
United States	248.595.0133 Boehringer Ingelheim Investigational Site	La Jolla	California
United States	248.595.0140 Boehringer Ingelheim Investigational Site	La Jolla	California
United States	248.595.0116 Boehringer Ingelheim Investigational Site	Memphis	Tennessee
United States	248.595.0112 Boehringer Ingelheim Investigational Site	New Haven	Connecticut
United States	248.595.0129 Boehringer Ingelheim Investigational Site	New York	New York
United States	248.595.0124 Boehringer Ingelheim Investigational Site	Palm Beach Gardens	Florida
United States	248.595.0123 Boehringer Ingelheim Investigational Site	Panama City	Florida
United States	248.595.0139 Boehringer Ingelheim Investigational Site	Raleigh	North Carolina
United States	248.595.0131 Boehringer Ingelheim Investigational Site	Scarbourough	Maine
United States	248.595.0104 Boehringer Ingelheim Investigational Site	Scottsdale	Arizona
United States	248.595.0109 Boehringer Ingelheim Investigational Site	South Miami	Florida
United States	248.595.0115 Boehringer Ingelheim Investigational Site	St. Petersburg	Florida
United States	248.595.0106 Boehringer Ingelheim Investigational Site	Tampa	Florida
United States	248.595.0102 Boehringer Ingelheim Investigational Site	Traverse City	Michigan
United States	248.595.0118 Boehringer Ingelheim Investigational Site	Tulsa	Oklahoma
United States	248.595.0114 Boehringer Ingelheim Investigational Site	Warwick	Rhode Island
United States	248.595.0136 Boehringer Ingelheim Investigational Site	Winston Salem	North Carolina
United States	248.595.0141 Boehringer Ingelheim Investigational Site	Worcester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

United States,  Austria,  Finland,  France,  Germany,  Italy,  Japan,  Spain,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in the Blinded Rater Unified Parkinson's Disease Rating Scale (UPDRS) Total Score at Month 15	The UPDRS total score (Parts I+II+III) measures the impact of PD on mentation, behaviour and mood, activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 176 (worst disability)	Baseline and Month 15	No
Secondary	Change From Baseline in the Investigator Rated UPDRS Total Score at Month 15	The UPDRS total score (Parts I+II+III) measures the impact of PD on mentation, behaviour and mood, activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 176 (worst disability)	Baseline and Month 15	No
Secondary	Change From Baseline in the Investigator Rated UPDRS Total Score at Month 9	The UPDRS total score (Parts I+II+III) measures the impact of PD on mentation, behaviour and mood, activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 176 (worst disability)	Baseline and Month 9	No
Secondary	Change From Baseline in the Investigator Rated UPDRS Total Score at Month 6	The UPDRS total score (Parts I+II+III) measures the impact of PD on mentation, behaviour and mood, activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 176 (worst disability)	Baseline and Month 6	No
Secondary	Change From Baseline in the Investigator Rated UPDRS Total Score at Month 3	The UPDRS total score (Parts I+II+III) measures the impact of PD on mentation, behaviour and mood, activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 176 (worst disability)	Baseline and Month 3	No
Secondary	Change From Baseline in the Blinded Rater UPDRS Parts II+III Total Score at Month 15	The UPDRS Parts II+III total score measures the impact of PD on activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 160 (worst disability)	Baseline and Month 15	No
Secondary	Change From Baseline in the Investigator Rated UPDRS Parts II+III Score at Month 15	The UPDRS Parts II+III total score measures the impact of PD on activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 160 (worst disability)	Baseline and Month 15	No
Secondary	Change From Baseline in the Investigator Rated UPDRS Parts II+III Score at Month 9	The UPDRS Parts II+III total score measures the impact of PD on activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 160 (worst disability)	Baseline and Month 9	No
Secondary	Change From Baseline in the Investigator Rated UPDRS Parts II+III Score at Month 6	The UPDRS Parts II+III total score measures the impact of PD on activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 160 (worst disability)	Baseline and Month 6	No
Secondary	Change From Baseline in the Investigator Rated UPDRS Parts II+III Score at Month 3	The UPDRS Parts II+III total score measures the impact of PD on activities of daily living and motor skills on an ordinal scale ranging from 0 (no disability) to 160 (worst disability)	Baseline and Month 3	No
Secondary	Change From Baseline in the Blinded Rater UPDRS Part III Total Score at Month 15	The UPDRS Part III total score measures the impact of PD on motor skills on an ordinal scale ranging from 0 (no disability) to 108 (worst disability)	Baseline and Month 15	No
Secondary	Change From Baseline in the Investigator Rated UPDRS Part III Score at Month 15	The UPDRS Part III total score measures the impact of PD on motor skills on an ordinal scale ranging from 0 (no disability) to 108 (worst disability)	Baseline and Month 15	No
Secondary	Change From Baseline in the Investigator Rated UPDRS Part III Score at Month 9	The UPDRS Part III total score measures the impact of PD on motor skills on an ordinal scale ranging from 0 (no disability) to 108 (worst disability)	Baseline and Month 9	No
Secondary	Change From Baseline in the Investigator Rated UPDRS Part III Score at Month 6	The UPDRS Part III total score measures the impact of PD on motor skills on an ordinal scale ranging from 0 (no disability) to 108 (worst disability)	Baseline and Month 6	No
Secondary	Change From Baseline in the Investigator Rated UPDRS Part III Score at Month 3	The UPDRS Part III total score measures the impact of PD on motor skills on an ordinal scale ranging from 0 (no disability) to 108 (worst disability)	Baseline and Month 3	No
Secondary	Change From Baseline in the Blinded Rater UPDRS Part II Total Score at Month 15	The UPDRS Part II total score measures the impact of PD on activities of daily living on an ordinal scale ranging from 0 (no disability) to 52 (worst disability)	Baseline and Month 15	No
Secondary	Change From Baseline in the Investigator Rated UPDRS Part II Score at Month 15	The UPDRS Part II total score measures the impact of PD on activities of daily living on an ordinal scale ranging from 0 (no disability) to 52 (worst disability)	Baseline and Month 15	No
Secondary	Change From Baseline in the Investigator Rated UPDRS Part II Score at Month 9	The UPDRS Part II total score measures the impact of PD on activities of daily living on an ordinal scale ranging from 0 (no disability) to 52 (worst disability)	Baseline and Month 9	No
Secondary	Change From Baseline in the Investigator Rated UPDRS Part II Score at Month 6	The UPDRS Part II total score measures the impact of PD on activities of daily living on an ordinal scale ranging from 0 (no disability) to 52 (worst disability)	Baseline and Month 6	No
Secondary	Change From Baseline in the Investigator Rated UPDRS Part II Score at Month 3	The UPDRS Part II total score measures the impact of PD on activities of daily living on an ordinal scale ranging from 0 (no disability) to 52 (worst disability)	Baseline and Month 3	No
Secondary	Change From Baseline in the Blinded Rater UPDRS Part I Total Score at Month 15	The UPDRS Part I total score measures the impact of PD on mentation, behaviour and mood on an ordinal scale ranging from 0 (no disability) to 16 (worst disability)	Baseline and Month 15	No
Secondary	Change From Baseline in the Investigator Rated UPDRS Part I Total Score at Month 15	The UPDRS Part I total score measures the impact of PD on mentation, behaviour and mood on an ordinal scale ranging from 0 (no disability) to 16 (worst disability)	Baseline and Month 15	No
Secondary	Change From Baseline in the Investigator Rated UPDRS Part I Total Score at Month 9	The UPDRS Part I total score measures the impact of PD on mentation, behaviour and mood on an ordinal scale ranging from 0 (no disability) to 16 (worst disability)	Baseline and Month 9	No
Secondary	Change From Baseline in the Investigator Rated UPDRS Part I Total Score at Month 6	The UPDRS Part I total score measures the impact of PD on mentation, behaviour and mood on an ordinal scale ranging from 0 (no disability) to 16 (worst disability)	Baseline and Month 6	No
Secondary	Change From Baseline in the Investigator Rated UPDRS Part I Total Score at Month 3	The UPDRS Part I total score measures the impact of PD on mentation, behaviour and mood on an ordinal scale ranging from 0 (no disability) to 16 (worst disability)	Baseline and Month 3	No
Secondary	Number of Responders Using the Blinded Rater Assessment of Clinical Global Impressions of Global Improvement (CGI-I) Score at Month 15	The CGI-I measures the overall improvement in the participants condition from baseline on an ordinal scale ranging from 1 (very much improved) to 7 (very much worse). Responders are defined as those patients with a CGI-I of 1 or 2.	Month 15	No
Secondary	Change From Baseline in Blinded Rater Assessment of Clinical Global Impressions of Severity of Illness (CGI-S) Category at Month 15	The CGI-S measures the participants severity of illness on an ordinal scale ranging from 1 (normal) to 7 (extremely ill). At Month 15 participants were categorised to 'Improved' (>1 category improvement), 'Unchanged' or 'Worsened' (>1 category worsening).	Baseline and Month 15	No
Secondary	Change From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Month 15	The BDI measures symptoms of depression on an ordinal scale ranging from 0 (no symptoms) to 63 (worst symptoms)	Baseline and Month 15	No
Secondary	Change From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Month 9	The BDI measures symptoms of depression on an ordinal scale ranging from 0 (no symptoms) to 63 (worst symptoms)	Baseline and Month 9	No
Secondary	Change From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Month 6	The BDI measures symptoms of depression on an ordinal scale ranging from 0 (no symptoms) to 63 (worst symptoms)	Baseline and Month 6	No
Secondary	Change From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Month 3	The BDI measures symptoms of depression on an ordinal scale ranging from 0 (no symptoms) to 63 (worst symptoms)	Baseline and Month 3	No
Secondary	Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Overall Index Score at Month 15	The PDQ-39 measures aspects of health in PD participants, the overall index score is the mean of the eight individual domain scores measured on a continuous scale ranging from 0 (no problem at all) to 100 (maximum level of the problem)	Baseline and Month 15	No
Secondary	Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Overall Index Score at Month 9	The PDQ-39 measures aspects of health in PD participants, the overall index score is the mean of the eight individual domain scores measured on a continuous scale ranging from 0 (no problem at all) to 100 (maximum level of the problem)	Baseline and Month 9	No
Secondary	Change From Baseline in the European Quality of Life Scale (EUROQOL (EQ)-5D) Overall Index Score at Month 15	The EQ-5D measures health status on a continuous scale ranging from 0 (dead) to 1 (full health)	Baseline and Month 15	No
Secondary	Change From Baseline in the European Quality of Life Scale (EUROQOL (EQ)-5D) Overall Index Score at Month 9	The EQ-5D measures health status on a continuous scale ranging from 0 (dead) to 1 (full health)	Baseline and Month 9	No
Secondary	Change From Baseline in the European Quality of Life Visual Analogue Scale (EUROQOL (EQ) VAS) Score at Month 15	The EQ-VAS is a self rating of current health-related quality of life measured on a continuous scale ranging from 0 (worst imaginable health state) to 100 (best imaginable health state)	Baseline and Month 15	No
Secondary	Change From Baseline in the European Quality of Life Visual Analogue Scale (EUROQOL (EQ) VAS) Score at Month 9	The EQ-VAS is a self rating of current health-related quality of life measured on a continuous scale ranging from 0 (worst imaginable health state) to 100 (best imaginable health state)	Baseline and Month 9	No
Secondary	Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 1	The MMIDI is a semi-structured interview designed to assess impulse control disorders; risk of gambling is assessed via 12 questions, a participant is considered at risk if answering 'Yes' to Q1 and 'Yes' to 5 or more of Q2 to Q12.	Month 1	No
Secondary	Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 6	The MMIDI is a semi-structured interview designed to assess impulse control disorders; risk of gambling is assessed via 12 questions, a participant is considered at risk if answering 'Yes' to Q1 and 'Yes' to 5 or more of Q2 to Q12.	Month 6	No
Secondary	Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 9	The MMIDI is a semi-structured interview designed to assess impulse control disorders; risk of gambling is assessed via 12 questions, a participant is considered at risk if answering 'Yes' to Q1 and 'Yes' to 5 or more of Q2 to Q12.	Month 9	No
Secondary	Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 12	The MMIDI is a semi-structured interview designed to assess impulse control disorders; risk of gambling is assessed via 12 questions, a participant is considered at risk if answering 'Yes' to Q1 and 'Yes' to 5 or more of Q2 to Q12.	Month 12	No
Secondary	Modified Minnesota Disorders Interview (MMIDI) Risk of Gambling at Month 15	The MMIDI is a semi-structured interview designed to assess impulse control disorders; risk of gambling is assessed via 12 questions, a participant is considered at risk if answering 'Yes' to Q1 and 'Yes' to 5 or more of Q2 to Q12.	Month 15	No
Secondary	Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 1	The MMIDI is a semi-structured interview designed to assess impulse control disorders; compulsive sexual behaviour is assessed via 4 questions, a participant is considered as being compulsive if answering 'Yes' to Q1 and 'Yes' to 1 or more of Q2 to Q4.	Month 1	No
Secondary	Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 6	The MMIDI is a semi-structured interview designed to assess impulse control disorders; compulsive sexual behaviour is assessed via 4 questions, a participant is considered as being compulsive if answering 'Yes' to Q1 and 'Yes' to 1 or more of Q2 to Q4.	Month 6	No
Secondary	Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 9	The MMIDI is a semi-structured interview designed to assess impulse control disorders; compulsive sexual behaviour is assessed via 4 questions, a participant is considered as being compulsive if answering 'Yes' to Q1 and 'Yes' to 1 or more of Q2 to Q4.	Month 9	No
Secondary	Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 12	The MMIDI is a semi-structured interview designed to assess impulse control disorders; compulsive sexual behaviour is assessed via 4 questions, a participant is considered as being compulsive if answering 'Yes' to Q1 and 'Yes' to 1 or more of Q2 to Q4.	Month 12	No
Secondary	Modified Minnesota Disorders Interview (MMIDI) for Compulsive Sexual Behaviour at Month 15	The MMIDI is a semi-structured interview designed to assess impulse control disorders; compulsive sexual behaviour is assessed via 4 questions, a participant is considered as being compulsive if answering 'Yes' to Q1 and 'Yes' to 1 or more of Q2 to Q4.	Month 15	No
Secondary	Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 1	The MMIDI is a semi-structured interview designed to assess impulse control disorders; compulsive buying is assessed via 4 questions, a participant is considered as being compulsive if answering 'Yes' to Q1a and 'Yes' to 1 or more of Q2a, Q3a and Q4a.	Month 1	No
Secondary	Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 6	The MMIDI is a semi-structured interview designed to assess impulse control disorders; compulsive buying is assessed via 4 questions, a participant is considered as being compulsive if answering 'Yes' to Q1a and 'Yes' to 1 or more of Q2a, Q3a and Q4a.	Month 6	No
Secondary	Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 9	The MMIDI is a semi-structured interview designed to assess impulse control disorders; compulsive buying is assessed via 4 questions, a participant is considered as being compulsive if answering 'Yes' to Q1a and 'Yes' to 1 or more of Q2a, Q3a and Q4a.	Month 9	No
Secondary	Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 12	The MMIDI is a semi-structured interview designed to assess impulse control disorders; compulsive buying is assessed via 4 questions, a participant is considered as being compulsive if answering 'Yes' to Q1a and 'Yes' to 1 or more of Q2a, Q3a and Q4a.	Month 12	No
Secondary	Modified Minnesota Disorders Interview (MMIDI) for Compulsive Buying at Month 15	The MMIDI is a semi-structured interview designed to assess impulse control disorders; compulsive buying is assessed via 4 questions, a participant is considered as being compulsive if answering 'Yes' to Q1a and 'Yes' to 1 or more of Q2a, Q3a and Q4a.	Month 15	No
Secondary	Percentage Change From Baseline in the Striatum Uptake at Month 15	The striatum beta-carbomethoxy-iodophenyl-tropane (beta-CIT) uptake was calculated as mean of the left and right caudate and putamen regions; measured by the Single-Photon Emission Computed Tomography (SPECT).	Baseline and Month 15	No
Secondary	Clinically Significant Abnormalities in Clinical Laboratory Measurements - Haematology and Electrolytes		Baseline and Month 15	No
Secondary	Clinically Significant Abnormalities in Clinical Laboratory Measurements - Enzymes		Baseline and Month 15	No
Secondary	Clinically Significant Abnormalities in Clinical Laboratory Measurements - Substrates		Baseline and Month 15	No
Secondary	Clinically Significant Abnormalities in Vital Signs		Baseline and Month 15	No

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