Overnight Switch Trial From Pramipexole IR to Pramipexole ER in Patients With Early Parkinson Disease

Parkinson Disease Clinical Trial

Official title:

A Double-blind, Double-dummy, Randomized, Parallel Groups Study to Assess the Efficacy, Safety and Tolerability of Switching Patients With Early Parkinson's Disease (PD) From Pramipexole IR to Pramipexole ER or Pramipexole IR

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00558025
• Other study ID #: 248.636
• Secondary ID: Eudract 2007-003
• Status: Completed
• Phase: Phase 3
• First received: November 12, 2007
• Last updated: May 7, 2014
• Start date: October 2007

Study information

• Verified date: May 2012
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: AFSSAPS 143/147, bld Anatole France 93285 Saint-Denis Cedex FRANCEGermany: Bundesinstitut fuer Arzneimittel und Medizinprodukte (BfArM), Kurt-Georg-Kiesinger-Allee 3, D-53175Netherlands: Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial Summary

The objectives of this trial conducted in early Parkinson's disease (PD) patients are:

• To assess if patients with early Parkinson's disease (PD) can be successfully switched (overnight switching) from Pramipexole (PPX) Immediate Release (IR) to Pramipexole Extended Release (ER). A successful switch at a specific visit is defined as no worsening of the Unified Parkinsons Disease Rating Scale (UPDRS) parts II+III score by more than 15% from baseline and no drug-related adverse events leading to withdrawal;

• To establish if this successful switch can be obtained with or without dose-adaptation;

• To provide information about the conversion ratio (mg:mg) from Pramipexole IR to Pramipexole ER.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 156
• Est. primary completion date: May 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years and older

Eligibility

Inclusion Criteria:

1. Male or female patient with idiopathic Parkinson's disease (PD) confirmed by at least two of the following signs: resting tremor, bradykinesia, rigidity.

2. Parkinson's disease diagnosed within 5 years.

3. Patients 30 years of age or older at the time of diagnosis.

4. Modified Hoehn and Yahr stage of 1 to 3.

5. Patients receiving pramipexole IR for at least three months prior to baseline visit (randomization visit, V2).

6. Pramipexole dose should be optimized (according investigator¿s judgement), greater or equal to 1.5 mg/day, stable and equally divided 3 times per day, for a least 4 weeks prior to baseline visit (V2).

7. Patients willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.

8. Signed informed consent obtained before any study procedures are carried out in accordance with International Conference on Harmonization - Good Clinical Practice (ICH-GCP) guidelines and local legislation).

Exclusion Criteria:

1. Motor complications under levodopa therapy at V1.

2. Atypical parkinsonian syndromes due to drugs, metabolic disorders, encephalitis or degenerative diseases.

3. Dementia, as defined by a Mini-Mental State Exam score < 24 at V1

4. Any psychiatric disorder according to Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) criteria

5. History of psychosis, except history of drug induced hallucinations

6. Clinically significant electrocardiogram (ECG) abnormalities at V1.

7. Clinically significant hypotension either at screening visit or at baseline visit.

8. Malignant melanoma or history of previously treated malignant melanoma.

9. Any other clinically significant disease

10. Pregnancy or breast-feeding.

11. Sexually active female of childbearing potential

12. Serum levels of Aspartate Aminotransferase (Serum Glutamic Oxaloacetic Transaminase) (AST (SGOT)), Alanine Aminotransferase (Serum Glutamate Pyruvate Transaminase) (ALT (SGPT)), alkaline phosphatases or bilirubin > 2 Upper Limit of Normal (ULN) (on screening lab test).

13. Patients with a creatinine clearance < 50 mL/min

14. Any dopamine agonist (except pramipexole IR) within three months prior to baseline visit.

15. History of discontinuation of treatment with pramipexole IR

16. Previous treatment with pramipexole ER.

17. Any medication (including intra-muscular formulations) with central dopaminergic antagonist activity within 4 weeks prior to the baseline visit (i.e. typical neuroleptics, atypical antipsychotics, reserpine, methyldopa, centrally-active antiemetics, etc).

18. Any of the following drugs within 4 weeks prior to the baseline visit:

methylphenidate, cinnarizine, amphetamines.

19. Flunarizine within 3 months prior to baseline visit.

20. Known hypersensitivity to Pramipexole or its excipients.

21. Drug abuse (including alcohol), according to Investigator¿s judgement, within 2 years prior to screening.

22. Participation in other investigational drug studies or use of other investigational drugs within 4 weeks or five times the half-life of the investigational drug (whichever is longer) prior to baseline visit.

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 Extended Release

• Pramipexole Immediate Release

Locations

Country	Name	City	State
France	248.636.3303A Boehringer Ingelheim Investigational Site	Aix en Provence
France	248.636.3303B Boehringer Ingelheim Investigational Site	Aix en Provence
France	248.636.3303C Boehringer Ingelheim Investigational Site	Aix en Provence
France	248.636.3307C Boehringer Ingelheim Investigational Site	Bron cedex
France	248.636.3309B Boehringer Ingelheim Investigational Site	Clermont Ferrand
France	248.636.3305A Boehringer Ingelheim Investigational Site	Créteil
France	248.636.3305B Boehringer Ingelheim Investigational Site	Créteil
France	248.636.3313A Boehringer Ingelheim Investigational Site	Dijon cedex
France	248.636.3304A Boehringer Ingelheim Investigational Site	Evreux
France	248.636.3308B Boehringer Ingelheim Investigational Site	Lille cedex
France	248.636.3308C Boehringer Ingelheim Investigational Site	Lille cedex
France	248.636.3308D Boehringer Ingelheim Investigational Site	Lille cedex
France	248.636.3308E Boehringer Ingelheim Investigational Site	Lille cedex
France	248.636.3302A Boehringer Ingelheim Investigational Site	Marseille cedex 5
France	248.636.3302B Boehringer Ingelheim Investigational Site	Marseille cedex 5
France	248.636.3306B Boehringer Ingelheim Investigational Site	Montpellier
France	248.636.3312A Boehringer Ingelheim Investigational Site	Rouen
France	248.636.3312B Boehringer Ingelheim Investigational Site	Rouen
France	248.636.3311A Boehringer Ingelheim Investigational Site	Strasbourg
France	248.636.3301A Boehringer Ingelheim Investigational Site	Toulouse cedex
France	248.636.3301B Boehringer Ingelheim Investigational Site	Toulouse cedex
France	248.636.3301D Boehringer Ingelheim Investigational Site	Toulouse cedex
Germany	248.636.49006 Boehringer Ingelheim Investigational Site	Achim bei Bremen
Germany	248.636.49004 Boehringer Ingelheim Investigational Site	Berlin
Germany	248.636.49007 Boehringer Ingelheim Investigational Site	Berlin
Germany	248.636.49008 Boehringer Ingelheim Investigational Site	Berlin
Germany	248.636.49003 Boehringer Ingelheim Investigational Site	Berlin-Steglitz
Germany	248.636.49002 Boehringer Ingelheim Investigational Site	Gera
Germany	248.636.49001 Boehringer Ingelheim Investigational Site	Karlsruhe
Germany	248.636.49005 Boehringer Ingelheim Investigational Site	Unterhaching
Netherlands	248.636.31005 Boehringer Ingelheim Investigational Site	`s-hertogenbosch
Netherlands	248.636.31002 Boehringer Ingelheim Investigational Site	Geldrop
Netherlands	248.636.31003 Boehringer Ingelheim Investigational Site	Helmond
Netherlands	248.636.31006 Boehringer Ingelheim Investigational Site	Maastricht
Netherlands	248.636.31004 Boehringer Ingelheim Investigational Site	Nijmegen
Netherlands	248.636.31001 Boehringer Ingelheim Investigational Site	Sittard

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

France,  Germany,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Patients Who Successfully Switched From Pramipexole Immediate Release (IR) to Pramipexole ER After a Possible Dose Adaptation, Full Analysis Set (FAS), Last Observation Carried Forward (LOCF)	A successful switch was defined by no change of the Unified Parkinson's Disease Rating Scale (UPDRS) II+III by more than 15% from baseline to week 9, UPDRS II+III score ranging from 0 (no impairment) to 160 (worst impairment)	from baseline to week 9	No
Secondary	Percentage of Patients Who Successfully Switched From Pramipexole IR to Pramipexole ER With no Dose Adaptation, FAS (LOCF)	A successful switch was defined by no change of the UPDRS II+III by more than 15% from baseline to week 4, UPDRS II+III score ranging from 0 (no impairment) to 160 (worst impairment).	from baseline to week 4	No
Secondary	Change From Baseline in UPDRS Part II+III Total Score at Week 9, FAS (LOCF)	Unified Parkinson's Disease Rating Scale part II+III total score on FAS, Week 9 - baseline, UPDRS II+III score ranging from 0 (no impairment) to 160 (worst impairment)	Baseline and week 9	No
Secondary	Change From Baseline in UPDRS Part II Total Score at Week 9, FAS (LOCF)	Unified Parkinson's Disease Rating Scale part II total score on FAS, Week 9 - baseline, UPDRS II score ranging from 0 (no impairment) to 52 (worst impairment)	Baseline and week 9	No
Secondary	Change From Baseline in UPDRS Part III Total Score at Week 9, FAS (LOCF)	Unified Parkinson's Disease Rating Scale part III total score on FAS, week 9 - baseline, UPDRS II+III score ranging from 0 (no impairment) to 108 (worst impairment)	Baseline and week 9	No
Secondary	Clinical Global Impression - Improvement (CGI-I), FAS (LOCF)	Clinical Global Impression - Improvement on FAS, CGI-I was rated from 1: very much improved, to 7: very much worse, CGI-I responder are defined as being rated as 'unchanged', 'minimally improved', 'much improved', or 'very much improved', CGI-I non-responder are defined as being rated 'minimally worse', 'much worse' or 'very much worse'	Week 9	No
Secondary	Patient Global Impression - Improvement (PGI-I), FAS (LOCF)	Patient Global Impression - Improvement on FAS, PGI-I was rated from 1: very much better, to 7: very much worse, PGI-I responder are defined as being rated as 'unchanged', 'minimally better', 'much better', or 'very much better', PGI-I non-responder are defined as being rated as 'minimally worse', 'much worse', or 'very much worse'	Week 9	No
Secondary	Pramipexole Dose Adaptation, FAS (LOCF)	Patients with increase in daily Pramipexole dose on FAS	Week 9	No
Secondary	Final Pramipexole Dose (mg) After 9 Weeks, Treated Set	The mean final daily Pramipexole dose is displayed	Week 9	No

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