ADX48621 for the Treatment of Levodopa Induced Dyskinesia in Patients With Parkinson's Disease

Parkinson's Disease Clinical Trial

Official title:

Phase 2, Randomized, Double-blind, Placebo-controlled, Parallel Group, Multicenter Study to Evaluate the Safety, Tolerability and Efficacy of ADX48621 in the Treatment of Levodopa Induced Dyskinesia in Patients With Parkinson's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01336088
• Other study ID #: ADX48621-201
• Status: Completed
• Phase: Phase 2
• First received: April 4, 2011
• Last updated: July 13, 2012
• Start date: April 2011
• Est. completion date: February 2012

Study information

• Verified date: July 2012
• Source: Addex Pharma S.A.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationAustria: Agency for Health and Food SafetyFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

The primary objective of the study is to evaluate the safety and tolerability of ADX48621 in Parkinson's disease patients following four weeks of dosing.

The secondary objectives of the study include the evaluation of the efficacy of ADX48621 compared with placebo in reducing levodopa induced dyskinesia in patients with Parkinson's; the evaluation of the effect of ADX48621 on symptoms of Parkinson's disease and patient ability to function, and the evaluation of the effect of coadministration of ADX48621 on L-dopa efficacy.

Description:

First study of ADX48621 in male and female Parkinson's disease patients with levodopa-induced dyskinesia. Four weeks, double-blind, placebo-controlled dose titration from 50 mg once daily up to 100 mg three times daily, at the start of week 4. Safety and tolerability assessed by adverse events enquiry, heart rate and blood pressure, 12-lead ECG, haematology and biochemistry. Efficacy assessments include Abnormal Involuntary Movement Scale (AIMS), Unified Parkinson's Disease rating Scale (UPDRS) patient PD symptom diaries, Hospital Anxiety Depression Scale (HADS), patient and clinician global impression of change in PD and dyskinesia (PGIC and CGIC).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: February 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 75 Years

Eligibility

Inclusion Criteria:

• outpatient with idiopathic PD according to the UK Parkinson's Disease Society Brain Bank Clinical Diagnosis Criteria (UKPDSBBCDC)

• experiences moderately disabling dyskinesia (screening visit UPDRS 33 score=2)

• has an mAIMS score at baseline = 7 with a score = 3 in at least one body area

Exclusion Criteria:

• surgical treatment for Parkinson's disease (e.g. Deep Brain Stimulation, within the last year or planned during the study)

• unstable co-existing psychiatric disease including cognitive impairment that, according to the Investigator, could interfere with the conduct of the study

• has a history of a significant medical condition that may affect the safety of the patient or preclude adequate participation in the study.

• is pregnant or breast-feeding. Female patients who are of child-bearing potential must be using adequate contraceptive methods (e.g. oral contraceptive, double-barrier method, intra-uterine device, intra-muscular hormonal contraceptive), and have a negative pregnancy test at Screening

Other protocol-defined inclusion and exclusion criteria may apply

Study Design

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

Related Conditions & MeSH terms

• Dyskinesias
• Parkinson Disease
• Parkinson's Disease

Intervention

Drug:
• ADX48621
oral administration
• Placebo
oral administration

Locations

Country	Name	City	State
Austria	Addex Investigator Site	Innsbruck
France	Addex Investigator Site	Bordeaux
France	Addex Investigator Site	Clermont Ferrand
France	Addex Investigator Site	Nantes
France	Addex Investigator Site	Paris
France	Addex Investigator Site	Toulouse
Germany	Addex Investigator Site	Bochum
Germany	Addex Investigator Site	Hanau
Germany	Addex Investigator Site	Hannover
Germany	Addex Investigator Site	Kassel
Germany	Addex Investigator Site	Marburg
Germany	Addex Investigator Site	Munich
United States	Addex Investigator Site	Birmingham	Alabama
United States	Addex Investigator Site	Boca Raton	Florida
United States	Addex Investigator Site	Chicago	Illinois
United States	Addex Investigator Site	Commack	New York
United States	Addex Investigator Site	Kirkland	Washington
United States	Addex Investigator Site	La Jolla	California
United States	Addex Investigator Site	Los Angeles	California
United States	Addex Investigator Site	New Haven	Connecticut
United States	Addex Investigator Site	Phoenix	Arizona
United States	Addex Investigator Site	Portland	Oregon
United States	Addex Investigator Site	Southfield	Michigan
United States	Addex Investigator Site	Sunnyvale	California
United States	Addex Investigator Site	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Addex Pharma S.A.

Countries where clinical trial is conducted

United States,  Austria,  France,  Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with abnormal safety and tolerability assessment parameters	Physical and neurological examination, heart rate and blood pressure, 12-lead ECG, hematology and biochemistry assessments, use of concomitant medications, adverse events and serious adverse events.	4 weeks	No
Secondary	Dyskinesia severity score measured by mAIMS		4 weeks	No
Secondary	Change in Parkinson's disease severity	Patient diary at weeks 1, 2, 3 and 4, UPDRS Part III at weeks 2 and 4, UPDRS total score at week 4	4 weeks	No
Secondary	Patient-rated and clinician-rated global impression of change in dyskinesia and Parkinson's disease		4 weeks	No