Evaluation of the Efficacy and Safety of AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT01385592

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

2.8

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study will assess the efficacy and safety of AFQ056 in patients that have Parkinson's Disease L-dopa Induced Dyskinesias (PD-LID)

Condition or Disease	Intervention/Treatment	Phase
Dyskinesias Parkinson Disease Movement Disorders Parkinsonian Disorders	Drug: AFQ056 Drug: Placebo	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

78 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

12-week, Double-blind, Placebo-controlled, Fixed-dose, Multicenter Study to Evaluate the Efficacy and Safety of AFQ056 in Reducing Moderate to Severe L-dopa Induced Dyskinesias in Patients With Parkinson's Disease

Study Start Date :

Nov 1, 2011

Actual Primary Completion Date :

Sep 1, 2012

Actual Study Completion Date :

Sep 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: AFQ056 100 mg	Drug: AFQ056
Placebo Comparator: Placebo	Drug: Placebo

Arm

Intervention/Treatment

Experimental: AFQ056 100 mg

Drug: AFQ056

Placebo Comparator: Placebo

Drug: Placebo

Outcome Measures

Primary Outcome Measures

Anti-dyskinetic efficacy as measured by the modified AIMS (Abnormal Involuntary Movement Scale) total score. To assess how titration of AFQ056 at 2-week intervals affects tolerability profile [12 weeks]

Secondary Outcome Measures

Anti-dyskinetic efficacy as measured by the Lang-Fahn Activities of Daily Living Dyskinesia Scale (LFADLDS) [12 weeks]
Change from baseline on patient's disability caused by the dyskinesia as assessed by a clinician-rated global impression of change (CGIC) [12 weeks]
Total ON- and OFF-times and ON-time with dyskinesia and with troublesome dyskinesias (patient diary) [12 weeks]
Anti-dyskinetic efficacy as measured by items 32, 33 and 34 of Part IV of the Unified Parkinson's Disease Rating Scale (UPDRS ) [12 weeks]
Safety of AFQ056 as measured by changes in vital signs, laboratory values, electrocardiogram and number of Adverse Events [12 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Outpatients with Parkinson's disease (PD), treated with L-Dopa, experiencing dyskinesias for at least three months
Outpatients who are on a stable anti-parkinsonian treatment regimen for at least four weeks

Exclusion Criteria:

Surgical treatment for PD
Cancer within the past 5 years (other than localized skin cancer and prostate cancer that has been effectively treated)
Advanced, severe or unstable disease (other than PD) or evidence of dementia that may interfere with the study outcome evaluations

Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Novartis Investigative Site	Sunnyvale	California	United States	94089
2	Novartis Investigative Site	Englewood	Colorado	United States	80113
3	Novartis Investigative Site	London	Ontario	Canada	N6A 4G5
4	Novartis Investigative Site	Gatineau	Quebec	Canada	J9J 0A5
5	Novartis Investigative Site	Clermont-Ferrand Cedex 1		France	63003
6	Novartis Investigative Site	Lille Cedex		France	59037
7	Novartis Investigative Site	Pessac		France	33604
8	Novartis Investigative Site	Poitiers		France	86021
9	Novartis Investigative Site	Beelitz-Heilstaetten		Germany	14547
10	Novartis Investigative Site	Berlin		Germany	12163
11	Novartis Investigative Site	Bochum		Germany	44791
12	Novartis Investigative Site	Duesseldorf		Germany	40225
13	Novartis Investigative Site	Kassel		Germany	34128
14	Novartis Investigative Site	Leipzig		Germany	04103
15	Novartis Investigative Site	Muenchen		Germany	80804
16	Novartis Investigative Site	München		Germany	81675
17	Novartis Investigative Site	Stadtroda		Germany	07646
18	Novartis Investigative Site	Westerstede/Oldenburg		Germany	26655
19	Novartis Investigative Site	Budapest		Hungary	1085
20	Novartis Investigative Site	Kaposvár		Hungary	7400
21	Novartis Investigative Site	Szeged		Hungary	H-6725
22	Novartis Investigative Site	Bolzano	BZ	Italy	39100
23	Novartis Investigative Site	Pisa	PI	Italy	56126
24	Novartis Investigative Site	Roma	RM	Italy	00163
25	Novartis Investigative Site	Sant Cugat	Barcelona	Spain	08190
26	Novartis Investigative Site	Barcelona	Cataluña	Spain	08036
27	Novartis Investigative Site	Madrid		Spain	28006
28	Novartis Investigative Site	San Sebastian		Spain	20014