Evaluation of the Efficacy and Safety of AFQ056 in Reducing Moderate to Severe L-dopa Induced Dyskinesias in Patients With Parkinson's Disease

Sponsor

Novartis (Industry)

Overall Status

Completed

CT.gov ID

NCT00986414

Collaborator

(none)

260

Enrollment

Locations

Arms

5.5

Patients Per Site

Study Details

Study Description

Brief Summary

This phase IIb study is designed to determine the safe and efficacious dose or dose range of AFQ056 for the treatment of patients with moderate to severe Parkinson's disease with L-Dopa induced dyskinesias.

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

260 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

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

Primary Purpose:

Treatment

Official Title:

13-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 :

Sep 1, 2009

Actual Primary Completion Date :

Dec 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Experimental: AFQ056-10mg	Drug: AFQ056
Experimental: AFQ056-25mg	Drug: AFQ056
Experimental: AFQ056-50mg	Drug: AFQ056
Experimental: AFQ056-75mg	Drug: AFQ056
Experimental: AFQ056-100mg	Drug: AFQ056
Placebo Comparator: Placebo	Drug: Placebo

Outcome Measures

Primary Outcome Measures

Change from baseline to endpoint in the modified AIMS (Abnormal Involuntary Movement Scale) total score [12 weeks]

Secondary Outcome Measures

Disability due to dyskinesias as measured by change from baseline to endpoint in the PDYS-26 (26-Item Parkinson Disease Dyskinesia Scale) total score [12 weeks]
Change from baseline on patient's dyskinesia, disability caused by the dyskinesia and the underlying symptoms of PD as assessed by a clinician-rated (CGIC) and a patient-rated (PGIC) global impression of change [12 weeks]
Anti-dyskinetic efficacy as measured by items 32 and 33 of Part IV of the UPDRS (Unified Parkinson's Disease Rating Scale) [12 weeks]
Worsening of underlying symptoms of PD as measured by: UPDRS Part III; patient diary (dyskinesias); patient/clinician assessments of change in PD symptoms; AEs related to worsening of PD [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

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) that may interfere with the study outcome evaluations

Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Novartis Investigative Site	East Gosford	Australia	2250
2	Novartis Investigative Site	Heidelberg	Australia
3	Novartis Investigative Site	Melbourne	Australia	3050
4	Novartis Investigative Site	Parkville	Australia	3181
5	Novartis Investigational Site	Westmead	Australia	NSW 2145
6	Clinique Neuro-Outaouais	Gatineau	Canada	J9J 0A5
7	Recherches Pembina, Inc	Greenfield Park	Canada	J4V 2J2
8	Novartis Investigative Site	Montreal	Canada	H2L 4M1
9	Parkinson's and Neurodegenerative Disorders Clinic	Ottawa	Canada	K1G 4G3
10	Quebec Memory & Motor Skills Disorders Clinic	Quebec	Canada	G1R 3X5
11	Toronto Western Hospital, UHN	Toronto	Canada	M5T 2S8
12	Novartis Investigative Site	Vancouver	Canada	V6T 2B5
13	Novartis Investigative Site	Kuopio	Finland
14	Novartis Investigative Site	Lahti	Finland	15110
15	Novartis Investigative Site	Oulu	Finland	90220
16	Novartis Investigative Site	Tampere	Finland	33520
17	Novartis Investigative Site	Turku	Finland	20520
18	Novartis Investigative Site	Clermont Ferrand Cedex	France	63003
19	Novartis Investigative Site	Lille Cedex	France	59037
20	Novartis Investigative Site	Pessac	France	33604
21	Novartis Investigative Site	St. Herblain	France	44800
22	Novartis Investigative Site	Toulouse	France	31059
23	Novartis Investigative Site	Beelitz-Heilstaetten	Germany	14547
24	Novartis Investigative Site	Berlin	Germany	13088
25	Novartis Investigative Site	Bochum	Germany
26	Novartis Investigative Site	Dresden	Germany	01307
27	Novartis Investigative Site	Kassel	Germany	34128
28	Novartis Investigative Site	Marburg	Germany	35039
29	Novartis Investigative Site	Muenchen	Germany	80804
30	Novartis Investigative Site	Stadtroda	Germany	07646
31	Novartis Investigative Site	Tuebingen	Germany	72076
32	Novartis Investigative Site	Lido di Camaiore	Italy	55041
33	Novartis Investigative Site	Napoli	Italy	80131
34	Novartis Investigative Site	Roma	Italy	00163
35	Novartis Investigative Site	Roma	Italy	00185
36	Novartis Investigative Site	Fukuoka	Japan	814-0180
37	Novartis Investigative Site	Tochigi	Japan	329-0498
38	Novartis Investigative Site	Tokyo	Japan	113-8431
39	Novartis Investigative Site	Tokyo	Japan	136-0075
40	Novartis Investigative SIte	Tokyo	Japan	187-8551
41	Novartis Investigative Site	Toon	Japan	791-0295
42	Novartis Investigative Site	Wakayama	Japan	641-8510
43	Novartis Investigative Site	Barcelona	Spain	08036
44	Novartis Investigative Site	Barcelona	Spain	08190
45	Novartis Investigative Site	Barcelona	Spain
46	Novartis Investigative Site	Madrid	Spain	28034
47	Novartis Investigative Site	San Sebastian	Spain