Open Label, Safety, Tolerability and Efficacy of AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Completed

CT.gov ID

NCT01173731

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to generate long-term safety, tolerability and efficacy data for AFQ056 in patients who have participated in and completed any AFQ056 phase II study in PD-LID (Parkinson's disease, L-dopa induced dyskinesias).

Condition or Disease	Intervention/Treatment	Phase
Parkinson Disease Dyskinesia, Drug-Induced Levodopa	Drug: AFQ056	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

66 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

An Open-label Treatment Study to Evaluate the Safety, Tolerability and Efficacy of AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias

Study Start Date :

Oct 1, 2010

Actual Primary Completion Date :

Oct 1, 2013

Actual Study Completion Date :

Oct 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: AFQ056	Drug: AFQ056

Arm

Intervention/Treatment

Experimental: AFQ056

Drug: AFQ056

Outcome Measures

Primary Outcome Measures

Incidence and severity of AEs/SAEs, changes in vital signs, lab assessments and ECGs, in cognitive function (MMSE), psychiatric symptoms (SCOPA-PC), and underlying symptoms of PD (UPDRS part III, CGIC, PGIC). [3.5 years]

Secondary Outcome Measures

Assessment of dyskinetic symptoms by change from baseline in mAIMS total score [3.5 years]
Investigator and patient assessment of clinical changes in dyskinetic symptoms and disability due to dyskinesia compared to baseline, as measured by the corresponding CGIC and PGIC items respectively [3.5 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Outpatients with Parkinson's disease (PD), treated with L-Dopa, experiencing dyskinesias who have been eligible for, participated in and completed an AFQ056 phase II core study.

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	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	Indianapolis	Indiana	United States	46202
4	Novartis Investigative Site	Heidelberg	Victoria	Australia	3081
5	Novartis Investigative Site	Parkville	Victoria	Australia	3050
6	Novartis Investigative Site	Prahran	Victoria	Australia	3181
7	Novartis Investigative Site	Ottawa	Ontario	Canada	K1G 4G3
8	Novartis Investigative Site	Gatineau	Quebec	Canada	J9J 0A5
9	Novartis Investigative Site	Greenfield Park	Quebec	Canada	J4V 2J2
10	Novartis Investigative Site	Clermont-Ferrand Cedex 1		France	63003
11	Novartis Investigative Site	Lille Cedex		France	59037
12	Novartis Investigative Site	Pessac		France	33604
13	Novartis Investigative Site	Bochum		Germany	44791
14	Novartis Investigative Site	Dresden		Germany	01307
15	Novartis Investigative Site	Kassel		Germany	34128
16	Novartis Investigative Site	Marburg		Germany	35039
17	Novartis Investigative Site	Muenchen		Germany	80804
18	Novartis Investigative Site	Stadtroda		Germany	07646
19	Novartis Investigative Site	Tuebingen		Germany	72076
20	Novartis Investigative Site	Lido di Camaiore	LU	Italy	55041
21	Novartis Investigative Site	Roma	RM	Italy	00163
22	Novartis Investigative Site	Napoli		Italy	80131