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

Phase 2

Completed

• Conditions: Dyskinesia, Drug-Induced; Levodopa; Parkinson Disease
• Interventions: Drug: AFQ056

• Registration Number: NCT01173731
• Lead Sponsor: Novartis Pharmaceuticals

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-07-28
• Study First Submitted QC: 2010-07-29
• Study First Posted: 2010-08-02
• Study Start: 2010-10
• Primary Completion: 2013-10
• Study Completion: 2013-10
• Status Verified: 2017-03
• Disposition First Submitted: 2020-08-20
• Disposition First Submitted QC: 2020-08-20
• Disposition First Posted: 2020-08-26
• Last Update Submitted: 2020-12-15
• Last Update Posted: 2020-12-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
AFQ056	AFQ056	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
Assessment of dyskinetic symptoms by change from baseline in mAIMS total score	3.5 years

Trial Locations

Locations (1)

Novartis Investigative Site; 🇮🇹 Napoli, Italy