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

Parkinson Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01173731
• Other study ID #: CAFQ056A2217
• Secondary ID: 2010-019418-25
• Status: Completed
• Phase: Phase 2
• Start date: October 2010
• Est. completion date: October 2013

Study information

• Verified date: March 2017
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Dyskinesia, Drug-Induced
• Dyskinesias
• Levodopa
• Parkinson Disease

Intervention

Drug:
• AFQ056

Locations

Country	Name	City	State
Australia	Novartis Investigative Site	Heidelberg	Victoria
Australia	Novartis Investigative Site	Parkville	Victoria
Australia	Novartis Investigative Site	Prahran	Victoria
Canada	Novartis Investigative Site	Gatineau	Quebec
Canada	Novartis Investigative Site	Greenfield Park	Quebec
Canada	Novartis Investigative Site	Ottawa	Ontario
France	Novartis Investigative Site	Clermont-Ferrand Cedex 1
France	Novartis Investigative Site	Lille Cedex
France	Novartis Investigative Site	Pessac
Germany	Novartis Investigative Site	Bochum
Germany	Novartis Investigative Site	Dresden
Germany	Novartis Investigative Site	Kassel
Germany	Novartis Investigative Site	Marburg
Germany	Novartis Investigative Site	Muenchen
Germany	Novartis Investigative Site	Stadtroda
Germany	Novartis Investigative Site	Tuebingen
Italy	Novartis Investigative Site	Lido di Camaiore	LU
Italy	Novartis Investigative Site	Napoli
Italy	Novartis Investigative Site	Roma	RM
United States	Novartis Investigative Site	Englewood	Colorado
United States	Novartis Investigative Site	Indianapolis	Indiana
United States	Novartis Investigative Site	Sunnyvale	California

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

United States,  Australia,  Canada,  France,  Germany,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Assessment of dyskinetic symptoms by change from baseline in mAIMS total score		3.5 years
Secondary	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

External Links

•   Results for CAFQ056A2217 from the Novartis Clinical Trials Website