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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date March 2017
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
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

Study Design


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
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