Clinical trial NCT01173731: Open Label, Safety, Tolerability and Efficacy of AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Parkinson Disease
Dyskinesia, Drug-Induced
Levodopa
Keywords: Parkinson Disease
L-dopa
Levodopa
Dyskinesia
involuntary movement
motor complication
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2010-08-02
Enrollment: 66
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).


Eligibility criteria: 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

Primary outcomes:
measure: 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).
timeFrame: 3.5 years
Secondary outcomes:
measure: Assessment of dyskinetic symptoms by change from baseline in mAIMS total score
timeFrame: 3.5 years
measure: 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
timeFrame: 3.5 years
Other outcomes:
Locations:
city: Sunnyvale
country: United States
facility: Novartis Investigative Site
state: California
city: Englewood
country: United States
facility: Novartis Investigative Site
state: Colorado
city: Indianapolis
country: United States
facility: Novartis Investigative Site
state: Indiana
city: Heidelberg
country: Australia
facility: Novartis Investigative Site
state: Victoria
city: Parkville
country: Australia
facility: Novartis Investigative Site
state: Victoria
city: Prahran
country: Australia
facility: Novartis Investigative Site
state: Victoria
city: Ottawa
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Gatineau
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Greenfield Park
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Clermont-Ferrand Cedex 1
country: France
facility: Novartis Investigative Site
city: Lille Cedex
country: France
facility: Novartis Investigative Site
city: Pessac
country: France
facility: Novartis Investigative Site
city: Bochum
country: Germany
facility: Novartis Investigative Site
city: Dresden
country: Germany
facility: Novartis Investigative Site
city: Kassel
country: Germany
facility: Novartis Investigative Site
city: Marburg
country: Germany
facility: Novartis Investigative Site
city: Muenchen
country: Germany
facility: Novartis Investigative Site
city: Stadtroda
country: Germany
facility: Novartis Investigative Site
city: Tuebingen
country: Germany
facility: Novartis Investigative Site
city: Lido di Camaiore
country: Italy
facility: Novartis Investigative Site
state: LU
city: Roma
country: Italy
facility: Novartis Investigative Site
state: RM
city: Napoli
country: Italy
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: