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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01173731




Registration number
NCT01173731
Ethics application status
Date submitted
28/07/2010
Date registered
2/08/2010
Date last updated
23/12/2020

Titles & IDs
Public title
Open Label, Safety, Tolerability and Efficacy of AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias
Scientific title
An Open-label Treatment Study to Evaluate the Safety, Tolerability and Efficacy of AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias
Secondary ID [1] 0 0
2010-019418-25
Secondary ID [2] 0 0
CAFQ056A2217
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parkinson Disease 0 0
Dyskinesia, Drug-Induced 0 0
Levodopa 0 0
Condition category
Condition code
Neurological 0 0 0 0
Parkinson's disease
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - AFQ056

Experimental: AFQ056 -


Treatment: Drugs: AFQ056
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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).
Timepoint [1] 0 0
3.5 years
Secondary outcome [1] 0 0
Assessment of dyskinetic symptoms by change from baseline in mAIMS total score
Timepoint [1] 0 0
3.5 years
Secondary outcome [2] 0 0
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
Timepoint [2] 0 0
3.5 years

Eligibility
Key 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.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/10/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2013
Sample size
Target
Accrual to date
Final
66
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Novartis Investigative Site - Heidelberg
Recruitment hospital [2] 0 0
Novartis Investigative Site - Parkville
Recruitment hospital [3] 0 0
Novartis Investigative Site - Prahran
Recruitment postcode(s) [1] 0 0
3081 - Heidelberg
Recruitment postcode(s) [2] 0 0
3050 - Parkville
Recruitment postcode(s) [3] 0 0
3181 - Prahran
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Indiana
Country [4] 0 0
Canada
State/province [4] 0 0
Ontario
Country [5] 0 0
Canada
State/province [5] 0 0
Quebec
Country [6] 0 0
France
State/province [6] 0 0
Clermont-Ferrand Cedex 1
Country [7] 0 0
France
State/province [7] 0 0
Lille Cedex
Country [8] 0 0
France
State/province [8] 0 0
Pessac
Country [9] 0 0
Germany
State/province [9] 0 0
Bochum
Country [10] 0 0
Germany
State/province [10] 0 0
Dresden
Country [11] 0 0
Germany
State/province [11] 0 0
Kassel
Country [12] 0 0
Germany
State/province [12] 0 0
Marburg
Country [13] 0 0
Germany
State/province [13] 0 0
Muenchen
Country [14] 0 0
Germany
State/province [14] 0 0
Stadtroda
Country [15] 0 0
Germany
State/province [15] 0 0
Tuebingen
Country [16] 0 0
Italy
State/province [16] 0 0
LU
Country [17] 0 0
Italy
State/province [17] 0 0
RM
Country [18] 0 0
Italy
State/province [18] 0 0
Napoli

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
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).
Trial website
https://clinicaltrials.gov/ct2/show/NCT01173731
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Novartis Pharmaceuticals
Address 0 0
Novartis Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01173731