Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00986414




Registration number
NCT00986414
Ethics application status
Date submitted
29/09/2009
Date registered
30/09/2009
Date last updated
23/02/2017

Titles & IDs
Public title
Evaluation of the Efficacy and Safety of AFQ056 in Reducing Moderate to Severe L-dopa Induced Dyskinesias in Patients With Parkinson's Disease
Scientific title
13-week, Double-blind, Placebo-controlled, Fixed-dose, Multicenter Study to Evaluate the Efficacy and Safety of AFQ056 in Reducing Moderate to Severe L-dopa Induced Dyskinesias in Patients With Parkinson's Disease
Secondary ID [1] 0 0
EUDRACT number 2008-008712-98
Secondary ID [2] 0 0
CAFQ056A2208
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parkinson Disease 0 0
Dyskinesias 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
Experimental: AFQ056-10mg -

Experimental: AFQ056-25mg -

Experimental: AFQ056-50mg -

Experimental: AFQ056-75mg -

Experimental: AFQ056-100mg -

Placebo comparator: Placebo -

Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change from baseline to endpoint in the modified AIMS (Abnormal Involuntary Movement Scale) total score
Timepoint [1] 0 0
12 weeks
Secondary outcome [1] 0 0
Disability due to dyskinesias as measured by change from baseline to endpoint in the PDYS-26 (26-Item Parkinson Disease Dyskinesia Scale) total score
Timepoint [1] 0 0
12 weeks
Secondary outcome [2] 0 0
Change from baseline on patient's dyskinesia, disability caused by the dyskinesia and the underlying symptoms of PD as assessed by a clinician-rated (CGIC) and a patient-rated (PGIC) global impression of change
Timepoint [2] 0 0
12 weeks
Secondary outcome [3] 0 0
Anti-dyskinetic efficacy as measured by items 32 and 33 of Part IV of the UPDRS (Unified Parkinson's Disease Rating Scale)
Timepoint [3] 0 0
12 weeks
Secondary outcome [4] 0 0
Worsening of underlying symptoms of PD as measured by: UPDRS Part III; patient diary (dyskinesias); patient/clinician assessments of change in PD symptoms; AEs related to worsening of PD
Timepoint [4] 0 0
12 weeks

Eligibility
Key inclusion criteria
* Outpatients with Parkinson's disease (PD), treated with L-Dopa, experiencing dyskinesias for at least three months
Minimum age
30 Years
Maximum age
80 Years
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
Randomised controlled trial
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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
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
1/09/2009
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
260
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Novartis Investigative Site - East Gosford
Recruitment hospital [2] 0 0
Novartis Investigative Site - Heidelberg
Recruitment hospital [3] 0 0
Novartis Investigative Site - Melbourne
Recruitment hospital [4] 0 0
Novartis Investigative Site - Parkville
Recruitment hospital [5] 0 0
Novartis Investigational Site - Westmead
Recruitment postcode(s) [1] 0 0
2250 - East Gosford
Recruitment postcode(s) [2] 0 0
- Heidelberg
Recruitment postcode(s) [3] 0 0
3050 - Melbourne
Recruitment postcode(s) [4] 0 0
3181 - Parkville
Recruitment postcode(s) [5] 0 0
NSW 2145 - Westmead
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
Gatineau
Country [2] 0 0
Canada
State/province [2] 0 0
Greenfield Park
Country [3] 0 0
Canada
State/province [3] 0 0
Montreal
Country [4] 0 0
Canada
State/province [4] 0 0
Ottawa
Country [5] 0 0
Canada
State/province [5] 0 0
Quebec
Country [6] 0 0
Canada
State/province [6] 0 0
Toronto
Country [7] 0 0
Canada
State/province [7] 0 0
Vancouver
Country [8] 0 0
Finland
State/province [8] 0 0
Kuopio
Country [9] 0 0
Finland
State/province [9] 0 0
Lahti
Country [10] 0 0
Finland
State/province [10] 0 0
Oulu
Country [11] 0 0
Finland
State/province [11] 0 0
Tampere
Country [12] 0 0
Finland
State/province [12] 0 0
Turku
Country [13] 0 0
France
State/province [13] 0 0
Clermont Ferrand Cedex
Country [14] 0 0
France
State/province [14] 0 0
Lille Cedex
Country [15] 0 0
France
State/province [15] 0 0
Pessac
Country [16] 0 0
France
State/province [16] 0 0
St. Herblain
Country [17] 0 0
France
State/province [17] 0 0
Toulouse
Country [18] 0 0
Germany
State/province [18] 0 0
Beelitz-Heilstaetten
Country [19] 0 0
Germany
State/province [19] 0 0
Berlin
Country [20] 0 0
Germany
State/province [20] 0 0
Bochum
Country [21] 0 0
Germany
State/province [21] 0 0
Dresden
Country [22] 0 0
Germany
State/province [22] 0 0
Kassel
Country [23] 0 0
Germany
State/province [23] 0 0
Marburg
Country [24] 0 0
Germany
State/province [24] 0 0
Muenchen
Country [25] 0 0
Germany
State/province [25] 0 0
Stadtroda
Country [26] 0 0
Germany
State/province [26] 0 0
Tuebingen
Country [27] 0 0
Italy
State/province [27] 0 0
Lido di Camaiore
Country [28] 0 0
Italy
State/province [28] 0 0
Napoli
Country [29] 0 0
Italy
State/province [29] 0 0
Roma
Country [30] 0 0
Japan
State/province [30] 0 0
Fukuoka
Country [31] 0 0
Japan
State/province [31] 0 0
Tochigi
Country [32] 0 0
Japan
State/province [32] 0 0
Tokyo
Country [33] 0 0
Japan
State/province [33] 0 0
Toon
Country [34] 0 0
Japan
State/province [34] 0 0
Wakayama
Country [35] 0 0
Spain
State/province [35] 0 0
Barcelona
Country [36] 0 0
Spain
State/province [36] 0 0
Madrid
Country [37] 0 0
Spain
State/province [37] 0 0
San Sebastian

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

TypeCitations or Other Details
Journal Stocchi F, Rascol O, Destee A, Hattori N, Hauser R... [More Details]

Results not provided in https://clinicaltrials.gov/study/NCT00986414