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
Evaluation of the Efficacy and Safety of AFQ056 in Reducing Moderate to Severe L-dopa Induced Dyskinesias in Patients With Parkinson's Disease
Sponsors
Source
Novartis
Brief Summary
This phase IIb study is designed to determine the safe and efficacious dose or dose range of
AFQ056 for the treatment of patients with moderate to severe Parkinson's disease with L-Dopa
induced dyskinesias.
Overall Status
Completed
Start Date
2009-09-01
Completion Date
N/A
Primary Completion Date
2010-12-01
Phase
Phase 2
Study Type
Interventional
Primary Outcome
Measure |
Time Frame |
|
Change from baseline to endpoint in the modified AIMS (Abnormal Involuntary Movement Scale) total score |
12 weeks |
Secondary Outcome
Measure |
Time Frame |
|
Disability due to dyskinesias as measured by change from baseline to endpoint in the PDYS-26 (26-Item Parkinson Disease Dyskinesia Scale) total score |
12 weeks |
|
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 |
12 weeks |
|
Anti-dyskinetic efficacy as measured by items 32 and 33 of Part IV of the UPDRS (Unified Parkinson's Disease Rating Scale) |
12 weeks |
|
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 |
12 weeks |
Enrollment
260
Conditions
Intervention
Eligibility
Criteria
Inclusion Criteria:
- Outpatients with Parkinson's disease (PD), treated with L-Dopa, experiencing
dyskinesias for at least three months
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
Gender
All
Minimum Age
30 Years
Maximum Age
80 Years
Healthy Volunteers
No
Overall Official
Last Name |
Role |
Affiliation |
|
Novartis Pharmaceuticals |
Study Director |
Novartis Pharmaceuticals |
Location
Facility |
|
Novartis Investigative Site East Gosford 2250 Australia |
|
Novartis Investigative Site Heidelberg Australia |
|
Novartis Investigative Site Melbourne 3050 Australia |
|
Novartis Investigative Site Parkville 3181 Australia |
|
Novartis Investigational Site Westmead NSW 2145 Australia |
|
Clinique Neuro-Outaouais Gatineau J9J 0A5 Canada |
|
Recherches Pembina, Inc Greenfield Park J4V 2J2 Canada |
|
Novartis Investigative Site Montreal H2L 4M1 Canada |
|
Parkinson's and Neurodegenerative Disorders Clinic Ottawa K1G 4G3 Canada |
|
Quebec Memory & Motor Skills Disorders Clinic Quebec G1R 3X5 Canada |
|
Toronto Western Hospital, UHN Toronto M5T 2S8 Canada |
|
Novartis Investigative Site Vancouver V6T 2B5 Canada |
|
Novartis Investigative Site Kuopio Finland |
|
Novartis Investigative Site Lahti 15110 Finland |
|
Novartis Investigative Site Oulu 90220 Finland |
|
Novartis Investigative Site Tampere 33520 Finland |
|
Novartis Investigative Site Turku 20520 Finland |
|
Novartis Investigative Site Clermont Ferrand Cedex 63003 France |
|
Novartis Investigative Site Lille Cedex 59037 France |
|
Novartis Investigative Site Pessac 33604 France |
|
Novartis Investigative Site St. Herblain 44800 France |
|
Novartis Investigative Site Toulouse 31059 France |
|
Novartis Investigative Site Beelitz-Heilstaetten 14547 Germany |
|
Novartis Investigative Site Berlin 13088 Germany |
|
Novartis Investigative Site Bochum Germany |
|
Novartis Investigative Site Dresden 01307 Germany |
|
Novartis Investigative Site Kassel 34128 Germany |
|
Novartis Investigative Site Marburg 35039 Germany |
|
Novartis Investigative Site Muenchen 80804 Germany |
|
Novartis Investigative Site Stadtroda 07646 Germany |
|
Novartis Investigative Site Tuebingen 72076 Germany |
|
Novartis Investigative Site Lido di Camaiore 55041 Italy |
|
Novartis Investigative Site Napoli 80131 Italy |
|
Novartis Investigative Site Roma 00163 Italy |
|
Novartis Investigative Site Roma 00185 Italy |
|
Novartis Investigative Site Fukuoka 814-0180 Japan |
|
Novartis Investigative Site Tochigi 329-0498 Japan |
|
Novartis Investigative Site Tokyo 113-8431 Japan |
|
Novartis Investigative Site Tokyo 136-0075 Japan |
|
Novartis Investigative SIte Tokyo 187-8551 Japan |
|
Novartis Investigative Site Toon 791-0295 Japan |
|
Novartis Investigative Site Wakayama 641-8510 Japan |
|
Novartis Investigative Site Barcelona 08036 Spain |
|
Novartis Investigative Site Barcelona 08190 Spain |
|
Novartis Investigative Site Barcelona Spain |
|
Novartis Investigative Site Madrid 28034 Spain |
|
Novartis Investigative Site San Sebastian Spain |
Location Countries
Country
Australia
Canada
Finland
France
Germany
Italy
Japan
Spain
Verification Date
2017-02-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Responsible Party
Responsible Party Type
Sponsor
Keywords
Has Expanded Access
No
Condition Browse
Secondary Id
EUDRACT number 2008-008712-98
Number Of Arms
6
Intervention Browse
Mesh Term
Levodopa
Arm Group
Arm Group Label
AFQ056-10mg
Arm Group Type
Experimental
Arm Group Label
AFQ056-25mg
Arm Group Type
Experimental
Arm Group Label
AFQ056-50mg
Arm Group Type
Experimental
Arm Group Label
AFQ056-75mg
Arm Group Type
Experimental
Arm Group Label
AFQ056-100mg
Arm Group Type
Experimental
Arm Group Label
Placebo
Arm Group Type
Placebo Comparator
Results Reference
Citation
Stocchi F, Rascol O, Destee A, Hattori N, Hauser RA, Lang AE, Poewe W, Stacy M, Tolosa E, Gao H, Nagel J, Merschhemke M, Graf A, Kenney C, Trenkwalder C. AFQ056 in Parkinson patients with levodopa-induced dyskinesia: 13-week, randomized, dose-finding study. Mov Disord. 2013 Nov;28(13):1838-46. doi: 10.1002/mds.25561. Epub 2013 Jul 12.
PMID
23853029
Firstreceived Results Date
N/A
Firstreceived Results Disposition Date
N/A
Study Design Info
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Study First Submitted
September 29, 2009
Study First Submitted Qc
September 29, 2009
Study First Posted
September 30, 2009
Last Update Submitted
February 20, 2017
Last Update Submitted Qc
February 20, 2017
Last Update Posted
February 23, 2017
ClinicalTrials.gov processed this data on December 05, 2019
Conditions
Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov,
conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.