Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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3 February 2014 |
Main ID: |
EUCTR2011-002073-30-DE |
Date of registration:
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20/09/2011 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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Evaluation of the Efficacy and Safety of AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias
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Scientific title:
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12-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 |
Date of first enrolment:
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Target sample size:
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63 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-002073-30 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
Number of treatment arms in the trial: 2
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Phase:
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Countries of recruitment
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Canada
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France
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Germany
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Hungary
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Italy
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Spain
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United States
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Contacts
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Name:
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Medical Competence Center
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Address:
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Roonstrasse 25
90429
Nuernberg
Germany |
Telephone:
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+49180223 23 00 |
Email:
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infoservice.novartis@novartis.com |
Affiliation:
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Novartis Pharma GmbH |
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Name:
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Medical Competence Center
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Address:
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Roonstrasse 25
90429
Nuernberg
Germany |
Telephone:
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+49180223 23 00 |
Email:
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infoservice.novartis@novartis.com |
Affiliation:
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Novartis Pharma GmbH |
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Key inclusion & exclusion criteria
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Inclusion criteria: • Outpatients with Parkinson's disease (PD), treated with L-Dopa, experiencing dyskinesias for at least three months
• Outpatients who are on a stable anti-parkinsonian treatment regimen for at least four weeks
Other protocol-defined inclusion criteria may apply
Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 30 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 33
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) or evidence of dementia that may interfere with the study outcome evaluations
Other protocol-defined exclusion criteria may apply
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
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L-dopa induced dyskinesias in patients with Parkinson’s disease MedDRA version: 14.1
Level: HLT
Classification code 10013929
Term: Dyskinesias and movement disorders NEC
System Organ Class: 10029205 - Nervous system disorders
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Intervention(s)
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Product Name: AFQ056 Product Code: AFQ056 Pharmaceutical Form: Capsule, hard CAS Number: 543906-09-8 Current Sponsor code: AFQ056 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use
Product Name: AFQ056 Product Code: AFQ056 Pharmaceutical Form: Capsule, hard CAS Number: 543906-09-8 Current Sponsor code: AFQ056 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 25- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use
Product Name: AFQ056 Product Code: AFQ056 Pharmaceutical Form: Capsule, hard CAS Number: 543906-09-8 Current Sponsor code: AFQ056 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use
Product Name: AFQ056 Product Code: AFQ056 Pharmaceutical Form: Capsule, hard CAS Number: 543906-09-8 Current Sponsor code: AFQ056 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 75- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use
Product Name: AFQ056 Product Code: AFQ056 Pharmaceutical Form: Capsule, hard CAS Number: 543906-09-8 Current Sponsor code: AFQ056 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use
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Primary Outcome(s)
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Primary end point(s): - Anti-dyskinetic efficacy as measured by the modified AIMS (Abnormal Involuntary Movement Scale) total score
- To assess how titration of AFQ056 at 2-week intervals affects tolerability profile
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Main Objective: To assess how titration of AFQ056 at 2-week intervals affects the tolerability profile
To demonstrate the anti-dyskinetic efficacy, as measured by the modified AIMS (Abnormal Involuntary Movement Scale) total score
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Secondary Objective: - To assess the anti-dyskinetic efficacy as measured by the Revised Lang-Fahn Activities of Daily Living Dyskinesia Scale (LFADLDS)
- To evaluate change from baseline on patient’s disability caused by the dyskinesia as assessed by a clinician-rated global impression of change (CGIC)
- To evaluate the Total ON- and OFF-times and ON-time with dyskinesia and with troublesome dyskinesias (patient diary)
- To evaluate anti-dyskinetic efficacy as measured by items 32, 33 and 34 of Part IV of the UPDRS (Unified Parkinson’s Disease Rating Scale)
- To evaluate the safety of AFQ056 as measured by changes in vital signs, laboratory values and ECGs and number of adverse events
Other secondary objectives may be defined in the protocol
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Timepoint(s) of evaluation of this end point: Timeframe 12 weeks
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Secondary Outcome(s)
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Timepoint(s) of evaluation of this end point: - LFADLDS: Weeks -2, 0, 6, 8, 12
- CGIC: Weeks 6, 8, 12
- patient diary: Weeks -2, 0, 8, 12
- UPDRS Part IV:Weeks -6 to -3, -2, 0, 8, 12
- Vital signs: Weeks -6 to -3, -2, 0, 2, 4, 6, 8, 12
- laboratory values: Weeks -6 to -3, -2, 6, 8, 12
- electrocardiogram: Weeks -6 to -3, -2, 6, 8, 12
- Adverse Events: all visits
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Secondary end point(s): - Anti-dyskinetic efficacy as measured by the Lang-Fahn Activities of Daily Living Dyskinesia Scale (LFADLDS)
- Change from baseline on patient’s disability caused by the dyskinesia as assessed by a clinician-rated global impression of change (CGIC)
- Total ON- and OFF-times and ON-time with dyskinesia and with troublesome dyskinesias (patient diary)
- Anti-dyskinetic efficacy as measured by items 32, 33 and 34 of Part IV of the Unified Parkinson’s Disease Rating Scale (UPDRS )
- Safety of AFQ056 as measured by changes in vital signs, laboratory values, electrocardiogram and number of Adverse Events
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Secondary ID(s)
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2011-002073-30-ES
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CAFQ056A2222
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NCT01385592
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Source(s) of Monetary Support
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Novartis Pharma Services AG
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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