Evaluation of the Efficacy and Safety of AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias

• Register: EUCTR
• Last refreshed on: 5 November 2012
• Main ID: EUCTR2011-002073-30-IT
• Date of registration: 06/03/2012
• Prospective Registration: No
• Primary sponsor: NOVARTIS FARMA
• Public title: Evaluation of the Efficacy and Safety of AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias
• Scientific title: 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: 14/11/2011
• Target sample size: 63
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-002073-30
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: yes 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

Countries of recruitment

Canada, European Union, Germany, Italy, Spain, Switzerland, United States

Contacts

• Name: Drug Regulatory Affairs
• Affiliation: Novartis Farma

• Name: Drug Regulatory Affairs
• Affiliation: Novartis Farma

Key inclusion & exclusion criteria

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

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

L-dopa induced dyskinesias in patients with Parkinson's disease
MedDRA version: 14.1 Level: PT Classification code 10043118 Term: Tardive dyskinesia System Organ Class: 10029205 - Nervous system disorders

Intervention(s)

Product Name: AFQ056
Product Code: AFQ056
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: NA
CAS Number: 543906-09-8
Current Sponsor code: AFQ056
Other descriptive name: NA
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
INN or Proposed INN: NA
CAS Number: 543906-09-8
Current Sponsor code: AFQ056
Other descriptive name: NA
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
INN or Proposed INN: NA
CAS Number: 543906-09-8
Current Sponsor code: AFQ056
Other descriptive name: NA
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
INN or Proposed INN: NA
CAS Number: 543906-09-8
Current Sponsor code: AFQ056
Other descriptive name: NA
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
INN or Proposed INN: NA
CAS Number: 543906-09-8
Current Sponsor code: AFQ056
Other descriptive name: NA
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

Primary Outcome(s)

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

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

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

Timepoint(s) of evaluation of this end point: Timeframe 12 weeks

Secondary Outcome(s)

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, 0, 6, 8, 12 - electrocardiogram: Weeks 6 to -3, -2, 6, 8, 12 - Adverse Events: all visits

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

Secondary ID(s)

2011-002073-30-ES

CAFQ056A2222

NCT01385592

Source(s) of Monetary Support

Novartis