Open-label, Long-term Safety Extension Study of AFQ056 in Parkinson's Patients With L-dopa Induced Dyskinesias

• Register: EUCTR
• Last refreshed on: 26 November 2013
• Main ID: EUCTR2011-004378-27-HU
• Date of registration: 15/02/2012
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharma Services AG
• Public title: Open-label, Long-term Safety Extension Study 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
• Date of first enrolment: 28/03/2012
• Target sample size: 65
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-004378-27
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no Number of treatment arms in the trial: 1

Countries of recruitment

Austria, Canada, France, Germany, Hungary, Italy, Spain, United States

Contacts

• Name: Public Information Desk
• Affiliation: Novartis Hungária Kft.

• Name: Public Information Desk
• Affiliation: Novartis Hungária Kft.

Key inclusion & exclusion criteria

Inclusion criteria:
- Patients who have completed a previous AFQ056A study or are eligible as defined in the core study protocol
- Outpatients
- Patients who have a primary caregiver willing and able to assess the condition of the patient throughout the study in accordance with protocol requirements

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 52
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 56

Exclusion criteria:
-Atypical or secondary form of Parkinson’s disease
-History of surgical treatment for PD including deep brain stimulation
-Advanced, severe, or unstable disease (other than PD)
-History of malignancy
-Evidence of dementia
-Untreated/ineffectively treated mental disorders
-Treatment with certain prohibited medications
-Abnormal lab values or heart abnormalities
-Pregnant or nursing women

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: HLT Classification code 10013929 Term: Dyskinesias and movement disorders NEC System Organ Class: 10029205 - Nervous system disorders

Intervention(s)

Product Name: AFQ056
Product Code: AFQ056
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: mavoglurant
CAS Number: 543906-09-8
Current Sponsor code: AFQ056
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25-

Product Name: AFQ056
Product Code: AFQ056
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: mavoglurant
CAS Number: 543906-09-8
Current Sponsor code: AFQ056
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-

Product Name: AFQ056
Product Code: AFQ056
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: mavoglurant
CAS Number: 543906-09-8
Current Sponsor code: AFQ056
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 75-

Product Name: AFQ056
Product Code: AFQ056
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: mavoglurant
CAS Number: 543906-09-8
Current Sponsor code: AFQ056
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-

Primary Outcome(s)

Primary end point(s): a)Incidence rate of adverse events including serious adverse events
b)Severity of adverse events including serious adverse events
c)Change in vital signs
d)Changes in hematology/blood chemistry and urinalysis laboratory evaluations
e)Change in ECGs
f)Change in Unified Parkinson’s Disease Rating Scale (UPDRS) part III scores
g)Incidence of AEs related to an exacerbation of the underlying movement disorder Parkinson’s disease

Main Objective: To evaluate the long-term safety and tolerability of AFQ056 in patients with PD-LID as assessed by
•Incidence and severity of adverse events and serious adverse events
•Changes in vital signs, laboratory assessments, and ECGs
•Changes in underlying symptoms of PD as measured by the UPDRS (Unified Parkinson’s Disease Rating Scale) part III (Motor Examination) and AEs potentially related to an exacerbation of the movement disorder of PD

Secondary Objective: To evaluate the anti-dyskinetic efficacy of AFQ056 treatment in patients with PD-LID on dyskinesia as assessed by
•mAIMS (modified Abnormal Involuntary Movement Scale) total score
•the Revised Lang-Fahn Activities of Daily Living Dyskinesia Scale (LFADLDS) patient and caregiver versions
•items 32, 33 and 34 of Part IV of the UPDRS

Timepoint(s) of evaluation of this end point: a) and b)Monitored for the duration of the study (anticipated to be an average of 3 years)
c)Assessed at Day -14 to -3, Day 1, Weeks 1, 2, 4, 8, 12, Months 6, 9, 12, every 6 months thereafter. If a patient discontinues in between these visits, this will be assessed at the time of discontinuation.
d) and e)Assessed at Day -14 to -3, Day 1,Weeks 4, 8, 12, Months 6, 9, 12, every 6 months thereafter. If a patient discontinues in between these visits, these will be assessed at the time of discontinuation.
f)Assessed at Day 1, Weeks 4, 8, 12, Months 6, 9, 12, every 6 months thereafter. If a patient discontinues in between these visits, this will be assessed at the time of discontinuation.
g)Monitored for the duration of the study (anticipated to be an average of 3 years)

Secondary Outcome(s)

Secondary end point(s): a)Change in mAIMS (modified Abnormal Involuntary Movement Scale) total score
b)Change in Revised Lang-Fahn Activities of Daily Living Dyskinesia Scale (LFADLDS) scores (patient and caregiver versions)
c)Change in score for items 32, 33, and 34 of Part IV of the UPDRS
d)Change in Mini Mental State Exam (MMSE) score
e)Change in the Scales for outcomes in Parkinson’s disease – Psychiatric Complications (SCOPA-PC) score
f)Proportion of patients who have suicidal ideation and behavior as mapped to Columbia Classification Algorithm for Suicide assessment (C-CASA) using data from Columbia-Suicide Severity Rating Scale (C-SSRS)

Timepoint(s) of evaluation of this end point: a)Assessed at Day 1, Weeks 1, 2, 4, 8, 12, Months 6, 9, 12, every 6 months thereafter.
b)Assessed at Day 1, Weeks 4, 12, Months 6, 9, 12, every 6 months thereafter.
c) and e)Assessed at Day 1, Weeks 4, 8, 12, Months 6, 9, 12, every 6 months thereafter.
d)Assessed at Day -14 to -3, Day 1 (only if not done in the respective core study), Months 6, 12, every 6 months thereafter.
a), b), c), d) and e) If a patient discontinues in between these visits, this will be assessed at the time of discontinuation.
f)monitored for the duration of the study (anticipated to be an average of 3 years)

Secondary ID(s)

NCT01491932

CAFQ056A2299

2011-004378-27-ES

Source(s) of Monetary Support

Novartis Pharma Services AG