L-dopa induced dyskinesias in Parkinson’s patients with severe motor complications
Conditions
Interventions
Product Name: AFQ056
Product Code: AFQ056
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: AFQ056
CAS Number: -
Current Sponsor code: AFQ056
Other descriptive name: -
Concentration unit: mg mil
Sponsors
Novartis Pharma AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients who are eligible for enrollment in the study will be males and females, aged between 30 and 85 years of age (both inclusive), non-smokers, with idiopathic Parkinson’s disease (diagnosed by UK Parkinson’s disease Society Brain Bank criteria), with an AIMS score of 18 or greater, with L-dopa induced dyskinesia greater than 20% (UPDRS item of 32, rating =1) of moderate to severe (complete disabling) intensity (UPDRS item 33 rating = 2), with dyskinesias for at least 3 months before randomization, and who are on L-dopa treatment for at least 3 years prior to randomization; L-dopa treatment has to be stable for at least 1 month prior to randomization (i.e. the total daily dose and dosing regimen can vary among patients but will be the same for individual patients). Other concomitant anti-parkinsonian medication is allowed but the total daily dose and dosing regimen has to be stable for at least one month prior to randomization. Female patients must be without childbearing potential (post-menopausal or surgically sterilized); for safety reasons they have to use a double-barrier local contraception (e.g., intra-uterine device plus condom) during the entire study from screening up to the study completion visit. Male patients must be using a double-barrier local contraception for the entire duration of the study (from screening up to the study completion visit), and refrain from fathering a child in the 3 months following last study drug administration. Patients must be able to provide written informed consent prior to study participation. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Following patients will be excluded from the study: smokers, with a prior surgery for Parkinson’s Disease, with a Hoehn and Yahr score of 5 when ‘off’, with cognitive impairment (MMSE less than 24), with atypical Parkinson’s disease (Progressive Supranuclear Palsy (PSP), Multi Systemic Atrophy (MSA)), with history or presence of psychosis and/or confusional states, with a history or presence of nephrolithiasis, renal impairment, and/or liver disease, who participated in an anti-dyskinetic clinical study within the 6 months before randomization, who are under deep brain stimulation, who received anti-dyskinetic medication (i.e. antipsychotics, amantadine) within 15 days before randomization and/or neuroleptics during 2 months before randomization, who is unable to perform cognitive assessments (scheduled at screening) as determined by the neurocognitive test guidelines.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): •Abnormal Involuntary Movement Scale (AIMS): screening; baseline (Day -4 and Day -3): in the morning* and once in the afternoon between 12:00 and 18:00**; on Days 1, 4, 8, 12, 16 and 20: at 2 h after the morning dose of the study medication and once in the afternoon between 12:00 and 18:00**; Study completion. * on Days -4 and -3, the morning and afternoon assessment should be performed at the similar day time as the scheduled time points during the multiple dose treatment. ** the time point in the afternoon (being patient specific as depending on the dosing regimen) will be identified on Day -4 based on the occurrence of dyskinesias. On the following days (Day -3 and Day 1 to 20), the assessment should be done at the similar day time as the time point identified on Day -4. For all scheduled AIMS time points a time window ± 1 h is acceptable. The AIMS should be done by the same neurologist for individual patients. •Unified Parkinson Disease Rating Scale (UPDRS – part III): screening; baseline (Day -4 and Day -3): in the morning* and once in the afternoon between 12:00 and 18:00**; on Days 1, 4, 8, 12, 16 and 20: at 2 h after the morning dose of the study medication and once in the afternoon between 12:00 and 18:00**; Study completion * on Days -4 and -3, the morning and afternoon assessment should be performed at the similar day time as the scheduled time points during the multiple dose treatment. ** the time point in the afternoon (being patient specific as depending on the dosing regimen) will be identified on Day -4 based on the occurrence of dyskinesias. On the following days (Day -3 and Day 1 to 20) the assessment should be done at the similar day time as the time point identified on Day -4. For all scheduled UPDRS time points a time window ± 1 h is acceptable. The UPDRS should be done by the same neurologist for individual patients. •Unified Parkinson Disease Rating Scale (UPDRS – part IV): screening; baseline (Day -4 and Day -3): in th | — |
Countries
Germany
Outcome results
None listed