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Approximately twenty four (24) subjects will participate in this research trial. The research trial will be conducted in approximately twelve (12) medical centers in the following countries: Germany, France, South Africa, Austria and Canada. The research trial will last until December 2011.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| Safinamide | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Evaluable dose levels are 100 mg (8 days), 200 mg (10 days), and 300 mg (42 days). Intermediate dose levels are 150 mg (Study days 9-11) and 250 mg (Study days 23-25) and have a duration of three days. Safinamide and identical Placebo will be provided in tablets equivalent of 50 mg in blisters. Dosing will be achieved using appropriate multiples of these tablet strengths |
| Measure | Description | Time Frame |
|---|---|---|
| The maximum reduction in Unified Dyskinesia Rating Score (UDysRS) compared to baseline across all post-baseline dose visits. | Day 66 |
| Measure | Description | Time Frame |
|---|---|---|
| Complete new Movement Disorder Society - Unified Parkinson Disease Rating Scale (MDS-UPDRS) and subscales | At each individual post-dose visit: Baseline | |
| Complete new Movement Disorder Society - Unified Parkinson Disease Rating Scale (MDS-UPDRS) and subscales |
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Inclusion Criteria:
The subject has given his/her written informed consent to participate in the trial.
The subject presents with a diagnosis of idiopathic Parkinson's disease according to the United Kingdom (UK) Parkinson's Disease Society Brain Bank Clinical Diagnosis Criteria
The subject is an out-patient aged 30 years or above.
PD subjects with a Hoehn and Yahr disease staging of II-IV (in the ON state).
PD subjects experiencing levodopa induced dyskinesias, specifically predictable peak-dose dyskinesia.
Peak-dose dyskinesia must be considered by the subject to be problematic and/or disabling.
Peak-dose dyskinesia must warrant medical treatment in the Investigator's opinion.
The subject has participated successfully in a diary-card training session.
In the judgment of the Investigator based on the subject's history, previous treatments, and the clinical presentation, the subject is considered as being optimally treated at screening (i.e., further adjustments of current medication will not further improve the subject's symptoms of Parkinson's disease).
Stable dose of PD drugs for at least 4 weeks before Screening Visit. This may include: levodopa dopamine agonists, c-ortho methyl transferase (COMT) inhibitors, and anticholinergics.
The dose of levodopa and all PD drugs used during the trial must remain unchanged throughout the trial.
Female subjects must be neither pregnant or breast-feeding and must lack child-bearing potential, as defined either by:
The subject shows adequate compliance with the schedule for intake of trial medication and the completion of the diaries.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jonathan Willmer, MD | Merck Serono S.A., Geneva | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University Graz, Klinische Abteilung für Spezielle Neurologie | Graz | Austria | ||||
| Medical University Innsbruck, Dept. of Neurology |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| C092797 | safinamide |
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| Safinamide | Drug | Evaluable dose levels are 100 mg (8 days), 200 mg (10 days), and 300 mg (42 days). Intermediate dose levels are 150 mg (Study days 9-11) and 250 mg (Study days 23-25) and have a duration of three days. Safinamide will be provided in tablets of 50 mg in blisters. Dosing will be achieved using appropriate multiples of these tablet strengths |
|
| At each individual post-dose visit: Day 8 |
| Complete new Movement Disorder Society - Unified Parkinson Disease Rating Scale (MDS-UPDRS) and subscales | At each individual post-dose visit: Day 22 |
| Complete new Movement Disorder Society - Unified Parkinson Disease Rating Scale (MDS-UPDRS) and subscales | At each individual post-dose visit: Day 36 |
| Complete new Movement Disorder Society - Unified Parkinson Disease Rating Scale (MDS-UPDRS) and subscales | At each individual post-dose visit: Day 66 |
| Complete new Movement Disorder Society - Unified Parkinson Disease Rating Scale (MDS-UPDRS) and subscales | At each individual post-dose visit: Day 101 |
| Unified Dyskinesia Rating Scale (UDysRS) and subscales (historical and objective) | At each individual visit: Baseline |
| Unified Dyskinesia Rating Scale (UDysRS) and subscales (historical and objective) | At each individual visit: Day 8 |
| Unified Dyskinesia Rating Scale (UDysRS) and subscales (historical and objective) | At each individual visit: Day 22 |
| Unified Dyskinesia Rating Scale (UDysRS) and subscales (historical and objective) | At each individual visit: Day 36 |
| Unified Dyskinesia Rating Scale (UDysRS) and subscales (historical and objective) | At each individual visit: Day 66 |
| Unified Dyskinesia Rating Scale (UDysRS) and subscales (historical and objective) | At each individual visit: Day 101 |
| Patient's diary (Hauser diary, all parts) | Hauser patient diary: daily total "on" time (ON w/o dyskinesia, or ON with non-troublesome dyskinesia), and daily total "off" time as measured by the patients' diary over the study period. | At each trial visit: Baseline |
| Patient's diary (Hauser diary, all parts) | Hauser patient diary: daily total "on" time (ON w/o dyskinesia, or ON with non-troublesome dyskinesia), and daily total "off" time as measured by the patients' diary over the study period. | At each trial visit: Day 8 |
| Patient's diary (Hauser diary, all parts) | Hauser patient diary: daily total "on" time (ON w/o dyskinesia, or ON with non-troublesome dyskinesia), and daily total "off" time as measured by the patients' diary over the study period. | At each trial visit: Day 22 |
| Patient's diary (Hauser diary, all parts) | Hauser patient diary: daily total "on" time (ON w/o dyskinesia, or ON with non-troublesome dyskinesia), and daily total "off" time as measured by the patients' diary over the study period. | At each trial visit: Day 36 |
| Patient's diary (Hauser diary, all parts) | Hauser patient diary: daily total "on" time (ON w/o dyskinesia, or ON with non-troublesome dyskinesia), and daily total "off" time as measured by the patients' diary over the study period. | At each trial visit: Day 66 |
| Patient's diary (Hauser diary, all parts) | Hauser patient diary: daily total "on" time (ON w/o dyskinesia, or ON with non-troublesome dyskinesia), and daily total "off" time as measured by the patients' diary over the study period. | At each trial visit: Day 101 |
| Parkinson's Disease Dyskinesia Scale (PDYS-26) (dyskinesia specific Activities of Daily Living (ADL) questionnaire) | At each trial visit: Baseline |
| Parkinson's Disease Dyskinesia Scale (PDYS-26) (dyskinesia specific Activities of Daily Living (ADL) questionnaire) | At each trial visit: Day 8 |
| Parkinson's Disease Dyskinesia Scale (PDYS-26) (dyskinesia specific Activities of Daily Living (ADL) questionnaire) | At each trial visit: Day 22 |
| Parkinson's Disease Dyskinesia Scale (PDYS-26) (dyskinesia specific Activities of Daily Living (ADL) questionnaire) | At each trial visit: Day 36 |
| Parkinson's Disease Dyskinesia Scale (PDYS-26) (dyskinesia specific Activities of Daily Living (ADL) questionnaire) | At each trial visit: Day 66 |
| Parkinson's Disease Dyskinesia Scale (PDYS-26) (dyskinesia specific Activities of Daily Living (ADL) questionnaire) | At each trial visit: Day 101 |
| Clinical Global Impression (CGI) (dyskinesia specific) | Scales measure the overall impression both the investigator and the patient have about the subject's general health. This is measured at baseline and the impression of change versus is measured at each visit. Here we are measuring efficacy. | At each trial visit: Baseline |
| Clinical Global Impression (CGI) (dyskinesia specific) | Scales measure the overall impression both the investigator and the patient have about the subject's general health. This is measured at baseline and the impression of change versus is measured at each visit. Here we are measuring efficacy. | At each trial visit: Day 8 |
| Clinical Global Impression (CGI) (dyskinesia specific) | Scales measure the overall impression both the investigator and the patient have about the subject's general health. This is measured at baseline and the impression of change versus is measured at each visit. Here we are measuring efficacy. | At each trial visit: Day 22 |
| Clinical Global Impression (CGI) (dyskinesia specific) | Scales measure the overall impression both the investigator and the patient have about the subject's general health. This is measured at baseline and the impression of change versus is measured at each visit. Here we are measuring efficacy. | At each trial visit: Day 36 |
| Clinical Global Impression (CGI) (dyskinesia specific) | Scales measure the overall impression both the investigator and the patient have about the subject's general health. This is measured at baseline and the impression of change versus is measured at each visit. Here we are measuring efficacy. | At each trial visit: Day 66 |
| Clinical Global Impression (CGI) (dyskinesia specific) | Scales measure the overall impression both the investigator and the patient have about the subject's general health. This is measured at baseline and the impression of change versus is measured at each visit. Here we are measuring efficacy. | At each trial visit: Day 101 |
| Patient Global Impression (PGI) (dyskinesia specific) | Scales measure the overall impression both the investigator and the patient have about the subject's general health. This is measured at baseline and the impression of change versus is measured at each visit. Here we are measuring efficacy. | At each trial visit: Baseline |
| Patient Global Impression (PGI) (dyskinesia specific) | Scales measure the overall impression both the investigator and the patient have about the subject's general health. This is measured at baseline and the impression of change versus is measured at each visit. Here we are measuring efficacy. | At each trial visit: Day 8 |
| Patient Global Impression (PGI) (dyskinesia specific) | Scales measure the overall impression both the investigator and the patient have about the subject's general health. This is measured at baseline and the impression of change versus is measured at each visit. Here we are measuring efficacy. | At each trial visit: Day 22 |
| Patient Global Impression (PGI) (dyskinesia specific) | Scales measure the overall impression both the investigator and the patient have about the subject's general health. This is measured at baseline and the impression of change versus is measured at each visit. Here we are measuring efficacy. | At each trial visit: Day 36 |
| Patient Global Impression (PGI) (dyskinesia specific) | Scales measure the overall impression both the investigator and the patient have about the subject's general health. This is measured at baseline and the impression of change versus is measured at each visit. Here we are measuring efficacy. | At each trial visit: Day 66 |
| Patient Global Impression (PGI) (dyskinesia specific) | Scales measure the overall impression both the investigator and the patient have about the subject's general health. This is measured at baseline and the impression of change versus is measured at each visit. Here we are measuring efficacy. | At each trial visit: Day 101 |
| Innsbruck |
| Austria |
| Quebec Memory and Motor Skills Disorders | Québec | Canada |
| Hôpital Roger Sallengro | Lille | France |
| CIC-Hospital Purpan | Toulouse | France |
| Neurologie Berlin Praxen | Berlin | Germany |
| St. Josef Hospital, Klinik für Neurologie | Bochum | Germany |
| Facharzt für Neurologie und Psychiatrie | Düsseldorf | Germany |
| Medical and Dental center (ZAF) | Johannesburg | South Africa |
| Sunninghill Hospital | Johannesburg | South Africa |
| Willows Medical Centre | Pretoria | South Africa |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |