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This is a French national trial, conducted using a double-blind, placebo-controlled, randomised design involving 7 centers and 80 patients of both sexes.
The primary objective of the trial is to evaluate the effects of the interruption of a long term treatment (ex. Greater than 6 months) with Amantadine (prescribed as an antidyskinetic) in patients suffering from Parkinson disease being treated with Levodopa and suffering from mid dose dyskinesias.
Secondary objectives of the trial are the evaluation of the other effects of withdrawal of Amantadine on the same group of patients: motor fluctuations, vigilance, apathy, fatigue, certain cognitive aspects, the disappearance or development of undesirable side effects and quality of life.
The trial will involve the participation of the patients for a period of 3 months each. The two groups of patients to be studied are:
The trial visits are scheduled as such:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | Amantadine MANTADIX |
|
| 2 | Placebo Comparator | placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| mantadix | Drug | dose greater or equal to 200 mg/day and progressively increasing doses (100mg every 3 days until the pre-study dose is reached). |
|
| Measure | Description | Time Frame |
|---|---|---|
| The primary efficacy endpoint is the variation in the sum of the items 32 and 33 (duration and severity of dyskinesias - maximum score = 8) evaluated using Part IV of the UPDRS scale | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| The number of patient "responders" | 3 months | |
| The number of premature withdrawals from the trial for reason of an aggravation of dyskinesias | 3 months | |
| The AIMS scale |
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Inclusion Criteria:
Exclusion Criteria:
Atypical parkinsonian syndrome (progressive supranuclear palsy, multi-system atrophy, etc)
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| Name | Affiliation | Role |
|---|---|---|
| Olivier Rascol, MD | University Hospital, Toulouse | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital d'Aix en Provence | Aix-en-Provence | 13616 | France | |||
| CHU de Clermont-Ferrand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15557510 | Background | Alves G, Wentzel-Larsen T, Larsen JP. Is fatigue an independent and persistent symptom in patients with Parkinson disease? Neurology. 2004 Nov 23;63(10):1908-11. doi: 10.1212/01.wnl.0000144277.06917.cc. | |
| 16203001 | Background | Bibbiani F, Oh JD, Kielaite A, Collins MA, Smith C, Chase TN. Combined blockade of AMPA and NMDA glutamate receptors reduces levodopa-induced motor complications in animal models of PD. Exp Neurol. 2005 Dec;196(2):422-9. doi: 10.1016/j.expneurol.2005.08.017. Epub 2005 Oct 3. |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D020820 | Dyskinesias |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D000547 | Amantadine |
| ID | Term |
|---|---|
| D000218 | Adamantane |
| D001952 | Bridged-Ring Compounds |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
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| 3 months |
| The Clinical Global Impression Severity Scale | 3 months |
| Other "exploratory" secondary efficacy | 3 months |
| Clermont-Ferrand |
| 63003 |
| France |
| CHU Timone | Marseille | 13385 | France |
| Hôpital Haut-Lévêque | Nantes | 44095 | France |
| CHU Pitié-Salpêtrière | Paris | 75013 | France |
| 15384126 | Background | Chapuis S, Ouchchane L, Metz O, Gerbaud L, Durif F. Impact of the motor complications of Parkinson's disease on the quality of life. Mov Disord. 2005 Feb;20(2):224-30. doi: 10.1002/mds.20279. |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009930 |
| Organic Chemicals |