Amantadine and L-DOPA-induced Dyskinesia in Early Parkinson's Disease (PREMANDYSK)
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| ClinicalTrials.gov Identifier: NCT01538329 |
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Recruitment Status : Unknown
Verified May 2016 by University Hospital, Toulouse.
Recruitment status was: Recruiting
First Posted : February 24, 2012
Last Update Posted : May 9, 2016
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Traditionally amantadine is used at the beginning of Parkinson Disease (PD) treatment in the early stages of the disease, as a modest antiparkinsonian symptomatic treatment. This treatment is usually maintained for no more than the first few months of management, before resorting to drugs deemed more effective as dopamine agonists and lévo-DOPA (L-DOPA). A more modern use of the drug is at a more advanced stage of PD when dyskinesia are already established and become disabling for the patients. There is no data between these two extremes of life stages of Parkinsonism. However, the mechanisms of action of amantadine and the pathophysiology of the motor complications induced by L-DOPA, in particular dyskinesia suggest that the early and prolonged use of amantadine in the early years of management, before L-DOPA-induced dyskinesia have already emerged, should have a positive impact on long-term occurrence and fate of these symptoms, possibly through a glutamatergic mechanism of brain plasticity-of the "disease modification" type.
The primary purpose of this study is to demonstrate that early introduction of treatment with amantadine (200 mg / d) in the early years of therapeutic care, that is to say during the "honeymoon" of levodopa (early phase of disease <3 years of diagnosis <1 year of L-dopa and lack of complications of levodopa therapy) decreases the rate of subjects with abnormal involuntary dyskinetic movements after 18 months of follow-up.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Parkinson Disease | Drug: Amantadine Drug: placebo | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 202 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | Impact of Amantadine on L-DOPA-induced Dyskinesia in Early Parkinson's Disease: a Placebo-controlled Randomized Study (the PREMANDYSK Study) |
| Study Start Date : | March 2012 |
| Estimated Primary Completion Date : | April 2017 |
| Estimated Study Completion Date : | June 2017 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Amantadine
Patients with amantadine
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Drug: Amantadine
200mg / day once daily in the morning and at noon - oral administration -
Other Name: active drug |
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Placebo Comparator: Placebo
Patients with amantadine placebo
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Drug: placebo
200mg / day once daily in the morning and at noon - oral administration -
Other Name: placebo of amantadine |
- after 18 months of Phase 1 of the study [ Time Frame: after 18 months of follow-up ]Rate of patient with abnormal involuntary dyskinetic movements (as specifically defined in the protocol) after 18 months of Phase 1 of the study (amantadine versus placebo).
- abnormal involuntary dyskinetic movements at the end of phase 3 of the study (wash out) [ Time Frame: 22 months after inclusion ]Rate of patients with abnormal involuntary dyskinetic movements at the end of phase 3 of the study (wash out)
- motor fluctuations after 18 months of Phase 1 of the study [ Time Frame: 18 months after inclusion ]Rate of patients with non-motor fluctuations after 18 months of Phase 1 (defined by the specific scale developed by the Marseille team involved in the project)
- Time to onset of dyskinesias [ Time Frame: each visits ]Time to onset of dyskinesias defined as the study visit at which the investigator answers "yes" for the first time the question "do you think this patient has dyskinesia as defined in Protocol "
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| Ages Eligible for Study: | 35 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age over 35 years,
- Patients having signed an informed consent before any specific study procedures,
- Patients having a health Insurance Coverage (according to local regulatory requirements),
- Patients suffering from idiopathic Parkinson's disease meeting the definition criteria of the UKPD Brain Bank (Gibb and Lees, 1988),
- Parkinson's disease diagnosed for <3 years,
- Patients receiving treatment with L-DOPA from <1year,
- Lack of complications of levodopa therapy
- Patients receiving a stable antiparkinsonian treatment that may involve, in addition to L-DOPA, a dopamine agonist, a monoamine oxidase-B (MAO-B) or a catecholamine O-methyl transferase (COMT) inhibitor, an anti-cholinergic for at least 2 months before enrollment and in whom we presume it will be possible to maintain this treatment unchanged during the study period (except the dose of L-dopa which can be adjusted during the study after the third month of Phase 1).
Exclusion Criteria:
- Atypical parkinsonian syndromes,
- Drug-induced Parkinsonism,
- Juvenile Parkinson,
- Patients with complications of levodopa therapy
- Inability to keep the current stable antiparkinsonian treatment during the study period, apart from L-DOPA,
- Pretreatment with amantadine,
- amantadine counter-indication
- Neuroleptic treatment,
- Patients with dementia, Mini Mental Status (MMS) <26,
- Patient with behavioral disorder, ECMP item ≥ 3
- Female subjects of childbearing potential without effective contraception
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01538329
| Contact: Delphine VERNET | 33-5 61 77 72 16 | vernet.d@chu-toulouse.fr |
Show 18 study locations
| Principal Investigator: | Olivier Rascol, MD | University Hospital, Toulouse |
| Responsible Party: | University Hospital, Toulouse |
| ClinicalTrials.gov Identifier: | NCT01538329 |
| Other Study ID Numbers: |
11 253 01 |
| First Posted: | February 24, 2012 Key Record Dates |
| Last Update Posted: | May 9, 2016 |
| Last Verified: | May 2016 |
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Dyskinesia L-DOPA Early introduced treatment Amantadine |
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Parkinson Disease Dyskinesias Parkinsonian Disorders Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Nervous System Diseases Movement Disorders Neurodegenerative Diseases Neurologic Manifestations Amantadine Antiparkinson Agents |
Anti-Dyskinesia Agents Antiviral Agents Anti-Infective Agents Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents |