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Could a common drug stop Parkinson's treatment side effect before it starts?

NCT ID NCT01538329

Disease control Sponsor: University Hospital, Toulouse Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study tested whether giving amantadine early in Parkinson's disease, before patients develop involuntary movements from their main medication (L-DOPA), could prevent or delay those movements. Researchers enrolled 210 people with early-stage Parkinson's who had been on L-DOPA for less than a year. Participants received either amantadine or a placebo for 18 months, and the team tracked who developed dyskinesia.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
amantadine
What this could lead to
If successful, this could show that starting amantadine early helps prevent or delay the involuntary movements caused by standard Parkinson's medication.
What could go wrong
This is a phase 2 trial with moderate size. The effect may be small or not clinically meaningful, and results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

210 people

The number who actually took part.

Started

Mar 2012

Finished

Feb 2019

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

35 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Dyskinesias Parkinson disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Parkinson disease

Contacts and locations

Locations

  • CH Charles Nicolle

    Rouen, 76031, France

  • CH Jean Rougier

    Cahors, 46005, France

  • CH Montauban

    Montauban, 82013, France

  • CH de Narbonne

    Narbonne, 11108, France

  • CHG Aix en Provence

    Aix-en-Provence, 13616, France

  • CHU Clermont-Ferrand

    Clermont-Ferrand, 63003, France

  • CHU Dijon

    Dijon, 21079, France

  • CHU Dupuytren

    Limoges, 87042, France

  • CHU Lille

    Lille, 59037, France

  • CHU de Bordeaux

    Bordeaux, 33604, France

  • CHU de Strasbourg

    Strasbourg, France

  • CHU de Toulouse

    Toulouse, 31000, France

  • CHu de Nantes

    Nantes, 44093, France

  • Hopital Jean Bernard

    Poitiers, 86021, France

  • Hopital Lyon

    Lyon, 69003, France

  • Hopital de la Timone

    Marseille, 13385, France

  • Hopital pitié Salpétriére

    Paris, 75013, France

  • hopital Saint Eloi

    Montpellier, 34295, France

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