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CompletedNCT00632762AMANDYSKUpdated Apr 8, 2011

Long-Term Effects of Amantadine in Parkinsonian (AMANDYSK)

A Phase 4 interventional study of mantadix in Parkinson's Disease, sponsored by University Hospital, Toulouse. Completed at 5 sites in France. Open to participants aged 30 Years to 80 Years. Per ClinicalTrials.gov, last updated 2011-04-08.

Sponsored by University Hospital, Toulouse · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
30 Years to 80 Years
Sex
All
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Study summary

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.

Read the detailed description

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:

  • a group who will continue their treatment with Amantadine with no modification to dosage;
  • a group who will have their dosage of Amantadine progressively replaced over several days with a placebo (with the aim of avoiding a "brutal" withdrawal which has been associated with symptoms of hyperthermia in rare cases in the literature).

The trial visits are scheduled as such:

  • weekly visits for the first 4 weeks, with a telephone call between each visit to assure that the withdrawal from Amantadine causes any problems.
  • every 2 weeks from week 4 until week 8, with weekly telephone calls in between these visits.
  • a telephone call in the 10th week followed by an end of study visit in week 12. In the event of an early withdrawal from the trial, and assuming that the patient gives their consent, a complete end of study visit will be performed prior to recommencing open label treatment with Amantadine in progressively increasing doses (100mg every 3 days until the pre-study dose is reached).
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Conditions studied

  • Parkinson's Disease

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Keywords

  • Amantadine benefit
  • Dyskinesia
  • Parkinson's disease
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In context

Parkinson Disease

4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.

This study's planned enrollment of 80 is above the median of 40 across 3,294 interventional studies indexed under Parkinson Disease.

Browse Parkinson Disease studies →

Lead sponsor

University Hospital, Toulouse is the lead sponsor of 794 studies on the registry; 214 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
30 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Female or Male Patients with Idiopathic Parkinson's disease
  • Presenting peak dose dyskinesias under levodopa therapy
  • Patient receiving Amantadine for dyskinesia at a dose greater or equal to 200 mg/day (minimum dose at which one can observe anti dyskinetic effects) for at least 6 months.
  • Patients between 30 and 80 years of age
  • Patients having reported a subjective amelioration in their dyskinesias under Amantadine (at the beginning of their treatment with same)
  • Patient with a Mini- Mental State Exam score > 24
  • Patient not presenting a cognitive problem that could impair the comprehension of the patient and their participation in the protocol (patient diaries)
  • Receiving an anti-parkinsonian treatment at a stable dose for at least 2 months with the expectation that the treatment will remain unchanged throughout the course of the patients participation in the trial.
  • Signed informed consent obtained
  • Patient eligible for social security (specific requirement under french law)

Exclusion criteria

Exclusion Criteria:

  • Atypical parkinsonian syndrome (progressive supranuclear palsy, multi-system atrophy, etc)

    • Patient with parkinsonian syndrome secondary to medication
    • Patients presenting with dyskinesias whose severity allow an insufficient margin for observing any aggravation which follows a potential withdrawal of treatment (UPDRS 32+33 >6)
    • Patients receiving treatment with Apokinon© injector pens (unless that treatment enters into a therapeutic schema at fixed hours)
    • Patient presenting with dementia or an evolving dopaminergic psychosis
    • Patient receiving neuroleptics or anticholinesterases
    • Patients having received functional surgery for their Parkinsons' Disease
    • Patients pregnant or at risk of same
    • Patients who are: wards of the state requirement under french law).
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Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
80 participants (estimated)

Study arms

  • Active comparator
    1

    Amantadine MANTADIX

    Drug: mantadix

  • Placebo comparator
    2

    placebo

    Drug: mantadix

Interventions

  • Drugmantadix

    dose greater or equal to 200 mg/day and progressively increasing doses (100mg every 3 days until the pre-study dose is reached).

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What researchers measure

Primary outcomes

  1. 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

    Time frame: 3 months

Secondary outcomes

  1. The number of patient "responders"

    Time frame: 3 months

  2. The number of premature withdrawals from the trial for reason of an aggravation of dyskinesias

    Time frame: 3 months

  3. The AIMS scale

    Time frame: 3 months

  4. The Clinical Global Impression Severity Scale

    Time frame: 3 months

  5. Other "exploratory" secondary efficacy

    Time frame: 3 months

07

Study locations

5 sites
  • Hôpital d'Aix en Provence
    Aix en Provence, 13616, France
  • CHU de Clermont-Ferrand
    Clermont-Ferrand, 63003, France
  • CHU Timone
    Marseille, 13385, France
  • Hôpital Haut-Lévêque
    Nantes, 44095, France
  • CHU Pitié-Salpêtrière
    Paris, 75013, France
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References and documents

Publications

  • 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. PubMed 15557510 ↗
  • 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. PubMed 16203001 ↗
  • 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. PubMed 15384126 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 8, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00632762
Lead sponsor
University Hospital, Toulouse
First posted
Mar 11, 2008
Start date
Nov 2007
Primary completion
Jan 2011
Completion
Jan 2011
Last update
Apr 8, 2011

Study contacts

Olivier Rascol, MD
principal investigator · CHU Toulouse

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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