Long-Term Effects of Amantadine in Parkinsonian (AMANDYSK)

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Toulouse
ClinicalTrials.gov Identifier:
NCT00632762
First received: February 20, 2008
Last updated: April 7, 2011
Last verified: April 2011
  Purpose

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.


Condition Intervention Phase
Parkinson's Disease
Drug: mantadix
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of the Long-term Effects of Amantadine in Parkinsonian's Suffering From Dyskinesia Induced by Levodopa: Study Randomised Double-blind, Placebo - Cessation of a Chronic Prescription. STUDY AMANDYSK.

Resource links provided by NLM:


Further study details as provided by University Hospital, Toulouse:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The number of patient "responders" [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • The number of premature withdrawals from the trial for reason of an aggravation of dyskinesias [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • The AIMS scale [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • The Clinical Global Impression Severity Scale [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • Other "exploratory" secondary efficacy [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 80
Study Start Date: November 2007
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Amantadine MANTADIX
Drug: mantadix
dose greater or equal to 200 mg/day and progressively increasing doses (100mg every 3 days until the pre-study dose is reached).
Placebo Comparator: 2
placebo
Drug: mantadix
dose greater or equal to 200 mg/day and progressively increasing doses (100mg every 3 days until the pre-study dose is reached).

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).
  Eligibility

Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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:

  • 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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00632762

Locations
France
Hôpital d'Aix en Provence
Aix en Provence, France, 13616
CHU de Clermont-Ferrand
Clermont-Ferrand, France, 63003
CHU Timone
Marseille, France, 13385
Hôpital Haut-Lévêque
Nantes, France, 44095
CHU Pitié-Salpêtrière
Paris, France, 75013
Sponsors and Collaborators
University Hospital, Toulouse
Investigators
Principal Investigator: Olivier Rascol, MD CHU Toulouse
  More Information

Publications:
Responsible Party: Marie-Elise LLAU, UH TOULOUSE
ClinicalTrials.gov Identifier: NCT00632762     History of Changes
Other Study ID Numbers: 06 008 01
Study First Received: February 20, 2008
Last Updated: April 7, 2011
Health Authority: France: Ministry of Health

Keywords provided by University Hospital, Toulouse:
Amantadine benefit
Dyskinesia
Parkinson's disease

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Amantadine
Antiparkinson Agents
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
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

ClinicalTrials.gov processed this record on August 28, 2014