Long-Term Effects of Amantadine in Parkinsonian (AMANDYSK)

NCT00632762 | Completed Phase 4

• 1 other identifier: 06 008 01
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Parkinson's Disease

Keywords

Amantadine benefit; Dyskinesia; Parkinson's disease

Outcome Measures

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

  3 months

Secondary Outcomes (5)

• 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

  3 months

• The Clinical Global Impression Severity Scale

  3 months

• Other "exploratory" secondary efficacy

  3 months

Study Arms (2)

1

ACTIVE COMPARATOR

Amantadine MANTADIX

Drug: mantadix

2

PLACEBO COMPARATOR

placebo

Drug: mantadix

Interventions

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).

1; 2

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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).

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (5)

Hôpital d'Aix en Provence

Aix-en-Provence, 13616, France

Location

CHU de Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

CHU Timone

Marseille, 13385, France

Location

Hôpital Haut-Lévêque

Nantes, 44095, France

Location

CHU Pitié-Salpêtrière

Paris, 75013, France

Location

Related Publications (3)

• 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.

  PMID: 15557510 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.

  PMID: 16203001 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.

  PMID: 15384126 BACKGROUND

MeSH Terms

Conditions

Parkinson Disease; Dyskinesias

Interventions

Amantadine

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Adamantane; Bridged-Ring Compounds; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Olivier Rascol, MD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 20, 2008
• First Posted: March 11, 2008
• Study Start: November 1, 2007
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: April 8, 2011

Record last verified: 2011-04

Locations

FR (5)