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Long-Term Effects of Amantadine in Parkinsonian (AMANDYSK) (AMANDYSK)

Primary Purpose

Parkinson's Disease

Status

Completed

Phase

Phase 4

Locations

France

Study Type

Interventional

Intervention

mantadix

About this trial

This is an interventional treatment trial for Parkinson's Disease focused on measuring Amantadine benefit, Dyskinesia, Parkinson's disease

Eligibility Criteria

30 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

Hôpital d'Aix en Provence
CHU de Clermont-Ferrand
CHU Timone
Hôpital Haut-Lévêque
CHU Pitié-Salpêtrière

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Arm Description

Amantadine MANTADIX

placebo

Outcomes

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

Secondary Outcome Measures

The number of patient "responders"

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

The AIMS scale

The Clinical Global Impression Severity Scale

Other "exploratory" secondary efficacy

Full Information

NCT ID

NCT00632762

First Posted

February 20, 2008

Last Updated

April 7, 2011

Sponsor

University Hospital, Toulouse

1. Study Identification

Unique Protocol Identification Number

NCT00632762

Brief Title

Long-Term Effects of Amantadine in Parkinsonian (AMANDYSK)

Acronym

AMANDYSK

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.

Study Type

Interventional

2. Study Status

Record Verification Date

April 2011

Overall Recruitment Status

Completed

Study Start Date

November 2007 (undefined)

Primary Completion Date

January 2011 (Actual)

Study Completion Date

January 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

University Hospital, Toulouse

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Parkinson's Disease

Keywords

Amantadine benefit, Dyskinesia, Parkinson's disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

Amantadine MANTADIX

Arm Title

Arm Type

Placebo Comparator

Arm Description

placebo

Intervention Type

Drug

Intervention Name(s)

mantadix

Intervention Description

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

Primary Outcome Measure Information:

Title

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 Outcome Measure Information:

Title

The number of patient "responders"

Time Frame

3 months

Title

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

Time Frame

3 months

Title

The AIMS scale

Time Frame

3 months

Title

The Clinical Global Impression Severity Scale

Time Frame

3 months

Title

Other "exploratory" secondary efficacy

Time Frame

3 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility 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).

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Olivier Rascol, MD

Organizational Affiliation

CHU Toulouse

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hôpital d'Aix en Provence

City

Aix en Provence

ZIP/Postal Code

13616

Country

France

Facility Name

CHU de Clermont-Ferrand

City

Clermont-Ferrand

ZIP/Postal Code

63003

Country

France

Facility Name

CHU Timone

City

Marseille

ZIP/Postal Code

13385

Country

France

Facility Name

Hôpital Haut-Lévêque

City

Nantes

ZIP/Postal Code

44095

Country

France

Facility Name

CHU Pitié-Salpêtrière

City

Paris

ZIP/Postal Code

75013

Country

France

12. IPD Sharing Statement

Citations:

PubMed Identifier

15557510

Citation

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.

Results Reference

background

PubMed Identifier

16203001

Citation

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.

Results Reference

background

PubMed Identifier

15384126

Citation

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.

Results Reference

background

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Long-Term Effects of Amantadine in Parkinsonian (AMANDYSK)

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