Treatment of Huntington's Chorea With Amantadine | NCT00001930

Studies
Treatment of Huntington's Chorea With Amantadine

NCT00001930

Sponsor

National Institute of Neurological Disorders and Stroke (NINDS)

Status

Completed

Last Update Posted

Mar 4, 2008Estimated

Enrollment

Phase

Phase 2

Conditions

Chorea
Huntington's Disease

Interventions

Amantadine

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
99-N-0098

Status Module

Record Verification Date

Apr 2000

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1999

Primary Completion Date

Not provided

Completion Date

Feb 2001

First Submitted Date

Nov 3, 1999

First Submission Date that Met QC Criteria

Dec 9, 2002

First Posted Date

Dec 10, 2002Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 3, 2008

Last Update Posted Date

Mar 4, 2008Estimated

Description Module

Brief Summary

Huntington's disease is a chronic disorder passed on through genetic autosomal dominant inheritance. The condition usually begins between the ages of 30 and 50 years and it is characterized by involuntary movements in the face and extremities, (chorea), accompanied by changes in behavior and gradual loss of the mental function. The disease typically ends in a state of disorientation, impaired memory, judgement, and intellect (dementia).

The objective of this study is to test the effectiveness of the drug amantadine for the treatment of chorea associated with Huntington's disease. Amantadine is an antiviral drug that has been used to treat a variety of illnesses including Parkinson's disease. Amantadine works by attaching to special sites called NMDA (N-methyl-D-aspartate) receptors and blocking the normal activity of glutamate there. Glutamate is an amino acid released by brain cells and has been associated with the symptoms of Parkinson's disease.

Detailed Description

The objective of this study is to evaluate the acute effects of the putative NMDA-receptor antagonist amantadine on chorea of patients with Huntington's disease (HD). Participants in this study will have mild to moderate HD associated with chorea.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
Amantadine	Drug

Eligibility Module

Eligibility Criteria

All patients will carry a diagnosis of Huntington's disease confirmed by DNA testing.

Patients will have mild to moderate disease with associated significant chorea.

Ability to comply with study requirements and to report on their condition by telephone.

Males and females between the ages of 18 and 82.

No patients with the presence or history of any medical condition that can reasonably be expected to subject the patient to unwarranted risk.

No patients with renal impairment (serum creatinine exceeding the upper limit of normal).

No patients with a history of intolerance to previous exposure to amantadine.

No patients with an MMSE of less than 18/30.

No patients receiving other anti-chorea therapies (such as Haldol). Those receiving other anti-chorea therapies must stop taking these medications for at least 4 weeks prior to the study to be eligible.

No pregnant women.

Patients must practice effective means of birth control.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
National Institute of Neurological Disorders and Stroke (NINDS)		Bethesda	Maryland	20892	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
8731	Background	Coyle JT, Schwarcz R. Lesion of striatal neurones with kainic acid provides a model for Huntington's chorea. Nature. 1976 Sep 16;263(5574):244-6. doi: 10.1038/263244a0. No abstract available.
1710657	Background	Beal MF, Ferrante RJ, Swartz KJ, Kowall NW. Chronic quinolinic acid lesions in rats closely resemble Huntington's disease. J Neurosci. 1991 Jun;11(6):1649-59. doi: 10.1523/JNEUROSCI.11-06-01649.1991.

ID	Term
D002819	Chorea
D006816	Huntington Disease

ID	Term
D020820	Dyskinesias
D009069	Movement Disorders
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

ID	Term
D000218	Adamantane
D001952	Bridged-Ring Compounds
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons