NCT00001930

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Apr 1999

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 1999

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 3, 1999

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2001

Completed
1.9 years until next milestone

First Posted

Study publicly available on registry

December 10, 2002

Completed
Last Updated

March 4, 2008

Status Verified

April 1, 2000

First QC Date

November 3, 1999

Last Update Submit

March 3, 2008

Conditions

ChoreaHuntington's Disease

Keywords

AmantadineChoreaGlutamate Antagonist

Interventions

AmantadineDRUG

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

National Institute of Neurological Disorders and Stroke (NINDS)

Bethesda, Maryland, 20892, United States

Location

Related Publications (2)

  • 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.

    PMID: 8731BACKGROUND

  • 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.

    PMID: 1710657BACKGROUND

MeSH Terms

Conditions

ChoreaHuntington Disease

Interventions

Amantadine

Condition Hierarchy (Ancestors)

DyskinesiasMovement DisordersCentral Nervous System DiseasesNervous System DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBasal Ganglia DiseasesBrain DiseasesDementiaHeredodegenerative Disorders, Nervous SystemNeurodegenerative DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesCognition DisordersNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

AdamantaneBridged-Ring CompoundsHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

November 3, 1999

First Posted

December 10, 2002

Study Start

April 1, 1999

Study Completion

February 1, 2001

Last Updated

March 4, 2008

Record last verified: 2000-04

Locations

US(1)