search
Back to results

Treatment of Huntington's Chorea With Amantadine

Primary Purpose

Chorea, Huntington's Disease

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Amantadine
Sponsored by
National Institute of Neurological Disorders and Stroke (NINDS)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chorea focused on measuring Amantadine, Chorea, Glutamate Antagonist

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • National Institute of Neurological Disorders and Stroke (NINDS)

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 3, 1999
Last Updated
March 3, 2008
Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
search

1. Study Identification

Unique Protocol Identification Number
NCT00001930
Brief Title
Treatment of Huntington's Chorea With Amantadine
Official Title
NMDA-Receptor Blockade in Huntington's Chorea
Study Type
Interventional

2. Study Status

Record Verification Date
April 2000
Overall Recruitment Status
Completed
Study Start Date
April 1999 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
February 2001 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chorea, Huntington's Disease
Keywords
Amantadine, Chorea, Glutamate Antagonist

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Enrollment
25 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Amantadine

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
National Institute of Neurological Disorders and Stroke (NINDS)
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
8731
Citation
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.
Results Reference
background
PubMed Identifier
1710657
Citation
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.
Results Reference
background

Learn more about this trial

Treatment of Huntington's Chorea With Amantadine

We'll reach out to this number within 24 hrs