|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
12 December 2020 |
|
Main ID: |
NCT01458470 |
|
Date of registration:
|
20/10/2011 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
A Trial of Memantine as Symptomatic Treatment for Early Huntington Disease
MITIGATE-HD |
|
Scientific title:
|
A Trial of Memantine as Symptomatic Treatment for Early Huntington Disease; a Phase IIb Study |
|
Date of first enrolment:
|
September 2011 |
|
Target sample size:
|
19 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/show/NCT01458470 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
|
|
Phase:
|
Phase 2
|
|
|
Countries of recruitment
|
|
Canada
| | | | | | | |
|
Contacts
|
|
Name:
|
Michael R. Hayden, MD,ChB,PhD |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
The University of British Columbia |
|
|
Name:
|
Blair R. Leavitt, MD,CM,FRCPC |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
University of British Columbia |
| |
|
Key inclusion & exclusion criteria
|
Inclusion Criteria:
To be eligible for the study, a subject must be enrolled in the early HD cohort of the
TRACK-HD study and:
- be at least 18 years of age and not older than 65
- able to provide written consent
- carry the abnormal HD gene and show early symptoms of HD
- be able and willing to comply with study requirements, including travel to study
center
- have no metal implants to be suitable for MRI scans and able to tolerate them
- able to tolerate blood draws
- be of stable medical, psychiatric and neurological health at the time of enrollment
- not have a history of significant head injury
- not have a history of significant hand injury that would prevent either writing or
performing rapid computer tasks
- not be abusing drugs and/or alcohol that may cause failure to comply with study
procedures
- not be currently participating in PREDICT-HD or a clinical drug trial.
Exclusion Criteria:
Prospective subjects will be excluded if:
- they are younger than 18 years of age and older than 65
- they are unable to provide written consent
- they show advanced symptoms of HD if they are HD gene carriers
- they are unwilling to comply with study requirements, including travel to study center
- they are unsuitable for MRI (e.g, claustrophobia, metal implants) or unable to
tolerate them
- they are unable to tolerate blood draws; or,
- they have a major psychiatric disorder, concomitant significant neurological disorder
or concomitant significant medical illness at the time of enrollment
- they have a history of CNS disease or significant head injury; or,
- they have a history of significant hand injury that would prevent either writing or
performing rapid computer tasks; or,
- they are likely to be non-compliant with study procedures due to drug and/or alcohol
abuse; or,
- they are participating in PREDICT-HD or a clinical drug trial at the time of
enrollment.
- they are not sighted
- English is not their first language
- they are currently or treated within the last 6 months with antipsychotic medications,
including the traditional neuroleptics such as haloperidol as well as the atypical
antipsychotics risperidone, clozapine, quetiapine and olanzapine
- they are use phenothiazine-derivative antiemetic medications such as prochlorperazine,
metoclopramide, promethazine and Inapsine on a regular basis (greater than 3 times per
month)
- they have a history of learning disability and/or mental retardation.
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Huntington Disease
|
|
Intervention(s)
|
|
Other: Placebo
|
|
Drug: Memantine
|
|
Primary Outcome(s)
|
|
Utility of TRACK-HD study endpoints in a clinical trial setting
[Time Frame: 24 weeks]
|
|
Secondary Outcome(s)
|
|
Neuropsychiatric and Cognitive Test Scores
[Time Frame: 24 weeks]
|
|
Secondary ID(s)
|
|
H11-01364
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|