Huntington DiseasePhase 2MITIGATE-HDNCT01458470
A Trial of Memantine as Symptomatic Treatment for Early Huntington Disease
A Phase 2 study testing Memantine in people with Huntington Disease, run by University of British Columbia at 1 site in Canada.
Trial summary
Huntington disease is characterized by difficulties in movement and thinking. Psychological disturbances including irritability, aggression, loss of interest, depressed mood, obsessions and compulsions, also represent common symptoms of HD. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Huntington Disease
- What is being tested?
- Memantine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2011to Nov 2012
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site
The Centre for Huntington Disease
Vancouver, British Columbia, V6T 2B5
About this study
Official title: A Trial of Memantine as Symptomatic Treatment for Early Huntington Disease; a Phase IIb Study
Huntington disease is characterized by difficulties in movement and thinking. Psychological disturbances including irritability, aggression, loss of interest, depressed mood, obsessions and compulsions, also represent common symptoms of HD. These symptoms are distressing both for HD patients and their caregivers, contribute to the loss of ability to carry out activities of daily living, and present a major treatment challenge for physicians. The goal of this study is to determine the effect of memantine on movement, thinking and emotional difficulties in HD patients. Memantine is a medication originally approved for the treatment of aggression and agitation in patients with moderate-to-severe Alzheimer's disease (AD), which has also recently been shown to improve the behavioural and neuropathological symptoms in a mouse model of Huntington Disease (HD).
Read the detailed description
TRACK-HD was a multi-centre, multi-national, prospective, observational study of pre-manifest and early Huntington's disease (HD) with a control group of volunteers not carrying the HD mutation. The goal of the project was to contribute essential methodology that will form the basis for clinical trials in pre-manifest and early HD. TRACK-HD complemented existing observational studies (e.g., Predict-HD, PHAROS, COHORT), sharing some features, but also having areas of unique emphasis.
The UBC site recruited 90 subjects including 30 control subjects, 30 asymptomatic pre-manifest HD gene carriers and 30 subjects with early symptoms of HD (stage 1 or 2). All subjects were assessed using the TRACK-HD battery at baseline, 1 year, 2 years, and 3 years. Following the fourth visit (3 year assessment), the TRACK-HD study will be completed, and the 30 subjects with early symptoms of HD will be invited to enroll in the MITIGATE-HD Study.
The MITIGATE-HD study is a single center Phase IIb,out-patient,randomized, double-blind, placebo-controlled trial of memantine treatment in subjects with Huntington disease (HD). The study will evaluate Memantine 10 mg two times daily (BID) administered orally (PO) for six months (24 weeks) compared with matching placebo BID. Safety and tolerability will be assessed by recording of adverse events and by monitoring of vital signs, physical examinations, and suicidality risk scores.
The TRACK-HD assessment battery will be administered to all subjects after six months of study drug administration. The effects of memantine will be evaluated both against placebo as well as compared to the previous 3 years of observational data from the TRACK-HD Study.
- Conditions
- Huntington Disease
- Being tested
- Memantine, Placebo
- Keywords
- huntington, huntingtin, memantine, ebixa, namenda
- Medical subject headings
- Huntington Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MemantineDrug
Also called Ebixa, DIN 02260638, Namenda
oral tablet, 1 BID, 24 weeks
PlaceboOther
oral tablet, 1 BID, 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| Memantine | Active comparator | NMDA Receptor Antagonist Receives: Drug: Memantine |
| Sugar pill | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Utility of TRACK-HD study endpoints in a clinical trial setting
To examine the clinical utility of novel trial endpoints (such as Putaminal NAA measured by MRS) developed in the TRACK-HD study in the setting of a placebo-controlled therapeutic trial.
Measured: 24 weeks
Secondary outcomes (1)
Neuropsychiatric and Cognitive Test Scores
To examine effect of memantine versus placebo on the scores of: a) the irritability and agitation/aggression sub-categories of the Neuropsychiatric Inventory (NPI), and also the total NPI, b) cognitive tests: Circle Tracing , Symbol Digit Modality, Stroop Word Reading, and Spot the Change, c) total HD-ADL, d) total UHDRS, and the UHDRS sub-scale: Cognitive, Behavioural, Functional, and Independence scales. e) In patients recruited at the UBC study site, the effect on striatal N-acetyl aspartate levels (a measure of neuronal dysfunction) will be assessed by Magnetic Resonance Spectroscopy.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2011 (estimated)
- Study startSep 2011
- Primary completionAug 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Huntington DiseaseStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- Huntington Society of Canada, Huntington Study Group
- Responsible party
- Principal investigator, Blair Leavitt, University of British Columbia
- Investigators
- Blair R. Leavitt, MD,CM,FRCPC, Principal investigator, University of British ColumbiaMichael R. Hayden, MD,ChB,PhD, Study chair, The University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01458470
- Sponsor's protocol ID
- H11-01364
- Acronym
- MITIGATE-HD
- Status last verified
- Jan 2020
- First submitted
- 20 Oct 2011
- Last updated
- 13 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Trial of Memantine as Symptomatic Treatment for Early Huntington Disease; a Phase IIb Study
- ClinicalTrials.gov ID
- NCT01458470
- Acronym / sponsor ID
- MITIGATE-HD / H11-01364
- Conditions
- Huntington Disease
- Keywords
- huntington, huntingtin, memantine, ebixa, namenda
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- Huntington Society of Canada, Huntington Study Group
- Study start
- Sep 2011
- Primary completion
- Aug 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 24 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Huntington disease is characterized by difficulties in movement and thinking. Psychological disturbances including irritability, aggression, loss of interest, depressed mood, obsessions and compulsions, also represent common symptoms of HD. These symptoms are distressing both for HD patients and their caregivers, contribute to the loss of ability to carry out activities of daily living, and present a major treatment challenge for physicians. The goal of this study is to determine the effect of memantine on movement, thinking and emotional difficulties in HD patients. Memantine is a medication originally approved for the treatment of aggression and agitation in patients with moderate-to-severe Alzheimer's disease (AD), which has also recently been shown to improve the behavioural and neuropathological symptoms in a mouse model of Huntington Disease (HD).
Detailed description
TRACK-HD was a multi-centre, multi-national, prospective, observational study of pre-manifest and early Huntington's disease (HD) with a control group of volunteers not carrying the HD mutation. The goal of the project was to contribute essential methodology that will form the basis for clinical trials in pre-manifest and early HD. TRACK-HD complemented existing observational studies (e.g., Predict-HD, PHAROS, COHORT), sharing some features, but also having areas of unique emphasis.
The UBC site recruited 90 subjects including 30 control subjects, 30 asymptomatic pre-manifest HD gene carriers and 30 subjects with early symptoms of HD (stage 1 or 2). All subjects were assessed using the TRACK-HD battery at baseline, 1 year, 2 years, and 3 years. Following the fourth visit (3 year assessment), the TRACK-HD study will be completed, and the 30 subjects with early symptoms of HD will be invited to enroll in the MITIGATE-HD Study.
The MITIGATE-HD study is a single center Phase IIb,out-patient,randomized, double-blind, placebo-controlled trial of memantine treatment in subjects with Huntington disease (HD). The study will evaluate Memantine 10 mg two times daily (BID) administered orally (PO) for six months (24 weeks) compared with matching placebo BID. Safety and tolerability will be assessed by recording of adverse events and by monitoring of vital signs, physical examinations, and suicidality risk scores.
The TRACK-HD assessment battery will be administered to all subjects after six months of study drug administration. The effects of memantine will be evaluated both against placebo as well as compared to the previous 3 years of observational data from the TRACK-HD Study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Memantine | Active comparator | Drug: MemantineNMDA Receptor Antagonist |
| Sugar pill | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MemantineAlso: Ebixa, DIN 02260638, Namendaoral tablet, 1 BID, 24 weeks | Drug | Memantine |
| Placebooral tablet, 1 BID, 24 weeks | Other | Sugar pill |
Primary outcome
Utility of TRACK-HD study endpoints in a clinical trial setting
Time frame: 24 weeks
To examine the clinical utility of novel trial endpoints (such as Putaminal NAA measured by MRS) developed in the TRACK-HD study in the setting of a placebo-controlled therapeutic trial.
1 secondary outcome
Neuropsychiatric and Cognitive Test Scores
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2020.
- The Huntington Study GroupLink provided by the sponsor.
- The Huntington Society of CanadaLink provided by the sponsor.
- Health CanadaLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Blair R. Leavitt, MD,CM,FRCPC principal investigator
University of British Columbia
Michael R. Hayden, MD,ChB,PhD study chair
The University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Memantine in people with Huntington Disease, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Utility of TRACK-HD study endpoints in a clinical trial setting (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2020.