Huntington's DiseasePhase 2DIMONDNCT00497159
A Study of the Novel Drug Dimebon in Patients With Huntington's Disease
A Phase 2 study testing Dimebon in people with Huntington's Disease, run by Medivation, Inc. at 1 site in United States.
Trial summary
This study will evaluate the safety of 3 months of Dimebon dosing and the efficacy of Dimebon in improving cognitive, motor, and overall function in subjects with Huntington's Disease. Read more about this study
- Who is it for?
- Ages 29 years and older
- Conditions the study is for
- Huntington's Disease
- What is being tested?
- Dimebon
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 91 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2007to Jun 2008
- 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 29 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical features of HD and a confirmatory family history of HD, and/or genetically confirmed HD;
- Able to take medication (capsules) by mouth.
Who cannot join
- Clinical evidence of unstable medical illness;
- Females who are pregnant or lactating or who intend to become pregnant during the study period.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multi-Center, Phase 2 Randomized, Double-Blinded, Placebo-Controlled Study of Dimebon in Subjects With Huntington's Disease
This study will evaluate the safety of 3 months of Dimebon dosing and the efficacy of Dimebon in improving cognitive, motor, and overall function in subjects with Huntington's Disease.
- Conditions
- Huntington's Disease
- Being tested
- Placebo, Dimebon
- Keywords
- Trial of Dimebon to treat patients with mild-to-moderate Huntington's disease.
- Medical subject headings
- Huntington Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboOther
Placebo TID x 90 days
DimebonDrug
Dimebon 20 mg TID x 90 days
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | Placebo Receives: Other: Placebo |
| 2 | Experimental | Dimebon Receives: Drug: Dimebon |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the safety and tolerability of Dimebon during 3 months of treatment in subjects with Huntington's Disease.
Measured: 90 days
Secondary outcomes (2)
To assess the impact of Dimebon during 3 months of treatment on cognitive, motor, and overall function in subjects with Huntington's Disease.
Measured: 90 days
To assess the pharmacokinetics of Dimebon.
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2007 (estimated)
- Study startJul 2007
- Primary completionJun 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Huntington's DiseaseStudies of the same condition, open and under way.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medivation, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Huntington Study Group
- Responsible party
- Sponsor
- Investigators
- Karl Kieburtz, MD, MPH, Principal investigator, Huntington Study Group, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00497159
- Sponsor's protocol ID
- DIM05
- Acronym
- DIMOND
- Status last verified
- May 2015
- First submitted
- 3 Jul 2007
- Last updated
- 8 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kieburtz K, McDermott MP, Voss TS, Corey-Bloom J, Deuel LM, Dorsey ER, Factor S, Geschwind MD, Hodgeman K, Kayson E, Noonberg S, Pourfar M, Rabinowitz K, Ravina B, Sanchez-Ramos J, Seely L, Walker F, Feigin A; Huntington Disease Study Group DIMOND Investigators. A randomized, placebo-controlled trial of latrepirdine in Huntington disease. Arch Neurol. 2010 Feb;67(2):154-60. doi: 10.1001/archneurol.2009.334.
PubMed 20142523
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Phase 2 Randomized, Double-Blinded, Placebo-Controlled Study of Dimebon in Subjects With Huntington's Disease
- ClinicalTrials.gov ID
- NCT00497159
- Acronym / sponsor ID
- DIMOND / DIM05
- Conditions
- Huntington's Disease
- Keywords
- Trial of Dimebon to treat patients with mild-to-moderate Huntington's disease.
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Medivation, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Huntington Study Group
- Study start
- Jul 2007
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 6 Jul 2007 (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.
This study will evaluate the safety of 3 months of Dimebon dosing and the efficacy of Dimebon in improving cognitive, motor, and overall function in subjects with Huntington's Disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Placebo comparator | Other: PlaceboPlacebo |
| 2 | Experimental | Drug: DimebonDimebon |
Who may qualify
- Ages
- 29 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical features of HD and a confirmatory family history of HD, and/or genetically confirmed HD;
- Able to take medication (capsules) by mouth.
Key exclusion criteria (2 listed)
- Clinical evidence of unstable medical illness;
- Females who are pregnant or lactating or who intend to become pregnant during the study period.
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 |
|---|---|---|
| PlaceboPlacebo TID x 90 days | Other | 1 |
| DimebonDimebon 20 mg TID x 90 days | Drug | 2 |
Primary outcome
To assess the safety and tolerability of Dimebon during 3 months of treatment in subjects with Huntington's Disease.
Time frame: 90 days
2 secondary outcomes
To assess the impact of Dimebon during 3 months of treatment on cognitive, motor, and overall function in subjects with Huntington's Disease.
Time frame: 90 days
To assess the pharmacokinetics of Dimebon.
Time frame: 90 days
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 8 Jun 2015.
- Derived from this study: PubMed 20142523Kieburtz K, McDermott MP, Voss TS, Corey-Bloom J, Deuel LM, Dorsey ER, Factor S, Geschwind MD, Hodgeman K, Kayson E, Noonberg S, Pourfar M, Rabinowitz K, Ravina B, Sanchez-Ramos J, Seely L, Walker F, Feigin A; Huntington Disease Study Group DIMOND Investigators. A randomized, placebo-controlled trial of latrepirdine in Huntington disease. Arch Neurol. 2010 Feb;67(2):154-60. doi: 10.1001/archneurol.2009.334.
- The Huntington Study Group is a non-profit group of physicians and health care providers from medical centers in the US, Canada, Europe, and Australia, experienced in the care of HD patients and dedicated to clinical research of HD. Click for more info.Link provided by the sponsor.
Related trials for Huntington's Disease
RecruitingPhase 2/3
Study to Evaluate the Pharmacodynamics, Safety and Efficacy of SKY-0515 in Participants With Huntington's Disease
Huntington Disease
RecruitingPhase 3
Pridopidine Phase 3 Study in Huntington's Disease
Huntington Disease
Not yet recruiting
Creatine and Beta-Hydroxy-Beta-Methylbutyrate (HMB) Supplementation Plus Home-Based Exercise for Sarcopenia in Huntington's Disease
Huntington Disease, Sarcopenia
RecruitingObservational study
Development of Non-Invasive Prenatal Diagnosis for Single Gene Disorders
Invasive PreNatal Diagnosis in a Context of Family History of Single-gene Disorders, Including, Sickle Cell Disease
RecruitingPhase 1
A First-in-human Study of the Effects of SRP-1005 in Participants With Huntington's Disease
Huntington's Disease
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.
Karl Kieburtz, MD, MPH principal investigator
Huntington Study Group, University of Rochester
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 Dimebon in people with Huntington's Disease, run by Medivation, Inc. at 1 site in United States.
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 2 inclusion and 2 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 8 Jun 2015. 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 United States. 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?
To assess the safety and tolerability of Dimebon during 3 months of treatment in subjects with Huntington's Disease. (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00497159, which also lists 1 linked publication.
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 8 Jun 2015.