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Huntington's DiseasePhase 2NCT02074410

Safety and Efficacy of OMS643762 in Subjects With Huntington's Disease

A Phase 2 study testing OMS643762 in people with Huntington's Disease, run by Omeros Corporation at 9 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The purpose of this study is to determine the safety, tolerability and pharmacokinetics of OMS643762 (the study drug) in subjects with Huntington's disease (HD). Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Huntington's Disease
What is being tested?
OMS643762
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
22 participants
Where
9 sitesUnited States
Study dates
Jan 2014to 15 Oct 2014
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 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Voluntarily provide informed consent, or have a legally authorized representative (LAR) provide informed consent with subject assent, in accordance with local regulations and governing Institution Review Board (IRB) requirements prior to any procedures or evaluations performed specifically for the sole purpose of the study (other than the Montreal Cognitive Assessment (MoCA) to assess capacity to provide informed consent). Capacity to provide informed consent will be determined by the MoCA and investigator judgment according to the following:
  • Subjects with scores of greater than or equal to 21 on the MoCA and, in the judgment of the investigator, have the capacity to provide valid informed consent, can give consent.
  • Subjects with scores of less than 21 but greater than or equal to 18 on the MoCA and, in the judgment of a mental health professional (independent of the investigator) have the capacity to provide valid informed consent, may give consent.
  • Subjects with scores less 21 but greater than or equal to 18 on the MoCA, who lack the capacity to give valid informed consent, in the judgment of a mental health professional (independent of the investigator), will need an LAR to provide informed consent with assent by the subject.
  • Subjects with scores of less than 18 on the MoCA will have an LAR provide informed consent with assent by the subject.
  • Have a clinical diagnosis of HD, confirmed by either CAG repeat number of greater than or equal to 39 or a positive family history (a first degree relative with a clinical diagnosis of HD) if CAG repeat number is not known.
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  • Are age greater than or equal to 18 and less than or equal to 65 years at the screening visit (Visit 1).
  • Have a UHDRS Total Functional Capacity greater than or equal to 7 at Visit 1.
  • If currently taking antipsychotic medication(s), have been on a stable regimen for at least 60 days prior to randomization.
  • Are fluent in English.
  • If female, are either a) not of childbearing potential (i.e., surgically sterilized or post-menopausal for more than 1 year) or b) have a negative pregnancy test and if sexually active must agree to use a medically reliable form of contraception throughout the study. Acceptable methods of contraception include a reliable intrauterine device, hormonal contraception or spermicide in combination with a barrier method.
  • If male, are either a) not of reproductive potential or b) if sexually active must agree to use a medically reliable form of contraception throughout the study. Acceptable methods of birth control include spermicide in combination with a barrier method, or subjects' female partner is willing to use medically acceptable methods of birth control.
  • Have normal clinical laboratory test results and ECG, or results with minor deviations, which are not considered to be clinically significant by the investigator.

Who cannot join

  • Have a history or presence of significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, or neurological disorders other than HD which, in the opinion of the investigator, increases the risk of the study drug or may confound the interpretation of study measures.
  • Have unstable or severe depression, in the opinion of the investigator.
  • Have alcohol or drug abuse or dependence, as defined by the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision.
  • Have received treatment with an investigational drug or device within 60 days prior to Visit 1.
  • Are pregnant or lactating.
  • Have serum alanine transaminase or aspartate transaminase greater than two times upper limit of normal at screening.
  • Have hemoglobin, white blood cell count, absolute neutrophil count, or platelet count outside the normal range at screening.
  • Are an employee of Omeros, an investigator, or study staff member, or their immediate family member.

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

United States9 sites

  • Study site

    Baltimore, Maryland, 21287

  • Study site

    Englewood, Colorado, 80113

  • Study site

    Gainesville, Florida, 32607

  • Study site

    Houston, Texas, 77030

  • Study site

    Kirkland, Washington, 98034

  • Study site

    Memphis, Tennessee, 38163

  • Study site

    New York, New York, 10032

  • Study site

    San Diego, California, 92037

  • Study site

    Tampa, Florida, 33612

Other trials in United States

About this study

Official title: Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Safety and Efficacy of OMS643762 in Subjects With Huntington's Disease

The purpose of this study is to determine the safety, tolerability and pharmacokinetics of OMS643762 (the study drug) in subjects with Huntington's disease (HD).

Being tested
OMS643762, Placebo
Medical subject headings
Huntington Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OMS643762Drug

    Also called OMS824

  • PlaceboDrug

Study groups in NCT02074410
Study groupRoleWhat they receive
OMS643762 Low Dose without foodExperimentalOrally administering OMS643762 low dose daily without food for 28 days
Receives: Drug: OMS643762
OMS643762 Medium Dose without foodExperimentalOrally administering OMS643762 medium dose daily without food for 28 days
Receives: Drug: OMS643762
OMS643762 Medium Dose with foodExperimentalOrally administering OMS643762 Medium dose daily with food for 28 days
Receives: Drug: OMS643762
PlaceboPlacebo comparatorOrally administering placebo daily for 28 days
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Assess the Safety of OMS643762

    Safety as assessed by adverse events

    Measured: 28 days

  2. Assess the Safety of OMS643762

    Safety as assessed by vital signs

    Measured: 28 days

  3. Assess the Safety of OMS643762

    Safety as assessed by clinical lab-tests

    Measured: 28 days

  4. Assess the Safety of OMS643762

    Safety as assessed by ECG

    Measured: 28 days

  5. Assess the Safety of OMS643762

    Safety as assessed by Columbia-Suicide Severity Rating Scale (C-SSRS)

    Measured: 28 days

Secondary outcomes (5)

  1. Motor function

    Change from baseline in the UHDRS - Total Motor Score

    Measured: Pre-dose and day 15 and 28 post-dose

  2. Motor function

    Change from baseline in the Speeded Tapping Test score

    Measured: Pre-dose and day 15 and 28 post-dose

  3. Cognition

    Change from baseline in the Cognitive Assessment Battery composite score

    Measured: Pre-dose and day 28 post-dose

  4. Behavior

    Change from baseline in the Problem Behavior Assessment score

    Measured: Pre-dose and day 28 of dosing

  5. Pharmacokinetics profile

    Maximum plasma concentration of OMS643762 following multiple-dose administration

    Measured: Pre-dose, day 15 and 28 of dosing and up to 14 days post-dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Feb 2014 (estimated)
  2. Study startJan 2014
  3. Primary completion15 Oct 2014
  4. Study completion15 Oct 2014

Why it stopped: Sponsor decision - pending further analysis of available data

Resources

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
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02074410
Sponsor's protocol ID
OMS824-HTD-002
Status last verified
Oct 2018
First submitted
21 Feb 2014
Last updated
22 Oct 2018
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing OMS643762 in people with Huntington's Disease, run by Omeros Corporation at 9 sites 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 13 inclusion and 8 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: stopped early, as of the sponsor's last update on 22 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites 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 was stopped early (reason given: Sponsor decision - pending further analysis of available data). Results are not available in the source record.

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?

Assess the Safety of OMS643762 (time frame: 28 days). The study lists 5 primary outcomes in all. 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 NCT02074410.

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 22 Oct 2018.

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