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

This study has suspended participant recruitment.
(Enrollment has been suspended in this study.)
Sponsor:
Information provided by (Responsible Party):
Omeros Corporation
ClinicalTrials.gov Identifier:
NCT02074410
First received: February 21, 2014
Last updated: October 17, 2014
Last verified: October 2014
  Purpose

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).


Condition Intervention Phase
Huntington's Disease
Drug: OMS643762
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Safety and Efficacy of OMS643762 in Subjects With Huntington's Disease

Resource links provided by NLM:


Further study details as provided by Omeros Corporation:

Primary Outcome Measures:
  • Assess the Safety of OMS643762 [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
    Safety as assessed by adverse events

  • Assess the Safety of OMS643762 [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
    Safety as assessed by vital signs

  • Assess the Safety of OMS643762 [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
    Safety as assessed by clinical lab-tests

  • Assess the Safety of OMS643762 [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
    Safety as assessed by ECG

  • Assess the Safety of OMS643762 [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
    Safety as assessed by Columbia-Suicide Severity Rating Scale (C-SSRS)


Secondary Outcome Measures:
  • Motor function [ Time Frame: Pre-dose and day 15 and 28 post-dose ] [ Designated as safety issue: No ]
    Change from baseline in the UHDRS - Total Motor Score

  • Motor function [ Time Frame: Pre-dose and day 15 and 28 post-dose ] [ Designated as safety issue: No ]
    Change from baseline in the Speeded Tapping Test score

  • Cognition [ Time Frame: Pre-dose and day 28 post-dose ] [ Designated as safety issue: No ]
    Change from baseline in the Cognitive Assessment Battery composite score

  • Behavior [ Time Frame: Pre-dose and day 28 of dosing ] [ Designated as safety issue: No ]
    Change from baseline in the Problem Behavior Assessment score

  • Pharmacokinetics [ Time Frame: Pre-dose, day 15 and 28 of dosing and up to 14 days post-dose ] [ Designated as safety issue: No ]
    Maximum plasma concentration of OMS643762 following multiple-dose administration


Estimated Enrollment: 36
Study Start Date: January 2014
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: OMS643762 Low Dose without food
Orally administering OMS643762 low dose daily without food for 28 days
Drug: OMS643762
Other Name: OMS824
Experimental: OMS643762 Medium Dose without food
Orally administering OMS643762 medium dose daily without food for 28 days
Drug: OMS643762
Other Name: OMS824
Experimental: OMS643762 Medium Dose with food
Orally administering OMS643762 Medium dose daily with food for 28 days
Drug: OMS643762
Other Name: OMS824
Placebo Comparator: Placebo
Orally administering placebo daily for 28 days
Drug: Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 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.
  2. 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.
  3. Are age greater than or equal to 18 and less than or equal to 65 years at the screening visit (Visit 1).
  4. Have a UHDRS Total Functional Capacity greater than or equal to 7 at Visit 1.
  5. If currently taking antipsychotic medication(s), have been on a stable regimen for at least 60 days prior to randomization.
  6. Are fluent in English.
  7. 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.
  8. 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.
  9. Have normal clinical laboratory test results and ECG, or results with minor deviations, which are not considered to be clinically significant by the investigator.

Exclusion Criteria:

  1. 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.
  2. Have unstable or severe depression, in the opinion of the investigator.
  3. Have alcohol or drug abuse or dependence, as defined by the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision.
  4. Have received treatment with an investigational drug or device within 60 days prior to Visit 1.
  5. Are pregnant or lactating.
  6. Have serum alanine transaminase or aspartate transaminase greater than two times upper limit of normal at screening.
  7. Have hemoglobin, white blood cell count, absolute neutrophil count, or platelet count outside the normal range at screening.
  8. Are an employee of Omeros, an investigator, or study staff member, or their immediate family member.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02074410

Locations
United States, California
San Diego, California, United States, 92037
United States, Colorado
Englewood, Colorado, United States, 80113
United States, Florida
Gainesville, Florida, United States, 32607
Tampa, Florida, United States, 33612
United States, Maryland
Baltimore, Maryland, United States, 21287
United States, New York
New York, New York, United States, 10032
United States, Tennessee
Memphis, Tennessee, United States, 38163
United States, Texas
Houston, Texas, United States, 77030
United States, Washington
Kirkland, Washington, United States, 98034
Sponsors and Collaborators
Omeros Corporation
Investigators
Study Director: Steve Whitaker, MD Omeros Corporation
  More Information

No publications provided

Responsible Party: Omeros Corporation
ClinicalTrials.gov Identifier: NCT02074410     History of Changes
Other Study ID Numbers: OMS824-HTD-002
Study First Received: February 21, 2014
Last Updated: October 17, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Huntington Disease
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Chorea
Cognition Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders
Dementia
Dyskinesias
Genetic Diseases, Inborn
Heredodegenerative Disorders, Nervous System
Mental Disorders
Movement Disorders
Nervous System Diseases
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on October 20, 2014