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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02074410
Recruitment Status : Terminated (Sponsor decision - pending further analysis of available data)
First Posted : February 28, 2014
Last Update Posted : October 22, 2018
Sponsor:
Information provided by (Responsible Party):
Omeros Corporation

Tracking Information
First Submitted Date  ICMJE February 21, 2014
First Posted Date  ICMJE February 28, 2014
Last Update Posted Date October 22, 2018
Study Start Date  ICMJE January 2014
Actual Primary Completion Date October 15, 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 26, 2014)
  • Assess the Safety of OMS643762 [ Time Frame: 28 days ]
    Safety as assessed by adverse events
  • Assess the Safety of OMS643762 [ Time Frame: 28 days ]
    Safety as assessed by vital signs
  • Assess the Safety of OMS643762 [ Time Frame: 28 days ]
    Safety as assessed by clinical lab-tests
  • Assess the Safety of OMS643762 [ Time Frame: 28 days ]
    Safety as assessed by ECG
  • Assess the Safety of OMS643762 [ Time Frame: 28 days ]
    Safety as assessed by Columbia-Suicide Severity Rating Scale (C-SSRS)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02074410 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 17, 2018)
  • Motor function [ Time Frame: Pre-dose and day 15 and 28 post-dose ]
    Change from baseline in the UHDRS - Total Motor Score
  • Motor function [ Time Frame: Pre-dose and day 15 and 28 post-dose ]
    Change from baseline in the Speeded Tapping Test score
  • Cognition [ Time Frame: Pre-dose and day 28 post-dose ]
    Change from baseline in the Cognitive Assessment Battery composite score
  • Behavior [ Time Frame: Pre-dose and day 28 of dosing ]
    Change from baseline in the Problem Behavior Assessment score
  • Pharmacokinetics profile [ Time Frame: Pre-dose, day 15 and 28 of dosing and up to 14 days post-dose ]
    Maximum plasma concentration of OMS643762 following multiple-dose administration
Original Secondary Outcome Measures  ICMJE
 (submitted: February 26, 2014)
  • Motor function [ Time Frame: Pre-dose and day 15 and 28 post-dose ]
    Change from baseline in the UHDRS - Total Motor Score
  • Motor function [ Time Frame: Pre-dose and day 15 and 28 post-dose ]
    Change from baseline in the Speeded Tapping Test score
  • Cognition [ Time Frame: Pre-dose and day 28 post-dose ]
    Change from baseline in the Cognitive Assessment Battery composite score
  • Behavior [ Time Frame: Pre-dose and day 28 of dosing ]
    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 ]
    Maximum plasma concentration of OMS643762 following multiple-dose administration
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of OMS643762 in Subjects With Huntington's Disease
Official Title  ICMJE Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Safety and Efficacy of OMS643762 in Subjects With Huntington's Disease
Brief 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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Huntington's Disease
Intervention  ICMJE
  • Drug: OMS643762
    Other Name: OMS824
  • Drug: Placebo
Study Arms  ICMJE
  • Experimental: OMS643762 Low Dose without food
    Orally administering OMS643762 low dose daily without food for 28 days
    Intervention: Drug: OMS643762
  • Experimental: OMS643762 Medium Dose without food
    Orally administering OMS643762 medium dose daily without food for 28 days
    Intervention: Drug: OMS643762
  • Experimental: OMS643762 Medium Dose with food
    Orally administering OMS643762 Medium dose daily with food for 28 days
    Intervention: Drug: OMS643762
  • Placebo Comparator: Placebo
    Orally administering placebo daily for 28 days
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: October 17, 2018)
22
Original Estimated Enrollment  ICMJE
 (submitted: February 26, 2014)
120
Actual Study Completion Date  ICMJE October 15, 2014
Actual Primary Completion Date October 15, 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02074410
Other Study ID Numbers  ICMJE OMS824-HTD-002
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Omeros Corporation
Study Sponsor  ICMJE Omeros Corporation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Steve Whitaker, MD Omeros Corporation
PRS Account Omeros Corporation
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP