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

Study Description

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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).

Condition or disease	Intervention/treatment	Phase
Huntington's Disease	Drug: OMS643762; Drug: Placebo	Phase 2

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	36 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Quadruple (Participant, Care Provider, 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
Study Start Date :	January 2014
Estimated Primary Completion Date :	March 2016
Estimated Study Completion Date :	March 2016

Arms and Interventions

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Arm	Intervention/treatment
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

Outcome Measures

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Primary Outcome Measures :

1. Assess the Safety of OMS643762 [ Time Frame: 28 days ]
   Safety as assessed by adverse events
2. Assess the Safety of OMS643762 [ Time Frame: 28 days ]
   Safety as assessed by vital signs
3. Assess the Safety of OMS643762 [ Time Frame: 28 days ]
   Safety as assessed by clinical lab-tests
4. Assess the Safety of OMS643762 [ Time Frame: 28 days ]
   Safety as assessed by ECG
5. Assess the Safety of OMS643762 [ Time Frame: 28 days ]
   Safety as assessed by Columbia-Suicide Severity Rating Scale (C-SSRS)

Secondary Outcome Measures :

1. Motor function [ Time Frame: Pre-dose and day 15 and 28 post-dose ]
   Change from baseline in the UHDRS - Total Motor Score
2. Motor function [ Time Frame: Pre-dose and day 15 and 28 post-dose ]
   Change from baseline in the Speeded Tapping Test score
3. Cognition [ Time Frame: Pre-dose and day 28 post-dose ]
   Change from baseline in the Cognitive Assessment Battery composite score
4. Behavior [ Time Frame: Pre-dose and day 28 of dosing ]
   Change from baseline in the Problem Behavior Assessment score
5. 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

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 65 Years (Adult)
Sexes Eligible for Study:	All
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

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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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Omeros Corporation
ClinicalTrials.gov Identifier:	NCT02074410 History of Changes
Other Study ID Numbers:	OMS824-HTD-002
First Posted:	February 28, 2014
Last Update Posted:	April 21, 2015
Last Verified:	October 2014

Additional relevant MeSH terms:

Huntington Disease; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Dementia; Chorea; Dyskinesias	Movement Disorders; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Genetic Diseases, Inborn; Cognition Disorders; Neurocognitive Disorders; Mental Disorders