Tolerability, Safety, and Activity of SRX246 in Irritable Subjects With Huntington's Disease
An Exploratory Phase II Study to Determine the Tolerability, Safety, and Activity of a Novel Vasopressin 1a Receptor Antagonist (SRX246) in Irritable Subjects With Huntington's Disease (HD)
2 other identifiers
interventional
106
1 country
22
Brief Summary
This study evaluates the tolerability, safety and activity of SRX246 in the treatment of irritability in patients with Huntington's disease. Two-thirds of all participants will receive SRX246, while the other third will receive a placebo.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started May 2016
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 22, 2015
CompletedFirst Posted
Study publicly available on registry
July 23, 2015
CompletedStudy Start
First participant enrolled
May 10, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 10, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 21, 2018
CompletedResults Posted
Study results publicly available
July 20, 2023
CompletedJuly 20, 2023
July 1, 2023
2.3 years
July 22, 2015
November 17, 2021
July 18, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Tolerability of SRX246
The primary endpoint, tolerability of SRX246, was assessed by the number of completers in each group.
12 weeks
Secondary Outcomes (1)
Safety of SRX246
12 weeks
Study Arms (3)
SRX246 120mg BID
EXPERIMENTALSRX246 capsules, administered orally, in divided doses twice daily
SRX246 160mg BID
EXPERIMENTALSRX246 capsules, administered orally, in divided doses twice daily
Placebo
PLACEBO COMPARATORPlacebo capsules, administered orally, in divided doses twice daily
Interventions
Eligibility Criteria
You may qualify if:
- Male and female Subjects aged 18 years or older
- Subjects must have clinical features of HD, which can include motor, cognitive, or behavioral symptoms
- A confirmatory family history of HD; OR CAG repeat expansion ≥ 37
- Total Functional Capacity (TFC) score of 5-13
- Evidence of irritability; a score of at least 2 or greater on the severity measure of either the UHDRS Irritability question (30b) or Aggression question (Disruptive or Aggressive Behavior, 31b)
- Women of childbearing potential (i.e., those not postmenopausal or surgically sterile) must have a negative pregnancy test, be non-lactating and use adequate contraception methods during the study. Adequate birth control includes: abstinence; oral, implanted or injected contraceptives, e.g., birth control pills; intra-uterine device; barrier (vaginal ring or diaphragm/cervical cap with spermicide); transdermal patch. Reliable contraception must have been in use 30 days prior to the Baseline Visit. Partner(s) contraception (e.g., male partner with vasectomy or other surgical contraception) is acceptable.
- Men must agree not to father a child during the study and one month after and to use contraception. Barrier with spermicide or surgical contraception is acceptable. Partner(s) contraception (e.g., female partner taking birth control pills or surgically sterile) is acceptable.
- Subjects must be able to swallow study drug capsules whole.
- Sufficient English skills to complete all assessments without assistance of an English language interpreter. Subjects with HD who cannot read or write might qualify for enrollment in the study. Site PIs will have to decide in each case whether the Subject can understand and fully participate with help from his/her Informant.
- Availability of a responsible Informant (referred to as a "study partner" in the consent document) who has good English skills, is familiar with the Subject, and is able and willing to comply with all required study procedures, ensuring that the patient attends all study visits and takes the study medicine as instructed. The study partner must spend time with the patient a minimum of 4 times per week on 4 separate days, and must monitor the patient's compliance and adverse events, participate in caregiver assessments, and use the eDiary.
- Subject has provided written, informed consent or, if Subject lacks the capacity to provide informed consent (as determined by an independent assessment by a qualified healthcare provider not directly involved in other study activities), a legally authorized representative (LAR) has provided written informed consent and the Subject has provided assent.
You may not qualify if:
- Any significant neurologic disease other than HD at Screening.
- Severe psychotic features or other severe psychiatric symptoms within the last three months which could lead to difficulty complying with the protocol.
- History of active alcohol or substance abuse within the past two years or Subject is unable to refrain from substance abuse throughout the study.
- Any chronic disability, significant systemic illness or unstable medical condition at Screening or Baseline that could lead to difficulty complying with the protocol.
- Use of any investigational drugs within 30 days of Screening.
- Subject has known allergy to any of the components of study medication.
- Subject is currently pregnant, breast-feeding and/or lactating.
- Subject acknowledges present use of illicit drugs at Screening.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Azevan Pharmaceuticalslead
- National Institute of Neurological Disorders and Stroke (NINDS)collaborator
- NeuroNEXT Networkcollaborator
Study Sites (22)
University of Alabama
Birmingham, Alabama, 35233, United States
UCLA, Neurology Clinic
Los Angeles, California, 90095, United States
UC Davis Medical Center, Department of Neurology, CTSC Clinical Research Center
Sacramento, California, 95817, United States
University of Colorado Hospital Translational Research Center
Aurora, Colorado, 80045, United States
University of Miami, Miller School of Medicine, Jackson Behavioral Health Hospital
Miami, Florida, 33136, United States
Emory University
Atlanta, Georgia, 30329, United States
Northwestern Out-Patient Neurology Clinic
Chicago, Illinois, 60611, United States
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
Massachusetts General Hospital
Charlestown, Massachusetts, 02129, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
SUNY Stony Brook Clinical Research Center, Department of Neurology
East Setauket, New York, 11733, United States
Columbia University Medical Center, New York Presbyterian Hospital
New York, New York, 10032, United States
University of Rochester Medical Center
Rochester, New York, 14618, United States
University Medical Arts Building
Cincinnati, Ohio, 45219, United States
Ohio State University, Wexner Medical Center, Department of Neurology
Columbus, Ohio, 43221, United States
Oregon Health and Science University
Portland, Oregon, 97239, United States
University of Pittsburgh Medical Center, Department of Neurology
Pittsburgh, Pennsylvania, 15213, United States
Vanderbilt Clinical Research Center
Nashville, Tennessee, 37232, United States
UT Southwestern Medical Center
Dallas, Texas, 75390, United States
University of Utah, Department of Neurology
Salt Lake City, Utah, 84108, United States
University of Virginia Health System, Department of Neurology
Charlottesville, Virginia, 22908, United States
Swedish Neuroscience Institute
Seattle, Washington, 98122, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Neal Simon, PhD
- Organization
- Azevan Pharmaceuticals, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 22, 2015
First Posted
July 23, 2015
Study Start
May 10, 2016
Primary Completion
September 10, 2018
Study Completion
December 21, 2018
Last Updated
July 20, 2023
Results First Posted
July 20, 2023
Record last verified: 2023-07