Intervention: Unii-372X2P22UY
Trial phase: Phase 2
SMILES: CC(NC(=O)C(CC(=O)N1CCC(N2CCCCC2)CC1)N1C(=O)C(N2C(=O)OCC2c2ccccc2)C1C=Cc1ccccc1)c1ccccc1
Sex: All
Age groups: Adult | Older Adult
Healthy volunteers: No
Participants at risk: 34
Group description: SRX246 capsules, administered orally, in divided doses twice daily. This group includes those participants that were enrolled and randomized to the group assigned to receive 160mg BID throughout the study. The data are reported based on 3 arms: SRX246 120mg, SRX246 160mg and Placebo. All subjects were randomized at the beginning of the study to one of those 3 arms. Thus, the data are displayed this way, even though all participants randomized to the SRX246 arms received a starting dose of SRX246 80mg, then escalated to SRX246 120mg, and then the group that was randomized to the SRX246 160mg was dose escalated.
Eligibility criteria:
Inclusion Criteria:

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.

Exclusion Criteria:

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.