EIP Pharma Inc
Study terminated (Due to the long delay because of COVID-19 and results from another study suggesting a higher dose may be more beneficial, EIP Pharma decided on October 15th, 2020, to end the trial prematurely.)
Ages Eligible for Study:
30 Years to 70 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
- Men and women age 30 to 70 years, inclusive.
- Willing and able to provide informed consent.
- Must have genetically confirmed HD and identified cognitive deficits
- Stage 1, as defined by Unified Huntington’s Disease Rating Scale (UHDRS) Total Functional Capacity (TFC) score >10, and,
- CANTAB Paired Associate Learning Total Adjusted Error Score of >16.
- Normal or corrected eye sight and auditory abilities, sufficient to perform all aspects of the cognitive and functional assessments.
- No history of learning difficulties that may interfere with the subject’s ability to complete the cognitive tests.
- A profile of impairment that is not consistent with Huntington’s disease (HD).
- Diagnosis of any other ongoing central nervous system condition other than HD, including, but not limited to, vascular dementia, dementia with Lewy bodies, and Parkinson’s disease.
- Suicidality, defined as active suicidal thoughts within 6 months before Screening or at Baseline, defined as answering yes to items 4 or 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS), or history of suicide attempt in previous 2 years, or, in the Investigator’s opinion, at serious risk of suicide.
- Ongoing major and active psychiatric disorder, moderate to severe depressive symptoms, and or other concurrent medical condition that, in the opinion of the Investigator, might compromise safety and/or compliance with study requirements.
- Diagnosis of alcohol or drug abuse within the previous 2 years.
- Poorly controlled clinically significant medical illness, such as hypertension (blood pressure >180 mmHg systolic or 100 mmHg diastolic); myocardial infarction within 6 months; uncompensated congestive heart failure or other significant cardiovascular, pulmonary, renal, liver, infectious disease, immune disorder, or metabolic/endocrine disorders or other disease that would preclude treatment with p38 mitogen activated protein (MAP) kinase inhibitor and/or assessment of drug safety and efficacy.
- Anemia with a hemoglobin ≤10 g/dL, clinically significant thyroid function abnormality, electrolyte abnormalities.
- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >1.5 × the upper limit of normal (ULN), total bilirubin >1.5 × ULN, and/or International Normalized Ratio (INR) >1.5.
- Known human immunodeficiency virus; or active hepatitis B or hepatitis C virus infection; evidence of active or latent tuberculosis.
- Subject participated in a study of an investigational drug less than 3 months or 5 half-lives of an investigational drug, whichever is longer, before enrollment in this study.
- History of previous neurosurgery to the brain.
- Female subjects who are pregnant or breast-feeding.
- Male subjects with female partners of child-bearing potential who are unwilling or unable to adhere to contraception requirements specified in the protocol (see Section 5.8).
- Female subjects who have not reached menopause or have not had a hysterectomy or bilateral oophorectomy/salpingo-oophorectomy and are not willing or unable to adhere to contraceptive requirements specified in the protocol (see Section 5.8).
- Requires concomitant use of cytochrome P450 (CYP) 3A4 inhibitors or anti-tumor necrosis factor-alpha therapies during study participation.
- Known allergy to any ingredient of the trial medication or placebo.