Phase
Condition
Dyskinesias
Treatment
Time-Restricted Eating Diet
Clinical Study ID
Ages > 21 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Subjects eligible to participate in this study are persons who:
Are of at least 21 years of age at Screening.
Must fulfill one of the following criteria:
Premanifest late prodromal HD as defined by a genetically confirmed CAG repeatgreater than or equal to 36 and a CAG-Age Product (CAP) score greater than 368 (CAP = (Age) x (CAG - 33.66)).
Early manifest (stage I and II) HD as defined by a TFC greater than or equal to
Subjects must have been determined to have a clinical diagnosis of HD by thesite investigator as defined by a diagnostic confidence level (DCL) of 4.
Must fulfill both of the following criteria:
Have undergone genetic testing with a known CAG repeat greater than or equal to
No features of juvenile HD (Westphal variant) Clarification of CAG Repeat Number (Allele length) Testing Requirements: A CAG repeat number obtained prior to the Screening Visit will be used to documentsubject eligibility if at Screening there is documentation available in thesubject's record that states that the subject has an expanded CAG repeat (greaterthan or equal to 36) from a prior validated laboratory assessment.
All female subjects of childbearing potential must have a negative urine pregnancytest at baseline, and female subjects of childbearing potential must practice ahighly effective method of contraception (e.g., oral contraceptives, a barriermethod of birth control [e.g. condoms with contraceptive foams, diaphragms withcontraceptive jelly], intrauterine devices, partner with vasectomy or sexualabstinence) for the duration of the study.
Are willing and capable of providing informed consent for study participation.
Are capable of reading, writing, and communicating effectively with others.
Exclusion
Exclusion Criteria:
Subjects ineligible to participate in this study are persons who:
Have participated in an investigational drug or device study within 30 days of thebaseline visit
Have had previous neurosurgery for Huntington's disease or other movement disorders.
Have clinically significant cognitive impairment that hinders the ability toappropriately consent or adhere to detailed study directions, in the opinion of theprincipal investigator.
Have a presence of clinically significant psychosis and/or confusional states, inthe opinion of the principal investigator.
Have clinically relevant hematologic, hepatic, cardiac, thyroid, or renal disease.
Have a history of substance abuse (based on DSMIV criteria) within the past 12months prior to screening.
If female, are pregnant or breastfeeding.
Have a high-risk for nutritional deficiency.
Are not weight stable for at least three months prior to enrolling in the study,defined as greater than 2 kg change in body mass.
Express a desire to lose weight during the study.
Have a clinically significant medical, surgical, laboratory, or behavioralabnormality which in the judgment of the site Investigator makes the subjectunsuitable for the study.
Have consistently practiced a time-restricted eating protocol within 3 months oftrial onset.
Study Design
Study Description
Connect with a study center
Oregon Health and Science University
Portland, Oregon 97239
United StatesActive - Recruiting
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