Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:28 PM
Ignite Modification Date:
2025-12-24 @ 2:28 PM
NCT ID:
NCT01795859
Eligibility Criteria:
Inclusion Criteria:
* Subject is at least 18 years of age or the age of majority (whichever is older) at Screening.
* Subject has been diagnosed with manifest HD
* Subject is able to swallow study medication whole.
* Female subjects of childbearing potential agree to use an acceptable method of contraception from screening through study completion.
* The subject has a reliable caregiver who interacts with the patient on a daily basis, oversees study drug administration, assures attendance at study visits and participates in evaluations, as required.
* Subject is able to ambulate without assistance for at least 20 yards (Note: The use of assistive devices (i.e., walker, cane) is permitted during ambulation).
Exclusion Criteria:
* Subject has a serious untreated or under-treated psychiatric illness, such as depression, at Screening or Baseline.
* Subject has active suicidal ideation at Screening or Baseline.
* Subject has history of suicidal behavior at Screening or Baseline:
* Subject has evidence for depression at Screening or Baseline.
* Subject has an unstable or serious medical or psychiatric illness at Screening or Baseline.
* Subject has been recently exposed to tetrabenazine.
* Subject has received any of the following concomitant medications within 30 days of Screening or Baseline:
* Antipsychotics
* Metoclopramide
* Monoamine oxidase inhibitors (MAOI)
* Levodopa or dopamine agonists
* Reserpine
* Amantadine
* Memantine
* Subject has significantly impaired swallowing function at Screening.
* Subject has significantly impaired speaking at Screening.
* Subject requires treatment with drugs known to prolong the QT interval.
* Subject has a prolonged QT interval on 12-lead ECG at Screening.
* Subject has evidence of hepatic impairment at Screening.
* Subject has evidence of significant renal impairment at Screening.
* Subject has known allergy to any of the components of study medication.
* Subject has participated in an investigational drug or device trial within 30 days (or 5 drug half-lives) of Screening, whichever is longer.
* Subject is pregnant or breast-feeding at Screening or Baseline.
* Subject acknowledges present use of illicit drugs at Screening.
* Subject has a history of alcohol or substance abuse in the previous 12 months.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01795859
Study Brief:
Protocol Section:
NCT01795859