A Pilot Efficacy and Safety Study of ST101 in Essential Tremor
|ClinicalTrials.gov Identifier: NCT01332695|
Recruitment Status : Completed
First Posted : April 11, 2011
Last Update Posted : January 6, 2012
|Condition or disease||Intervention/treatment||Phase|
|Essential Tremor||Drug: ST101 Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Randomized, Double-Blind, Placebo-Controlled, Cross-Over, Safety, Tolerability and Proof of Concept Study of ST101 for Essential Tremor|
|Study Start Date :||April 2011|
|Actual Primary Completion Date :||December 2011|
|Actual Study Completion Date :||December 2011|
ST101 oval tablets
tablets for oral administration
Placebo Comparator: Placebo
oval tablets to match ST101 tablet
placebo to match
- Washington Heights-Inwood Genetic Study of Essential Tremor (WHIGET) Rating Scale [ Time Frame: Baseline, Week 3, Week 5, Week 8 ]The WHIGET Rating Scale is a 6-item scale. Ratings are performed for the right and left side for each activity. Each subject is videotaped in the same manner performing set activities, which are then rated. Rated tasks involve fine motor skills. Each item is scored by an independent, central, blinded reader, and the item scores are summed to provide a total score. Total score range is from 0 to 48, with an increase in score reflecting an increase in ET severity.
- Functional Disabilities Scale [ Time Frame: Screening, Baseline, Weeks 3, 5, 8 ]An 8-Item functional scale that assesses the following functional domains: Speaking/Phonation, Feeding (other than liquids), Bringing Liquids to Mouth, Hygiene, Dressing, Writing, Working, and Social Activities. Higher scores indicate worsening of disease.
- Clinical Global Impression of Change [ Time Frame: Week 3, Week 8 ]A 7-point Likert scale with Marked Worsening to Marked Improvement at the extremes, and Unchanged in the center. Scores range from -3 to +3 wherein negative scores indicate worsening, while positive scores indicate improvement.
- Subject Clinical Global Impression of Change [ Time Frame: Week 3, Week 8 ]A global visual analog scale (VAS) which is a 100 mm horizontal line on which the subject indicates their overall assessment of response to study drug by making a mark on the horizontal line.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01332695
|United States, California|
|Los Angeles, California, United States|