A Double-Blind, Double-Dummy, Randomized, Placebo-Controlled, 3-Period, Crossover Study to Investigate the Effects of Ethanol and L-000830982 on Essential Tremor.
Completed
- Conditions
- Outpatient intervention study.
- Registration Number
- NL-OMON22574
- Lead Sponsor
- Centre for Human Drug Research
- Brief Summary
/A
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 9
Inclusion Criteria
1. Men and women;
2. At least 18 years of age;
Exclusion Criteria
1. Medical condition interfering with clinical evaluations or conduct of the study;
2. Smoking > 5 cigarettes per day;
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The sensitivity and specificity of Actiwatch and DynaPort MiniMod in discriminating tremor movements from other movements holding the clinical accelerometry/myography-based tremography as the gold standard.
- Secondary Outcome Measures
Name Time Method 1. Tremor intensity, measured by average acceleration amplitude (ìV);<br /><br>2. Tremor duration measured by average duration of epochs classified as tremor (sec);<br /><br>3. Tremor amount, measured by proportion of tremor movements per time unit (min/hr);<br /><br>4. Tremor Clinical Rating Scale.