Outpatient intervention study.
Conditions
Interventions
1. L-000830982 2.0 mg PO or placebo
2. EtOH, infused at a rate to maintain a plasma concentration of ~0.6 g/L (4 hrs) or placebo IV.
Sponsors
Centre for Human Drug Research
Eligibility
Inclusion criteria
Inclusion criteria: 1. Men and women; 2. At least 18 years of age; 3. Essential Tremor diagnosed by a neurologist; 4. General good health; 5. Tremor symptoms present for > 6 months and relieved by ethanol.
Exclusion criteria
Exclusion criteria: 1. Medical condition interfering with clinical evaluations or conduct of the study; 2. Smoking > 5 cigarettes per day; 3. Blood donation > 500 ml in previous 3 months; 4. Particpation clinical trial within previous 3 months; 5. Medication use.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 1. Tremor intensity, measured by average acceleration amplitude (ìV); 2. Tremor duration measured by average duration of epochs classified as tremor (sec); 3. Tremor amount, measured by proportion of tremor movements per time unit (min/hr); 4. Tremor Clinical Rating Scale. | — |
Contacts
Public ContactS.L. Haas, de
Center for Human Drug Research (CHDR), Zernikedreef 10
Outcome results
None listed