No registrations found.
ID
Source
Brief title
Health condition
Outpatient intervention study.
Sponsors and support
Intervention
Outcome measures
Primary outcome
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
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.
Background summary
In the current study, ambulatory methods for measuring tremor will be compared against a gold-standard laboratory tremography method to determine their utility for outpatient proof-of-concept studies. Additionally, the effects of L-000830982 and ethanol infusion on tremor will be determined and compared to placebo. This will be studied in a double-blind, double-dummy, randomized, placebo-controlled, 3-Period, crossover study.
Study objective
1. The effect of a single oral dose of L-000830982 versus oral placebo and an
intravenous infusion of ethanol versus placebo on tremor over a 8-hour period in men and women with essential tremor will be estimated;
2. The sensitivity and specificity of laboratory tremography versus 2 ambulant tremography methods in classifying tremor movements versus other movements over a 8-hour period in men and women with essential tremor will be estimated.
Study design
N/A
Intervention
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.
Zernikedreef 10
S.L. Haas, de
Zernikedreef 10
Leiden 2333 CL
The Netherlands
+31 (0)71 5246400
Zernikedreef 10
S.L. Haas, de
Zernikedreef 10
Leiden 2333 CL
The Netherlands
+31 (0)71 5246400
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
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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL374 |
| NTR-old | NTR414 |
| Other | : P05.058 |
| ISRCTN | ISRCTN71182680 |