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…
ID
Bron
Verkorte titel
Aandoening
Outpatient intervention study.
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
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.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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.
Onderzoeksopzet
N/A
Onderzoeksproduct en/of interventie
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.
Publiek
Zernikedreef 10
S.L. Haas, de
Zernikedreef 10
Leiden 2333 CL
The Netherlands
+31 (0)71 5246400
Wetenschappelijk
Zernikedreef 10
S.L. Haas, de
Zernikedreef 10
Leiden 2333 CL
The Netherlands
+31 (0)71 5246400
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL374 |
| NTR-old | NTR414 |
| Ander register | : P05.058 |
| ISRCTN | ISRCTN71182680 |