search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


A Double-Blind, Double-Dummy, Randomized, Placebo-Controlled, 3-Period, Crossover Study to Investigate the Effects of Ethanol and L-000830982 on Essential Tremor.


- candidate number1674
- NTR NumberNTR414
- ISRCTNISRCTN71182680
- Date ISRCTN created27-jan-2006
- date ISRCTN requested18-nov-2005
- Date Registered NTR15-sep-2005
- Secondary IDsP05.058 
- Public TitleA Double-Blind, Double-Dummy, Randomized, Placebo-Controlled, 3-Period, Crossover Study to Investigate the Effects of Ethanol and L-000830982 on Essential Tremor.
- Scientific TitleA Double-Blind, Double-Dummy, Randomized, Placebo-Controlled, 3-Period, Crossover Study to Investigate the Effects of Ethanol and L-000830982 on Essential Tremor.
- ACRONYMN/A
- hypothesis1. 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.
- Healt Condition(s) or Problem(s) studiedTremor
- Inclusion criteria1. 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 criteria1. 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.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 6-jul-2005
- planned closingdate1-dec-2005
- Target number of participants9
- Interventions1. 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.
- Primary outcomeThe 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 outcome1. Tremor intensity, measured by average acceleration amplitude (ýV);
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.
- TimepointsN/A
- Trial web sitehttp://www.chdr.nl
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIESDrs. S.L. Haas, de
- CONTACT for SCIENTIFIC QUERIESProf. Dr. J.M.A. Gerven, van
- Sponsor/Initiator Center for Human Drug Research (CHDR)
- Funding
(Source(s) of Monetary or Material Support)
Centre for Human Drug Research (CHDR), Leiden
- PublicationsN/A
- Brief summaryIn 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.
- Main changes (audit trail)
- RECORD15-sep-2005 - 17-sep-2008


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl