Condition category
Nervous System Diseases
Date applied
27/01/2006
Date assigned
27/01/2006
Last edited
03/07/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.chdr.nl

Contact information

Type

Scientific

Primary contact

Dr S.L. Haas, de

ORCID ID

Contact details

Centre for Human Drug Research
Zernikedreef 10
Leiden
2333 CL
Netherlands

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR414; P05.058

Study information

Scientific title

Acronym

Study hypothesis

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

Ethics approval

Received from the local medical ethics committee

Study design

randomised, double blind, placebo controlled, crossover group study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Tremor

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 hours) or placebo IV

Intervention type

Drug

Phase

Not Specified

Drug names

L-000830982, ethanol

Primary outcome measures

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

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/hour)
4. Tremor Clinical Rating Scale

Overall trial start date

06/07/2005

Overall trial end date

01/12/2005

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

9

Participant 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 the previous 3 months
4. Participation in a clinical trial within the previous 3 months
5. Medication use

Recruitment start date

06/07/2005

Recruitment end date

01/12/2005

Locations

Countries of recruitment

Netherlands

Trial participating centre

Centre for Human Drug Research
Leiden
2333 CL
Netherlands

Sponsor information

Organisation

Centre for Human Drug Research (CHDR) (Netherlands)

Sponsor details

Zernikedreef 10
Leiden
2333 CL
Netherlands

Sponsor type

Research organisation

Website

Funders

Funder type

Research organisation

Funder name

Centre for Human Drug Research (CHDR) (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes