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
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