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

ISRCTN	ISRCTN71182680
DOI	https://doi.org/10.1186/ISRCTN71182680
Secondary identifying numbers	NTR414; P05.058

Submission date: 27/01/2006
Registration date: 27/01/2006
Last edited: 03/07/2009

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nervous System Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Study website

Contact information

Dr S.L. Haas, de
Scientific

Centre for Human Drug Research
Zernikedreef 10
Leiden
2333 CL
Netherlands

Study information

Study design	randomised, double blind, placebo controlled, crossover group study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title
Study objectives	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(s)	Received from the local medical ethics committee
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	L-000830982, ethanol
Primary outcome measure	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 study start date	06/07/2005
Completion date	01/12/2005

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	9
Key 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
Key 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
Date of first enrolment	06/07/2005
Date of final enrolment	01/12/2005

Locations

Countries of recruitment

Netherlands

Study participating centre

Centre for Human Drug Research

Leiden
2333 CL
Netherlands

Sponsor information

Centre for Human Drug Research (CHDR) (Netherlands)
Research organisation

Zernikedreef 10
Leiden
2333 CL
Netherlands

"ROR"	https://ror.org/044hshx49

Funders

Funder type

Research organisation

Centre for Human Drug Research (CHDR) (Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan