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 |
| Protocol serial number | NTR414; P05.058 |
| Sponsor | Centre for Human Drug Research (CHDR) (Netherlands) |
| Funder | Centre for Human Drug Research (CHDR) (Netherlands) |
- 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
Contact information
Dr S.L. Haas, de
Scientific
Scientific
Centre for Human Drug Research
Zernikedreef 10
Leiden
2333 CL
Netherlands
Study information
| Primary study design | Interventional |
|---|---|
| Study design | randomised, double blind, placebo controlled, crossover group study |
| Secondary study design | Randomised controlled trial |
| 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 |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | L-000830982, ethanol |
| Primary outcome measure(s) |
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. |
| Key secondary outcome measure(s) |
1. Tremor intensity, measured by average acceleration amplitude (ìV) |
| Completion date | 01/12/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 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
2333 CL
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
