UMIN ID: UMIN000003760
Registered date:15/06/2010
Evaluation of L-carnitine: a double-blind comparison of L-carnitine vs. placebo in narcolepsy with cataplexy patients
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | narcolepsy with cataplexy |
| Date of first enrollment | 2010/05/01 |
| Target sample size | 30 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | L-carnitine to placebo placebo to L-carnitine |
Outcome(s)
| Primary Outcome | Evaluation of sleep diary and actigraph from 4 to 8 weeks of each administration |
|---|---|
| Secondary Outcome |
Key inclusion & exclusion criteria
| Age minimum | 15years-old |
|---|---|
| Age maximum | Not applicable |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | 1. patients with epilepsia (including past history) 2. patients who take a acenocoumarol 3. patients with hypersensitive to components of L-carnitine and placebo 4. patients who are pregnant or desire pregnancy within this study 5. patients who participate in another clinical trial 6. doctor's judgment |
Related Information
| Primary Sponsor | Yoyogi Sleep Clinic, Neuropsychiatric Research Institute |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Takeda Science Foundation,Kowa Life Science Foundation, Mitsubishi Pharma Research Foundation and Grant-in-Aid for Young Scientists (B) |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Taku Miyagawa |
| Address | Medical Building No.1, 7-3-1 Hongo, Bunkyo, Tokyo, Japan Japan |
| Telephone | 03-5841-3693 |
| taku@jn2.so-net.ne.jp | |
| Affiliation | The University of Tokyo Department of Human Genetics |
| scientific contact | |
| Name | Makoto Honda |
| Address | TS building, 1-24-10 Yoyogi, Shibuya, Tokyo, Japan Japan |
| Telephone | |
| Affiliation | Neuropsychiatric Research Institute Yoyogi Sleep Clinic |