CLINICAL TRIALS PROFILE FOR MYSOLINE
✉ Email this page to a colleague
All Clinical Trials for MYSOLINE
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT00016679 ↗ | 1-Octanol to Treat Essential Tremor | Completed | National Institute of Neurological Disorders and Stroke (NINDS) | Phase 1 | 2001-05-01 | This study will determine the optimal dose of 1-octanol that will safely reduce tremors in patients with essential tremor-a disorder in which the hands, and sometimes the head, shake involuntarily. Current treatments may be ineffective or produce unwanted side effects. Ethanol (the chemical in beer and wine that causes intoxication) reduces tremor in many patients, but patients generally don't use it regularly because it interferes with daily activities. Laboratory studies show that 1-octanol, a drug that is similar to ethanol, may have the same beneficial effect on tremors with less likelihood of intoxication. Patients 21 years of age and older with essential tremor may be eligible for this 10-day study. Candidates will be evaluated with a neurological examination, blood tests, urinalysis and electrocardiogram (EKG). Those enrolled will be admitted to the hospital for 4 days for 1-octanol administration and monitoring. On day 1, patients will have a medical history and physical examination. A catheter (a thin plastic tube) will be placed in a vein of the forearm for sampling blood. Patients will take one 1-octanol capsule (at one of seven doses) by mouth and will be monitored for tremors and drug side effects. Blood will be sampled periodically in the first 3 hours to determine 1-octanol blood levels. On days 2 and 3, patients will be monitored for additional side effects. On days 3 and 4, laboratory tests (blood and urine) will be done to evaluate liver and kidney function. On day 4, the catheter will be removed and the patient will be discharged from the hospital. A follow-up visit will be scheduled 1 week after discharge for a physical examination and blood, urine and EKG tests. |
| NCT00080366 ↗ | Octanol to Treat Essential Tremor | Completed | National Institute of Neurological Disorders and Stroke (NINDS) | Phase 2 | 2004-03-01 | This study will evaluate the effectiveness of 1-octanol, a substance similar to alcohol but less intoxicating, for treating essential tremor. Essential tremor is an involuntary shaking, usually of the hands, for which there is no satisfactory treatment. It affects about 1.4 percent of the general U.S. population, with the figure climbing to nearly 4 percent among people over 40. Results of two previous NIH studies have shown 1-octanol to be promising as a potential new treatment. This study will test the effectiveness of 1-octanol on essential tremor at doses lower than those given previously. Patients 21 years old and older with essential tremor may be eligible for this study. Participants are admitted to the NIH Clinical Center for two treatment periods of 1 week each, with a 1-week break at home between treatments. Before beginning treatment, participants undergo a medical history, physical examination, blood and urine tests, and an electrocardiogram (EKG). In addition, tremors are measured using accelerometry, a procedure in which a small device, mounted on a piece of cardboard, is taped to the patient's hand for about 30 minutes. Patients are randomly assigned to one of two groups. One group takes 2 to 4 capsules of 1-octanol 3 times a day for 1 week, followed by a 1-week "washout" period (no treatment), and then 2 to 4 capsules of placebo 3 times a day for 1 week. Following the same dosage schedule, the second group takes placebo the first week, followed by the washout period and then 1-octanol treatment. Blood pressure and pulse are measured at 15, 30, and 60 minutes after the first dose of the day and then 3 times a day each day of hospitalization, EKG and blood draws are done every other day during hospitalization, and blood is drawn again 1 week after the end of the study. Patients evaluate their tremor daily according to a tremor scale and are also rated according to an alcohol intoxication scale. |
| NCT00685165 ↗ | Fasted Bioequivalence Study of Primidone Tablets and Mysoline Tablets | Completed | Mutual Pharmaceutical Company, Inc. | Phase 1 | 2004-05-01 | The purpose of this study is to compare the bioequivalence of a test formulation of primidone tablets to an equivalent oral dose of the commercially available Mysoline®(primidone tablets) in adult subjects under fasting conditions. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
Clinical Trial Conditions for MYSOLINE
Condition Name
Clinical Trial Locations for MYSOLINE
Trials by Country
Clinical Trial Progress for MYSOLINE
Clinical Trial Phase
Clinical Trial Sponsors for MYSOLINE
Sponsor Name
