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Generated: October 19, 2018

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CLINICAL TRIALS PROFILE FOR MYSOLINE

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Clinical Trials for MYSOLINE

Trial ID Title Status Sponsor Phase Summary
NCT00016679 1-Octanol to Treat Essential Tremor Completed National Institute of Neurological Disorders and Stroke (NINDS) Phase 1 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 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 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.
NCT01132040 Bioequivalence Study of Primidone Tablets 50 mg of Dr. Reddy's Under Fasting Conditions Completed Dr. Reddy's Laboratories Limited Phase 1 The purpose of this study is to assess the bioavailability of Primidone 50 mg tablets of Dr.Reddy's comparing with that of Mysoline@ tablets of Yamanouchi Pharma Technologies Inc, in healthy, adult, human subjects under fasting conditions.
NCT02754960 Efficacy Study of Thalidomide in Gastrointestinal Vascular Malformation Related Bleeding Withdrawn Shanghai Jiao Tong University School of Medicine Phase 2 Background: Repeated bleeding from gastrointestinal vascular malformations remains to be a major therapeutic challenge. Methods: The investigators performed a randomised, double-blind, placebo-controlled, single centre study to assess the long-term efficacy and safety of thalidomide 100mg qn p.o. or placebo 100 mg qn p.o. administration for 4 months in subjects with recurrent gastrointestinal bleeding due to vascular malformations. Patients with at least six episodes of bleeding in the prior year due to vascular malformation were randomly grouped, prescribed a four-month regimen of either 100mg of thalidomide or 100 mg of placebo orally one time daily, and monitored for at least one year. The primary end point was defined as the patients whose rebleeds decreased from baseline by ≥ 50% at 12 months. Rebleeding was defined based on a positive fecal occult blood test (FOBT) (monoclonal colloidal gold color technology) at any visit after treatment. Secondary outcomes included the changes from baseline in participants dependent on blood transfusions and transfused packed red cell units, bleeding episodes, bleeding durations, and hemoglobin levels at 12 months. Statistical significance was defined at P < 0.05.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for MYSOLINE

Condition Name

Condition Name for MYSOLINE
Intervention Trials
Essential Tremor 2
Gastrointestinal Hemorrhage 1
Vascular Malformation 1
Therapeutic Equivalency 1
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Condition MeSH

Condition MeSH for MYSOLINE
Intervention Trials
Tremor 2
Essential Tremor 2
Vascular Malformations 1
Hemorrhage 1
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Clinical Trial Locations for MYSOLINE

Trials by Country

Trials by Country for MYSOLINE
Location Trials
United States 2
China 1
India 1
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Trials by US State

Trials by US State for MYSOLINE
Location Trials
Maryland 2
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Clinical Trial Progress for MYSOLINE

Clinical Trial Phase

Clinical Trial Phase for MYSOLINE
Clinical Trial Phase Trials
Phase 2 2
Phase 1 3
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Clinical Trial Status

Clinical Trial Status for MYSOLINE
Clinical Trial Phase Trials
Completed 4
Withdrawn 1
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Clinical Trial Sponsors for MYSOLINE

Sponsor Name

Sponsor Name for MYSOLINE
Sponsor Trials
National Institute of Neurological Disorders and Stroke (NINDS) 2
Shanghai Jiao Tong University School of Medicine 1
Dr. Reddy's Laboratories Limited 1
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Sponsor Type

Sponsor Type for MYSOLINE
Sponsor Trials
Industry 2
NIH 2
Other 1
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Serving hundreds of leading biopharmaceutical companies globally:

Julphar
Chinese Patent Office
Mallinckrodt
Johnson and Johnson
Covington
Queensland Health
Accenture
McKesson
Fish and Richardson

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