National Institute of Neurological Disorders and Stroke (NINDS)
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
National Institute of Neurological Disorders and Stroke (NINDS)
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.
Fasted Bioequivalence Study of Primidone Tablets and Mysoline Tablets
Mutual Pharmaceutical Company, Inc.
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.
Bioequivalence Study of Primidone Tablets 50 mg of Dr. Reddy's Under Fasting Conditions
Dr. Reddy's Laboratories Limited
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.
Efficacy Study of Thalidomide in Gastrointestinal Vascular Malformation Related Bleeding
Shanghai Jiao Tong University School of Medicine
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.
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