View clinical trials related to Essential Tremor.
Filter by:The purpose of this study is to obtain information on whether or not the medication Memantine reduces tremor in persons with essential tremor and is well-tolerated.
The purpose of the study is to determine the sensitivity and specificity of transcranial duplex scanning (TCD) and single photon emission computer tomography (SPECT) in patients suspected of having Idiopathic Parkinson Disease (PD) or Atypical Parkinson Syndromes (APS) with as golden standard the clinical diagnosis after 2-year follow-up.
This study will evaluate the safety and efficacy of T2000 when used to treat patients with moderate to severe essential tremor over a 20 week period. Essential tremor (ET) is a common form of involuntary shaking not related to Parkinson's disease. The medications that are currently used to treat ET work in a small proportion of patients and provide only partial improvement in symptoms. Use of these current medications is also limited by side-effects in many patients. T2000 is a medication currently under development for the treatment of essential tremor. Although T2000 is a new medication, it belongs to a class of medications that has been used for many years for the treatment of a variety of medical conditions. In previous studies, T2000 appeared to be effective in controlling symptoms of ET and some patients with severe ET had major improvements in tremor. T2000 was well tolerated for periods up to 20 days and the minimal side-effects seen were those that would be expected for medications in this class. The current study will evaluate the safety and efficacy of T2000 in patients with moderate to severe essential tremor. Patients will receive doses of T2000 beginning at 600 mg a day, followed by 800 mg a day and up to 1000 mg a day. The total duration of treatment will be 20 weeks. Patient's tremor and neurological examination will be monitored throughout the study. The response to T2000 will be determined by comparing the severity of tremor while patients are receiving T2000 compared to the tremor observed without active medication.
The purpose of this study is to assess the safety and effectiveness of topiramate as compared to placebo in treating patients with tremor of unknown cause.
The purpose of this pilot study is to obtain information whether the medication zonisamide reduces tremor in persons with essential tremor and is well tolerated.
OVERVIEW Essential tremor (ET) is a common movement disorder affecting 0.4% of the general population and up to 14% of people 65 years and older. Response to medications such as beta blockers and primidone may be of benefit, but are often accompanied by intolerable side effects. Response to ethanol, on the other hand, has a roughly 80% chance of significant tremor reduction, though daily use of this as a treatment has potentially serious medical, social, and legal consequences. The leading hypothesis for ET pathophysiology is an unmasking of spontaneous oscillations originating in neurons of the inferior olive. Both ethanol and 1-octanol have been shown to reduce these spontaneous oscillations in an animal model of ET; however, 1-octanol does this at a dose much lower than that leading to intoxication, suggesting in may be useful in the treatment of essential tremor. Our initial studies with 1-octanol have shown it to be safe at dosages up to 64mg/kg without signs of intoxication, while at the same time showing benefit. OBJECTIVE We plan to evaluate the efficacy of different 1-octanol formulations in humans based on accelerometry and spirography. We will also evaluate drug and metabolite bioavailabilities using a high performance liquid chromatography (HPLC) detection method from plasma and urine samples. STUDY POPULATION We will study adult subjects with ethanol-responsive Essential Tremor (ET). DESIGN This study is designed as a two-phase unblinded inpatient study of adults with ET receiving weight-adjusted oral dosages of 2 different formulations of 1-octanol in a crossover fashion. Phase I of the study is designed to develop an octanol detection assay using HPLC. Four subjects will receive daily escalating dosages (1-32 mg/kg) of a single 1-octanol formulation followed by a crossover trial of both formulations at a dosage of 64 mg/kg. Phase II will study 20 subjects receiving one of the two formulations at 64 mg/kg on inpatient day 1 followed by a 24 hour period of close monitoring. The second formulation will be given on day 3 and the patient will again undergo close monitoring for 24 hours. OUTCOME MEASURES The primary outcome measures for the study will be efficacy based on tremor ratings from accelerometry and spirography. Secondary outcome measures will be the determination of bioavailability, pharmacodynamic and pharmacokinetic profiles of octanol #61864 and octanol #68751 and their metabolites.
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.
This clinical research program is designed to evaluate medications as new treatments for essential tremor. Essential tremor is a common condition with few available therapies.
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.
This study will evaluate the safety and effectiveness of the food additive 1-octanol for treating essential tremor. This disorder, which is an involuntary shaking, usually of the hands, has no satisfactory treatment. It affects more than one of every 100 people in the general population, with the figure climbing to nearly 4 in every hundred among people over 40 years old. In animal studies, 1-octanol reduced chemically induced tremors in rats. This study will test the effects of the accepted daily intake of 1-octanol (1 milligram per kilogram of body weight) on essential tremor in humans. Patients with essential tremor 21 years old and older who wish to enroll in this study will undergo eligibility screening with a medical history and physical examination that includes tests for thyroid, liver and kidney problems. Participants will be randomly assigned to receive either 1-octanol or a placebo (an inactive substance). Patients in both groups will have an intravenous catheter (a thin, plastic tube) placed in an arm vein for collecting blood samples during the study. Those in the 1-octanol group will be given a 1-octanol capsule; the placebo group will receive a look-alike capsule containing no active ingredient. Neither the patient nor the doctor will know which patients are taking 1-octanol or placebo until the end of the study. Tremors will be measured once before the catheter is placed, every 15 minutes during the first 2 hours after taking the capsule, twice during the third hour (30 minutes apart), and once again after 5 hours. The tremors are measured using procedures called accelerometry and surface electromyography. For these procedures, electrodes are taped to the skin; needles are not used. Blood samples will be collected once before taking the capsule, every 15 minutes for the first hour and a half after taking the capsule and again at 2 hours, 4 hours and 5 hours after taking the capsule. Vital signs (blood pressure, pulse, and respiratory rate) will be measured every 15 minutes during the first 2 hours of taking the capsule, every 30 minutes during the third hour, and again at 4 hours and 5 hours. Participants will stay in the hospital overnight for observation and return after 3 days for a follow-up physical examination, including a blood test.