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The purpose of this study is to assess the safety and effectiveness of levetiracetam in reducing the pain of fibromyalgia when compared to placebo. Levetiracetam, an anti-seizure drug, is currently FDA-approved and marketed for use in patients with seizures. Levetiracetam may relieve pain by reducing abnormal activity in the nervous system. A placebo is an inactive substance.
The UCSF Pain Clinical Research Center (PCRC) will be conducting this investigator-initiated 9-week, randomized, double-blind, placebo-controlled, parallel group study of Levetiracetam. There will be a total of 6 study visits. Visit 1 is a screening visit to assess subject eligibility, followed by a one-week period of baseline daily pain and sleep assessments. Visit 2 (one week after Visit 1) subjects will be randomized in a 3/2-randomization scheme and administered study medication. Subjects randomized to the treatment group will start Levetiracetam at 1 tablet of 500/mg/day, and will titrate by 500mg each week to a maximum dose of 3000 mg/day. Visits 3, 4, 5, and 6 (occurring 2, 4, 6 and 8 weeks after started study drug) include safety and efficacy assessments. Study drug taper is initiated at Visit 6.
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double-Blind, Primary Purpose: Treatment
University of California, San Francisco
Published on BioPortfolio: 2014-08-27T03:47:37-0400
The test article for this study is levetiracetam (Keppra, which is commercially available. Keppra is indicated for use as adjunctive therapy in the treatment of partial onset seizure disor...
For ethical reasons to give opportunity for adult subjects (≥16 or 18 years) suffering from newly diagnosed epilepsy who completed the therapeutic confirmatory, open-label trial N01175 (...
The purpose of this study is to determine whether levetiracetam is safe and well tolerated by patients while suffering a status epilepticus. Levetiracetam is added to the standard treatmen...
The main purpose of this research study is to determine whether the drug Levetiracetam (Keppra™) is effective in the prevention of panic attacks. The drug Levetiracetam (Keppra™) has b...
The study proposed aims to evaluate the effect of Levetiracetam in patients with Alzheimer's disease (AD) in a Phase 2 Clinical Trial. Levetiracetam is an established anti-epileptic medic...
To develop and test in a preliminary way a new self-administered and user-friendly screening tool, called SImple FIbromyalgia Screening (SIFIS) questionnaire, to screen Italian speaking patients for t...
Work and workplace factors are important in fibromyalgia management. We investigated factors associated with sick leave in professionally active women living with fibromyalgia.
Antiseizure prophylaxis is required during busulfan administration for hematopoietic stem cell transplantation. However, antiseizure agents such as benzodiazepines and phenytoin may produce adverse ef...
Small fiber neuropathy and fibromyalgia are two conditions that share overlapping features. Although various treatments are available for use in fibromyalgia, the response often remains unsatisfactory...
Previous research suggested isolated associations of physical and psychological factors with fibromyalgia severity. Integration of physical and psychological, experienced and observed, modifiable fact...
A common nonarticular rheumatic syndrome characterized by myalgia and multiple points of focal muscle tenderness to palpation (trigger points). Muscle pain is typically aggravated by inactivity or exposure to cold. This condition is often associated with general symptoms, such as sleep disturbances, fatigue, stiffness, HEADACHES, and occasionally DEPRESSION. There is significant overlap between fibromyalgia and the chronic fatigue syndrome (FATIGUE SYNDROME, CHRONIC). Fibromyalgia may arise as a primary or secondary disease process. It is most frequent in females aged 20 to 50 years. (From Adams et al., Principles of Neurology, 6th ed, p1494-95)
A gamma-aminobutyric acid (GABA) derivative that functions as a CALCIUM CHANNEL BLOCKER and is used as an ANTICONVULSANT as well as an ANTI-ANXIETY AGENT. It is also used as an ANALGESIC in the treatment of NEUROPATHIC PAIN and FIBROMYALGIA.
A thiophene derivative and selective NEUROTRANSMITTER UPTAKE INHIBITOR for SEROTONIN and NORADRENALINE (SNRI). It is an ANTIDEPRESSIVE AGENT and ANXIOLYTIC, and is also used for the treatment of pain in patients with DIABETES MELLITUS and FIBROMYALGIA.
A syndrome characterized by persistent or recurrent fatigue, diffuse musculoskeletal pain, sleep disturbances, and subjective cognitive impairment of 6 months duration or longer. Symptoms are not caused by ongoing exertion; are not relieved by rest; and result in a substantial reduction of previous levels of occupational, educational, social, or personal activities. Minor alterations of immune, neuroendocrine, and autonomic function may be associated with this syndrome. There is also considerable overlap between this condition and FIBROMYALGIA. (From Semin Neurol 1998;18(2):237-42; Ann Intern Med 1994 Dec 15;121(12): 953-9)
An anesthesiologist (US English) or anaesthetist (British English) is a physician trained in anesthesia and perioperative medicine. Anesthesiologists are physicians who provide medical care to patients in a wide variety of (usually acute) situations. ...
Arthritis Fibromyalgia Gout Lupus Rheumatic Rheumatology is the medical specialty concerned with the diagnosis and management of disease involving joints, tendons, muscles, ligaments and associated structures (Oxford Medical Diction...