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Amlodipine Plus Botulinum Toxin for Focal Dystonia Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified medical advice, visits or professional assistance with a genuine dr.. We are not doctors. Always consult your mD about Amlodipine Plus Botulinum Toxin for Focal Dystonia conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Amlodipine Plus Botulinum Toxin for Focal Dystonia Clinical research trials and Amlodipine Plus Botulinum Toxin for Focal Dystonia medical trials take place in many of places throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectiveness of new does drugs. The purpose of the studies / projects is to solve specific human healthcare questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to find cures for all varieties of conditions, like Amlodipine Plus Botulinum Toxin for Focal Dystonia. Amlodipine Plus Botulinum Toxin for Focal Dystonia Clinical Trials and other clinical trials allow for volunteers to have health treatment options before they are available to the masses. Many times the human subjects acquire professional assistance for free of charge, and sometimes they are compensated for their time. Occasionally there is a cost for a Amlodipine Plus Botulinum Toxin for Focal Dystonia clinical trial. Test subjects typically obtain the finest healthcare available for their Amlodipine Plus Botulinum Toxin for Focal Dystonia condition. Dangers are a reality, nevertheless, and might include additional or frequent doctor trips, medical dangers (possibly life-jeopardising), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials patients.
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Home > "A" Clinical Trials Conditions > Amlodipine Plus Botulinum Toxin for Focal Dystonia  Amlodipine Plus Botulinum Toxin for Focal Dystonia
Amlodipine Plus Botulinum Toxin for Focal Dystonia
For Condition: Focal Dystonia
Status: Recruiting
Sponsor(s): National Institute of Neurological Disorders and Stroke (NINDS) ,
Synopsis: This study will examine whether amlodipine (Norvasc) can improve the effect of botulinum toxin injections for dystonia a movement disorder causing abnormal postures and disrupted movements. Amlodipine, a drug commonly used to treat high blood pressure and heart disease, prevents calcium from entering cells under certain conditions. Botulinum toxin works by weakening muscles that are overactive in dystonia. It prevents the release of a chemical called acetylcholine from nerve terminals that signal the muscle to contract. The release of acetylcholine also requires that small amounts of calcium enter the cell. This calcium can be blocked by amlodipine. Therefore, the use of the two drugs together may produce more weakness and possibly more benefit than botulinum toxin injection alone. Patients enrolled in NINDS's protocol 85-N-0195 (Efficacy and Pathophysiology of Botulinum Toxin for Treatment of Involuntary Movement Disorders) who are being treated with botulinum toxin for focal hand dystonia or cervical dystonia may be eligible for this study. Candidates will be screened with blood tests and electrocardiogram (EKG). Participants will have three injections of botulinum toxin, during which the following will occur: First injection - Patients' dystonia will be rated and their hand strength tested. They will be randomly assigned to receive either amlodipine or placebo (a look-alike pill with no active ingredient) for 6 months or until the effects of the botulinum toxin injection have worn off and the second injection is required. Second injection - No amlodipine or placebo will be given with the second injection in order to allow any effects of amlodipine to wear off. Third injection - Will be given when the effects of the second injection have worn off. At this time, patients who received amlodipine at the time of the first injection will now be given placebo, and vice versa. Patients will be seen at monthly intervals after the first and third injections to evaluate their response to treatment. At each visit, patients will report any side effects of treatment, their dystonia will be videotaped and rated and their hand strength will be tested. In addition, 2 weeks after the first and third injections, patients will have electromyography (EMG) testing to evaluate how the study medication affects the nerves and release of acetylcholine from the nerve. This test involves inserting a needle into an arm muscle. For part of the study, patients will tense the muscle slightly and maintain tension while the EMG signal is collected. This test may take 1 to 2 hours.
Details: Botulinum toxin injections are now in widespread use for the treatment of focal dystonias. Although many patients respond to treatment, their response is often suboptimal, both in the degree and duration of benefit. Botulinum toxin works by blocking acetylcholine exocytosis, a process that also requires calcium influx from the extracellular environment. Botulinum toxin type A does not completely prevent neurotransmitter release in poisoned nerve terminals. Calcium channel blockers, by preventing calcium entry into the presynaptic cell, can augment the blockade of acetylcholine release by botulinum toxin type A. This is a double-blind, placebo-controlled, cross-over trial of the calcium channel blocker, amlodipine, in patients with focal dystonia and in normal volunteer to determine if calcium channel blockage can enhance weakness due to and the clinical efficacy of botulinum toxin injections.
Eligibility:
Study Type: Interventional, Treatment, Safety/Efficacy
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA: Good general health Focal hand dystonia or cervical dystonia Stable response to botulinum toxin demonstrated through a series of at least 3 injections over a period of at least a year Benefit from the 3 immediately prior btx injections rated as 75% or less or a duration of benefit lasting less than or equal to 2 months No other medications for dystonia EXCLUSION CRITERIA: Cervical dystonia accompanied by dysphagia or dyspnea, either before or with botulinum toxin injection Present or past cardiac disease, hypertension, arrhythmia or congestive heart failure Anterocollis or other neck dystonia requiring bilateral anterior neck muscle injections Use concomitant medications affecting calcium channels or those metabolized by the cytochrome p450 3A4 system including grapefruit juice, St. John's wort, HIV protease inhibitors, cimetidine, antibiotics (macrolides, fluoroquinones, antifungal, rifampin), antidepressants (fluvoxamine, norfluoxetine), barbiturates, anticonvulsants (carbamazepine, phenytoin), oral diabetes agents (pioglitazone, troglitazone), and glucocorticoids Allergy to amlodipine or related compounds Pregnany/ nursing Age less than 18 years of age Abnormal EKG Abnormal coagulation profile or liver function tests Use of anticoagulants
Total Enrollment: 70
Location and Contact Information:
National Institute of Neurological Disorders and Stroke (NINDS) *Recruiting*
Bethesda, Maryland, 20892
United States
Recruiting Patient and Public Liaison Office 1-800-411-1222
Additional Information:
Study ID Numbers: 010147; 01-N-0147
Study Start Date: April 13, 2001
Record last reviewed: March 23, 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00015457
Other Focal Dystonia Studies:
1. Motor Training to Treat Hand Dystonia
2. EEG and EMG Studies of Hand Dystonia
3. Amlodipine Plus Botulinum Toxin for Focal Dystonia
Related Studies:
Other Focal Dystonia Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
Amlodipine Plus Botulinum Toxin for Focal Dystonia
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