Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
16 participants
INTERVENTIONAL
2001-04-30
Brief Summary
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Study Population: 20 patients with cervical dystonia
Design: Double-bind, placebo-controlled clinical trail.
Outcome measures: For patients: dystonia rating scales (Twistrs, Fahn-Marsden dystonia scale, NINDS subjective patient rating scale), and hand grip strength. For healthy volunteers: Amplitude of EDB MEP.
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Detailed Description
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Study Population: 20 patients with cervical dystonia
Design: Double-bind, placebo-controlled clinical trail.
Outcome measures: dystonia rating scales (TWISTRS)
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
TRIPLE
Study Groups
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cervical dystonia
cervical dsytonia patinets
Amlodipine plus Botulinum toxin
Interventions
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Amlodipine plus Botulinum toxin
Eligibility Criteria
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Exclusion Criteria
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
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 of 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
18 Years
ALL
No
Sponsors
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National Institute of Neurological Disorders and Stroke (NINDS)
NIH
Responsible Party
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Barbara Karp, M.D.
MD
Locations
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National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States
Countries
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References
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Anderson RL, Patel BC, Holds JB, Jordan DR. Blepharospasm: past, present, and future. Ophthalmic Plast Reconstr Surg. 1998 Sep;14(5):305-17.
Jankovic J, Schwartz K. Botulinum toxin injections for cervical dystonia. Neurology. 1990 Feb;40(2):277-80. doi: 10.1212/wnl.40.2.277.
Jankovic J, Schwartz K, Donovan DT. Botulinum toxin treatment of cranial-cervical dystonia, spasmodic dysphonia, other focal dystonias and hemifacial spasm. J Neurol Neurosurg Psychiatry. 1990 Aug;53(8):633-9. doi: 10.1136/jnnp.53.8.633.
Other Identifiers
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01-N-0147
Identifier Type: OTHER
Identifier Source: secondary_id
010147
Identifier Type: -
Identifier Source: org_study_id
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