NCT00015457|CompletedPhase 2Results
Amlodipine Plus Botulinum Toxin for Focal Dystonia
Trial of Amlodipine Combined With Botulinum Toxin Injections for Focal Dystonia
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Sponsor study identifier
Secondary identifiers
OTHER · NIH
interventional
16
1 country
1
Study Start
April 2001
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
April 2009
Actual (reported)Study Completion
Not reported
Date not reportedObjective: To determine if the calcium channel blockers, amlodipine can augment the effect of botulinum toxin injections in the treatment of focal dystonia. 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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Not reported
Date not reportedClick on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 2001
Date type not reportedThis date has not been verified as actual or estimated.
April 18, 2001
Actual (reported)April 19, 2001
Actual (reported)April 2009
Actual (reported)April 1, 2013
Actual (reported)Toronto Western Spasmodic Torticollis Rating Scale (TWSTR) Sum Score
Rating scale assessing sum of severity of dystonia, disability score and pain scale. Ordinal scale ranging from 0 (least severe) to 30 (maximally severe). Score is maximal response TWSTR rating minus baseline rating.
1-2 month maximal rating
Duration of Response to Botulinum Toxin Injection With Amlodipine and With Placebo
3 months
cervical dsytonia patinets
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892, United States
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.
16 participants (actual enrollment reported by the registry).
First Submitted
April 18, 2001
First Posted
April 19, 2001
Study Start
April 2001
Date type not reportedThis date has not been verified as actual or estimated.
Brain Changes in Patients With Focal Hand Dystonia
Contact the study team to confirm eligibility.
Primary Completion
April 2009
Actual (reported)Last Updated
April 1, 2013
Results First Posted
April 1, 2013
Record last verified: 2013-03
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Source: ClinicalTrials.gov.
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