Amlodipine Plus Botulinum Toxin for Focal Dystonia - Tabular View

Tracking Information
First Received Date ^ICMJE	April 18, 2001
Last Updated Date	April 15, 2009
Start Date ^ICMJE	April 2001
Primary Completion Date
Current Primary Outcome Measures ^ICMJE (submitted: July 18, 2008)	Change in response to botulinum toxin injection. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE (submitted: June 19, 2006)	Patients: Dystonia rating scales and hand grip strength.
Change History	Complete list of historical versions of study NCT00015457 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: July 18, 2008)	Change in duration of response to bolulinum toxin injection. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE (submitted: June 19, 2006)	Healthy Volunteers: Aplitude of EDB MEP.

Descriptive Information
Brief Title ^ICMJE	Amlodipine Plus Botulinum Toxin for Focal Dystonia
Official Title ^ICMJE	Trial of Amlodipine Combined With Botulinum Toxin Injections for Focal Dystonia
Brief Summary	Objective: 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, 20 patients with focal hand dystonia; 40 healthy volunteers. 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.
Detailed Description	Objective: To determine if the calcium channel blocker, amlodipine can augment the effect of botulinum toxin injections in the treatment of focal dystonia. Study Population: 20 patients with cervical dystonia, 20 patients with focal hand dystonia; 40 healthy volunteers. 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.
Study Phase	Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Crossover Assignment, Efficacy Study
Condition ^ICMJE	Focal Dystonia
Intervention ^ICMJE	Drug: Amlodipine plus Botulinum toxin
Study Arms / Comparison Groups
Publications *	Anderson RL, Patel BC, Holds JB, Jordan DR. Blepharospasm: past, present, and future. Ophthal 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. 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.
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	80
Completion Date	April 2009
Primary Completion Date
Eligibility Criteria ^ICMJE	INCLUSION CRITERIA: Patients enrolled in Protocol 85-N-0195, Efficacy and Pathophysiology of Botulinum Toxin for Treatment of Involuntary Movement Disorders are eligible for enrollment if they meet the following inclusion and exclusion 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 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
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT ID ^ICMJE	NCT00015457
Responsible Party	Barbara I. Karp, M.D./National Institute of Neurological Disorders and Stroke, National Institutes of Health
Study ID Numbers ^ICMJE	010147, 01-N-0147
Study Sponsor ^ICMJE	National Institute of Neurological Disorders and Stroke (NINDS)
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	National Institutes of Health Clinical Center (CC)
Verification Date	April 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP