Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Bethesda, Maryland 20892


Purpose:

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.


Study summary:

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.


Criteria:

- 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


Study is Available At:


Original ID:

010147


NCT ID:

NCT00015457


Secondary ID:

01-N-0147


Study Acronym:


Brief Title:

Amlodipine Plus Botulinum Toxin for Focal Dystonia


Official Title:

Trial of Amlodipine Combined With Botulinum Toxin Injections for Focal Dystonia


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

National Institutes of Health Clinical Center (CC)


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

80


Enrollment Type:


Study Dates

Start Date:April 2001
Primary Completion Date:April 2009
Primary Completion Type:Actual
Verification Date:April 2009
Last Changed Date:January 28, 2010
First Received Date:April 18, 2001

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Change in duration of response to bolulinum toxin injection.
Time Frame:3 months
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Change in response to botulinum toxin injection.
Time Frame:3 months
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Amlodipine plus Botulinum toxin
Description:N/A

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:NIH
Agency Type:Lead Sponsor
Agency Name:National Institute of Neurological Disorders and Stroke (NINDS)

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Reference
Citation: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.
PMID:2213039
Reference Type:Reference
Citation:Jankovic J, Schwartz K. Botulinum toxin injections for cervical dystonia. Neurology. 1990 Feb;40(2):277-80.
PMID:2300249
Reference Type:Reference
Citation:Anderson RL, Patel BC, Holds JB, Jordan DR. Blepharospasm: past, present, and future. Ophthal Plast Reconstr Surg. 1998 Sep;14(5):305-17.
PMID:9783280

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


This study is not currently recruiting Study Participants. The form below is not enabled.