Botulinum Toxin for the Treatment of Involuntary Movement Disorders
|First Received Date ICMJE||November 3, 1999|
|Last Updated Date||May 20, 2015|
|Start Date ICMJE||November 1985|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE||Not Provided|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00001208 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Botulinum Toxin for the Treatment of Involuntary Movement Disorders|
|Official Title ICMJE||A Training Protocol for the Use of Botulinum Toxin in the Treatment of Neurological Disorders|
Botulism is a severe form of food poisoning caused by bacteria. This bacteria produces several toxins one of which is botulinum toxin A. This toxin causes the symptoms of food poisoning. Small amounts of botulinum toxin A have been used to treat speech disorders such as stuttering and problems with the muscles of the eyes.
The study examines the effectiveness of botulinum toxin as treatment for a variety of movement disorders. The goals of the study are to refine the technique of treatment to provide the best results, to improve the understanding of how botulinum toxin works on movement disorders, and find other conditions that may be treatable with botulinum toxin.
In addition, researchers also plan to study the possible use of botulinum toxin F alone and in combination with botulinum toxin A in patients who do not respond to botulinum A toxin treatment.< TAB>
The efficacy of botulinum toxin (BTX) has now been demonstrated for a variety of diseases associated with involuntary muscle spasms or movement. The application of botulinum toxin therapy to movement disorders requires treatment tailored to the individual patient and specific techniques of injection. This protocol 1) provides for training of physicians in the use of botulinum toxin and 2) allows us to provide botulinum toxin injections for patients participating in other studies on the physiology of sensorimotor systems and physiological effects of botulinum toxin. Patients can be in the study at any one time either for the teaching value or for participation in other protocols, or both.
|Study Type ICMJE||Interventional|
|Study Phase||Not Provided|
|Study Design ICMJE||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Intervention ICMJE||Other: Botulinum Toxin|
|Study Arm (s)||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Recruiting|
|Estimated Enrollment ICMJE||1000|
|Estimated Completion Date||October 2019|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
Patients will be eligible for participation if they have a disorder that, in the judgment of the treating physician, might be amenable to treatment with BTX.
Applicable disorders include but are not limited to dystonia, hemifacial spasm, blepharospasm, tremor, spasmodic dysphonia, tics, vocal fold tremor, oral lingual dyskinesia, tardive dyskinesia, spasticity, and spasmodic dysphonia.
Patients will be excluded form participation if:
|Ages||4 Years and older|
|Accepts Healthy Volunteers||No|
|Listed Location Countries ICMJE||United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT00001208|
|Other Study ID Numbers ICMJE||850195, 85-N-0195|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) )|
|Study Sponsor ICMJE||National Institute of Neurological Disorders and Stroke (NINDS)|
|Collaborators ICMJE||Not Provided|
|Information Provided By||National Institutes of Health Clinical Center (CC)|
|Verification Date||May 2015|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP