Botulinum Toxin for the Treatment of Involuntary Movement Disorders

Movement Disorders Clinical Trial

Official title:

Botulinum Toxin for the Treatment of Neurological Disorders

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00001208
• Other study ID #: 850195
• Secondary ID: 85-N-0195
• Status: Recruiting
• Start date: October 26, 1989

Study information

• Verified date: February 7, 2024
• Source: National Institutes of Health Clinical Center (CC)
• Contact: Vivian S Koo
• Phone: (301) 435-8518
• Email: vivian.koo[@]nih.gov
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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>

Description:

The efficacy of botulinum toxin (BTX) has now been demonstrated for a variety of diseases associated with involuntary muscles 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) allows us to follow the natural history of subjects with movement disorders who receive standard botox injections for treatment of movement disorders and 2) allows us to provide botulinum toxin injections for patients participating in other studies on the physiology of sensorimotor systems and on the physiological effects of botulinum toxin.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years and older

Eligibility

• INCLUSION CRITERIA:

1. Patients 2 years and older, 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.

2. 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.

EXCLUSION CRITERIA:

1. Women who are planning on becoming pregnant, are pregnant or breastfeeding, for the duration of the condition.

2. Subjects who require treatment with an aminoglycoside antibiotic, until treatment is complete.

3. For laryngeal injections, subjects must have a paradoxical vocal fold movement with intermittent stridor due to either gastroesophageal reflux or emotional disorders.

Related Conditions & MeSH terms

• Movement Disorders

Locations

Country	Name	City	State
United States	National Institutes of Health Clinical Center	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Neurological Disorders and Stroke (NINDS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Study Natural History- data analysis	Data regarding the movement disorder of the subject and observations of their standard treatment will be collected. Data may be used for future research questions that are related to subjects movement disorder and/or treatment.	Ongoing
Primary	Maintain cohort of subjects	To maintain a cohort of patients with dystonia and other movement disorders for participation in other studies on the physiology of dystonia and BTX injection	Ongoing

External Links

•   NIH Clinical Center Detailed Web Page