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Protocol Details

Botulinum Toxin for the Treatment of Neurological Disorders

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

85-N-0195

Sponsoring Institute

National Institute of Neurological Disorders and Stroke (NINDS)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 2 Years
Max Age: N/A

Referral Letter Required

Yes

Population Exclusion(s)

Fetuses;
Pregnant Women

Keywords

Botulinum Toxin;
BTW;
Natural History

Recruitment Keyword(s)

None

Condition(s)

Movement Disorders

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Institute of Neurological Disorders and Stroke

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>

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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.


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

Debra J. Ehrlich, M.D.
National Institute of Neurological Disorders and Stroke (NINDS)
NIHBC 10 - CLINICAL CENTER BG RM 7D37
10 CENTER DR
BETHESDA MD 20892
(301) 443-7888
debra.ehrlich@nih.gov

Vivian S. Koo
National Institute of Neurological Disorders and Stroke (NINDS)
BG 10 RM 7D36A
10 CENTER DR
BETHESDA MD 20814
(301) 435-8518
vivian.koo@nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: TTY Users Dial 7-1-1
ccopr@nih.gov

Clinical Trials Number:

NCT00001208

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