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Botulinum Toxin for the Treatment of Involuntary Movement Disorders

This study is currently recruiting participants.
Verified August 2012 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00001208
First received: November 3, 1999
Last updated: August 18, 2012
Last verified: August 2012
History of Changes
  Purpose

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.


Condition
Chorea
Drug Induced Dyskinesia
Movement Disorder
Muscular Disease
Tic Disorder

Study Type: Observational
Official Title: A Training Protocol for the Use of Botulinum Toxin in the Treatment of Neurological Disorders

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 1000
Study Start Date: November 1985
Detailed Description:

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • INCLUSION CRITERIA:

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.

EXCLUSION CRITERIA:

Patients will be excluded form participation if:

  1. They are pregnant or breastfeeding, for the duration of the condition.
  2. They require treatment with an aminoglycoside antibiotic, until treatment is complete.
  3. For laryngeal injections, they have a paradoxical vocal fold movement with intermittent stridor due to either gastroesophageal reflux or emotional disorders.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00001208

Contacts
Contact: Elaine P Considine, R.N. (301) 435-8518 considinee@ninds.nih.gov
Contact: Codrin I Lungu, M.D. (301) 402-0976 lunguci@ninds.nih.gov

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL)     800-411-1222 ext TTY8664111010     prpl@mail.cc.nih.gov    
Sponsors and Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
Principal Investigator: Codrin I Lungu, M.D. National Institute of Neurological Disorders and Stroke (NINDS)
  More Information

Additional Information:
NIH Clinical Center Detailed Web Page  This link exits the ClinicalTrials.gov site

Publications:

ClinicalTrials.gov Identifier: NCT00001208     History of Changes
Other Study ID Numbers: 850195, 85-N-0195
Study First Received: November 3, 1999
Last Updated: August 18, 2012
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Spasmodic Torticollis
Writer's Cramp
Spasmodic Dysphonia
Stuttering
Oromandibular Dystonia
 Palatal Myoclonus
Dystonia
Essential Tremor
Movement Disorders

Additional relevant MeSH terms:
Chorea
Dyskinesias
Dyskinesia, Drug-Induced
Movement Disorders
Muscular Diseases
Nervous System Diseases
Tic Disorders
Tics
Central Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Neurotoxicity Syndromes
 Drug Toxicity
Poisoning
Substance-Related Disorders
Musculoskeletal Diseases
Neuromuscular Diseases
Mental Disorders Diagnosed in Childhood
Mental Disorders
Botulinum Toxins
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013