Botulinum Toxin for the Treatment of Involuntary Movement Disorders - Full Text View

Sponsor:	National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by:	National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:	NCT00001208

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:

Genetics Home Reference related topics: chorea-acanthocytosis early-onset primary dystonia essential tremor familial paroxysmal nonkinesigenic dyskinesia McLeod neuroacanthocytosis syndrome

MedlinePlus related topics: Movement Disorders Muscle Disorders Neurologic Diseases Poisoning Stuttering

Drug Information available for: Clostridium botulinum toxin

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.

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

They are pregnant or breastfeeding, for the duration of the condition.
They require treatment with an aminoglycoside antibiotic, until treatment is complete.
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: Patient Recruitment and Public Liaison Office	(800) 411-1222	prpl@mail.cc.nih.gov
Contact: TTY	1-866-411-1010

Locations

United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike	Recruiting
Bethesda, Maryland, United States, 20892

Sponsors and Collaborators

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:

Hott JS, Dalakas MC, Sung C, Hallett M, Youle RJ. Skeletal muscle-specific immunotoxin for the treatment of focal muscle spasm. Neurology. 1998 Feb;50(2):485-91.

Karp BI, Cole RA, Cohen LG, Grill S, Lou JS, Hallett M. Long-term botulinum toxin treatment of focal hand dystonia. Neurology. 1994 Jan;44(1):70-6.

Ludlow CL, Hallett M, Rhew K, Cole R, Shimizu T, Sakaguchi G, Bagley JA, Schulz GM, Yin SG, Koda J. Therapeutic use of type F botulinum toxin. N Engl J Med. 1992 Jan 30;326(5):349-50. No abstract available.

Study ID Numbers:	850195, 85-N-0195
Study First Received:	November 3, 1999
Last Updated:	July 1, 2009
ClinicalTrials.gov Identifier:	NCT00001208 History of Changes
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:

Neurotoxicity Syndromes
Anti-Dyskinesia Agents
Disorders of Environmental Origin
Tics
Signs and Symptoms
Pathologic Processes
Musculoskeletal Diseases
Neuromuscular Diseases
Movement Disorders
Mental Disorders
Therapeutic Uses
Mental Disorders Diagnosed in Childhood
Disease

Dyskinesia, Drug-Induced
Nervous System Diseases
Poisoning
Central Nervous System Diseases
Tic Disorders
Dyskinesias
Pharmacologic Actions
Muscular Diseases
Drug Toxicity
Botulinum Toxins
Neurologic Manifestations
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 27, 2009