Botulinum Toxin for the Treatment of Involuntary Movement Disorders

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2016 by National Institutes of Health Clinical Center (CC)
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) ) Identifier:
First received: November 3, 1999
Last updated: May 3, 2016
Last verified: April 2016

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>

Condition Intervention
Drug Induced Dyskinesia
Movement Disorder
Muscular Disease
Tic Disorder
Other: Botulinum Toxin

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Training Protocol for the Use of Botulinum Toxin in the Treatment of Neurological Disorders

Resource links provided by NLM:

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

Estimated Enrollment: 1000
Study Start Date: November 1985
Estimated Study Completion Date: October 2019
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.

Ages Eligible for Study:   4 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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:

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00001208

Contact: Elaine P Considine, R.N. (301) 435-8518
Contact: Codrin I Lungu, M.D. (301) 402-0976

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   
Sponsors and Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
Principal Investigator: Codrin I Lungu, M.D. National Institute of Neurological Disorders and Stroke (NINDS)
  More Information

Additional Information:
Responsible Party: National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) ) Identifier: NCT00001208     History of Changes
Other Study ID Numbers: 850195  85-N-0195 
Study First Received: November 3, 1999
Last Updated: May 3, 2016
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Dyskinesia, Drug-Induced
Movement Disorders
Muscular Diseases
Tic Disorders
Central Nervous System Diseases
Chemically-Induced Disorders
Drug-Related Side Effects and Adverse Reactions
Mental Disorders
Musculoskeletal Diseases
Nervous System Diseases
Neurodevelopmental Disorders
Neurologic Manifestations
Neuromuscular Diseases
Neurotoxicity Syndromes
Pathologic Processes
Signs and Symptoms
Botulinum Toxins
Acetylcholine Release Inhibitors
Cholinergic Agents
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs processed this record on May 26, 2016