Botulinum Toxin for the Treatment of Involuntary Movement Disorders

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2015 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) )
ClinicalTrials.gov Identifier:
NCT00001208
First received: November 3, 1999
Last updated: May 20, 2015
Last verified: May 2015

November 3, 1999
May 20, 2015
November 1985
Not Provided
Not Provided
Not Provided
Complete list of historical versions of study NCT00001208 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Botulinum Toxin for the Treatment of Involuntary Movement Disorders
A Training Protocol for the Use of Botulinum Toxin in the Treatment of Neurological Disorders

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>

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.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Chorea
  • Drug Induced Dyskinesia
  • Movement Disorder
  • Muscular Disease
  • Tic Disorder
Other: Botulinum Toxin
N/A
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1000
October 2019
Not Provided
  • 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.
Both
4 Years and older
No
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
United States
 
NCT00001208
850195, 85-N-0195
Not Provided
National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) )
National Institute of Neurological Disorders and Stroke (NINDS)
Not Provided
Principal Investigator: Codrin I Lungu, M.D. National Institute of Neurological Disorders and Stroke (NINDS)
National Institutes of Health Clinical Center (CC)
May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP