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Botulinum Toxin for the Treatment of Involuntary Movement Disorders

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ClinicalTrials.gov Identifier: NCT00001208
Recruitment Status : Recruiting
First Posted : November 4, 1999
Last Update Posted : March 23, 2021
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) )

Tracking Information
First Submitted Date November 3, 1999
First Posted Date November 4, 1999
Last Update Posted Date March 23, 2021
Actual Study Start Date October 26, 1989
Primary Completion Date Not Provided
Current Primary Outcome Measures
 (submitted: March 13, 2020)
  • Study Natural History- data analysis [ Time Frame: Ongoing ]
    Data regarding the movement disorder of the subject and observations of their standard treatment will be collected. Data may be used for future research questions that are related to subjects movement disorder and/or treatment.
  • Maintain cohort of subjects [ Time Frame: Ongoing ]
    To maintain a cohort of patients with dystonia and other movement disorders for participation in other studies on the physiology of dystonia and BTX injection
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Botulinum Toxin for the Treatment of Involuntary Movement Disorders
Official Title Botulinum Toxin for the Treatment of Neurological Disorders
Brief Summary

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>

Detailed Description The efficacy of botulinum toxin (BTX) has now been demonstrated for a variety of diseases associated with involuntary muscles 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) allows us to follow the natural history of subjects with movement disorders who receive standard botox injections for treatment of movement disorders and 2) allows us to provide botulinum toxin injections for patients participating in other studies on the physiology of sensorimotor systems and on the physiological effects of botulinum toxin.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Primary clinical- Patients are evaluated for treatment with BTX in the movement disorders clinic of the Human Motor Control Section or by the Voice and Speech section, NINDS.
Condition Movement Disorders
Intervention Not Provided
Study Groups/Cohorts Patients
Patients will be eligible for participation if they have a movement disorder that, in the judgment of the treating physician, might be amenable to treatment with BTX.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: April 29, 2017)
2000
Original Enrollment
 (submitted: June 23, 2005)
800
Study Completion Date Not Provided
Primary Completion Date Not Provided
Eligibility Criteria
  • 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 2 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Shashi B Ravindran, C.R.N.P. (301) 402-7129 ravindrs@mail.nih.gov
Contact: Debra J Ehrlich, M.D. (301) 443-7888 debra.ehrlich@nih.gov
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00001208
Other Study ID Numbers 850195
85-N-0195
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) )
Study Sponsor National Institute of Neurological Disorders and Stroke (NINDS)
Collaborators Not Provided
Investigators
Principal Investigator: Debra J Ehrlich, M.D. National Institute of Neurological Disorders and Stroke (NINDS)
PRS Account National Institutes of Health Clinical Center (CC)
Verification Date February 12, 2021