Not Signed In -
Stroke |
Brain Attack; Carotid Endarterectomy; Cerebrovascular Disease |
Clinical Trial: A BOTOX ® Study for Stroke Patients with Muscle Tightness in the Wrist, Fingers, and Elbow and with Some Breathing Problems
This study is currently recruiting patients.
|
Purpose
The study involves injecting an investigational medication not yet approved by the FDA into your arm and hand muscles to see if the amount of tightness can be relieved.
Spasticity or tightness in the arm and hand after a stroke happens because the muscles are pulling and cramping. This causes the arm and hand to curl in toward the body. Often the hand will look like a claw. The tightness in the muscles may make it hard to straighten out the wrist, fingers and/or elbow without pain.
The purpose of this research study is to see if the medication will affect your breathing and also to see if the medication will relax the tightness in the muscles and allow the wrist, fingers, and/or elbow to be straightened.
If you participate:
You will be asked to make nine (9) visits to the study center. Your participation in the research study will last for approximately 32 weeks. You will have injections into your arm and your hand. You will have blood drawn at 2 visits. You will have tests done to check your breathing at each visit. All costs are paid for by a research grant. Inclusion / Exclusion Criteria:
You must be at least 18 years old. You must have had a stroke six months ago or longer. You must have muscle tightness from the stroke in one arm. You must have a pulmonary/breathing problem. You must not have used BOTOX ® or any other botulinum toxin previously for any condition.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| Stroke | Drug: BOTOX® (Botulinum Toxin Type A) | Phase II Phase III |
MedlinePlus related topics: Stroke
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety Study
Official Title: A Multi-Center, Double-Blind, Placebo-Controlled, Parallel Group Safety Study of Pulmonary Function in Patients with Reduced Lung Function Treated with BOTOX® (Botulinum Toxin Type A) Purified Neurotoxin Complex for Focal Upper Limb Poststroke Spasticity
Expected Total Enrollment: 150
Study start: October 2003; Expected completion: December 2006
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
Criteria
Inclusion / Exclusion Criteria:
- You must be at least 18 years old.
- You must have had a stroke six months ago or longer.
- You must have muscle tightness from the stroke in one arm.
- You must have a pulmonary/breathing problem.
- You must not have used BOTOX ® or any other botulinum toxin previously for any condition.
Location and Contact Information
Arizona
Banner Health Institute, Phoenix, Arizona, 85006, United States; Recruiting
Johan Samanta, MD, Principal Investigator
California
Pacific Neuroscience Medical Group, Inc, Oxnard, California, 93030, United States; Recruiting
James Sutton, MD, Principal Investigator
East Bay Region Associates in Neurology, Berkeley, California, 94705, United States; Recruiting
Bradley Wrubel, MD, Principal Investigator
Connecticut
Associated Neurologists of Southern Connecticut, Fairfield, Connecticut, 06430, United States; Recruiting
Peter McAllister, MD, Principal Investigator
Florida
Bradenton Neurology, Inc., Bradenton, Florida, 34206, United States; Recruiting
Ralph Gonzalez, MD, Principal Investigator
Melbourne Internal Medicine Associates (MIMA), Melbourne, Florida, 32901, United States; Recruiting
Bill Sunter, MD, Principal Investigator
University of Miami, School of Medicine, Miami, Florida, 33136, United States; Recruiting
Julie Steele 305-243-7424 Jsteele@med.miami.edu
Bruce Rubin, MD, Principal Investigator
Georgia
Savannah Neurology PC, Savannah, Georgia, 31405, United States; Recruiting
Michael Hemphill, MD, Principal Investigator
Shepherd Center, Atlanta, Georgia, 30309, United States; Recruiting
Gerald Bilsky, MD, Principal Investigator
Neurotrials Research, Inc., Atlanta, Georgia, 30342, United States; Recruiting
Matthews Gwynn, MD 404-851-9934
Matthews Gwynn, MD, Principal Investigator
Illinois
Neurologic Associates, Palos Heights, Illinois, 60463, United States; Recruiting
Arthur Itkin, MD, Principal Investigator
Indiana
Indiana University, Indianapolis, Indiana, 46202, United States; Recruiting
Allison Brashear, MD, Principal Investigator
Maryland
Parkinson's & Movement Disorders Center of Maryland, Columbia, Maryland, 21044, United States; Recruiting
Susanne Goldstein, MD, Principal Investigator
Missouri
Washington University School of Medicine, St. Louis, Missouri, 63110, United States; Recruiting
Pat Deppen 314-362-8548 deppenp@neuro.wustl.edu
Brad Racette, MD, Principal Investigator
Nevada
Nevada Neurological Consultants, Henderson, Nevada, 89052, United States; Recruiting
David L. Ginsburg, MD, Principal Investigator
New York
Lutheran Medical Center, Brooklyn, New York, 11220, United States; Recruiting
Mary Catherine George 212-241-0784 mary-catherine.george@mssm.edu
Anthony Geraci, MD, Principal Investigator
Long Island Jewish Medical Center, Dept. of Neurology, New Hyde Park, New York, 11040, United States; Recruiting
Mark Forrest Gordon, MD 718-470-7366 mfgordon@lij.edu
Mark Forrest Gordon, MD, Principal Investigator
Lutheran Medical Center, Brooklyn, New York, 11220, United States; Recruiting
Anthony Geraci, M.D., Principal Investigator
North Carolina
Charlotte Institute of Rehabilitation, Charlotte, North Carolina, 28203, United States; Recruiting
Vu Nguyen, MD, Principal Investigator
Ohio
The Drake Center, Cincinnati, Ohio, 45216, United States; Recruiting
Sue Pierson, MD, Principal Investigator
West Virginia
Charleston Area Medical Center, Charleston, West Virginia, 25301, United States; Recruiting
Kristi Sutphin 304-388-9945 kristi.sutphin@camc.org
Ramon Lansang, Jr., MD, Principal Investigator
Wisconsin
Froedert Memorial Lutheran Hospital/Medical College of Wisconsin (FMLH/MCW), Milwaukee, Wisconsin, 53226, United States; Recruiting
John McGuire, MD, Principal Investigator
More Information
Record last reviewed: March 2005
Last Updated: March 15, 2005
Record first received: January 29, 2004
ClinicalTrials.gov Identifier: NCT00076687
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 8, 2005
Resources
- ''''The Free-Radical Theory of Aging: Part I - How it all began'''' (HealthWorld)
- Accidente Cerebrovascular: Esperanza en la Investigaciуn (National Institute of Neurological Diseases and Stroke)
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