Efficacy and Safety Study of Botulinum Neurotoxin A With Rehabilitation Versus Botulinum Neurotoxin A Alone in Treatment of Post-stroke Spasticity

Completed · Not applicable

Conditions studied: Upper Limb Spasticity

In brief

The purpose of this study is to determine if a combination of botulinum neurotoxin A and rehabilitation therapy is better than botulinum neurotoxin A alone for improvement in function based on the Fugl-Meyer and other validated measures. Hypothesis: The combination of botulinum neurotoxin A and rehabilitation therapy will produce better functional improvement than botulinum neurotoxin A alone in post-stroke upper limb spasticity measured by the Fugl-Meyer Assessment of Sensorimotor Recovery after Stroke.

Key facts

Study ID

NCT00945295

Run by

JoAnn Harnar

People needed

31

Starts

2009-01-01

Expected to finish

2012-05-01

Last updated by the study team

2013-11-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Adults 18 years of age or older
• Stroke (ischemic or hemorrhagic) diagnosed by a neurologist at least 6 months prior to enrollment
• Focal spasticity in upper limb measured at the elbow, wrist, fingers and thumb with a Modified Ashworth Scale (MAS) of 3 or greater in the wrist and/or fingers
• Functional impairment secondary to spasticity such as difficulty with hygiene, dressing, posture or pain
• Minimum weight of 44 kg (88 lbs) in order to tolerate the minimum required dosage of 200 U
• Written informed consent has been obtained
• Written authorization for Use and Release of Health and Research Study Information has been obtained
• Laboratory findings required (if applicable)
• Ability to follow study instructions and likely to complete all required visits
• Negative urine pregnancy test on the day of treatment prior to the administration of study medication (for females of childbearing potential). (If applicable.)

You may not qualify if…

• Uncontrolled clinically significant medical condition other than the condition under evaluation
• Known allergy or sensitivity to any of the components in the study medication
• Females who are pregnant, breast-feeding, or planning a pregnancy during the study or who think that they may be pregnant at the start of the study, or females of childbearing potential who are unable or unwilling to use a reliable form of contraception during the study
• Concurrent participation in another investigational drug or device study or participation in the 30 days immediately prior to study enrollment
• Fixed contracture or profound atrophy in the spastic limb
• Prior or current treatment with neurolytic agents such as phenol or surgery; any version of botulinum toxin (other than BoNT-A more than 6 months prior to enrollment)
• Current rehabilitation therapy that cannot be altered to the treatment plan in the study
• Unable or unwilling to participate in a weekly rehab program
• Any medical condition that may put the subject at increased risk with exposure to BOTOX including diagnosed myasthenia gravis, Eaton-Lambert syndrome, amyotrophic lateral sclerosis, or any other disorder that might interfere with neuromuscular function
• Current treatment with agents affecting neuromuscular transmission
• Evidence of recent alcohol or drug abuse
• Infection or skin disorder at an anticipated injection site (if applicable)
• Any condition or situation that, in the investigator's opinion, may put the subject at significant risk, confound the study results, or interfere significantly with the subject's participation in the study

Where it is running

• New Mexico VA Health Care System — Albuquerque, New Mexico, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.