Botulinum toxin type B in the spastic arm: a randomized, double-blind, placebo-controlled, preliminary study.
OBJECTIVE
To determine the efficacy and safety of 2 doses of botulinum toxin type B (rimabotulinumtoxinB, BoNT/B) in spastic upper limb muscles.


METHODS
Randomized, double-blind, placebo-controlled trial with a 3-month follow-up.


METHODS
Tertiary care center.


METHODS
Referred sample of adult hemiparetic patients (N=24) with disabling elbow flexor overactivity after stroke or traumatic brain injury.


METHODS
Injection of 10,000U of rimabotulinumtoxinB (fixed 2500U dose into elbow flexors; n=8), 15,000U (5000U into elbow flexors; n=8), or placebo (n=8) into overactive upper limb muscles selected as per investigator's discretion.


METHODS
At 1 month postinjection, active range of elbow extension (goniometry; primary outcome); active upper limb function (Modified Frenchay Scale [MFS]); subjective global self-assessment (GSA) of arm pain, stiffness, and function; rapid alternating elbow flexion-extension movement frequency over the maximal range; elbow flexor spasticity grade and angle (Tardieu), and tone (Ashworth).


RESULTS
No adverse effects were associated with either BoNT/B dose. Both doses improved active elbow extension versus placebo (+8.3°; 95% confidence interval, 1.1°-15.5°; analysis of covariance, P=.028). The high dose of BoNT/B also improved subject-perceived stiffness (P=.005) and the composite pain, stiffness, and function GSA (P=.017), effects that persisted 3 months from injection. No MFS change was demonstrated, although subjects with a baseline MFS <70/100 seemed more likely to benefit from BoNT/B.


CONCLUSIONS
In this short-term study, BoNT/B up to 15,000U into spastic upper limb muscles, including the elbow flexors, was well tolerated and improved active elbow extension and subject-perceived stiffness.
Department of Neurology, Mount Sinai Medical Center, New York, NY. Electronic address: jean-michel.gracies@hmn.aphp.fr.
Jean-Michel
JM
Gracies
Department of Neurology, Mount Sinai Medical Center, New York, NY.
Nicolas
N
Bayle
Department of Neurology, Mount Sinai Medical Center, New York, NY.
Sarah
S
Goldberg
Department of Neurology, Mount Sinai Medical Center, New York, NY.
David M
DM
Simpson
D000328:Adult; D000368:Aged; D018726:Anti-Dyskinesia Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001132:Arm; D001905:Botulinum Toxins / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D019274:Botulinum Toxins, Type A; D004185:Disability Evaluation; D004311:Double-Blind Method; D004550:Elbow; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009128:Muscle Spasticity; D010243:Paralysis / Q000188:drug therapy*; D016059:Range of Motion, Articular; D062606:Tertiary Care Centers
D018726:Anti-Dyskinesia Agents; C096323:rimabotulinumtoxinB; D001905:Botulinum Toxins; D019274:Botulinum Toxins, Type A
Botulinum toxin; Controlled clinical trials, randomized; Rehabilitation; Stroke