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Efficacy and Safety of OnabotulinumtoxinA 400 Units in Patients with Post-Stroke Upper Limb Spasticity: Final Report of a Randomized, Double-Blind, Placebo-Controlled Trial with an Open-Label Extension Phase

1
Department of Rehabilitation Medicine, The Jikei University School of Medicine, Tokyo 105-8461, Japan
2
Department of Rehabilitation Medicine, Seirei Hamamatsu City Rehabilitation Hospital, Shizuoka 433-8511, Japan
3
Department of Rehabilitation Medicine, Kikyogahara Hospital, Nagano 399-6461, Japan
4
GlaxoSmithKline K.K., Tokyo 107-0052, Japan
*
Authors to whom correspondence should be addressed.
Current affiliation: Department of Rehabilitation Medicine, Seirei Awaji Hospital, Hyogo 656-2306, Japan.
Current affiliation: Neurorehabilitation Center, Ainomiyako Neurosurgery Hospital, Osaka 538-0044, Japan.
Toxins 2020, 12(2), 127; https://doi.org/10.3390/toxins12020127
Received: 24 December 2019 / Revised: 13 February 2020 / Accepted: 14 February 2020 / Published: 18 February 2020
In many countries, 400 units (U) is the maximum dose of onabotulinumtoxinA available to treat upper limb spasticity, but few studies have demonstrated the optimal use of this dose. In the double-blind phase of this randomized, controlled trial, we compared the efficacy and safety of 400 vs. 240 U onabotulinumtoxinA in patients with post-stroke upper limb spasticity. Both groups received 240 U onabotulinumtoxinA injected in the forearm. An additional 160 U onabotulinumtoxinA (400 U group) or placebo (240 U group) was injected in the elbow flexors. Both groups showed similar muscle tone reduction in the wrist, fingers, and thumb; muscle tone reduction in the elbow flexors was greater in the group treated with onabotulinumtoxinA (400 U group) compared to placebo (240 U group). Functional disabilities improved in both groups. No substantial difference was found in safety profiles. In the subsequent open-label phase, all participants received repeat injections of 400 U onabotulinumtoxinA (target muscles and doses per muscle determined by the physician). Similar efficacy and safety outcomes, as with the 400 U group in the double-blind phase, were confirmed. This final report demonstrates that injection of onabotulinumtoxinA 400 U relieves muscle tone in a wide range of areas and improves functional disabilities; generally, it was well-tolerated, and no new safety concerns were identified. The dosing data in the open-label phase will inform optimal use of onabotulinumtoxinA in clinical practice (ClinicalTrials.gov: NCT03261167). View Full-Text
Keywords: botulinum toxin; stroke; upper limb spasticity; randomized controlled trial botulinum toxin; stroke; upper limb spasticity; randomized controlled trial
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Abo, M.; Shigematsu, T.; Hara, H.; Matsuda, Y.; Nimura, A.; Yamashita, Y.; Takahashi, K. Efficacy and Safety of OnabotulinumtoxinA 400 Units in Patients with Post-Stroke Upper Limb Spasticity: Final Report of a Randomized, Double-Blind, Placebo-Controlled Trial with an Open-Label Extension Phase. Toxins 2020, 12, 127.

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