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
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 on...
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MDPI AG
2020-02-01
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| Online Access: | https://www.mdpi.com/2072-6651/12/2/127 |
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| author | Masahiro Abo Takashi Shigematsu Hiroyoshi Hara Yasuko Matsuda Akinori Nimura Yoshiyuki Yamashita Kaoru Takahashi |
| author_facet | Masahiro Abo Takashi Shigematsu Hiroyoshi Hara Yasuko Matsuda Akinori Nimura Yoshiyuki Yamashita Kaoru Takahashi |
| author_sort | Masahiro Abo |
| collection | DOAJ |
| description | 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). |
| first_indexed | 2024-04-14T06:34:42Z |
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| language | English |
| last_indexed | 2024-04-14T06:34:42Z |
| publishDate | 2020-02-01 |
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| series | Toxins |
| spelling | doaj.art-a6bf7959536249768f2d0a77cbec3a6e2022-12-22T02:07:30ZengMDPI AGToxins2072-66512020-02-0112212710.3390/toxins12020127toxins12020127Efficacy 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 PhaseMasahiro Abo0Takashi Shigematsu1Hiroyoshi Hara2Yasuko Matsuda3Akinori Nimura4Yoshiyuki Yamashita5Kaoru Takahashi6Department of Rehabilitation Medicine, The Jikei University School of Medicine, Tokyo 105-8461, JapanDepartment of Rehabilitation Medicine, Seirei Hamamatsu City Rehabilitation Hospital, Shizuoka 433-8511, JapanDepartment of Rehabilitation Medicine, Kikyogahara Hospital, Nagano 399-6461, JapanGlaxoSmithKline K.K., Tokyo 107-0052, JapanGlaxoSmithKline K.K., Tokyo 107-0052, JapanGlaxoSmithKline K.K., Tokyo 107-0052, JapanGlaxoSmithKline K.K., Tokyo 107-0052, JapanIn 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).https://www.mdpi.com/2072-6651/12/2/127botulinum toxinstrokeupper limb spasticityrandomized controlled trial |
| spellingShingle | Masahiro Abo Takashi Shigematsu Hiroyoshi Hara Yasuko Matsuda Akinori Nimura Yoshiyuki Yamashita Kaoru Takahashi 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 botulinum toxin stroke upper limb spasticity randomized controlled trial |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | botulinum toxin stroke upper limb spasticity randomized controlled trial |
| url | https://www.mdpi.com/2072-6651/12/2/127 |
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