Early AbobotulinumtoxinA (Dysport®) in Post-Stroke Adult Upper Limb Spasticity: ONTIME Pilot Study
The ONTIME study investigated whether early post-stroke abobotulinumtoxinA injection delays appearance or progression of upper limb spasticity (ULS) symptoms. ONTIME (NCT02321436) was a 28-week, exploratory, double-blind, randomized, placebo-controlled study of abobotulinumtoxinA 500U in patients wi...
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MDPI
2018
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| _version_ | 1825721582264254464 |
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| author | Rosales, Raymond Balcaitiene, Jovita Berard, Hugues Maisonobe, Pascal Goh, Khean Kumthornthip, Witsanu Mazlan, Mazlina Abdul Latif, Lydia Delos Santos, Mary Chotiyarnwong, Chayaporn Tanvijit, Phakamas Nuez, Odessa Kong, Keng |
| author_facet | Rosales, Raymond Balcaitiene, Jovita Berard, Hugues Maisonobe, Pascal Goh, Khean Kumthornthip, Witsanu Mazlan, Mazlina Abdul Latif, Lydia Delos Santos, Mary Chotiyarnwong, Chayaporn Tanvijit, Phakamas Nuez, Odessa Kong, Keng |
| author_sort | Rosales, Raymond |
| collection | UM |
| description | The ONTIME study investigated whether early post-stroke abobotulinumtoxinA injection delays appearance or progression of upper limb spasticity (ULS) symptoms. ONTIME (NCT02321436) was a 28-week, exploratory, double-blind, randomized, placebo-controlled study of abobotulinumtoxinA 500U in patients with ULS (Modified Ashworth Scale [MAS] score ≥ 2) 2–12 weeks post-stroke. Patients were either symptomatic or asymptomatic (only increased MAS) at baseline. Primary efficacy outcome measure: time between injection and visit at which re-injection criteria were met (MAS ≥ 2 and ≥1, sign of symptomatic spasticity: pain, involuntary movements, impaired active or passive function). Forty-two patients were randomized (abobotulinumtoxinA 500U: n = 28; placebo: n = 14) with median 5.86 weeks since stroke. Median time to reach re-injection criteria was significantly longer for abobotulinumtoxinA (156 days) than placebo (32 days; log-rank: p = 0.0176; Wilcoxon: p = 0.0480). Eleven (39.3%) patients receiving abobotulinumtoxinA did not require re-injection for ≥28 weeks versus two (14.3%) in placebo group. In this exploratory study, early abobotulinumtoxinA treatment significantly delayed time to reach re-injection criteria compared with placebo in patients with post-stroke ULS. These findings suggest an optimal time for post-stroke spasticity management and help determine the design and sample sizes for larger confirmatory studies. |
| first_indexed | 2024-03-06T05:52:32Z |
| format | Article |
| id | um.eprints-20873 |
| institution | Universiti Malaya |
| last_indexed | 2024-03-06T05:52:32Z |
| publishDate | 2018 |
| publisher | MDPI |
| record_format | dspace |
| spelling | um.eprints-208732021-05-25T03:17:24Z http://eprints.um.edu.my/20873/ Early AbobotulinumtoxinA (Dysport®) in Post-Stroke Adult Upper Limb Spasticity: ONTIME Pilot Study Rosales, Raymond Balcaitiene, Jovita Berard, Hugues Maisonobe, Pascal Goh, Khean Kumthornthip, Witsanu Mazlan, Mazlina Abdul Latif, Lydia Delos Santos, Mary Chotiyarnwong, Chayaporn Tanvijit, Phakamas Nuez, Odessa Kong, Keng R Medicine The ONTIME study investigated whether early post-stroke abobotulinumtoxinA injection delays appearance or progression of upper limb spasticity (ULS) symptoms. ONTIME (NCT02321436) was a 28-week, exploratory, double-blind, randomized, placebo-controlled study of abobotulinumtoxinA 500U in patients with ULS (Modified Ashworth Scale [MAS] score ≥ 2) 2–12 weeks post-stroke. Patients were either symptomatic or asymptomatic (only increased MAS) at baseline. Primary efficacy outcome measure: time between injection and visit at which re-injection criteria were met (MAS ≥ 2 and ≥1, sign of symptomatic spasticity: pain, involuntary movements, impaired active or passive function). Forty-two patients were randomized (abobotulinumtoxinA 500U: n = 28; placebo: n = 14) with median 5.86 weeks since stroke. Median time to reach re-injection criteria was significantly longer for abobotulinumtoxinA (156 days) than placebo (32 days; log-rank: p = 0.0176; Wilcoxon: p = 0.0480). Eleven (39.3%) patients receiving abobotulinumtoxinA did not require re-injection for ≥28 weeks versus two (14.3%) in placebo group. In this exploratory study, early abobotulinumtoxinA treatment significantly delayed time to reach re-injection criteria compared with placebo in patients with post-stroke ULS. These findings suggest an optimal time for post-stroke spasticity management and help determine the design and sample sizes for larger confirmatory studies. MDPI 2018 Article PeerReviewed Rosales, Raymond and Balcaitiene, Jovita and Berard, Hugues and Maisonobe, Pascal and Goh, Khean and Kumthornthip, Witsanu and Mazlan, Mazlina and Abdul Latif, Lydia and Delos Santos, Mary and Chotiyarnwong, Chayaporn and Tanvijit, Phakamas and Nuez, Odessa and Kong, Keng (2018) Early AbobotulinumtoxinA (Dysport®) in Post-Stroke Adult Upper Limb Spasticity: ONTIME Pilot Study. Toxins, 10 (7). p. 253. ISSN 2072-6651, DOI https://doi.org/10.3390/toxins10070253 <https://doi.org/10.3390/toxins10070253>. https://doi.org/10.3390/toxins10070253 doi:10.3390/toxins10070253 |
| spellingShingle | R Medicine Rosales, Raymond Balcaitiene, Jovita Berard, Hugues Maisonobe, Pascal Goh, Khean Kumthornthip, Witsanu Mazlan, Mazlina Abdul Latif, Lydia Delos Santos, Mary Chotiyarnwong, Chayaporn Tanvijit, Phakamas Nuez, Odessa Kong, Keng Early AbobotulinumtoxinA (Dysport®) in Post-Stroke Adult Upper Limb Spasticity: ONTIME Pilot Study |
| title | Early AbobotulinumtoxinA (Dysport®) in Post-Stroke Adult Upper Limb Spasticity: ONTIME Pilot Study |
| title_full | Early AbobotulinumtoxinA (Dysport®) in Post-Stroke Adult Upper Limb Spasticity: ONTIME Pilot Study |
| title_fullStr | Early AbobotulinumtoxinA (Dysport®) in Post-Stroke Adult Upper Limb Spasticity: ONTIME Pilot Study |
| title_full_unstemmed | Early AbobotulinumtoxinA (Dysport®) in Post-Stroke Adult Upper Limb Spasticity: ONTIME Pilot Study |
| title_short | Early AbobotulinumtoxinA (Dysport®) in Post-Stroke Adult Upper Limb Spasticity: ONTIME Pilot Study |
| title_sort | early abobotulinumtoxina dysport r in post stroke adult upper limb spasticity ontime pilot study |
| topic | R Medicine |
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