Sustained Benefit with Repeated Treatments of OnabotulinumtoxinA in Post-Stroke Lower Limb Spasticity: 1-Year Open-Label Final Results from a Double-Blind, Placebo-Controlled, Phase 3 Trial (S7.002)
Bibliographic record
Abstract
Objective:To evaluate the sustained benefit with repeated treatments of onabotulinumtoxinA in adults with post-stroke lower limb spasticity (PSLLS). Background:OnabotulinumtoxinA is under investigation for the treatment of PSLLS; however, the maintenance of benefit for multiple injection cycles is not established. Design/Methods:A multicenter, phase 3, placebo-controlled trial enrolled patients with PSLLS (Modified Ashworth Scale [MAS] ≥3) of the ankle plantar flexors. The 12-week double-blind phase provided onabotulinumtoxinA 300U-400U (300U, ankle plantar flexors [gastrocnemius, soleus, tibialis posterior]; ≤100U, optional lower limb muscles [flexor digitorum longus, flexor hallucis longus, flexor digitorum brevis, extensor hallucis, rectus femoris]) or placebo. During the open-label phase, patients received ≤3 treatments of onabotulinumtoxinA ≤400U at ~12-week intervals. The double-blind primary endpoint was MAS change from baseline (average score at weeks 4 and 6). Open-label secondary endpoints included the MAS change from baseline, Clinical Global Impression of Change (CGI) by physician, and Goal Attainment Scale (GAS), each at week 6 of each treatment cycle. Results:Of 468 patients enrolled, 450 (96[percnt]) completed the double-blind phase, and 413 (88[percnt]) completed the study. Improvements in MAS scores observed with onabotulinumtoxinA during the double-blind phase (onabotulinumtoxinA, -0.8; placebo, -0.6, P=0.01) continued and were further enhanced with additional treatments through week 6 of the third open-label treatment cycle (onabotulinumtoxinA/onabotulinumtoxinA, -1.2; placebo/onabotulinumtoxinA, -1.4). Improvements in CGI scores observed during the double-blind phase (onabotulinumtoxinA, 0.9; placebo, 0.7, P=0.01) also continued and were further enhanced through week 6 of the third open-label treatment cycle (onabotulinumtoxinA/onabotulinumtoxinA, 1.6; placebo/onabotulinumtoxinA, 1.6). Physician- and patient-assessed GAS (active and passive) scores and percent of responders improved with each subsequent treatment. OnabotulinumtoxinA (300-400 U) was well tolerated with no new safety findings. Conclusions:Improvements in MAS, CGI, and GAS scores were consistent and increased with repeated treatments of onabotulinumtoxinA over 1 year in patients with PSLLS. Study Supported By: Allergan
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.003 | 0.001 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.004 | 0.003 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.002 | 0.003 |
| Insufficient payload (model declined to judge) | 0.005 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".