Muscle Selection Patterns for Injection of OnabotulinumtoxinA in Adult Patients with Post-Stroke Lower-Limb Spasticity Influence Outcome: Results from a Double-Blind, Placebo-Controlled Phase 3 Clinical Trial (S7.001)
Bibliographic record
Abstract
Objective:To identify an optimal muscle selection pattern for onabotulinumtoxinA injection for the treatment of post-stroke lower limb spasticity (PSLLS). Background:OnabotulinumtoxinA (300U-400U) is being investigated for the treatment of PSLLS in the ankle; however, the optimal combination of muscles for injection is not established. Design/Methods:In a multicenter, phase 3, placebo-controlled study, adults with PSLLS (Modified Ashworth Scale [MAS] ≥3 in the ankle) were enrolled. The 12-week double-blind phase randomized patients to onabotulinumtoxinA (300U, mandatory muscles [gastrocnemius, soleus, tibialis posterior] and ≤100U, optional lower limb muscles [flexor digitorum longus (FDL), flexor digitorum brevis, flexor hallucis longus (FHL), extensor hallucis, rectus femoris]) or placebo. The primary endpoint, MAS change from baseline, and a secondary endpoint, physician-assessed Clinical Global Impression of Change (CGI), were each reported as the average score of weeks 4 and 6. Results:In the intent-to-treat group (n=468), onabotulinumtoxinA significantly improved ankle MAS (-0.81 vs -0.61; P=0.01) and CGI (0.86 vs 0.65; P=0.012) versus placebo. 211 patients received treatment in the mandatory muscles only; 119 received treatment in the mandatory muscles plus FHL and FDL muscles. Injection of the mandatory muscles alone was not sufficient in improving ankle MAS (P=0.255) or CGI (P=0.576) in all patients, however, it was adequate among those ≤2 years post-stroke (MAS, -1.13 vs -0.62, P=0.019; CGI, 1.24 vs. 0.68, P=0.006). Additional injections into FDL and FHL muscles significantly improved ankle MAS (-0.98 vs -0.52; P=0.002) and CGI (0.80 vs 0.38; P=0.023) versus placebo regardless of their time since stroke. OnabotulinumtoxinA 300-400 U was well tolerated with no new safety findings. Conclusions:Additional injections of onabotulinumtoxinA into the toe flexors (FDL, FHL) significantly improved ankle MAS and CGI scores compared with injections into the mandatory muscles alone, particularly when treatment was initiated >2 years post-stroke. Study Supported by: Allergan, Inc.
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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 | 0.001 | 0.001 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.001 | 0.001 |
| Insufficient payload (model declined to judge) | 0.003 | 0.000 |
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".