An open-label trial of alsuma auto-injector for migraine
Bibliographic record
Abstract
To assess the ability of patients, during an acute migraine attack, to successfully self-inject a single dose of sumatriptan using the Alsuma Auto-Injector; and to evaluate the safety and tolerability of the Auto-Injector. The Alsuma Auto-Injector is a single-use system for the rapid subcutaneous delivery of 6 mg of sumatriptan succinate in the acute management of migraine pain. The Auto-Injector was developed to address the clinical need for an easy to use and rapid to administer system that did not require any assembly. This was an open-label, Phase 3 trial conducted at 10 sites in the US. Male or female adults, ages 18 to 60 years old, were eligible for study entry if they met IHS criteria for migraine with or without aura, with at least 2 attacks per month, and if they reported use of subcutaneous injectable sumatriptan on at least 2 occasions within the previous 2 months. During the onset of a migraine attack of moderate-to-severe intensity, patients were asked to administer a 6 mg subcutaneous dose of sumatriptan using the Auto-Injector. Subjects returned to the study site within 72 hours of the migraine for the post-treatment assessment visit. A total of 63 patients met entry criteria and received a dose of study medication. All self-administered the Alsuma Auto-Injector successfully. On the patient questionnaire, 100% of patients agreed that the written instructions for the Auto-Injector were clear and easy to follow, and that the Auto-Injector was easy to use (95%). A majority of patients agreed that they preferred the new Auto-Injector to the traditional one that they were using prior to study entry (65.1%). The most frequent AEs was injection site bruising, reported by 15.9% of patients, and rated in all instance as mild in intensity. The majority of injection-experienced patients reported the pre-assembled, single-use Alsuma Auto-Injector to be an easy to use, preferred treatment for an acute migraine attack. The study found the Auto-Injector to be safe and well-tolerated.
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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 | 0.001 | 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) | 0.007 | 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".