Somnolence and Sedation Were Transient Adverse Events for Most Patients Receiving Clobazam Therapy: Post Hoc Analysis of Trial OV-1012 Data
Bibliographic record
Abstract
Background: Somnolence-related adverse events (AEs) are common with benzodiazepine treatment. Clobazam is a uniquely structured 1,5-benzodiazepine indicated in the US for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients ≥ 2 years old. This post hoc analysis of the phase III OV-1012 trial evaluated the incidence, as well as time to onset and resolution, of somnolence and/or sedation AEs following treatment with clobazam for patients with LGS. Methods: OV-1012 was a double-blind, placebo-controlled study that compared three oral dosages of clobazam with placebo as adjunctive therapy in patients 2 - 60 years of age with LGS. Following a 4-week baseline phase, patients who had ≥ 2 drop seizures per week were randomized to placebo or clobazam 0.25, 0.5, or 1.0 mg/kg/day (low-dosage, medium-dosage, and high-dosage, respectively). Treatment included a 3-week titration phase, followed by a 12-week maintenance phase. Incidence, time to onset, duration, and time to resolution of somnolence/sedation AEs were analyzed for patients treated with placebo, or low-, medium-, or high-dosage clobazam. Results: The incidence of somnolence and/or sedation was greater for patients treated with any dosage of clobazam (26%) than placebo (15%), and the incidence increased with greater dosages of clobazam (low-dosage, 17%; medium-dosage, 27%; and high-dosage, 32%). For most patients, onset of these events was within the first 3 weeks of treatment, corresponding to the titration phase. The majority of these events resolved (placebo, 73%; low-dosage, 82%; medium-dosage, 63%; and high-dosage, 83%). The median duration of these somnolence/sedation AEs was 1 month for all clobazam treatment groups. Conclusions: Somnolence and sedation were relatively common AEs observed during clobazam treatment for LGS in OV-1012 and were dosage-related. Most of these events were transient and resolved within a few weeks. J Neurol Res. 2015;5(4-5):252-256 doi: http://dx.doi.org/10.14740/jnr334w
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.003 | 0.002 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.001 |
| Insufficient payload (model declined to judge) | 0.000 | 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 teacher head, 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".