A prospective open‐label trial of a <scp>CBD</scp>/<scp>THC</scp> cannabis oil in dravet syndrome
Bibliographic record
Abstract
Abstract Introduction Both Δ 9 Tetrahydrocannabidiol ( THC ) and cannabidiol ( CBD ) components of cannabis, have been shown to have anticonvulsant effects. Cannabis oils are used to treat seizures in drug‐resistant epilepsy ( DRE ). Recent trials provide data on dosing, side effects, and efficacy of CBD , yet there is a paucity of information on THC in epilepsy. Primary objective was to establish dosing and tolerability of TIL ‐ TC 150 ‐ a cannabis plant extract produced by Tilray ® , containing 100 mg/mL CBD and 2 mg/mL THC ‐ in children with Dravet syndrome. Secondary objectives were to assess impact of therapy on seizures, electroencephalogram ( EEG ) and quality of life. Methods Twenty children received add‐on therapy with TIL ‐ TC 150. The dose ranged from 2 to 16 mg/kg/day of CBD and 0.04 to 0.32 mg/kg/day of THC . Patients were monitored for tolerability and adverse events, and secondary objectives. Results Nineteen participants completed the 20‐week intervention. Mean dose achieved was 13.3 mg/kg/day of CBD (range 7–16 mg/kg/day) and 0.27 mg/kg/day of THC (range 0.14–0.32 mg/kg/day). Adverse events, common during titration included somnolence, anorexia, and diarrhea. Abnormalities of liver transaminases and platelets were observed with concomitant valproic acid therapy. There was a statistically significant improvement in quality of life, reduction in EEG spike activity, and median motor seizure reduction of 70.6%, with 50% responder rate of 63%. Conclusions TIL ‐ TC 150 was safe and well tolerated in our subjects. TIL ‐ TC 150 treatment resulted in a reduction in seizure counts, spike index on EEG , and improved quality of life measures. This study provides safety and dosing information for THC ‐containing cannabinoid preparations.
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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 | 0.002 | 0.003 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.000 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.000 | 0.002 |
| 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".