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NCT03676049
Cannabidiol for Drug Resistant Pediatric Epilepsy (Expanded Access Use)
trial testing Cannabidiol in Drug Resistant Epilepsy. Available.
Quick facts
| Lead sponsor | John |
|---|---|
| Status | AVAILABLE |
| Study type | EXPANDED_ACCESS |
| Sites | 1 location across United States |
Drugs / interventions tested
- Cannabidiol (CANNABIDIOL) — full drug profile →
Conditions studied
- Drug Resistant Epilepsy — all drugs for Drug Resistant Epilepsy →
Sponsor
John — full company profile →
Who can join
Adults 5 to 19, any sex, with Drug Resistant Epilepsy. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a treatment study under an approved Expanded Use IND protocol for using Cannabidiol (CBD) Extract. CBD will be used for the treatment of 5-10 children with drug resistant epilepsy. The CBD used in this study is prepared at the University of Mississippi under approval of the National Institute on Drug Abuse (NIDA) for its preparation and FDA approval under an expanded access mechanism on a compassionate use basis. The target patient population is who would otherwise have no appropriate remaining treatment modality left. These are patients for whom the risks of a relatively untested product are outweighed by the potential benefit. Using seizure-diaries to register seizure frequency, drug log and questionnaire to measure parent/patient quality of life and side effects will be assessed in each visit. Visits are: baseline, 4, 8, and 12 weeks visit. A 24 weeks visit (6 months) will be performed if the patient is stable on therapy during the 3 initial months and want to continue on the study for 3 more months. CBD will be administered as an adjunct to all current anti-epileptic therapies.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Use of Cannabidiol in the Treatment of Epilepsy: Efficacy and Security in Clinical Trials.
Silvestro S, Mammana S, Cavalli E, Bramanti P, et al · · 2019 · cited 114× · PMID 31013866 · DOI 10.3390/molecules24081459 -
Medical Cannabis in Pediatric Oncology: Friend or Foe?
Malach M, Kovalchuk I, Kovalchuk O. · · 2022 · cited 8× · PMID 35337156 · DOI 10.3390/ph15030359
Verify or expand the search:
- PubMed search for NCT03676049
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Other recruiting trials for Drug Resistant Epilepsy
Currently open trials in the same condition.
- NCT07145489 — Infrared Photobiomodulation in Humans With Epilepsy · NA · recruiting
- NCT06899230 — Safety, Tolerability, and Pharmacokinetics (PK) of Single and Multiple Ascending Oral Doses of iQ-007 · Phase 1 · active not recruiting
- NCT05527093 — Cartography of Social Cognition Network and Their Alterations in Patients With Epilepsy · NA · recruiting
- NCT06334952 — Efficacy of Personnalized Transcranial Direct Current Electrical Stimulation (tDCS) in Drug-resistant Epileptic · NA · recruiting
- NCT06708143 — Temporal Interference for Drug Resistant Epilepsy · NA · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03676049 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by John
- Last refreshed: 9 May 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03676049.
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