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NCT05413187
A Trial to Assess the Efficacy and Safety of Medical Grade Cannabis in Children Diagnosed With Autism Spectrum Disorder
Phase 2 trial testing Medical Grade Cannabis oil in Autistic Disorder. Withdrawn.
1 September 2022
Quick facts
| Lead sponsor | TO Pharmaceuticals |
|---|---|
| Phase | Phase 2 |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | double |
| Primary purpose | treatment |
| Start date | 1 September 2020 |
| Primary completion | 1 September 2022 |
| Estimated completion | 1 September 2022 |
| Sites | 1 location across Israel |
Drugs / interventions tested
- Medical Grade Cannabis oil — full drug profile →
- Placebos — full drug profile →
Conditions studied
- Autistic Disorder — all drugs for Autistic Disorder →
Sponsor
TO Pharmaceuticals — full company profile →
Who can join
Adults 2 to 8, any sex, with Autistic Disorder. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This single center, double-blinded, randomized, placebo-controlled crossover trial will assess the efficacy and safety of extraction of cannabis flowers dissolved in olive oil (30% CBD and 1.5% Δ9-THC) vs. placebo in patients diagnosed with Autism Spectrum Disorder. The trial will contain two phases in which patients will first receive a twelve-week treatment of either cannabis or placebo followed by four weeks wash out period and another twelve weeks of crossover in the trial arms.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05413187
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Autistic Disorder
Currently open trials in the same condition.
- NCT05910502 — Project AFECT (Autism Family Empowerment Coaching and Training Program) · NA · active not recruiting
- NCT06227780 — Alpha Auditory Entrainment for Cognitive Enhancement and Sensory Hypersensitivity in Youth With Developmental Disorders · NA · recruiting
- NCT05176808 — Telehealth Parent-Implemented Intervention for Young Children With Autism Spectrum Disorder (ASD) · NA · recruiting
Other TO Pharmaceuticals trials
Trials by the same sponsor.
- NCT03929835 — Study to Investigate the Efficacy and Safety of Cannabis Oil for the Treatment of Subjects With Hidradenitis Suppurativa · Phase 2 · withdrawn
- NCT03328676 — The Effect of Cannabis on Dementia Related Agitation and Aggression · Phase 2 · completed
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 NCT05413187 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by TO Pharmaceuticals
- Last refreshed: 9 June 2022
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/NCT05413187.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing