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Cannabidivarin (CBDV) vs. Placebo in Children With Autism Spectrum Disorder (ASD)

StatusRecruiting
PhasePhase 2
Started
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Record History

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  1. Primary and study completion dates: Dec 2025 to Feb 2027v23
  2. Primary endpoint revised
    • Secondary endpoints revised (6)
    • Collaborators: 2 to 3
    v22
  3. Primary and study completion dates: Jul 2024 to Dec 2025
    • Site contacts updated at 1 of 2 sites
    • Collaborators revised (2)
    v21
  4. Primary and study completion dates: Jul 31, 2023 to Jul 2024
    • Study sites: 1 to 2
    • Secondary endpoints reordered
    v20
  5. Primary and study completion dates: Aug 31, 2022 to Jul 31, 2023
    • Collaborators revised (2)
    v19
Show 17 earlier versionsHide 17 earlier versions
  1. Primary and study completion dates: Oct 6, 2021 to Aug 31, 2022v18
  2. Lead sponsor: Eric Hollander to Montefiore Medical Center
    • Primary completion date: Jun 30, 2021 to Oct 6, 2021
    • Study completion date: Sep 30, 2021 to Oct 6, 2021
    v17
  3. Site contact updatedv16
  4. Eligibility criteria expanded, about 79 words
    • Site contact updated
    v15
  5. Eligibility criteria expanded, about 158 words
    • Secondary endpoints: 5 to 6
    v14
  6. Interventions: Cannabidivarin (CBDV) (Drug), Matched Placebo (Drug) to Cannabidivarin (Drug), Matched Placebo (Drug)
    • Study description expanded, about 320 words
    v13
  7. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Jun 2019 to Apr 12, 2019
    v12
  8. Secondary endpoints revised (5)
    • Collaborators: 1 to 2
    v11
  9. Re-verified, no change to tracked fieldsv10
  10. Start date: Dec 2018 to Jun 2019v9
  11. Re-verified, no change to tracked fieldsv8
  12. Start date: Oct 2018 to Dec 2018v7
  13. Start date: Jul 2018 to Oct 2018v6
  14. Start date: May 2018 to Jul 2018v5
  15. Lead sponsor: Montefiore Medical Center to Eric Hollander
    • Start date: Oct 2017 to May 2018
    v4
  16. Eligibility criteria expanded, about 11 wordsv3
  17. Re-verified, no change to tracked fieldsv2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This trial aims to study the efficacy and safety of cannabidivarin (CBDV) in children with ASD.
Trial Details
NCT Number NCT03202303
Lead Sponsor Montefiore Medical Center
Collaborators: United States Department of Defense, GW Pharmaceuticals Ltd, Jazz Pharmaceuticals
Conditions
(from sponsor)		 Autism Spectrum Disorder
Related terms Autism Spectrum Disorder, Autistic Disorder
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov