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ARISTOCRAT: Blinded Trial of Temozolomide +/- Cannabinoids

Study acronym: ARISTOCRAT
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated May 5, 2026 (before its estimated September 2026 completion). Its status may not reflect the trial's current state.

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Apr 2026 to Sep 2026
    • Site details revised at 1 of 22 sites
    v21
  2. Site details revised at 1 of 22 sitesv20
  3. Study sites: 21 to 22v19
  4. Enrollment target: 234 to 120v18 Show 5 more changesShow less
    • Primary completion date: Feb 2026 to Apr 2026
    • Study completion date: Feb 2027 to Apr 2027
    • Study description expanded, about 17 words
    • Site contacts updated at 15 of 21 sites
    • Eligibility criteria expanded, about 4 words
  5. Study sites revised (21)v17
Show 15 earlier versionsHide 15 earlier versions
  1. Study sites: 20 to 21v16
  2. Site details revised at 1 of 20 sitesv15
  3. Site details revised at 1 of 20 sitesv14
  4. Study sites: 19 to 20v13
  5. Study sites: 18 to 19v12
  6. Publications: details revised at 1 of 1 entryv11
  7. Site details revised at 1 of 18 sitesv10
  8. Site details revised at 1 of 18 sitesv9
  9. Site details revised at 1 of 18 sitesv8
  10. Study sites: 16 to 18
    • Interventions: Sativex (Drug), Sativex-matched placebo (Drug), Temozolomide (Drug) to Nabiximols (Drug), Nabiximols-matched placebo (Drug), Temozolomide (Drug)
    • Eligibility criteria shortened, about 2 words
    • Study description expanded, about 1 word
    v7
  11. Study sites: 15 to 16
    • Eligibility criteria expanded, about 22 words
    v6
  12. Site details revised at 2 of 15 sitesv5
  13. Site details revised at 2 of 15 sitesv4
  14. Trial status: Not Yet Recruiting to Recruitingv3 Show 5 more changesShow less
    • Primary completion date: Dec 2025 to Feb 2026
    • Study completion date: Dec 2026 to Feb 2027
    • Start date changed from estimate of Dec 2022 to Feb 3, 2023
    • Site details revised at 15 of 15 sites
    • Collaborators: 2 to 3
  15. Secondary endpoints: details revised at 2 of 4 entriesv2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
University of Birmingham
44 trials monitored
See 3 trials at risk
Glioma
1,251 trials monitored
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Glioblastoma
710 trials monitored
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ARISTOCRAT is a phase II, multi-centre, double-blind, placebo-controlled, randomised trial to compare the cannabinoid Nabiximols with placebo in patients with recurrent MGMT methylated glioblastoma (GBM) treated with temozolomide (TMZ).
Trial Details
NCT Number NCT05629702
Lead Sponsor University of Birmingham
Collaborators: University of Leeds, The Brain Tumour Charity, Jazz Pharmaceuticals
Conditions
(from sponsor)		 Glioblastoma, Brain Tumor, Cannabis, Brain Tumor, Recurrent
Related terms Brain Neoplasms, Glioblastoma, Marijuana Abuse, Recurrence
Enrollment 120 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov