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ARISTOCRAT: Blinded Trial of Temozolomide +/- Cannabinoids

NCT05629702 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-05-05

No results posted yet for this study

Summary

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).

Conditions

Interventions

DRUG

Nabiximols

Oromucosal spray

DRUG

Temozolomide

Oral capsule

DRUG

Nabiximols-matched placebo

Nabiximols-matched placebo oromucosal spray

Sponsors & Collaborators

  • University of Leeds

    collaborator OTHER

  • The Brain Tumour Charity

    collaborator OTHER

  • Jazz Pharmaceuticals

    collaborator INDUSTRY

  • University of Birmingham

    lead OTHER

Principal Investigators

  • Fiona Collinson, MBBS, BSc, MRCP, FRCR, PhD · University of Leeds

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-03
Primary Completion
2026-09-30
Completion
2027-04-30

Countries

  • United Kingdom

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05629702 on ClinicalTrials.gov