Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Nabiximols · 6 trials · 7 indications
LLMT-6 is defined as the average of the 6 individual Modified Ashworth Scale (MAS) transformed scores of knee flexors, knee extensors, and plantar flexors on both sides of the body. Transformed MAS ranges from 0 (no increase in muscle tone) to 5 (affected part rigid in flexion or extension). The combined (treatment period 1 and treatment period 2) least square mean change from baseline in LLMT-6 score is being reported. Negative values indicate an improvement in muscle tone.
Participants indicated the level of pain experienced in the last 24 hours on an 11-point NRS, where a score of 0 indicated "no pain" and a score of 10 indicated "pain as bad as you can imagine." Change in mean NRS average pain was calculated as: End of Treatment NRS average pain score - Randomization (Part B) Baseline NRS average pain score. The participant's Randomization (Part B) baseline pain 0-10 NRS value was the mean over the last 4 consecutive days of the single-blind treatment period (Part A; pre-randomization). A negative value indicates an improvement in average pain score from Randomization (Part B) Baseline.
Participants indicated level of pain in the last 24 hours on an 11-point Numerical Rating Scale (NRS), where a score of 0 was "no pain" and 10 was "pain as bad as you can imagine". Baseline = mean score from first day of 3-day eligibility period through to the day before first dose of study drug. End of Treatment = mean score over last (up to) 7 days to the final pain score at End of Treatment or up until Day 35, whichever is earlier, or final score available (prematurely terminated). Percentage improvement from baseline (Imp%) was calculated as: Imp% = (Baseline pain NRS mean - End of Treatment pain NRS mean)/Baseline pain NRS mean \* 100. For participants who died or withdrew due to disease progression, Imp% values were used. For participants who died or withdrew, unrelated to disease progression, before end of Week 5 (no diary data from Day 33 onwards), Imp% was zero for participants whose Imp% value was positive and it was Imp% for participants whose Imp% value was not positive.
Treatment-emergent Adverse Events (TEAEs) were coded according to the Medical Dictionary for Regulatory Activities (MedDRA) dictionary version 17.0. A TEAE is defined as an adverse event with an onset after the start of study drug treatment. The percent of participants who experienced one or more TEAEs is reported.
To establish whether the addition of cannabinoids (Nabiximols) to standard TMZ treatment improves overall survival time (OS) in MGMT methylated recurrent GBM compared to the addition of placebo to TMZ.
| Arm | Type | Description |
|---|---|---|
| Nabiximols | EXPERIMENTAL | Nabiximols is a complex botanical medicine formulated from extracts of the cannabis plant that contains the principal cannabinoids delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD) and also contains minor constituents, including other cannabinoid and non-cannabinoid plant components, such as terpenes, sterols, and triglycerides. Each spray delivers 100 microliters (μL) of nabiximols. Nabiximols will be self-administered by participants as an oromucosal spray in the morning and evening, up to a maximum of 12 sprays per day for 12 weeks. |
| Placebo | PLACEBO_COMPARATOR | Placebo to match nabiximols will be presented as an oromucosal spray containing the excipients ethanol and propylene glycol (50% v/v) with colorings and flavored with peppermint oil (0.05% v/v). Each spray will deliver 100 μL containing no active ingredients. Placebo will be self-administered by participants as an oromucosal spray in the morning and evening, up to a maximum of 12 sprays per day for 12 weeks. |
| Placebo (GA-0034) | PLACEBO_COMPARATOR | Placebo was self-administered by participants as a 100 μL oromucosal spray in the morning and evening, up to a maximum of 10 sprays per day for 5 weeks. Placebo oromucosal spray contained ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavoring and colorings. |
| Non-comparative, open-label Nabiximols | EXPERIMENTAL | Nabiximols was self-administered by participants as a 100 microliter (μL) oromucosal spray, in the morning and evening, up to a maximum of 10 sprays per day for 6 months. Nabiximols oromucosal spray contained delta-9-tetrahydrocannabinol (THC) (27 milligrams \[mg\]/milliliter \[mL\]):cannabidiol (CBD) (25 mg/mL), in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavoring. Each 100 μL actuation delivered 2.7 mg THC and 2.5 mg CBD. |
| Standard Temozolomide with Nabiximols | EXPERIMENTAL | * Temozolomide 150mg/m2 for cycle 1, increasing to 200mg/m2 for subsequent cycles, once daily for days 1-5, orally, at the start of each 28 day cycle, up to a maximum of 6 cycles. * Nabiximols up to 12 oromucosal sprays per day up to a maximum of 6 cycles; self titrated over days 1-14 in cycle 1. |
| Standard Temozolomide with Nabiximols-matched placebo | PLACEBO_COMPARATOR | * Temozolomide 150mg/m2 for cycle 1, increasing to 200mg/m2 for subsequent cycles, once daily for days 1-5, orally, at the start of each 28 day cycle, up to a maximum of 6 cycles. * Nabiximols-matched placebo up to 12 oromucosal sprays per day up to a maximum of 6 cycles; self titrated over days 1-14 in cycle 1. |
| Name | Type | Description |
|---|---|---|
| Nabiximols | DRUG | oromucosal spray |
| Placebo | DRUG | oromucosal spray |
| Placebo (GA-0034) | DRUG | - |
| Temozolomide | DRUG | Oral capsule |
| Nabiximols-matched placebo | DRUG | Nabiximols-matched placebo oromucosal spray |
Inclusion Criteria: Screening (Visit 1) * Has had a diagnosis with any disease subtype of multiple sclerosis (MS), by revised 2017 McDonald criteria, for at least 12 months prior to Visit 1 and is expected to remain stable for the duration of the trial * Has a Modified Ashworth Scale (MAS) untrans...
Nabiximols is an investigational oromucosal spray being studied for glioblastoma, spasticity in participants with multiple sclerosis, and pain. In clinical trials, it has been evaluated for relieving persistent pain in patients with advanced cancer and for clinical measures of spasticity in multiple sclerosis.
Nabiximols is being developed by Jazz Pharmaceuticals plc, which trades under the ticker JAZZ. The company is conducting clinical trials of the drug for conditions including cancer-related pain and multiple sclerosis spasticity.
Nabiximols is in Phase 2 clinical development. It remains investigational and has not been approved by regulatory authorities. Completed trials include Phase 3 studies for cancer pain and multiple sclerosis spasticity, but the drug is still being studied.
Nabiximols has been studied in several clinical trials, including NCT01337089, NCT01361607, and NCT01424566 for pain in advanced cancer, and NCT04657666 for spasticity in multiple sclerosis. These trials are completed and enrolled a total of 1,862 participants.
Yes, Nabiximols is the same as Sativex. Several clinical trials refer to the drug as Sativex oromucosal spray, including studies for cancer-related pain and multiple sclerosis spasticity.
Nabiximols is not FDA approved. It is an investigational drug currently in Phase 2 clinical development. While Phase 3 trials have been completed for cancer pain and multiple sclerosis spasticity, approval status has not been established.