An Study to Investigate the Efficacy of Delta-9-tetrahydrocannabinol (THC) and Cannabidiol (CBD) in Multiple Sclerosis: nabiximols in MS (type not specified), phase 3

Double Blind, Randomised, Parallel Group, Placebo Controlled Trial of a Combination of THC and CBD in Patients With Multiple Sclerosis, Followed by an Open Label Assessment and Study Extension

CompletedPhase 3MS (type not specified)NCT01610713

What it found

Results posted, not judged

Results are posted in the registry, but without a statistical test of the main measure. See the numbers below.

What was tested

Treatment tested

Nabiximols

Results by group

Change From Mean Part A Primary Impairment Visual Analogue Scale Score (After 6 Weeks) at the End of Four Weeks of Open-label Treatment (10 Weeks Total)

End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])

Group	Value	Interval	Number analysed
GW-1000-02 DB/OL	-5.41 units on a scale	24.2 (Standard Deviation)	75
Placebo DB/GW-1000-02 OL	-7.51 units on a scale	24.75 (Standard Deviation)	73

GW-1000-02 DB/OL

Placebo DB/GW-1000-02 OL

Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.

Safety

Group	Participants at risk	Serious adverse events	Deaths
GW-1000-02 DB/OL	77	2 (2.6%)
Placebo DB/GW-1000-02 OL	77	0 (0.0%)

As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.

What it measured

Main measures

Change From Mean Part A Primary Impairment Visual Analogue Scale Score (After 6 Weeks) at the End of Four Weeks of Open-label Treatment (10 Weeks Total)
End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])

Other measures (25)

Change From Mean Part A Guy's Neurological Disability Scale Score at the End of Open-label Treatment
End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])
VisionThinking and memoryFatigueArm and hand functionBladder, bowel and sexual functionMood and sleep
Change From Mean Part A Care-Giver Strain Index Score at the End of Open-label Treatment
End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])
Change From Mean Part A Reading Visual Acuity Test Score at the End of Open-label Treatment
End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])
Vision
Change From Mean Part A Ashworth Scale Score at the End of Open-label Treatment
End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])
Spasticity
Change From Mean Part A Short Orientation Memory Concentration Score at the End of Open-label Treatment
End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])
Thinking and memory
Change From Mean Part A Barthel Activities for Daily Living Score at the End of Open-label Treatment
End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])
Walking and mobilityBladder, bowel and sexual function
Change From Mean Part A Total Adult Memory and Information Processing Battery Score at the End of Open-label Treatment
End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])
Thinking and memory
Change From Mean Part A Beck's Depression Inventory (BDI-II) Score at the End of Open-label Treatment
End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])
Mood and sleep
Change From Mean Part A Fatigue Severity Scale Questionnaire Score at the End of Open-label Treatment
End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])
Fatigue
Change From Mean Part A Rivermead Mobility Index Score at the End of Open-label Treatment
End of Part A (week 6) - end of Part B (week 10 [4 weeks total open-label treatment])
Walking and mobilityArm and hand function

Who could take part

MS (type not specified) · 18 and over

Show the full criteria

Inclusion criteria

* Aged at least 18 years. * Multiple Sclerosis of any type. * Stable Multiple Sclerosis symptomatology during the four weeks before study entry. * Symptoms of the required severity (>50 mm on a 100 mm Visual Analogue Scale severity scale) in least one of the specified impairment categories; spasticity, muscle spasms, disturbed bladder control, neuropathic pain, limb tremor. * A stable medication regime during the four weeks before study entry. * Willing to abstain from cannabis or cannabinoids for at least seven days before study entry, and during the study. * Agreed either to use effective contraception during the study and for three months thereafter, or had been surgically sterilised or, if female, were post-menopausal. * Clinically acceptable laboratory results for pre-study screening. * Willing and able to undertake and comply with all study requirements. * Willing and able to read, consider and understand the subject information and consent form and give written informed consent. Subjects unable to read or to sign the document procedures were treated as detailed in the Declaration of Helsinki. * Willing for their general practitioner, and consultant if appropriate, to be informed of study participation. * Willing for their name to be notified to Home Office for participation in the study.

Exclusion criteria

* Known or strongly suspected to be abusing drugs, including alcohol. * Not prepared to abstain from cannabis or cannabinoids during the study. * Current or past addiction to cannabis. * Known or suspected to have had an adverse reaction to cannabinoids causing psychosis or other severe psychiatric illness. * History of any type of schizophrenia, any other psychotic illness, or other significant psychiatric illness or personality disorder other than depression associated with chronic illness. * Received any drug containing levodopa (Sinemet®, Sinemet plus®, Levodopa®, L-dopa®, Madopar®, Benserazide®). * Serious cardiovascular disorder including angina, uncontrolled hypertension, or an uncontrolled symptomatic cardiac arrhythmia. * Significant renal or hepatic impairment as shown in medical history or indicated by laboratory results. * History of epilepsy. * Terminal illness or other condition in which placebo medication would be inappropriate. * Pregnant, lactating or at risk of pregnancy. * Participated in any other clinical research study during the 12 weeks before study entry. * Planned hospital admission between study entry and Visit 6. * Planned travel outside the UK between study entry and Visit 6.

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

An open-label extension study in which patients with multiple sclerosis received GW-1000-02 [named Sativex® in Canada and also named Sativex® Oromucosal Spray] for four weeks in an open-label manner.

Papers

Loading reviews and guidelines…

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History

Started
May 2001
Main results due
Jul 2002
Finished
Jul 2002
Results posted
Sept 2012

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