A Long-term Safety Extension Study of Delta-9-tetrahydrocannabinol (TH
A 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
What it found
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
Incidence of Adverse Events as a Measure of Patient Safety
up to1206 days
| Group | Value | Interval | Number analysed |
|---|---|---|---|
| GW-1000-02 | 126 participants | 137 |
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 | 137 | 23 (16.8%) |
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
Incidence of Adverse Events as a Measure of Patient Safety
up to1206 days
Safety
Other measures (7)
Mean Number of Sprays of Study Medication Taken During the Last 6 Days of Treatment
up to 1206 days
Change From Baseline in Mean Intoxication 100 mm Visual Analogue Scale Scores at Week 18.
18 weeks
Investigator Assessed Global Severity Score at Week 18
week 18
Change From Baseline in the Mean Pain 100 mm Visual Analogue Scale Score at Week 18
week 18
PainChange From Baseline in the Mean Spasticity 100 mm Visual Analogue Scale Score at Week 18
week 18
SpasticityChange From Baseline in the Mean Tremor 100 mm Visual Analogue Scale Score at Week 18
week 18
Physical functionChange From Baseline in the Mean Bladder Problems 100 mm Visual Analogue Scale Score at Week 18
18 weeks
Bladder, bowel and sexual 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 extension study to evaluate the long-term safety, tolerability and efficacy of GW-1000-02 treatment in multiple sclerosis.
Papers
Loading reviews and guidelines…
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History
Started
Jul 2001
Main results due
Feb 2005
Finished
Feb 2005
Results posted
Aug 2012