Clinical trial NCT01610687: A Long-term Safety Extension Study of Delta-9-tetrahydrocannabinol (THC) and Cannabidiol (CBD) in Multiple Sclerosis
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Multiple Sclerosis
Spasticity
Lead sponsor: Jazz Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2012-06-04
Enrollment: 137
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: An extension study to evaluate the long-term safety, tolerability and efficacy of GW-1000-02 treatment in multiple sclerosis.

Detailed description: Patients who participated in the placebo controlled phase of this study and opted to continue receiving open label GW-1000-02 entered the follow-on extension of the study and completed symptom assessments to determine whether they were continuing to receive clinical benefit from GW-1000-02.

Eligibility 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.

Primary outcomes:
measure: Incidence of Adverse Events as a Measure of Patient Safety
timeFrame: up to1206 days
Secondary outcomes:
measure: Mean Number of Sprays of Study Medication Taken During the Last 6 Days of Treatment
timeFrame: up to 1206 days
measure: Change From Baseline in Mean Intoxication 100 mm Visual Analogue Scale Scores at Week 18.
timeFrame: 18 weeks
measure: Investigator Assessed Global Severity Score at Week 18
timeFrame: week 18
measure: Change From Baseline in the Mean Pain 100 mm Visual Analogue Scale Score at Week 18
timeFrame: week 18
measure: Change From Baseline in the Mean Spasticity 100 mm Visual Analogue Scale Score at Week 18
timeFrame: week 18
measure: Change From Baseline in the Mean Tremor 100 mm Visual Analogue Scale Score at Week 18
timeFrame: week 18
measure: Change From Baseline in the Mean Bladder Problems 100 mm Visual Analogue Scale Score at Week 18
timeFrame: 18 weeks
Other outcomes:
Locations:
city: Oxford
country: United Kingdom
facility: Rivermead Rehabilitation Centre
Study officials:
References:
citation: Wade DT, Makela PM, House H, Bateman C, Robson P. Long-term use of a cannabis-based medicine in the treatment of spasticity and other symptoms in multiple sclerosis. Mult Scler. 2006 Oct;12(5):639-45. doi: 10.1177/1352458505070618.