Back to resultsA Long-term Safety Extension Study of Delta-9-tetrahydrocannabinol (THC) and Cannabidiol (CBD) in Multiple Sclerosis
Primary Purpose
Multiple Sclerosis, Spasticity
Status
Completed
Phase
Phase 3
Locations
United Kingdom
Study Type
Interventional
Intervention
GW-1000-02
Sponsored by
About this trial
This is an interventional treatment trial for Multiple Sclerosis
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.
Sites / Locations
- Rivermead Rehabilitation Centre
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
GW-1000-02
Arm Description
Active treatment
Outcomes
Primary Outcome Measures
Incidence of Adverse Events as a Measure of Patient Safety
The number of patients who experienced an adverse event during the course of this extension study is presented
Secondary Outcome Measures
Mean Number of Sprays of Study Medication Taken During the Last 6 Days of Treatment
A categorical summary was produced of the mean number of sprays per day during the last six days of treatment, and the mean number of sprays was rounded to the nearest whole number for categorisation.
Change From Baseline in Mean Intoxication 100 mm Visual Analogue Scale Scores at Week 18.
Intoxication levels were recorded on a Visual Analogue Scale, where 0 equals 'no intoxication' and 10 equals 'extreme intoxication'. A decrease in score indicates an improvement in intoxication levels.
Investigator Assessed Global Severity Score at Week 18
The investigator rated the global severity of the subject's primary condition since entry into the study using a five-point verbal rating scale-5: 1=much worse, 2=worse, 3=no change, 4=better, 5=much better. The number of patients which were considered better or much better (scores 4 and 5) at week 18 of the study better is presented.
Change From Baseline in the Mean Pain 100 mm Visual Analogue Scale Score at Week 18
A clinical assessment of pain was made at each study visit using a 100 mm Visual Analogue Scale, where 0 = no pain and 100 = worst possible pain. A decrease in score indicates an improvement.
Change From Baseline in the Mean Spasticity 100 mm Visual Analogue Scale Score at Week 18
A clinical assessment of spasticity was made at each study visit using a 100 mm Visual Analogue Scale, where 0 = no spasticity and 100 = worst possible spasticity. A decrease in score indicates an improvement.
Change From Baseline in the Mean Tremor 100 mm Visual Analogue Scale Score at Week 18
A clinical assessment of tremor was made at each study visit using a 100 mm Visual Analogue Scale, where 0 = no tremor and 100 = worst possible tremor. A decrease in score indicates an improvement.
Change From Baseline in the Mean Bladder Problems 100 mm Visual Analogue Scale Score at Week 18
A clinical assessment of bladder problems was made at each study visit using a 100 mm Visual Analogue Scale, where 0 = no bladder problems and 100 = worst possible bladder problems. A decrease in score indicates an improvement.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01610687
Brief Title
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
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
July 2001 (undefined)
Primary Completion Date
February 2005 (Actual)
Study Completion Date
February 2005 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jazz Pharmaceuticals
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis, Spasticity
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
137 (Actual)
8. Arms, Groups, and Interventions
Arm Title
GW-1000-02
Arm Type
Experimental
Arm Description
Active treatment
Intervention Type
Drug
Intervention Name(s)
GW-1000-02
Other Intervention Name(s)
Sativex
Intervention Description
Contained THC and CBD as extract of Cannabis sativa L. Each 100 μl actuation delivered a dose containing 2.7 mg THC and 2.5mg CBD. The maximum permitted dose was eight actuations (22 mg THC and 20 mg CBD) in any three hour period, and 48 actuations (130 mg THC and 120 mg CBD) in any 24 hour period.
Primary Outcome Measure Information:
Title
Incidence of Adverse Events as a Measure of Patient Safety
Description
The number of patients who experienced an adverse event during the course of this extension study is presented
Time Frame
up to1206 days
Secondary Outcome Measure Information:
Title
Mean Number of Sprays of Study Medication Taken During the Last 6 Days of Treatment
Description
A categorical summary was produced of the mean number of sprays per day during the last six days of treatment, and the mean number of sprays was rounded to the nearest whole number for categorisation.
Time Frame
up to 1206 days
Title
Change From Baseline in Mean Intoxication 100 mm Visual Analogue Scale Scores at Week 18.
Description
Intoxication levels were recorded on a Visual Analogue Scale, where 0 equals 'no intoxication' and 10 equals 'extreme intoxication'. A decrease in score indicates an improvement in intoxication levels.
Time Frame
18 weeks
Title
Investigator Assessed Global Severity Score at Week 18
Description
The investigator rated the global severity of the subject's primary condition since entry into the study using a five-point verbal rating scale-5: 1=much worse, 2=worse, 3=no change, 4=better, 5=much better. The number of patients which were considered better or much better (scores 4 and 5) at week 18 of the study better is presented.
Time Frame
week 18
Title
Change From Baseline in the Mean Pain 100 mm Visual Analogue Scale Score at Week 18
Description
A clinical assessment of pain was made at each study visit using a 100 mm Visual Analogue Scale, where 0 = no pain and 100 = worst possible pain. A decrease in score indicates an improvement.
Time Frame
week 18
Title
Change From Baseline in the Mean Spasticity 100 mm Visual Analogue Scale Score at Week 18
Description
A clinical assessment of spasticity was made at each study visit using a 100 mm Visual Analogue Scale, where 0 = no spasticity and 100 = worst possible spasticity. A decrease in score indicates an improvement.
Time Frame
week 18
Title
Change From Baseline in the Mean Tremor 100 mm Visual Analogue Scale Score at Week 18
Description
A clinical assessment of tremor was made at each study visit using a 100 mm Visual Analogue Scale, where 0 = no tremor and 100 = worst possible tremor. A decrease in score indicates an improvement.
Time Frame
week 18
Title
Change From Baseline in the Mean Bladder Problems 100 mm Visual Analogue Scale Score at Week 18
Description
A clinical assessment of bladder problems was made at each study visit using a 100 mm Visual Analogue Scale, where 0 = no bladder problems and 100 = worst possible bladder problems. A decrease in score indicates an improvement.
Time Frame
18 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Rivermead Rehabilitation Centre
City
Oxford
ZIP/Postal Code
OX3 7LD
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
17086911
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.
Results Reference
result
Learn more about this trial
A Long-term Safety Extension Study of Delta-9-tetrahydrocannabinol (THC) and Cannabidiol (CBD) in Multiple Sclerosis
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