INTERVENTIONALCOMPLETEDNCT01610687

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

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

Locally preserved from ClinicalTrials.govOpen ClinicalTrials.govlast source update 2023-01-10

What this record can show

Registry results are available

Results are reported by the registry submitter and preserved exactly. They are not independent verification or a treatment recommendation.

Registry facts

Study at a glance

Phase: PHASE3
Enrollment: 137 (ACTUAL)
Start date: 2001-07
Sponsor: Jazz Pharmaceuticals
Design: NA · SINGLE GROUP · TREATMENT
Locations: 1
Results record: Present in registry snapshot

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.

Linked local records

Related local records

Local links use governed condition terms or exact source-reported intervention names. They are navigation candidates, not efficacy claims.

Conditions

Multiple Sclerosis

Cannabinoids and active compounds

No governed compound link was found.

Medicines

SATIVEX

Interventions

What was registered

DRUG

GW-1000-02

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.

Sativex

Source-reported results

Results posted to the registry

8 outcomes

Results are reported by the registry submitter and preserved exactly. They are not independent verification or a treatment recommendation.

Primary outcomes: 1
Secondary outcomes: 7
Statistical analyses: 0
Adverse-event terms: 89

PRIMARYIncidence of Adverse Events as a Measure of Patient Safety

Time frame: up to1206 days
Measure: NUMBER · participants
Reporting status: POSTED

The number of patients who experienced an adverse event during the course of this extension study is presented

Population: All subjects who took at least one dose of study medication after the end of the Part B open-label phase of the acute study, and yielded on-treatment efficacy data was classed as the efficacy and safety population.

Group	N	Value	Spread / interval
GW-1000-02	137	126	-

SECONDARYMean Number of Sprays of Study Medication Taken During the Last 6 Days of Treatment

Time frame: up to 1206 days
Measure: MEAN · sprays of study medication
Reporting status: POSTED

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.

Group	N	Value	Spread / interval

Eligibility

Population and criteria

Sex: ALL
Minimum age: 18 Years
Maximum age: Not reported
Healthy volunteers: Not accepted

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.

primary outcomes

primary measures

Incidence of Adverse Events as a Measure of Patient Safety

Time frame: up to1206 days

The number of patients who experienced an adverse event during the course of this extension study is presented

secondary outcomes

secondary measures

Mean Number of Sprays of Study Medication Taken During the Last 6 Days of Treatment

Time frame: up to 1206 days

Change From Baseline in Mean Intoxication 100 mm Visual Analogue Scale Scores at Week 18.

Time frame: 18 weeks

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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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.

Publications

Locally readable linked articles

No exact PMID-linked public article is currently readable locally.

Snapshot provenance

Snapshot: a82ff7ba-f68c-4205-9873-863765cc6c94
Retrieved: 11/09/2026, 14:15:46
SHA-256: ac7f14d9237d442e926573614f783daf722333e3fee5d1e9a80bdda3f540d577

Milestone	GW-1000-02
STARTED	137
COMPLETED	70
NOT COMPLETED	67

Event	System	Groups: affected / at risk
Urinary Tract Infection Not Otherwise Specified (NOS)	Infections and infestations	GW-1000-02: 4 / 137
Pneumonia NOS	Infections and infestations	GW-1000-02: 1 / 137
Bone infection NOS	Infections and infestations	GW-1000-02: 1 / 137
Cellulitis	Infections and infestations	GW-1000-02: 1 / 137
Multiple Sclerosis Relapse	Nervous system disorders	GW-1000-02: 3 / 137
Balance Impaired NOS	Nervous system disorders	GW-1000-02: 2 / 137
Convulsions NOS	Nervous system disorders	GW-1000-02: 1 / 137
Hypotonia	Nervous system disorders	GW-1000-02: 1 / 137
Fall	General disorders	GW-1000-02: 1 / 137
Oedema Peripheral	General disorders	GW-1000-02: 1 / 137
Weakness	General disorders	GW-1000-02: 1 / 137
Femur Fracture	Injury, poisoning and procedural complications	GW-1000-02: 1 / 137
Lower Limb Fracture NOS	Injury, poisoning and procedural complications	GW-1000-02: 1 / 137
Muscle Spasms	Musculoskeletal and connective tissue disorders	GW-1000-02: 2 / 137
Muscle Weakness NOS	Musculoskeletal and connective tissue disorders	GW-1000-02: 2 / 137
Breast Cancer Metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	GW-1000-02: 1 / 137
Breast Cancer NOS	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	GW-1000-02: 1 / 137
Lung Cancer Stage Unspecified (excl metastatic tumours to lung)	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	GW-1000-02: 1 / 137
Vomiting NOS	Gastrointestinal disorders	GW-1000-02: 2 / 137
Diarrhoea NOS	Gastrointestinal disorders	GW-1000-02: 1 / 137
Lymphadenopathy	Blood and lymphatic system disorders	GW-1000-02: 1 / 137
Atrial Fibrillation	Cardiac disorders	GW-1000-02: 1 / 137
Biliary Cirrhosis Primary	Hepatobiliary disorders	GW-1000-02: 1 / 137
Dehydration	Metabolism and nutrition disorders	GW-1000-02: 1 / 137
Panic Attack	Psychiatric disorders	GW-1000-02: 1 / 137
Psychotic Disorder NOS	Psychiatric disorders	GW-1000-02: 1 / 137
Decubitus Ulcer	Skin and subcutaneous tissue disorders	GW-1000-02: 2 / 137
Deep Vein Thrombosis NOS	Vascular disorders	GW-1000-02: 1 / 137
Head Injury	Injury, poisoning and procedural complications	GW-1000-02: 1 / 137
Hyperglycaemia NOS	Metabolism and nutrition disorders	GW-1000-02: 1 / 137
Pleurisy	Respiratory, thoracic and mediastinal disorders	GW-1000-02: 1 / 137

Event	System	Groups: affected / at risk
ORAL PAIN	Gastrointestinal disorders	GW-1000-02: 32 / 137
DIARRHOEA NOS	Gastrointestinal disorders	GW-1000-02: 27 / 137
NAUSEA	Gastrointestinal disorders	GW-1000-02: 24 / 137
VOMITING NOS	Gastrointestinal disorders	GW-1000-02: 16 / 137
GLOSSODYNIA	Gastrointestinal disorders	GW-1000-02: 15 / 137
ORAL MUCOSAL DISORDER	Gastrointestinal disorders	GW-1000-02: 15 / 137
CONSTIPATION	Gastrointestinal disorders	GW-1000-02: 12 / 137
DRY MOUTH	Gastrointestinal disorders	GW-1000-02: 11 / 137
ORAL DISCOMFORT	Gastrointestinal disorders	GW-1000-02: 9 / 137
MOUTH ULCERATION	Gastrointestinal disorders	GW-1000-02: 8 / 137
DYSPEPSIA	Gastrointestinal disorders	GW-1000-02: 7 / 137
LOOSE STOOLS	Gastrointestinal disorders	GW-1000-02: 7 / 137
TOOTHACHE	Gastrointestinal disorders	GW-1000-02: 7 / 137
TOOTH DISCOLOURATION	Gastrointestinal disorders	GW-1000-02: 6 / 137
FALL	General disorders	GW-1000-02: 21 / 137
FATIGUE	General disorders	GW-1000-02: 16 / 137
WEAKNESS	General disorders	GW-1000-02: 11 / 137
LETHARGY	General disorders	GW-1000-02: 10 / 137
APPLICATION SITE IRRITATION	General disorders	GW-1000-02: 9 / 137
APPLICATION SITE PAIN	General disorders	GW-1000-02: 6 / 137
MALAISE	General disorders	GW-1000-02: 6 / 137
FEELING ABNORMAL	General disorders	GW-1000-02: 5 / 137
URINARY TRACT INFECTION NOS	Infections and infestations	GW-1000-02: 56 / 137
NASOPHARYNGITIS	Infections and infestations	GW-1000-02: 37 / 137
LOWER RESPIRATORY TRACT INFECTION NOS

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

Registry results are available

Study at a glance

Related local records

Conditions

Cannabinoids and active compounds

Medicines

What was registered

GW-1000-02

Results posted to the registry

Population and criteria

Inclusion criteria

Exclusion criteria

primary measures

Incidence of Adverse Events as a Measure of Patient Safety

secondary measures

Mean Number of Sprays of Study Medication Taken During the Last 6 Days of Treatment

Change From Baseline in Mean Intoxication 100 mm Visual Analogue Scale Scores at Week 18.

Investigator Assessed Global Severity Score at Week 18

Change From Baseline in the Mean Pain 100 mm Visual Analogue Scale Score at Week 18

Change From Baseline in the Mean Spasticity 100 mm Visual Analogue Scale Score at Week 18

Change From Baseline in the Mean Tremor 100 mm Visual Analogue Scale Score at Week 18

Locally readable linked articles

Overall Study

Age, Categorical

Age, Continuous

Sex: Female, Male

Region of Enrollment

GW-1000-02

Change From Baseline in the Mean Bladder Problems 100 mm Visual Analogue Scale Score at Week 18