A Study of the Long-term Safety of Sativex Use

NCT ID: NCT01606137

Last Updated: 2023-05-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 507 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-02-28
• Study Completion Date: 2004-12-31

Brief Summary

Subjects who had previously received GW-1000-02 in a GW study who opted to continue using it in the long-term were monitored for ongoing tolerability and evidence of clinical benefit.

Detailed Description

Subjects who had previously participated in a placebo controlled GW clinical study were screened and if eligible began dosing with GW-1000-02. Subjects were reviewed for tolerability and evidence of clinical benefit at weeks two and four and then every eight weeks. Subjects self-titrated to symptom resolution or maximum tolerated/allowable dose of 130 mg THC and 120 mg CBD.

Conditions

Multiple Sclerosis; Spasticity; Pain

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

GW-1000-02

Active treatment

Group Type: EXPERIMENTAL

GW-1000-02

Intervention Type: DRUG

Contained delta-9-tetrahydrocannabinol (THC) (27 mg/ml) and cannabidiol (CBD) (25 mg/ml) as extract of Cannabis sativa L., with peppermint oil, 0.05% (v/v), in ethanol:propylene glycol (50:50) excipient. Each 100 μl actuation of the pump action spray delivered 2.7 mg THC and 2.5 mg CBD. A maximum daily exposure of 130 mg THC was specified by the UK regulatory authority authorisation.

Interventions

GW-1000-02

Contained delta-9-tetrahydrocannabinol (THC) (27 mg/ml) and cannabidiol (CBD) (25 mg/ml) as extract of Cannabis sativa L., with peppermint oil, 0.05% (v/v), in ethanol:propylene glycol (50:50) excipient. Each 100 μl actuation of the pump action spray delivered 2.7 mg THC and 2.5 mg CBD. A maximum daily exposure of 130 mg THC was specified by the UK regulatory authority authorisation.

Intervention Type: DRUG

Other Intervention Names

Sativex

Eligibility Criteria

Inclusion Criteria

• Willing and able to give informed consent.
• Male or female aged 18 years or above.
• Diagnosed with a condition categorised as one of the following: multiple sclerosis, spinal cord conditions, peripheral nerve injury or central nervous system damage associated with vascular, traumatic, infective, genetic or metabolic disease and whose symptom(s) were not wholly relieved by currently available therapy, prior to the previous study of GW-1000-02 or placebo.
• Had participated in a GW clinical study using GW-1000-02 within the previous month.
• Had shown tolerability to the study medication during the previous GW study.
• Was expected, by the investigator, to gain clinical benefit from receiving long-term GW-1000-02.
• Were willing, if female and of child bearing potential or male subjects with a partner of child bearing potential, to ensure that effective contraception was used during the study and for three months thereafter.
• Had not used cannabinoids (cannabis, Marinol or Nabilone) for at least seven days before Visit 1 (the exception being GW-1000-02 given as study medication) and were willing to abstain from any use of cannabis during the study.
• Recent (within seven days) haematology and blood chemistry that was normal or considered clinically acceptable in view of the subjects underlying condition.
• Able (in the investigators opinion) and willing to comply with all study requirements.
• Willing for the Home Office to be notified of his or her participation in the study.
• Willing to allow his or her general practitioner and consultant, if appropriate, to be notified of participation in the study.

Exclusion Criteria

• History of serious psychiatric illness, including schizophrenia, other psychotic illness or severe personality disorder other than depression associated with the underlying condition.
• Known or strongly suspected of alcohol or substance abuse or considered by the investigator to have been at risk of alcohol or substance abuse.
• Severe cardiovascular disorder, such as ischaemic heart disease, arrhythmias (other than well controlled atrial fibrillation), poorly controlled hypertension or severe heart failure.
• History of epilepsy or convulsions.
• Significant renal or hepatic impairment.
• Terminally ill.
• Any other significant disease or disorder which, in the opinion of the investigator, may have either put the subject at risk because of participation in the study, or may have influenced the result of the study, or the subject's ability to participate in the study.
• Female subjects who were pregnant, lactating or planning pregnancy during the course of the study.
• Regular levodopa (Sinemet, Sinemet Plus, Levodopa, L-dopa, Madopar, Benserazide) therapy within seven days of study entry.
• Known or suspected hypersensitivity to cannabinoids or any of the excipients of the study medication.
• Known or suspected adverse reaction to cannabinoids.
• Donation of blood during the study.
• Previous participation in this study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jazz Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Serpell, ChB FRCA

Role: PRINCIPAL_INVESTIGATOR

Gartnavel General Hospital

Locations

Gartnavel General Hospital

Glasgow, , United Kingdom

Countries

United Kingdom

References

Serpell MG, Notcutt W, Collin C. Sativex long-term use: an open-label trial in patients with spasticity due to multiple sclerosis. J Neurol. 2013 Jan;260(1):285-95. doi: 10.1007/s00415-012-6634-z. Epub 2012 Aug 10.

Reference Type: RESULT

PMID: 22878432 (View on PubMed)

Other Identifiers

GWEXT0102

Identifier Type: -

Identifier Source: org_study_id