A Study of the Long-term Safety of Sativex Use

NCT01606137 | Completed Phase 3 Results

• 1 other identifier: GWEXT0102
• Study Type: interventional
• Target: 507
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis; Spasticity; Pain

Outcome Measures

Primary Outcomes (1)

• Incidence of Adverse Events as a Measure of Subject Safety.

  Following data entry, all adverse events were medically encoded using the Medical Dictionary for Regulatory Activities (MedDRA) 6.0. All subjects who experienced an adverse event during the treatment period is presented.

  Up to 1051 days

Secondary Outcomes (16)

• Change From Parent Study Baseline in Spasticity 0-10 Numerical Rating Scale Score After 52 Weeks of Treatment.

  0 - 52 weeks

• Change From Parent Study Baseline in Central Neuropathic Pain 0-10 Numerical Rating Scale Score at 52 Weeks of Treatment.

  0 - 52 weeks.

• Change From Parent Study Baseline in Neuropathic Pain 0-10 Numerical Rating Scale Score at 52 Weeks of Treatment in Multiple Sclerosis Subjects.

  0 - 52 weeks.

• Change From Parent Study Baseline in Pain 0-10 Numerical Rating Scale Score at 52 Weeks of Treatment.

  0 - 52 weeks.

• Subject Assessment of Benefit at the Last Study Visit in Those Experiencing Neuropathic Pain Due to Multiple Sclerosis.

  Up to 1051 days

Study Arms (1)

GW-1000-02

EXPERIMENTAL

Active treatment

Drug: GW-1000-02

Interventions

GW-1000-02 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.

Also known as: Sativex

GW-1000-02

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Jazz Pharmaceuticals: lead

Study Sites (1)

Gartnavel General Hospital

Glasgow, G12 0YN, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 22878432 RESULT

MeSH Terms

Conditions

Multiple Sclerosis; Muscle Spasticity; Pain

Interventions

nabiximols

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Mr Richard Potts, Clinical Operations Director
• Organization: GW Pharma Ltd.

rp@gwpharm.com

0044 1223 266800

Study Officials

• Michael Serpell, ChB FRCA

  Gartnavel General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2012
• First Posted: May 25, 2012
• Study Start: February 1, 2002
• Primary Completion: December 1, 2004
• Study Completion: December 1, 2004
• Last Updated: May 6, 2023
• Results First Posted: August 23, 2012

Record last verified: 2023-04

Locations

GB (1)