A Study of Sativex in the Treatment of Central Neuropathic Pain Due to Multiple Sclerosis

NCT01604265 | Completed Phase 3 Results

• 1 other identifier: GWMS0107
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

To investigate the ability of Sativex to relieve central neuropathic pain in multiple sclerosis subjects.

Conditions

Multiple Sclerosis; Neuropathic Pain

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in the Mean Pain 0-10 Numerical Rating Scale Score at the End of Treatment (4 Weeks)

  The average pain Numerical Rating Scale was completed at the same time each day, i.e. bedtime in the evening. The patient was asked "on a scale of '0 to 10', please indicate the number that best describes your pain or average pain in the last 24 hours" where 0 = no pain and 10 = pain as bad as you can imagine. A negative value indicates an improvement in pain score from baseline.

  0 - 4 weeks

Secondary Outcomes (14)

• Change From Baseline in the Mean 0-10 Numerical Rating Scale Sleep Score at the End of Treatment (4 Weeks)

  0 - 4 weeks

• Subject Global Impression of Change at Week 4

  4 weeks

• Change From Baseline in the Mean Neuropathic Pain Scale 0-10 Numerical Rating Scale Score at the End of Treatment (Week 4)

  Baseline to end of treatment (0 - 4 weeks).

• Change From Baseline in the Mean Brief Repeatable Battery of Neuropsychological Test Score for 'Selective Reminding' at the End of Treatment (Week 4)

  Baseline to end of study (0 - 4 weeks)

• Change From Baseline in the Mean Brief Repeatable Battery of Neuropsychological Test Score for '10/36 Spatial Recall' at the End of Treatment (Week 4)

  Weeks 0 - 4

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo control.

Drug: Placebo

Sativex

EXPERIMENTAL

Active treatment.

Drug: Sativex

Interventions

Placebo DRUG

Contained peppermint oil, 0.05% (v/v), quinoline yellow, 0.005% (w/v), sunset yellow, 0.0025% (w/v), in ethanol:propylene glycol (50:50) excipient. Each actuation delivered 100 μl. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations in any 24 hour period.

Placebo

Sativex DRUG

Contained delta-9-tetrahydrocannabinol (THC), (25 mg/ml):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 actuation delivered 100 μl (THC 2.5 mg and CBD 2.5 mg). The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations in any 24 hour period.

Also known as: GW-1000-02

Sativex

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 for participation in the study.
• Male or female subjects aged 18 years or above.
• Diagnosed with any disease sub-type of multiple sclerosis, with relapses/remission not expected to influence neuropathic pain.
• Duration of multiple sclerosis greater than six months.
• Central neuropathic pain, due to multiple sclerosis, of at least three months duration, for which a nociceptive, peripheral neuropathic or psychogenic cause appeared unlikely and was expected to remain stable for the duration of the study.
• Pain score with a severity of four or more on at least four completed Numerical Rating Scale scores in the baseline week.
• Regular medication regime for neuropathic pain had been stable during the previous two weeks, prior to reduction of tricyclic antidepressants, if applicable.
• Willing to reduce the dosage of amitriptyline, or equivalent of other tricyclic antidepressants, to a maximum of 75 mg per day, if applicable.
• No cannabinoid use (cannabis, Marinol or Nabilone) at least seven days before study entry and willing to abstain from any use of cannabis during the study.
• Female subjects of child bearing potential or male subjects whose partner was of child bearing potential, who were willing to ensure that they or their partner used effective contraception during the study and for three months thereafter.
• Able (in the investigators opinion) and willing to comply with all study requirements.
• Willing for his or her name to be notified to the Home Office for participation in this study.
• Willing for his or her general practitioner and consultant, if appropriate, to be notified of participation in the study.

You may not qualify if:

• History of schizophrenia, other psychotic illness, severe personality disorder or other significant psychiatric disorder other than depression associated with their underlying condition.
• Concomitant severe non-neuropathic pain or the presence of illness such as diabetes mellitus that could have caused peripheral neuropathic pain.
• Known or strongly suspected alcohol or substance abuse or considered to be at risk of alcohol or substance abuse by the investigator.
• 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 as shown in medical history or indicated by clinical laboratory results from samples taken at baseline.
• Elective surgery or other procedures requiring general anaesthesia scheduled during the study.
• Terminal illness.
• Any other significant disease or disorder which, in the opinion of the Investigator, could either have put the subject at risk because of participation in the study, or 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 medications.
• Known or suspected adverse reaction to cannabinoids.
• Travel outside the UK planned during study.
• Donation of blood during the study.

Sponsors & Collaborators

• Jazz Pharmaceuticals: lead

Study Sites (1)

Walton Centre for Neurology and Neurosurgery

Liverpool, L9 7LJ, United Kingdom

Location

Related Publications (1)

• Rog DJ, Nurmikko TJ, Friede T, Young CA. Randomized, controlled trial of cannabis-based medicine in central pain in multiple sclerosis. Neurology. 2005 Sep 27;65(6):812-9. doi: 10.1212/01.wnl.0000176753.45410.8b.

  PMID: 16186518 RESULT

MeSH Terms

Conditions

Multiple Sclerosis; Neuralgia

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; Peripheral Nervous System Diseases; Neuromuscular Diseases; Pain; 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

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2012
• First Posted: May 23, 2012
• Study Start: March 1, 2002
• Primary Completion: August 1, 2002
• Study Completion: August 1, 2002
• Last Updated: January 10, 2023
• Results First Posted: September 19, 2012

Record last verified: 2022-12

Locations

GB (1)