A Study of the Safety and Effectiveness of Sativex®, for the Relief of Symptoms of Spasticity in Subjects, From Phase B, With Multiple Sclerosis (MS)

NCT00681538 | Completed Phase 3 Results

• 1 other identifier: GWSP0604
• Study Type: interventional
• Target: 572
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether Sativex® versus Placebo is effective in the relief of symptoms of spasticity in subjects with multiple sclerosis, who have been identified as having a capacity to respond to Sativex.

Conditions

Spasticity; Multiple Sclerosis

Keywords

Spasticity; Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• The Change in Mean Spasticity Numerical Rating Scale (NRS) Score From Baseline to End of Treatment (Phase B).

  Subjects were asked "On a scale of '0 to 10' please indicate the average level of your spasticity over the last 24 hours" with the anchors: 0 = 'no spasticity' and 10 = 'worst possible spasticity'. They were asked to relate 'no spasticity' to the time prior to the onset of their spasticity.

  Baseline (last 7 days of Week 4) - End of treatment (last 7 days of Week 17)

Secondary Outcomes (12)

• Number of Subjects Showing an Improvement of at Least 30% or 50% in Their Mean NRS Spasticity Score (Phase B) From Baseline.

  Baseline (Day 1) - End of treatment (last 7 days of Week 17)

• Change in Spasm Frequency (Number of Spasms Per Day) From Baseline to End of Treatment (Phase B).

  Baseline (last 7 days of Week 4) - End of treatment (last 7 days of Week 17)

• Change in Sleep Disruption (Daily 11-point NRS) From Baseline to End of Treatment (Phase B).

  Baseline (last 7 days of Week 4) - End of treatment (last 7 days of Week 17)

• Change in Spasticity as Measured Using the Modified Ashworth Scale From Baseline to End of Treatment (Phase B).

  Baseline (End of Week 4) - End of treatment (End of Week 17)

• Change in Motricity Index Score From Baseline to End of Treatment (Phase B)for Affected Limbs.

  Baseline (End of Week 4) - End of treatment (End of Week 17)

Study Arms (2)

Sativex

EXPERIMENTAL

Contains Δ9 tetrahydrocannabinol (THC), 27 mg/ml: cannabidiol (CBD), 25 mg/ml, as extracts of Cannabis sativa L. Subjects received study medication delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations (THC 32.4 mg:CBD 30 mg) in 24 hours

Drug: Sativex®

Placebo

PLACEBO COMPARATOR

Contains no active drug but colourants and excipients. Subjects received placebo delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose was 12 actuations in 24 hours.

Drug: Placebo

Interventions

Sativex® DRUG

containing THC (27 mg/ml):CBD (25 mg/ml), in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavouring. Maximum dose within any 24-hour interval is 12 sprays (THC 32.4 mg: CBD 30 mg)

Also known as: GW-1000-02

Sativex

Placebo DRUG

containing ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavouring and colouring FD\&C Yellow No.5 (E102 tartrazine) (0.0260%), FD\&C Yellow No.6 (E110 sunset yellow) (0.0038%), FD\&C Red No. 40 (E129 Allura red AC) (0.00330%) and FD\&C Blue No.1 (E133 Brilliant blue FCF) (0.00058%).

Also known as: GA0034

Placebo

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 written informed consent for participation in the study.
• Male or female, aged 18 years or above.
• Subject is able (in the investigator's opinion) and willing to comply with all study requirements.
• Diagnosed with any disease sub-type of MS of at least six months duration.
• Spasticity due to MS of at least three months duration, which is not wholly relieved with current anti-spasticity therapy, and which is expected to remain stable for the duration of the study.
• Subject fulfils at least one of the two criteria below. Subject must be either: Currently established on a regular dose of anti-spasticity therapy or Previously tried and failed, or could not tolerate suitable anti-spasticity therapy.
• Subject is currently receiving a stable regimen (for at least 30 days prior to study entry) of all medications that may have an effect on spasticity; and willing to maintain this for the duration of the study. If the subject is currently taking disease-modifying medication, this must be at a stable dose for at least three months prior to the screening visit; the dose must also remain stable for the duration of the study.
• Willing for his or her name to be notified to his or her primary care physician, and consultant and the responsible authorities for participation in this study, as applicable.

You may not qualify if:

• Any concomitant disease or disorder that has spasticity-like symptoms or that may influence the subject's level of spasticity.
• Subject's medical history suggests that relapse/remission is likely to occur during the study (over the next 19 weeks) which, in the opinion of the investigator, is expected to influence the subject's spasticity.
• Currently receiving a prohibited medication and unwilling to stop for the stated period prior to the screening visit and for the duration of the study.
• Any known or suspected history of: schizophrenia or other psychotic illness;diagnosed dependence disorder;poorly controlled epilepsy or recurrent seizures;hypersensitivity to cannabinoids.
• Significant cardiac, renal or hepatic disease.
• Female subjects of child bearing potential and male subjects whose partner is of child bearing potential, unless willing to ensure that they or their partner use effective contraception during the study and for three months thereafter.
• Female subject who is pregnant, lactating or planning pregnancy during the course of the study or for three months thereafter.
• Subjects who have received an IMP within the 12 weeks before Visit 1.
• Any other significant disease or disorder which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or may influence the result of the study, or the subject's ability to participate in the study.
• Following a physical examination, the subject has any abnormalities that, in the opinion of the investigator, would prevent them from safely participating in the study.
• Unwilling to abstain from donation of blood during the study.
• Travel outside the country of residence planned during the study.
• Subjects previously randomised into this study.

Sponsors & Collaborators

• Jazz Pharmaceuticals: lead

Study Sites (1)

Department of Neurology, Northampton General Hospital

Cliftonville, Northampton, NN1 5BD, United Kingdom

Location

Related Publications (1)

• Novotna A, Mares J, Ratcliffe S, Novakova I, Vachova M, Zapletalova O, Gasperini C, Pozzilli C, Cefaro L, Comi G, Rossi P, Ambler Z, Stelmasiak Z, Erdmann A, Montalban X, Klimek A, Davies P; Sativex Spasticity Study Group. A randomized, double-blind, placebo-controlled, parallel-group, enriched-design study of nabiximols* (Sativex((R)) ), as add-on therapy, in subjects with refractory spasticity caused by multiple sclerosis. Eur J Neurol. 2011 Sep;18(9):1122-31. doi: 10.1111/j.1468-1331.2010.03328.x. Epub 2011 Mar 1.

  PMID: 21362108 RESULT

MeSH Terms

Conditions

Muscle Spasticity; Multiple Sclerosis

Interventions

nabiximols

Condition Hierarchy (Ancestors)

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

Results Point of Contact

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

rp@gwpham.com

+44 1353 616600

Study Officials

• Paul Davies, MRCP, FRCP

  Department of Neurology

  PRINCIPAL INVESTIGATOR

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: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2008
• First Posted: May 21, 2008
• Study Start: January 1, 2008
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2009
• Last Updated: May 6, 2023
• Results First Posted: December 7, 2011

Record last verified: 2023-04

Locations

GB (1)