A Double Blind, Randomised, Parallel Group, Placebo Controlled Study of Sativex in the Treatment of Central Neuropathic Pain in Multiple Sclerosis.

Jazz Pharmaceuticals1 site in 1 country66 target enrollmentMarch 2002

ConditionsMultiple Sclerosis Neuropathic Pain

InterventionsPlacebo Sativex

DrugsPlacebo Sativex

Overview

Phase: Phase 3
Intervention: Placebo
Conditions: Multiple Sclerosis
Sponsor: Jazz Pharmaceuticals
Enrollment: 66
Locations: 1
Primary Endpoint: Change From Baseline in the Mean Pain 0-10 Numerical Rating Scale Score at the End of Treatment (4 Weeks)
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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

Detailed Description

Multiple sclerosis subjects with a clinical diagnosis of central neuropathic pain entered a seven to ten day baseline period, followed by a four week double blind, randomised, parallel group comparison of Sativex, with placebo. The study medication was self-titrated to symptom resolution or maximum tolerated or allowed dose. Visits occurred at the end of weeks one and four (end of the study) or earlier if they withdrew. A follow-up visit occurred 30 - 40 days after completion or withdrawal.

Registry

clinicaltrials.gov

Start Date

March 2002

End Date

August 2002

Last Updated

3 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Jazz Pharmaceuticals

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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.

Exclusion Criteria

•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.

Arms & Interventions

Placebo

Placebo control.

Intervention: Placebo

Sativex

Active treatment.

Intervention: Sativex

Outcomes

Primary Outcomes

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

Time Frame: 0 - 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.

Secondary Outcomes

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)
Change From Baseline in the Mean Brief Repeatable Battery of Neuropsychological Test Score for 'Symbol Digit Modalities' at the End of Treatment (Week 4)(0 - 4 weeks)
Change From Baseline in the Mean Brief Repeatable Battery of Neuropsychological Test Score for the 'Paced Auditory Serial Addition Task' (PASAT) at the End of Treatment (Week 4)(0 - 4 weeks)
Change From Baseline in the Mean Brief Repeatable Battery of Neuropsychological Test Score for 'Word List Generation' at the End of Treatment (4 Weeks)(0 - 4 weeks)
Change From Baseline in the Mean Total Guy's Neurological Disability Scale Score at the End of Treatment (4 Weeks)(0 - 4 weeks)
Change From Baseline in the Mean 0-100 mm Visual Analogue Scale Score for Intoxication Levels at the End of Treatment (4 Weeks)(0 - 4 weeks)
Change From Baseline in The Hospital Anxiety and Depression Scale Score for Depression at the End of Treatment (4 Weeks)(0 - 4 weeks)
Change From Baseline in The Hospital Anxiety and Depression Scale Score for Anxiety at the End of Treatment (4 Weeks)(0 - 4 weeks)
Change From Baseline in the Multiple Sclerosis Functional Composite Score at the End of Treatment (4 Weeks)(Baseline to end of treatment (0 - 4 weeks).)
Incidence of Adverse Events as a Measure of Patient Safety.(0 - 4 weeks)