Phase 3 N=116 Randomized Quadruple-blind Treatment

A Study of Cannabis Based Medicine Extracts and Placebo in Patients With Pain Due to Spinal Cord Injury

Pain

Bottom Line

View on ClinicalTrials.gov: NCT01606202 ↗

Enrolled (actual)

116

Serious AEs

4.3%

Results posted

Sep 2012

Primary outcome: Primary: Change From Baseline in Mean Central Neuropathic Pain 11-Point Numerical Rating Scale Scores at the End of Treatment (up to 51 Days). — -0.74; -0.69 units on a scale — p=0.708

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: GW-1000-02 (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Jazz Pharmaceuticals
Primary completion: Jan 2005

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in Mean Central Neuropathic Pain 11-Point Numerical Rating Scale Scores at the End of Treatment (up to 51 Days).	-0.74; -0.69	0.708
SECONDARY Change From Baseline in the Mean Percentage of Days on Which Escape Medication Was Used at the End of Treatment	-4.68; -2.91	0.852
SECONDARY Change From Baseline in Mean Spasm Severity Numerical Rating Scale Score at the End of Treatment	-0.50; -0.69	0.860
SECONDARY Change From Baseline in the Percentage of Days on Which Spasm Was Experienced at the End of Treatment	-1.92; -1.57	0.873
SECONDARY Change From Baseline in Mean Spasticity Severity Numerical Rating Scale Scores the End of Treatment.	-0.37; -0.46	0.830
SECONDARY Change From Baseline in the Percentage of Days on Which Spasticity Was Experienced at the End of Treatment	0.86; 0.48	0.860
SECONDARY Change From Baseline in Modified Ashworth Scale Score at the End of Treatment	-0.13; -0.01	0.142
SECONDARY Change From Baseline in the Mean Short Orientation Memory Function Concentration Test Score at the End of Treatment	0.4; 0.2	0.824
SECONDARY Change From Baseline in Mean Spitzer Quality of Life Index Score at the End of Treatment	0.1; 0.1	0.847
SECONDARY Change From Baseline in the Mean Caregiver Strain Index Score at the End of Treatment	-0.3; 1.2	0.287
SECONDARY Number of Subjects Who Reported an Improvement in Their Overall Condition in the Patient Global Impression of Change at the End of Treatment	30; 12	<0.001 sig
SECONDARY Change From Baseline in the Mean Brief Pain Inventory Score at the End of Treatment	-3.1; -1.2	0.032 sig
SECONDARY Change From Baseline in the Mean Sleep Disturbance Numerical Rating Scale Score at the End of Treatment	-0.41; -0.38	—
SECONDARY Incidence of Adverse Events as a Measure of Patient Safety.	46; 29	—

Summary

A study to investigate the effects of sublingual cannabis based medicine extracts on neuropathic pain associated with spinal cord injury.

Eligibility Criteria

Inclusion Criteria

Gave informed consent for participation in the study.
Male or Female, aged 18 years or above.
Diagnosis of non-acute spinal cord injury, with central neuropathic pain not wholly relieved by current therapy.
Central neuropathic pain with a mean severity Numerical Rating Scale score at least four during last seven days of the baseline period.
Relatively stable neurology during the preceding six months.
Stable medication regimen during the preceding four weeks.
Agreement, if female and of child bearing potential or if male 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 for at least the preceding seven days and willing to abstain from any use of cannabinoids during the study.
Clinically acceptable laboratory results at Visit 2.
Ability (in the investigator's opinion) and willingness to comply with all study requirements.
Agreement for the UK Home Office, their general practitioner, and their consultant if appropriate, to be notified of their participation in the study.

Exclusion Criteria

History of schizophrenia, other psychotic illness, severe personality disorder or other significant psychiatric disorder other than depression associated with their underlying condition.
History 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 autonomic dysreflexia.
History of epilepsy.
If female, were pregnant or lactating, or were planning a pregnancy to occur during the course of the study.
Significant renal or hepatic impairment.
Elective surgery or other procedures requiring general anaesthesia scheduled to occur during the study.
Terminal illness or were considered inappropriate for placebo medication.
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 influenced the result of the study, or the subject's ability to participate in the study.
Regular levodopa therapy within the seven days leading to study entry.
If male, were receiving and were unwilling to stop sildenafil for the duration of the study.
Known or suspected hypersensitivity to cannabinoids or any of the excipients of the study medications.
Known or suspected adverse reaction to cannabinoids.
Intention to travel internationally during the study.
Intention to donate blood during the study.
Participation in another research study in the 12 weeks leading to study entry.
Previous randomisation into this study.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01606202). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.