A Study to Evaluate the Effects of Cannabis Based Medicine in Patients With Pain of Neurological Origin

NCT01606176 | Completed Phase 3 Results

• 1 other identifier: GWPS0105
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

To investigate the ability of a cannabis based medicine extract to relieve chronic refractory pain of neurological origin.

Conditions

Pain; Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Mean Pain Box Scale-11 Score at 3 Weeks.

  Each day, in the morning (on waking), at lunchtime and in the evening (just before going to bed), patients recorded in their patient diary their level of pain using a Box Scale-11 pain score ranging from zero "no pain" to 10 "worst possible pain". Week 3 analysis was defined as the mean of the last seven days in the study. The last day was taken as the last day with complete diary card pain data that occurred on or before the last day the patient took study medication. A negative value from baseline indicates and improvement.

  0 - 3 weeks

Secondary Outcomes (14)

• Use of Analgesic Escape Medication.

  0 - 3 weeks

• Change From Baseline in Mean Sleep Disturbance Score at 3 Weeks.

  0 - 3 weeks

• Change From Baseline in Mean Total Pain Disability Index Score at 3 Weeks.

  0 - 3 weeks

• Change From Baseline in Mean Total Brief Pain Inventory (Short Form) Score at 3 Weeks.

  0 - 3 weeks

• Change From Baseline in Mean Spitzer Quality of Life Index Scores at 3 Weeks.

  0 - 3 weeks

Study Arms (2)

GW-1000-02

EXPERIMENTAL

Each 100 μl actuation contains 2.5 mg delta-9-tetrahydrocannabinol (THC) and 2.5 mg cannabidiol (CBD). The maximum permitted dose was 48 actuations in any 24 hour period (120 mg THC/120 mg CBD).

Drug: GW-1000-02

Placebo

PLACEBO COMPARATOR

Each 100 μl actuation contains the excipients only. The maximum permitted dose was 48 actuations in any 24 hour period

Drug: Placebo

Interventions

GW-1000-02 DRUG

Each actuation of GW-1000-02 (100 μl) delivered a dose containing 2.5 mg delta-9-tetrahydrocannabinol (THC) and 2.5 mg cannabidiol (CBD). The maximum permitted dose of study medication was eight actuations in any three hour period (20 mg THC/20 mg CBD) and 48 actuations in any 24 hour period (120 mg THC/120 mg CBD).

Also known as: Sativex

GW-1000-02

Placebo DRUG

Each actuation of placebo (100 μl) delivered the excipients only. The maximum permitted dose of study medication was eight actuations in any three hour period and 48 actuations in any 24 hour period.

Placebo

Eligibility Criteria

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

You may qualify if:

• Patient, or legal representative, willing and able to give informed consent for participation in the study.
• Male or Female, aged 18 years or above.
• Diagnosed with chronic refractory pain due to Multiple Sclerosis or other defects of neurological function.
• Diagnosed with pain, not wholly alleviated with current analgesic therapy at Visit 1 and an average score of over 4 on a Box Scale-11 scale on the four consecutive days leading up to Visit 2, where: zero = "no pain" and 10 = "worst possible pain".
• Stable dose of pain relieving medication for at least two weeks prior to study entry.
• Willing to ensure that they or their partner use effective contraception during the study and for three months thereafter (applicable to female patients of child bearing potential and male patients whose partners were of child bearing potential).
• No cannabinoid use (cannabis, Marinol or Nabilone) for at least seven days before Visit 1 and be willing to abstain from any use of cannabis during the study.
• Able (in the investigator's 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 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 schizophrenia, other psychotic illness, severe personality disorder or other significant psychiatric disorder other than depression associated with their underlying condition.
• Known 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 epilepsy.
• Female patients who were pregnant, lactating or planning pregnancy during the course of the study.
• Significant renal or hepatic impairment.
• Scheduled elective surgery or other procedures requiring general anaesthesia during the study.
• Terminally ill or inappropriate for placebo medication.
• Any other significant disease or disorder which, in the opinion of the investigator, may have put the patient at risk because of participation in the study, or may have influenced the result of the study, or the patient's ability to participate in 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 of having adverse reaction to cannabinoids.
• Travel outside the UK planned during the study.
• Donation of blood during the study.
• Patients who had participated in another research study in the 12 weeks leading up to study entry.

Sponsors & Collaborators

• Jazz Pharmaceuticals: lead

Study Sites (1)

James Paget Hospital

Norfolk, NR31 6LA, United Kingdom

Location

MeSH Terms

Conditions

Pain; Multiple Sclerosis

Interventions

nabiximols

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

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 25, 2012
• Study Start: March 1, 2002
• Primary Completion: August 1, 2002
• Study Completion: August 1, 2002
• Last Updated: January 10, 2023
• Results First Posted: August 24, 2012

Record last verified: 2022-12

Locations

GB (1)