A Study to Evaluate the Effects of Cannabis Based Medicine in Patients With Pain of Neurological Origin
CompletedPhase 3NCT01606176
View the official record on ClinicalTrials.gov Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.
This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
To investigate the ability of a cannabis based medicine extract to relieve chronic refractory pain of neurological origin.
Study details
- Official title
- A Multi Centre Randomised, Double Blind, Placebo Controlled, Parallel Group Comparison of the Effects of Cannabis Based Medicine Standardised Extracts Over 4 Weeks, in Patients With Chronic Refractory Pain Due to Multiple Sclerosis or Other Defects of Neurological Function.
- Conditions
- Interventions
- Drug: GW-1000-02
- Drug: Placebo
- Sponsor
- Jazz Pharmaceuticals
- Start date
- 2002-03
- Primary completion
- 2002-08
- Sex
- All
- Age range
- from 18 Years
- Results posted
- Yes, on ClinicalTrials.gov
- Countries
- United Kingdom
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * 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. Exclusion Criteria: * 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. * …
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT01606176