A Double Blind, Randomized, Placebo Controlled, Parallel Group Study of Sativex® in the Treatment of Subjects With Peripheral Neuropathic Pain, Associated With Allodynia
Overview
- Phase
- Phase 3
- Intervention
- Sativex
- Conditions
- Pain
- Sponsor
- Jazz Pharmaceuticals
- Enrollment
- 246
- Locations
- 1
- Primary Endpoint
- Change From Baseline in Mean Peripheral Neuropathic Pain on a 0-10 Numerical Rating Scale (NRS) Score at the End of Treatment (15 Weeks)
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
The purpose of this study is to evaluate the efficacy of Sativex® compared with placebo in relieving peripheral neuropathic pain associated with allodynia.
Detailed Description
This was a 15 week (one week baseline and fourteen weeks treatment period), multicentre, double blind, randomised, placebo controlled, parallel group study to evaluate the efficacy of Sativex® in subjects with PNP, associated with allodynia. Subjects were screened to determine eligibility and completed a seven-day baseline period. Subjects then returned to the centre for assessment, randomisation and dose introduction. Visits occurred at the end of weeks two, six, ten and at the end of the study (treatment week 14) or earlier if they withdrew. A follow up visit occurred 28 days after completion or withdrawal. Subjects in this study were given the opportunity to be enrolled in an open label extension study.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Willing and able to give informed consent.
- •Male or female, aged 18 years or above.
- •Ability (in the investigators opinion) and willingness to comply with all study requirements.
- •Diagnosed with PNP of at least six months duration and in who pain is not wholly relieved with their current therapy.
- •Presence of mechanical allodynia within the territory of the affected nerve(s) which has been confirmed by either a positive response to stroking the allodynic area with a SENSELABTM Brush 05 or to force applied by a 5.07 gram Semmes-Weinstein monofilament.
- •Had at least one of the following underlying conditions, which caused their peripheral neuropathic pain; post herpetic neuralgia, peripheral neuropathy, focal nerve lesion, radiculopathy or Complex Regional Pain Syndrome (CRPS) type
- •The daily diary 0-10 NRS pain scores on days B2 - B7 of the baseline period were completed and summed to at least
- •Stable dose of regular pain medication and non-pharmacological therapies (including TENS) for at least 14 days prior to the screening visit and willingness for these to be maintained throughout the study. Where subjects were taking a medication containing paracetamol further instructions were provided, refer to Section 9.4.
- •In the opinion of the investigator the subject has received or was currently receiving the appropriate PNP treatments for their condition.
- •Agreement for the responsible authorities (as applicable in individual countries), their primary care physician, and their consultant, if appropriate, to be notified of their participation in the study.
Exclusion Criteria
- •Concomitant pain thought by the investigator to be of a nature or severity to interfere with the subject's assessment of their PNP.
- •Receiving a prohibited medication and were unwilling to stop or comply for the duration of the study.
- •Had CRPS type 1, cancer related neuropathic pain or neuropathic pain resulted from diabetes mellitus.
- •Has used either cannabis (either for recreational or medical purposes) or cannabis based medications within the last year and were unwilling to abstain for the duration for the study.
- •History of schizophrenia, other psychotic illness, severe personality disorder or other significant psychiatric disorder other than depression associated with their underlying condition.
- •Known or suspected history of alcohol or substance abuse.
- •History of epilepsy or recurrent seizures.
- •Known or suspected hypersensitivity to cannabinoids or any of the excipients of the study medication.
- •Evidence of cardiomyopathy.
- •Experienced myocardial infarction or clinically relevant cardiac dysfunction within the last 12 months or had a cardiac disorder that, in the opinion of the investigator would put the subject at risk of a clinically relevant arrhythmia or myocardial infarction.
Arms & Interventions
Sativex
Intervention: Sativex
Placebo
Intervention: Placebo
Outcomes
Primary Outcomes
Change From Baseline in Mean Peripheral Neuropathic Pain on a 0-10 Numerical Rating Scale (NRS) Score at the End of Treatment (15 Weeks)
Time Frame: Day 7 to Day 98
The peripheral neuropathic pain NRS 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. No pain relates to the time prior to the onset of pain. A negative value indicates an improvement in pain score from baseline.
Secondary Outcomes
- Change From Baseline in Neuropathic Pain Scale Score at the End of Treatment (15 Weeks)(Day 7 to Day 98)
- Change From Baseline in Sleep Quality 0-10 Numerical Rating Scale Scores at the End of Treatment (15 Weeks)(Day 7 to Day 98)
- Change in Baseline Mean Dynamic Allodynia Test Score at the End of Treatment (15 Weeks)(Day 7 and Day 98)
- Change in Baseline Mean Punctate Allodynia Test Scores at the End of Treatment (15 Weeks)(Day 7 and Day 98)
- Subject Global Impression of Change(Day 98)
- Change From Baseline in Brief Pain Inventory (Short Form) Scores at the End of Treatment(Day 7 and Day 98)
- Change From Baseline in Quality of Life EuroQol 5-D (Health Status Index) Score at the End of Treatment (15 Weeks)(Day 7 and Day 98)
- Change From Baseline in Quality of Life EuroQol 5-D (Health Status Visual Analogue Scale) Score at the End of Treatment (15 Weeks)(Day 7 and Day 98)
- Change From Baseline in the Use of Rescue Analgesia at the End Treatment (15 Weeks)(Days 0-7 and Days 92-98)
- Incidence of Adverse Events as a Measure of Subject's Safety.(19 weeks)