Efficacy and Safety of the Pain Relieving Effect of Dronabinol in Central Neuropathic Pain Related to Multiple Sclerosis
What it found
The main measure did not show a significant benefit.
“Pain intensity during 16-weeks dronabinol and placebo treatment was reduced by 1.92 and 1.81 points without significant difference in between (p = 0.676).”Read by software from the paper's abstract
Change of pain intensity on the 11-point Numerical Rating Scale over a 16-weeks treatment period
| Group | n | Value |
|---|---|---|
| dronabinol | reduced by 1.92 points | |
| placebo | reduced by 1.81 points |
p = 0.676
Read by software from the paper's abstract
What was tested
Treatment tested
- Dronabinol
Cannabinoid CB1 receptor agonist
Placebo or sham
- Placebo
What it measured
Main measures
Mean change of baseline pain severity score on the 11-point Likert Numerical Rating Scale recorded in patient diary
max. 2.5 years
PainThe primary endpoint of efficacy will be the mean change of baseline pain severity score taken from the initial patient assessment and the daily patient recordings of his/her average chronic pain on the 11-point NRS within a maximum of 16 weeks
Pain
Other measures (4)
Likert Numerical Rating Scale pain relief
max. 2.5 years
PainPain-related sleep interference
max. 2.5 years
PainMood and sleepSF-36 (QoL-questionnaire)
max. 2.5 years
Quality of life (reported by participants)Intake of rescue medication
48 weeks
Who could take part
MS (type not specified) · 18 to 70
Inclusion Criteria: * Diagnosis of multiple sclerosis acc. to McDonald diagnostic criteria * EDSS score between 3 and 8 (incl.) * Patients who are in a stable phase of multiple sclerosis * Patients with MS-related central neuropathic pain for at least 3 months Exclusion Criteria: * Severe concomitant diseases * Certain concomitant therapies (in particular: pain influencing concomitant therapies) * Dronabinol intake within the last 12 months prior to study entry or Marihuana use within one month prior to study entry
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
The purpose of this study is to determine whether Dronabinol is effective and safe in relieving central neuropathic pain in multiple sclerosis patients.
Papers
Results
Dronabinol Is a Safe Long-Term Treatment Option for Neuropathic Pain Patients.Eur Neurol · 2017
Pain intensity during 16-weeks dronabinol and placebo treatment was reduced by 1.92 and 1.81 points without significant difference in between (p = 0.676).
Read by software from the paper's abstract
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History
Started
Jun 2007
Main results due
Mar 2010
Finished
Apr 2010
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