| Study name |
The effect of cannabis‐based medicine on neuropathic pain and spasticity in patients with multiple sclerosis and spinal cord injury: study protocol of a national multicenter double‐blinded, placebo‐controlled trial |
| Methods |
Trial design: RCT, multicentre, parallel‐group, double‐blind Sample size: 448 participants Country: Denmark Number of centres: 5 |
| Participants |
Definite or probable central neuropathic pain for more than 3 months with mean pain intensity in baseline NRS > 3 and NRS ≤ 9 and/or presence of spasticity of more than 3 months with an intensity of > 3 (NRS) Stable disease (for patients with MS; no relapse within the past month and no change indisease‐modifying treatment during the previous three months) Age ≥ 18 years Informed consent is available |
| Interventions |
|
| Outcomes |
Primary: patient‐reported pain and spasticity on a NRS
Secondary: quality of life and sleep, depression and anxiety, relief of pain and spasticity
Adverse events |
| Starting date |
February 2019 |
| Contact information |
Julie Schjødtz Hansen. Department of Neurology, Aarhus University Hospital, DK‐8200 Aarhus N, Denmark. julihans@rm.dk |
| Notes |
Recruitment status: recruiting Prospective completion date: December 2021 Sponsor: This research is funded by The Danish Ministry of Health, The Danish Multiple Sclerosis Society, Bdr. Hartmann Foundation, Karen A Tolstrup Foundation, ”Direktør Ejnar Jonasson kaldet Johnsen og Hustru’s Mindelegat”, Fonden for neurologisk forskning. |
