CompletedPhase 2MS (type not specified)2018-002315-98

What it found

Missed its main goal

The main measure did not show a significant benefit.

“Nevertheless, in this four-arm parallel trial, no effect was found between placebo and active treatment with THC or CBD alone or in combination on NP or spasticity in patients with either MS or SCI.”
Read by software from the paper's abstract
GroupnValue
THC32pain 0.42 (-0.54-1.38); spasticity 0.24 (-0.67-1.45)
CBD31pain 0.45 (-0.47-1.38); spasticity 0.46 (-0.74-1.65)
THC&CBD31pain 0.16 (-0.75-1.08); spasticity 0.10 (-1.18-1.39)

Total participants: 134

Read by software from the paper's abstract

What was tested

Treatment tested

  • Cannabidiol

    Cannabinoid CB1 receptor negative allosteric modulator

  • Dronabinol

    Cannabinoid CB1 receptor agonist

What it measured

Main measures

  • 1) Mean pain intensity during the last week of active treatment compared with baseline (Diary, Numeric Rating Scale (NRS)).

    Pain

Other measures (1)

  • 1) Patient Global Impression of Change (PGIC)

Who could take part

MS (type not specified)

Inclusion: 1) Probable or definite neuropathic pain in more than three months with a mean baseline pain intensity NRS >3 and < 9 and/or spasticity severity NRS > 3. Exclusion: 1) Other pain conditions (e.g. diabetic neuropathy), which cannot be distinguished from central pain in MS and/or SCI

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

To evaluate the efficacy of the cannabinoids THC, CBD and a combination of CBD/THC on central neuropathic pain and spasticity in patients with multiple sclerosis and in patients with spinal cord injury

Papers

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Related trials

History

    1. Started

      Jul 2018

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