Efficacy and Safety of the Pain Relieving Effect of Dronabinol in Central Neuropathic Pain Related to Multiple Sclerosis

Multi-centre, Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of the Pain Relieving Effect of Dronabinol in Patients With Multiple Sclerosis Associated With Central Neuropathic Pain

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00959218

Enrollment

240

Registered

2009-08-14

Start date

2007-06-30

Completion date

2010-04-30

Last updated

2012-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Central Neuropathic Pain in Multiple Sclerosis

Keywords

Dronabinol, (-)trans-delta9-tetrahydrocannabinol, central neuropathic pain, multiple sclerosis, analgesic, Central neuropathic pain related to multiple sclerosis

Brief summary

The purpose of this study is to determine whether Dronabinol is effective and safe in relieving central neuropathic pain in multiple sclerosis patients.

Detailed description

Multiple sclerosis (MS) is in all probability an autoimmune disease causing severe neurological disability due to inflammation and degeneration in the central nervous system (CNS). MS affects over 1 million people worldwide. Central neuropathic pain is associated with approximately 30% of all patients with MS. MS-accompanying pain has a major impact on the patients' quality of life as usual conventional analgesics are little effective. The aim of this clinical study is to determine whether Dronabinol is effective and safe in relieving central neuropathic pain in multiple sclerosis patients.

Interventions

DRUGDronabinol

oral solution, daily dose up to 15 mg, treatment up to 2.5 years

DRUGPlacebo

oral solution

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Mean change of baseline pain severity score on the 11-point Likert Numerical Rating Scale recorded in patient diary	max. 2.5 years

Secondary

Measure	Time frame
Likert Numerical Rating Scale pain relief	max. 2.5 years
Pain-related sleep interference	max. 2.5 years
SF-36 (QoL-questionnaire)	max. 2.5 years
Intake of rescue medication	48 weeks

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026