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

Primary Purpose

Central Neuropathic Pain in Multiple Sclerosis

Status
Completed
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Dronabinol
Placebo
Sponsored by
Bionorica Research GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Central Neuropathic Pain in Multiple Sclerosis focused on measuring Dronabinol, (-)trans-delta9-tetrahydrocannabinol, central neuropathic pain, multiple sclerosis, analgesic, Central neuropathic pain related to multiple sclerosis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Maerkische Kliniken GmbH, Klinikum Luedenscheid, Akademisches Lehrkrankenhaus der Universitaet Bonn, Klinik fuer Neurologie

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Dronabinol

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Mean change of baseline pain severity score on the 11-point Likert Numerical Rating Scale recorded in patient diary

Secondary Outcome Measures

Likert Numerical Rating Scale pain relief
Pain-related sleep interference
SF-36 (QoL-questionnaire)
Intake of rescue medication

Full Information

First Posted
August 13, 2009
Last Updated
February 2, 2012
Sponsor
Bionorica Research GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT00959218
Brief Title
Efficacy and Safety of the Pain Relieving Effect of Dronabinol in Central Neuropathic Pain Related to Multiple Sclerosis
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
April 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bionorica Research GmbH

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Central Neuropathic Pain in Multiple Sclerosis
Keywords
Dronabinol, (-)trans-delta9-tetrahydrocannabinol, central neuropathic pain, multiple sclerosis, analgesic, Central neuropathic pain related to multiple sclerosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
240 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dronabinol
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Dronabinol
Other Intervention Name(s)
(-)trans-delta9-tetrahydrocannabinol
Intervention Description
oral solution, daily dose up to 15 mg, treatment up to 2.5 years
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
oral solution
Primary Outcome Measure Information:
Title
Mean change of baseline pain severity score on the 11-point Likert Numerical Rating Scale recorded in patient diary
Time Frame
max. 2.5 years
Secondary Outcome Measure Information:
Title
Likert Numerical Rating Scale pain relief
Time Frame
max. 2.5 years
Title
Pain-related sleep interference
Time Frame
max. 2.5 years
Title
SF-36 (QoL-questionnaire)
Time Frame
max. 2.5 years
Title
Intake of rescue medication
Time Frame
48 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sebastian Schimrigk, MD
Organizational Affiliation
Klinikum Luedenscheid
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maerkische Kliniken GmbH, Klinikum Luedenscheid, Akademisches Lehrkrankenhaus der Universitaet Bonn, Klinik fuer Neurologie
City
Luedenscheid
ZIP/Postal Code
58515
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

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

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