NCT00959218

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jun 2007

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2007

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

August 13, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 14, 2009

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
Last Updated

February 3, 2012

Status Verified

February 1, 2012

Enrollment Period

2.8 years

First QC Date

August 13, 2009

Last Update Submit

February 2, 2012

Conditions

Central Neuropathic Pain in Multiple Sclerosis

Keywords

Dronabinol(-)trans-delta9-tetrahydrocannabinolcentral neuropathic painmultiple sclerosisanalgesicCentral neuropathic pain related to multiple sclerosis

Outcome Measures

Primary Outcomes (1)

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

    max. 2.5 years

Secondary Outcomes (4)

  • 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

Study Arms (2)

Dronabinol

EXPERIMENTAL
Drug: Dronabinol

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

DronabinolDRUG

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

Also known as: (-)trans-delta9-tetrahydrocannabinol
Dronabinol
PlaceboDRUG

oral solution

Placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Lüdenscheid, 58515, Germany

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Dronabinol

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

CannabinoidsTerpenesHydrocarbonsOrganic Chemicals

Study Officials

  • Sebastian Schimrigk, MD

    Klinikum Luedenscheid

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 13, 2009

First Posted

August 14, 2009

Study Start

June 1, 2007

Primary Completion

March 1, 2010

Study Completion

April 1, 2010

Last Updated

February 3, 2012

Record last verified: 2012-02

Locations

DE(1)