NCT00480181

Brief Summary

The purpose of this study is to determine whether nabilone (Cesamet) when used as an adjunctive agent with gabapentin (Neurontin) provides significantly improved pain relief over gabapentin alone for the management of neuropathic pain in MS.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jun 2007

Longer than P75 for phase_4

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

First Submitted

Initial submission to the registry

May 28, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 30, 2007

Completed
2 days until next milestone

Study Start

First participant enrolled

June 1, 2007

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

July 27, 2012

Status Verified

March 1, 2011

Enrollment Period

5.1 years

First QC Date

May 28, 2007

Last Update Submit

July 26, 2012

Conditions

Neuropathic PainMultiple Sclerosis

Keywords

Neuropathic painMultiple SclerosisNabiloneGabapentin

Outcome Measures

Primary Outcomes (1)

  • VAS

    9 weeks

Secondary Outcomes (3)

  • SF MPQ

    9 weeks

  • SF-36

    9 weeks

  • PGIC

    9 weeks

Study Arms (2)

Active

EXPERIMENTAL
Drug: nabilone

placebo

PLACEBO COMPARATOR
Other: placebo

Interventions

nabiloneDRUG

Cesamet (nabilone) capsules given at titrating dosages as per protocol.

Also known as: Cesamet
Active
placeboOTHER

placebo capsules (identical appearance to Cesamet) given at titrating dosages as per protocol.

placebo

Eligibility Criteria

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

You may qualify if:

  • Males and females between the ages of 18-65 years old with clinically definite RRMS
  • EDSS of \< 6.5
  • Current treatment with gabapentin that is not effective at a stabilized dose of (\>1800mg/day) for at least 1 month.
  • Visual Analogue Scale score for NPP symptoms \> 5; pain present for at least 3 months
  • Negative serum pregnancy test for all females of childbearing age; not currently breastfeeding
  • No history of alcohol or substance abuse
  • No history of non-psychotic emotional disorders
  • No significant hepatic or renal insufficiency
  • No significant cardiovascular disease or hypertension
  • No known hypersensitivity and/or allergy to nabilone or its derivatives
  • No current use of cannabinoid or related products

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Health Sciences Centre Multiple Sclerosis Clinic

Winnipeg, Manitoba, R3A 1R9, Canada

Location

MeSH Terms

Conditions

NeuralgiaMultiple Sclerosis

Interventions

nabilone

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsDemyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Michael P Namaka, PhD

    University of Manitoba

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 28, 2007

First Posted

May 30, 2007

Study Start

June 1, 2007

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

July 27, 2012

Record last verified: 2011-03

Locations

CA(1)