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A Study to Test the Use of Duloxetine for Pain in MS

NCT00457730 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2015-04-27

Study results available
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Summary

Many patients with Multiple Sclerosis experience pain that is caused by the effects of MS on the nervous system.

The purpose of this study is to see if an investigational drug (Duloxetine) will reduce pain in subjects with MS.

The US Food and Drug administration (FDA) has approved this drug for use with depression or pain from diabetes.However, it is considered investigational for this study because it has not been approved for patients with MS.

This study will recruit patients with MS who have central pain which is 4 or greater on a scale of 1-10. Patients must have experienced pain for 2 months or longer prior to begining the study.The study will last 10 weeks, patients will be randomized either Duloxetine or placebo and will be carefully monitored throughout the study. Patients will keep pain/sleep diaries during the study period and will be provided Ibuprofen for pain control.

Conditions

Interventions

DRUG

Duloxetine

Patients will be randomly assigned to Duloxetine 30mg/d for 1 week, 60mg/d for 5 weeks and 30mg/d for 1 week or placebo for 7 weeks under double-blind conditions.

DRUG

Placebo

Subjects are randomized to either Duloxetine or Placebo

Sponsors & Collaborators

Principal Investigators

  • Theodore R Brown, MD.MPH · Evergreen Healthcare

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-01-31
Primary Completion
2012-08-31
Completion
2012-08-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00457730 on ClinicalTrials.gov