Duloxetine for Multiple Sclerosis Pain

Lilly

Status and phase

Completed

Phase 3

Conditions

Multiple Sclerosis

Treatments

Drug: Placebo

Drug: Duloxetine Hydrochloride (HCI)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00755807

11666

F1J-US-HMFR (Other Identifier)

Details and patient eligibility

About

This study is designed to primarily assess the efficacy and safety of duloxetine 60-120 mg once daily (QD) compared with placebo on the reduction of pain severity in participants with central neuropathic pain due to Multiple Sclerosis.

Full description

Study is a multicenter, randomized, double-blind, parallel, placebo-controlled, 20-week trial with 4 study periods. Participants who screen successfully (Study Period I) will be randomized in a 1:1 fashion to duloxetine 60 mg QD or placebo. Starting with Study Period II, participants will be treated in a double-blind manner for 6 weeks. Participants who complete the 6-week, double-blind period will have the opportunity to participate in a 12-week, open-label, flexible-dose portion of the study (Study Period III). Study Period IV is a taper phase designed to reduce the occurrence of discontinuation adverse events. Participants may enter Study Period IV at any time after Visit 3.

Enrollment

239 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Have central neuropathic pain due to multiple sclerosis (MS) based on the disease diagnostic criteria
Adult males or females
Have a score of 4 or greater on the daily 24-hour average pain score
Females must test negative for pregnancy at study entry
Complete the daily diaries for at least 70% of the days of the study
Participants may continue other prescription and nonprescription analgesic pain medications as long as the dose has been stable for 1 month prior to study entry, and they agree to maintain that stable dose throughout the study Disease Diagnostic Criteria:
- Diagnosis of MS at least 1 year prior to study entry
- No MS flares or change in disease treatment for the 3 months prior to study entry
- Daily pain due to MS for a minimum of 3 months prior to study entry

Exclusion criteria

Are currently in a clinical trial of MS disease-modifying therapy
Have pain that cannot be clearly differentiated from causes other than MS
Any current or historical diagnosis of mania, bipolar disorder, psychosis, or schizoaffective disorder
History of substance abuse or dependence
Are pregnant or breast-feeding