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Duloxetine for Multiple Sclerosis Pain

Primary Purpose

Multiple Sclerosis

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Duloxetine Hydrochloride (HCI)

Placebo

About this trial

This is an interventional treatment trial for Multiple Sclerosis focused on measuring Central Neuropathic Pain, Multiple Sclerosis

Eligibility Criteria

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

Sites / Locations

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

Duloxetine

Arm Description

Outcomes

Primary Outcome Measures

Change From Baseline in the Weekly 24-Hour Average Pain Scores at Week 6 (Acute Phase)

24-hour average pain severity scores recorded daily on an 11-point Likert scale, evaluated as a weekly mean, with scores ranging from 0 (no pain) to 10 (worst possible pain). Participants should complete electronic diary each day upon awakening. The 11-point Likert scale was used for assessment of 24-hour average pain and evaluated as weekly means. Scores range from 0 (no pain) to 10 (worst possible pain). The Least Squares Mean (LS Mean) Value was adjusted for investigative site and baseline severity.

Secondary Outcome Measures

Change From Baseline in the Weekly 24-Hour Average Pain Scores up to Week 6 (Acute Phase)

This is a nominal outcome reflecting whether or not a clinically-important efficacy outcome (≥30% or ≥50% pain reduction from baseline) was achieved at endpoint. It is based on a comparison between baseline and endpoint scores on an ordinal scale with scores from 0 (no pain) to 10 (worst possible pain). Used were the weekly mean of the scores of the average pain severity over the last 24 hours. The weekly averages were based on daily assessments recorded by participants in their diaries.

Patient Global Impressions of Improvement Scale (PGI-I) at 6 Weeks

A scale that measures the participant's perception of improvement at the time of assessment compared with the start of treatment. The score ranges from 1 (very much better) to 7 (very much worse). The Least Squares (LS) Mean Value was adjusted for investigative site and baseline severity.

Change From Baseline in the Brief Pain Inventory Severity and Interference Scores (BPI-S/BPI-I) at Week 6 (Acute Phase)

Measures pain severity and interference on function. Severity scores: 0 (no pain) to 10 (severe pain) on each question assessing worst, least, and average pain in past 24 hours, and pain right now. Interference scores: 0 (does not interfere) to 10 (completely interferes) on each question assessing pain interference in past 24 hours, such as general activity, mood, normal work, relations with other people, and sleep. Average interference=average of non-missing scores of individual interference items. Least Squares (LS) Mean Value was adjusted for investigative site and baseline severity.

Change From Baseline in the Clinical Global Impression of Severity Scale (CGI-S) at 6 Weeks (Acute Phase)

Measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill participants). The Least Squares (LS) Mean Value was adjusted for investigative site and baseline severity.

Change From Baseline in the Multiple Sclerosis Quality of Life-54 Instrument (MS-QOL-54) at 6 Weeks (Acute Phase)

A 54 question measure covers 12 domains; assesses mental and physical health. Each domain score is converted into a 0-100 score based on individual item responses; higher scores=better health status. The physical health composite score is a weighted average of the physical health scales, such as physical function, health perceptions, and energy. The mental health composite score is a weighted average of the mental health scales, such as overall quality of life, cognitive function, and health distress. The Least Squares (LS) Mean Value was adjusted for investigative site and baseline severity.

Number of Participants With Suicidal Behaviors, Ideations, and Acts Based on The Columbia Suicide Severity Rating Scale (C-SSRS) at Week 6

C-SSRS scale captures occurrence, severity, and frequency of suicide-related thoughts and behaviors. Number of participants with suicidal behaviors, ideations, and acts are provided. Suicidal behavior: a "yes" answer to any of 5 suicidal behavior questions: preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide. Suicidal ideation: a "yes" answer to any one of 5 suicidal ideation questions, which includes wish to be dead, and 4 different categories of active suicidal ideation. Suicidal act: a "yes" answer to actual attempt or completed suicide.

Change From Baseline in the Weekly Mean of Night Pain Scores at Week 6 (Acute Phase)

Weekly mean of the night pain severity scores recorded daily on an 11-point Likert scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). Participants should complete the electronic diary each day upon awakening. The Least Squares (LS) Mean Value was adjusted for investigative site and baseline severity.

Change From Baseline in the Beck Depression Inventory II (BDI-II) Question #9 at Week 6 (Acute Phase)

The BDI-II is completed by the participant to rate the severity of depressive symptoms and any improvement during the course of the trial. The total score ranges from 0 to 63 with higher the score indicating more severe depressive symptoms. Question #9 is suicidal thoughts and wishes with a score ranging from 0 to 3.

Number of Participants Who Discontinued During the Acute Phase (by Week 6)

Number of Participants With Treatment Emergent Adverse Events (TEAEs) During the Acute Phase

Summary tables of serious adverse events (SAEs) and all other non-serious adverse events are located in the Reported Adverse Event Module.

Number of Participants With Adverse Events (AEs) Resulting in Discontinuation From Baseline During the Acute Phase

Change From Baseline in Blood Pressure at Week 6 (Acute Phase)

Change From Baseline in Pulse Rate at Week 6 (Acute Phase)

Change From Baseline in Weight at Week 6 (Acute Phase)

Patient Global Impressions of Improvement Scale (PGI-I) Score at 18 Weeks

A scale that measures the participant's perception of improvement at the time of assessment compared with the start of treatment. The scores range from 1 (very much better) to 7 (very much worse).

Change From Baseline in Brief Pain Inventory Severity and Interference Scores (BPI-S/BPI-I) at Week 18

BPI-S and BPI-I are self-reported scales measuring severity of pain and interference on function. Severity scores: 0 (no pain) to 10 (severe pain) on each question assessing worst pain, least pain, and average pain in past 24 hours, and pain right now. Interference scores: 0 (does not interfere) to 10 (completely interferes) on each question assessing interference of pain in past 24 hours for general activity, mood, walking ability, normal work, relations with other people, sleep, and enjoyment of life. Average interference = average of non-missing scores of individual interference items.

Change From Baseline in the Clinical Global Impression of Severity Scale (CGI-S) Score at Week 18 (Open-label Extension Phase)

Measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill participants).

Change From Baseline in Multiple Sclerosis Quality of Life-54 Instrument (MS-QOL-54) at Week 18 (Open-label Extension Phase)

Number of Participants With Suicidal Behaviors, Ideations, and Acts Based on The Columbia Suicide Severity Rating Scale (C-SSRS) at Week 18

Change in the Weekly Mean of the Night Pain Scores From Week 6 Through Week 18 (Open-label Extension Phase)

Weekly mean of the night pain severity scores recorded daily on an 11-point Likert scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). Participants should complete the electronic diary each day upon awakening. Each weekly mean change represents change relative to week 6, the baseline of the extension phase.

Change From Baseline in Beck Depression Inventory II (BDI-II), Question #9 at Week 18 (Open-label Extension Phase)

Number of Participants Who Discontinued During the Open-label Extension Phase (by Week 18)

Number of Participants With Treatment Emergent Adverse Events (TEAEs) During the Open-label Extension Phase

Summary tables of serious adverse events (SAEs) and all other non-serious adverse events are located in the Reported Adverse Event Module.

Number of Participants With Adverse Events (AEs) Resulting in Discontinuation During the Open-label Extension Phase

Change From Baseline in Blood Pressure at Week 18 (Open-label Extension Phase)

Change From Baseline in Pulse Rate at Week 18 (Open-label Extension Phase)

Change From Baseline in Weight at Week 18 (Open-label Extension Phase)

Full Information

NCT ID

NCT00755807

First Posted

September 17, 2008

Last Updated

November 4, 2011

Sponsor

Eli Lilly and Company

1. Study Identification

Unique Protocol Identification Number

NCT00755807

Brief Title

Duloxetine for Multiple Sclerosis Pain

Official Title

Duloxetine in Patients With Central Neuropathic Pain Due to Multiple Sclerosis.

Study Type

Interventional

2. Study Status

Record Verification Date

November 2011

Overall Recruitment Status

Completed

Study Start Date

October 2008 (undefined)

Primary Completion Date

August 2010 (Actual)

Study Completion Date

November 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Eli Lilly and Company

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Multiple Sclerosis

Keywords

Central Neuropathic Pain, Multiple Sclerosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

239 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Title

Duloxetine

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Duloxetine Hydrochloride (HCI)

Other Intervention Name(s)

LY248686, Cymbalta

Intervention Description

Participants received 30 mg duloxetine (po, QD) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period. If the participant completes the double-blind portion of the trial, the participant will be offered the option to participate in the open-label extension period (given 60, 90, or 120 mg QD for 12 weeks).

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Participants received placebo oral (po), once daily (QD) for 6 weeks (acute phase). If the participant completes the 6-week double-blind portion of the trial, the participant will be offered the option to participate in the open-label extension period (given 60, 90, or 120 milligrams [mg] QD for 12 weeks).

Primary Outcome Measure Information:

Title

Change From Baseline in the Weekly 24-Hour Average Pain Scores at Week 6 (Acute Phase)

Description

Time Frame

Baseline, 6 weeks

Secondary Outcome Measure Information:

Title

Change From Baseline in the Weekly 24-Hour Average Pain Scores up to Week 6 (Acute Phase)

Description

Time Frame

Baseline, 6 weeks

Title

Patient Global Impressions of Improvement Scale (PGI-I) at 6 Weeks

Description

Time Frame

6 weeks

Title

Change From Baseline in the Brief Pain Inventory Severity and Interference Scores (BPI-S/BPI-I) at Week 6 (Acute Phase)

Description

Time Frame

Baseline, 6 weeks

Title

Change From Baseline in the Clinical Global Impression of Severity Scale (CGI-S) at 6 Weeks (Acute Phase)

Description

Time Frame

Baseline, 6 weeks

Title

Change From Baseline in the Multiple Sclerosis Quality of Life-54 Instrument (MS-QOL-54) at 6 Weeks (Acute Phase)

Description

Time Frame

Baseline, 6 weeks

Title

Number of Participants With Suicidal Behaviors, Ideations, and Acts Based on The Columbia Suicide Severity Rating Scale (C-SSRS) at Week 6

Description

Time Frame

6 weeks

Title

Change From Baseline in the Weekly Mean of Night Pain Scores at Week 6 (Acute Phase)

Description

Time Frame

Baseline, 6 weeks

Title

Change From Baseline in the Beck Depression Inventory II (BDI-II) Question #9 at Week 6 (Acute Phase)

Description

Time Frame

Baseline, 6 weeks

Title

Number of Participants Who Discontinued During the Acute Phase (by Week 6)

Time Frame

Baseline through 6 weeks

Title

Number of Participants With Treatment Emergent Adverse Events (TEAEs) During the Acute Phase

Description

Summary tables of serious adverse events (SAEs) and all other non-serious adverse events are located in the Reported Adverse Event Module.

Time Frame

Baseline through 6 weeks

Title

Number of Participants With Adverse Events (AEs) Resulting in Discontinuation From Baseline During the Acute Phase

Time Frame

Baseline through 6 weeks

Title

Change From Baseline in Blood Pressure at Week 6 (Acute Phase)

Time Frame

Baseline, 6 weeks

Title

Change From Baseline in Pulse Rate at Week 6 (Acute Phase)

Time Frame

Baseline, 6 weeks

Title

Change From Baseline in Weight at Week 6 (Acute Phase)

Time Frame

Baseline, 6 weeks

Title

Patient Global Impressions of Improvement Scale (PGI-I) Score at 18 Weeks

Description

A scale that measures the participant's perception of improvement at the time of assessment compared with the start of treatment. The scores range from 1 (very much better) to 7 (very much worse).

Time Frame

18 weeks

Title

Change From Baseline in Brief Pain Inventory Severity and Interference Scores (BPI-S/BPI-I) at Week 18

Description

Time Frame

Baseline (end of acute phase/Week 6), Endpoint (Week 18)

Title

Change From Baseline in the Clinical Global Impression of Severity Scale (CGI-S) Score at Week 18 (Open-label Extension Phase)

Description

Measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill participants).

Time Frame

Baseline (6 weeks), Endpoint (18 weeks)

Title

Change From Baseline in Multiple Sclerosis Quality of Life-54 Instrument (MS-QOL-54) at Week 18 (Open-label Extension Phase)

Description

Time Frame

Baseline (6 weeks), Endpoint (18 weeks)

Title

Number of Participants With Suicidal Behaviors, Ideations, and Acts Based on The Columbia Suicide Severity Rating Scale (C-SSRS) at Week 18

Description

Time Frame

18 weeks

Title

Change in the Weekly Mean of the Night Pain Scores From Week 6 Through Week 18 (Open-label Extension Phase)

Description

Weekly mean of the night pain severity scores recorded daily on an 11-point Likert scale, an ordinal scale ranging from 0 (no pain) to 10 (worst possible pain). Participants should complete the electronic diary each day upon awakening. Each weekly mean change represents change relative to week 6, the baseline of the extension phase.

Time Frame

Baseline (6 weeks) through Endpoint (18 weeks)

Title

Change From Baseline in Beck Depression Inventory II (BDI-II), Question #9 at Week 18 (Open-label Extension Phase)

Description

Time Frame

Baseline (6 weeks), Endpoint (18 weeks)

Title

Number of Participants Who Discontinued During the Open-label Extension Phase (by Week 18)

Time Frame

Baseline (6 weeks) through Endpoint (18 weeks)

Title

Number of Participants With Treatment Emergent Adverse Events (TEAEs) During the Open-label Extension Phase

Description

Summary tables of serious adverse events (SAEs) and all other non-serious adverse events are located in the Reported Adverse Event Module.

Time Frame

Baseline (6 weeks) through Endpoint (18 weeks)

Title

Number of Participants With Adverse Events (AEs) Resulting in Discontinuation During the Open-label Extension Phase

Time Frame

Baseline (6 weeks) through Endpoint (18 weeks)

Title

Change From Baseline in Blood Pressure at Week 18 (Open-label Extension Phase)

Time Frame

Baseline (6 weeks), Endpoint (18 weeks)

Title

Change From Baseline in Pulse Rate at Week 18 (Open-label Extension Phase)

Time Frame

Baseline (6 weeks), endpoint (18 weeks)

Title

Change From Baseline in Weight at Week 18 (Open-label Extension Phase)

Time Frame

Baseline (6 weeks), Endpoint (18 weeks)

Other Pre-specified Outcome Measures:

Title

Change From Baseline in Bicarbonate (HCO3) at Week 6 (Acute Phase)

Description

Change from baseline to acute phase endpoint in laboratory assessment for bicarbonate, HCO3.

Time Frame

Baseline, 6 weeks

Title

Change From Baseline in Creatinine at Week 6 (Acute Phase)

Description

Change from baseline to acute phase endpoint in laboratory assessment of creatinine.

Time Frame

Baseline, 6 weeks

Title

Change From Baseline in the Platelet Count at Week 6 (Acute Phase)

Description

Change from baseline to acute phase endpoint in laboratory assessment of platelet count.

Time Frame

Baseline, 6 weeks

Title

Change From Baseline in Inorganic Phosphorus at Week 6 (Acute Phase)

Description

Change from baseline to acute phase endpoint in laboratory assessment of inorganic phosphorus.

Time Frame

Baseline, 6 weeks

Title

Change From Baseline in Uric Acid at Week 6 (Acute Phase)

Description

Change from baseline to acute phase endpoint in laboratory assessment of uric acid.

Time Frame

Baseline, 6 weeks

Title

Change From Baseline in Monocytes at Week 18 (Open-label Extension Phase)

Time Frame

Baseline (6 weeks), Endpoint (18 weeks)

Title

Change From Baseline in Sodium at Week 18 (Open-label Extension Phase)

Time Frame

Baseline (6 weeks), Endpoint (18 weeks)

Title

Change From Baseline in Total Protein at Week 18 (Open-label Extension Phase)

Time Frame

Baseline (6 weeks), Endpoint (18 weeks)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 Hours, EST)

Organizational Affiliation

Eli Lilly and Company

Official's Role

Study Director

Facility Information:

Facility Name

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35294

Country

United States

Facility Name

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85018

Country

United States

Facility Name

City

Tucson

State/Province

Arizona

ZIP/Postal Code

85741

Country

United States

Facility Name

City

Aurora

State/Province

Colorado

ZIP/Postal Code

80045

Country

United States

Facility Name

City

Denver

State/Province

Colorado

ZIP/Postal Code

80204

Country

United States

Facility Name

City

Bradenton

State/Province

Florida

ZIP/Postal Code

34205

Country

United States

Facility Name

City

Lenexa

State/Province

Kansas

ZIP/Postal Code

66214

Country

United States

Facility Name

City

Roseville

State/Province

Michigan

ZIP/Postal Code

48066

Country

United States

Facility Name

City

St Louis

State/Province

Missouri

ZIP/Postal Code

63141

Country

United States

Facility Name

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28207

Country

United States

Facility Name

City

Bismarck

State/Province

North Dakota

ZIP/Postal Code

58501

Country

United States

Facility Name

City

Akron

State/Province

Ohio

ZIP/Postal Code

44320

Country

United States

Facility Name

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45219

Country

United States

Facility Name

City

Oklahoma City

State/Province

Oklahoma

ZIP/Postal Code

73109

Country

United States

Facility Name

City

Portland

State/Province

Oregon

ZIP/Postal Code

97225

Country

United States

Facility Name

City

Allentown

State/Province

Pennsylvania

ZIP/Postal Code

18102

Country

United States

Facility Name

City

Melsbroek

ZIP/Postal Code

1820

Country

Belgium

Facility Name

City

Winnipeg

State/Province

Manitoba

ZIP/Postal Code

R3A 1R9

Country

Canada

Facility Name

City

Greenfield Park

State/Province

Quebec

ZIP/Postal Code

J4V 2J2

Country

Canada

Facility Name

City

Lublin

ZIP/Postal Code

20-090

Country

Poland

Facility Name

City

Szczecin

ZIP/Postal Code

70-215

Country

Poland

Facility Name

City

Wroclaw

ZIP/Postal Code

50-556

Country

Poland

12. IPD Sharing Statement

Learn more about this trial

Duloxetine for Multiple Sclerosis Pain

We'll reach out to this number within 24 hrs