Duloxetine for Multiple Sclerosis Pain - Full Text View

Sponsor:	Eli Lilly and Company
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00755807

Purpose

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 patients with central neuropathic pain due to Multiple Sclerosis.

Condition	Intervention	Phase
Multiple Sclerosis	Drug: Duloxetine HCI Drug: Placebo	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Duloxetine in Patients With Central Neuropathic Pain Due to Multiple Sclerosis.

Resource links provided by NLM:

MedlinePlus related topics: Multiple Sclerosis

Drug Information available for: Duloxetine Duloxetine hydrochloride

U.S. FDA Resources

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

11-point Likert scale, reduction in pain severity, weekly mean of the 24-hour average pain scores [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

30% and 50% response rates, weekly 24 hour average pain scores [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Patient Global Impression of Improvement (PGI-Improvement) [ Time Frame: 6 and 18 weeks ] [ Designated as safety issue: No ]
Brief Pain Inventory (BPI) [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
Clinical Global Impression of Severity (CGI-Severity) [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
Multiple Sclerosis Quality of Life-54 Instrument (MS-QOL-54) [ Time Frame: 6 and 18 weeks ] [ Designated as safety issue: No ]
Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: 6 and 18 weeks ] [ Designated as safety issue: Yes ]
11-point Likert scale, weekly mean of night pain scores [ Time Frame: 18 week ] [ Designated as safety issue: No ]
Discontinuation rates [ Time Frame: 6 and 18 weeks ] [ Designated as safety issue: Yes ]
Treatment emergent adverse events (TEAEs) [ Time Frame: 18 weeks ] [ Designated as safety issue: Yes ]
Adverse events resulting in discontinuation [ Time Frame: 18 weeks ] [ Designated as safety issue: Yes ]
Beck Depression Inventory II question #9 [ Time Frame: 18 weeks ] [ Designated as safety issue: Yes ]
Laboratory assessments [ Time Frame: 18 weeks ] [ Designated as safety issue: Yes ]
Vital Signs [ Time Frame: 18 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	238
Study Start Date:	October 2008
Estimated Study Completion Date:	February 2010
Estimated Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Placebo Comparator	Drug: Placebo Oral, QD for 6-weeks. If patient completes 6-week double-blind portion of trial, patient will be offered the option to participate in the open label period (given 60, 90, or 120 mg QD of duloxetine for 12-weeks).
2: Experimental	Drug: Duloxetine HCI 60 mg oral, QD for 6-weeks followed by 60, 90, or 120 mg QD for 12-weeks.

Detailed Description:

Study is a multicenter, randomized, double-blind, parallel, placebo-controlled, 20-week trial with 4 study periods. Patients 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, patients will be treated in a double-blind manner for 6 weeks. Patients 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. Patients may enter Study Period IV at any time after Visit 3.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Have central neuropathic pain due to 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
Patients 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00755807

Contacts

Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559)

1-317-615-4559

Show 34 Study Locations

Sponsors and Collaborators

Eli Lilly and Company

Investigators

Study Director:

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)

Eli Lilly and Company

More Information

Additional Information:

Lilly Clinical Trial Registry This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Eli Lilly ( Chief Medical Officer )
Study ID Numbers:	11666, F1J-US-HMFR
Study First Received:	September 17, 2008
Last Updated:	November 16, 2009
ClinicalTrials.gov Identifier:	NCT00755807 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Eli Lilly and Company:

Central Neuropathic Pain
Multiple Sclerosis

Additional relevant MeSH terms:

Dopamine Uptake Inhibitors
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Physiological Effects of Drugs
Psychotropic Drugs
Duloxetine
Pathologic Processes
Multiple Sclerosis
Therapeutic Uses
Autoimmune Diseases of the Nervous System

Antidepressive Agents
Autoimmune Diseases
Immune System Diseases
Demyelinating Diseases
Nervous System Diseases
Sclerosis
Serotonin Uptake Inhibitors
Pharmacologic Actions
Serotonin Agents
Demyelinating Autoimmune Diseases, CNS
Dopamine Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 20, 2009