Clinical trial NCT00755807: Duloxetine for Multiple Sclerosis Pain
Official title: Duloxetine in Patients With Central Neuropathic Pain Due to Multiple Sclerosis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Multiple Sclerosis
Keywords: Central Neuropathic Pain
Multiple Sclerosis
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2008-09-19
Enrollment: 239
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change From Baseline in the Weekly 24-Hour Average Pain Scores at Week 6 (Acute Phase)
timeFrame: Baseline, 6 weeks
Secondary outcomes:
measure: Change From Baseline in the Weekly 24-Hour Average Pain Scores up to Week 6 (Acute Phase)
timeFrame: Baseline, 6 weeks
measure: Patient Global Impressions of Improvement Scale (PGI-I) at 6 Weeks
timeFrame: 6 weeks
measure: Change From Baseline in the Brief Pain Inventory Severity and Interference Scores (BPI-S/BPI-I) at Week 6 (Acute Phase)
timeFrame: Baseline, 6 weeks
measure: Change From Baseline in the Clinical Global Impression of Severity Scale (CGI-S) at 6 Weeks (Acute Phase)
timeFrame: Baseline, 6 weeks
measure: Change From Baseline in the Multiple Sclerosis Quality of Life-54 Instrument (MS-QOL-54) at 6 Weeks (Acute Phase)
timeFrame: Baseline, 6 weeks
measure: Number of Participants With Suicidal Behaviors, Ideations, and Acts Based on The Columbia Suicide Severity Rating Scale (C-SSRS) at Week 6
timeFrame: 6 weeks
measure: Change From Baseline in the Weekly Mean of Night Pain Scores at Week 6 (Acute Phase)
timeFrame: Baseline, 6 weeks
measure: Change From Baseline in the Beck Depression Inventory II (BDI-II) Question #9 at Week 6 (Acute Phase)
timeFrame: Baseline, 6 weeks
measure: Number of Participants Who Discontinued During the Acute Phase (by Week 6)
timeFrame: Baseline through 6 weeks
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs) During the Acute Phase
timeFrame: Baseline through 6 weeks
measure: Number of Participants With Adverse Events (AEs) Resulting in Discontinuation From Baseline During the Acute Phase
timeFrame: Baseline through 6 weeks
measure: Change From Baseline in Blood Pressure at Week 6 (Acute Phase)
timeFrame: Baseline, 6 weeks
measure: Change From Baseline in Pulse Rate at Week 6 (Acute Phase)
timeFrame: Baseline, 6 weeks
measure: Change From Baseline in Weight at Week 6 (Acute Phase)
timeFrame: Baseline, 6 weeks
measure: Patient Global Impressions of Improvement Scale (PGI-I) Score at 18 Weeks
timeFrame: 18 weeks
measure: Change From Baseline in Brief Pain Inventory Severity and Interference Scores (BPI-S/BPI-I) at Week 18
timeFrame: Baseline (end of acute phase/Week 6), Endpoint (Week 18)
measure: Change From Baseline in the Clinical Global Impression of Severity Scale (CGI-S) Score at Week 18 (Open-label Extension Phase)
timeFrame: Baseline (6 weeks), Endpoint (18 weeks)
measure: Change From Baseline in Multiple Sclerosis Quality of Life-54 Instrument (MS-QOL-54) at Week 18 (Open-label Extension Phase)
timeFrame: Baseline (6 weeks), Endpoint (18 weeks)
measure: Number of Participants With Suicidal Behaviors, Ideations, and Acts Based on The Columbia Suicide Severity Rating Scale (C-SSRS) at Week 18
timeFrame: 18 weeks
measure: Change in the Weekly Mean of the Night Pain Scores From Week 6 Through Week 18 (Open-label Extension Phase)
timeFrame: Baseline (6 weeks) through Endpoint (18 weeks)
measure: Change From Baseline in Beck Depression Inventory II (BDI-II), Question #9 at Week 18 (Open-label Extension Phase)
timeFrame: Baseline (6 weeks), Endpoint (18 weeks)
measure: Number of Participants Who Discontinued During the Open-label Extension Phase (by Week 18)
timeFrame: Baseline (6 weeks) through Endpoint (18 weeks)
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs) During the Open-label Extension Phase
timeFrame: Baseline (6 weeks) through Endpoint (18 weeks)
measure: Number of Participants With Adverse Events (AEs) Resulting in Discontinuation During the Open-label Extension Phase
timeFrame: Baseline (6 weeks) through Endpoint (18 weeks)
measure: Change From Baseline in Blood Pressure at Week 18 (Open-label Extension Phase)
timeFrame: Baseline (6 weeks), Endpoint (18 weeks)
measure: Change From Baseline in Pulse Rate at Week 18 (Open-label Extension Phase)
timeFrame: Baseline (6 weeks), endpoint (18 weeks)
measure: Change From Baseline in Weight at Week 18 (Open-label Extension Phase)
timeFrame: Baseline (6 weeks), Endpoint (18 weeks)
Other outcomes:
measure: Change From Baseline in Bicarbonate (HCO3) at Week 6 (Acute Phase)
timeFrame: Baseline, 6 weeks
measure: Change From Baseline in Creatinine at Week 6 (Acute Phase)
timeFrame: Baseline, 6 weeks
measure: Change From Baseline in the Platelet Count at Week 6 (Acute Phase)
timeFrame: Baseline, 6 weeks
measure: Change From Baseline in Inorganic Phosphorus at Week 6 (Acute Phase)
timeFrame: Baseline, 6 weeks
measure: Change From Baseline in Uric Acid at Week 6 (Acute Phase)
timeFrame: Baseline, 6 weeks
measure: Change From Baseline in Monocytes at Week 18 (Open-label Extension Phase)
timeFrame: Baseline (6 weeks), Endpoint (18 weeks)
measure: Change From Baseline in Sodium at Week 18 (Open-label Extension Phase)
timeFrame: Baseline (6 weeks), Endpoint (18 weeks)
measure: Change From Baseline in Total Protein at Week 18 (Open-label Extension Phase)
timeFrame: Baseline (6 weeks), Endpoint (18 weeks)
Locations:
city: Birmingham
country: United States
facility: 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.
state: Alabama
city: Phoenix
country: United States
facility: 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.
state: Arizona
city: Tucson
country: United States
facility: 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.
state: Arizona
city: Aurora
country: United States
facility: 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.
state: Colorado
city: Denver
country: United States
facility: 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.
state: Colorado
city: Bradenton
country: United States
facility: 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.
state: Florida
city: Lenexa
country: United States
facility: 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.
state: Kansas
city: Roseville
country: United States
facility: 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.
state: Michigan
city: St Louis
country: United States
facility: 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.
state: Missouri
city: Charlotte
country: United States
facility: 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.
state: North Carolina
city: Bismarck
country: United States
facility: 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.
state: North Dakota
city: Akron
country: United States
facility: 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.
state: Ohio
city: Cincinnati
country: United States
facility: 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.
state: Ohio
city: Oklahoma City
country: United States
facility: 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.
state: Oklahoma
city: Portland
country: United States
facility: 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.
state: Oregon
city: Allentown
country: United States
facility: 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.
state: Pennsylvania
city: Melsbroek
country: Belgium
facility: 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: Winnipeg
country: Canada
facility: 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.
state: Manitoba
city: Greenfield Park
country: Canada
facility: 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.
state: Quebec
city: Lublin
country: Poland
facility: 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: Szczecin
country: Poland
facility: 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: Wroclaw
country: Poland
facility: 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.
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References: