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Duloxetine for Multiple Sclerosis Pain

Duloxetine in Patients With Central Neuropathic Pain Due to Multiple Sclerosis.
CompletedPhase 3MS (type not specified)NCT00755807

What it found

Met its main goal

The main measure showed a statistically significant benefit.

MeasureEstimate95% CIp
Change From Baseline in the Weekly 24-Hour Average Pain Scores at Week 6 (Acute Phase) 0.001

Statistical analysis as posted on ClinicalTrials.gov.

What was tested

Treatment tested

  • Duloxetine

Placebo or sham

  • Placebo

Results by group

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

Baseline, 6 weeks

GroupValueIntervalNumber analysed
Duloxetine-1.83 units on a scale0.17 (Standard Error)103
Placebo-1.07 units on a scale0.16 (Standard Error)115

Duloxetine

-1.83

Placebo

-1.07

p = 0.001

Values as posted on ClinicalTrials.gov. Outcomes measured differently across trials are not directly comparable.

Safety

GroupParticipants at riskSerious adverse eventsDeaths
Duloxetine - Double-Blind Acute Phase1184 (3.4%)
Placebo - Double-Blind Acute Phase1210 (0.0%)
Duloxetine - Open-label Extension Phase2097 (3.3%)

As posted on ClinicalTrials.gov. Serious adverse events include any serious health event during the trial, whether or not the treatment caused it.

What it measured

Main measures

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

    Baseline, 6 weeks

    Pain

Other measures (27)

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

    Baseline, 6 weeks

    Pain

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

    6 weeks

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

    Baseline, 6 weeks

    PainMood and sleep

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

    Baseline, 6 weeks

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

    Baseline, 6 weeks

    Thinking and memoryQuality of life (reported by participants)

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

    6 weeks

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

    Baseline, 6 weeks

    Pain

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

    Baseline, 6 weeks

    Mood and sleep

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

    Baseline through 6 weeks

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

    Baseline through 6 weeks

    Safety

Who could take part

MS (type not specified) · 18 and over

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

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

Papers

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    History

      1. Started

        Oct 2008

      2. Main results due

        Aug 2010

      3. Finished

        Nov 2010

      4. Results posted

        Dec 2011

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