Phase 3
Completed N=239
Duloxetine for Multiple Sclerosis Pain
Source: ClinicalTrials.gov NCT00755807 ↗Enrolled (actual)
239
Serious AEs
2.5%
Results posted
Dec 2011
Primary outcomePrimary: Change From Baseline in the Weekly 24-Hour Average Pain Scores at Week 6 (Acute Phase) — -1.83; -1.07 units on a scale — p=0.001
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in the Weekly 24-Hour Average Pain Scores at Week 6 (Acute Phase) |
-1.83; -1.07 | 0.001 sig |
| SECONDARY Change From Baseline in the Weekly 24-Hour Average Pain Scores up to Week 6 (Acute Phase) |
47; 32; 26; 19; 44; 29 | 0.027 sig |
| SECONDARY Patient Global Impressions of Improvement Scale (PGI-I) at 6 Weeks |
3.27; 3.48 | 0.121 |
| SECONDARY Change From Baseline in the Brief Pain Inventory Severity and Interference Scores (BPI-S/BPI-I) at Week 6 (Acute Phase) |
-1.95; -1.29; -1.20; -0.72; -1.36; -0.84 | 0.016 sig |
| SECONDARY Change From Baseline in the Clinical Global Impression of Severity Scale (CGI-S) at 6 Weeks (Acute Phase) |
-0.67; -0.44 | 0.041 sig |
| SECONDARY Change From Baseline in the Multiple Sclerosis Quality of Life-54 Instrument (MS-QOL-54) at 6 Weeks (Acute Phase) |
6.11; 5.12; 5.81; 4.59; 3.35; 2.65 | 0.500 |
| SECONDARY Number of Participants With Suicidal Behaviors, Ideations, and Acts Based on The Columbia Suicide Severity Rating Scale (C-SSRS) at Week 6 |
3; 0; 1; 0; 1; 0 | 0.119 |
| SECONDARY Change From Baseline in the Weekly Mean of Night Pain Scores at Week 6 (Acute Phase) |
-1.25; -0.74 | 0.002 sig |
| SECONDARY Change From Baseline in the Beck Depression Inventory II (BDI-II) Question #9 at Week 6 (Acute Phase) |
-0.04; -0.03 | 0.662 |
| SECONDARY Number of Participants Who Discontinued During the Acute Phase (by Week 6) |
18; 12; 16; 5; 1; 3 | 0.244 |
| SECONDARY Number of Participants With Treatment Emergent Adverse Events (TEAEs) During the Acute Phase |
70; 59; 4; 0 | — |
| SECONDARY Number of Participants With Adverse Events (AEs) Resulting in Discontinuation From Baseline During the Acute Phase |
16; 5; 3; 1; 2; 0 | — |
| SECONDARY Change From Baseline in Blood Pressure at Week 6 (Acute Phase) |
1.34; 0.48; 0.34; -0.06 | 0.322 |
| SECONDARY Change From Baseline in Pulse Rate at Week 6 (Acute Phase) |
1.76; 0.22 | 0.160 |
| SECONDARY Change From Baseline in Weight at Week 6 (Acute Phase) |
-0.69; 0.08 | 0.003 sig |
| SECONDARY Patient Global Impressions of Improvement Scale (PGI-I) Score at 18 Weeks |
2.67 | <0.001 sig |
| SECONDARY Change From Baseline in Brief Pain Inventory Severity and Interference Scores (BPI-S/BPI-I) at Week 18 |
-1.27; -0.96; -1.26; -1.03; -1.01; -1.08 | <0.001 sig |
| SECONDARY Change From Baseline in the Clinical Global Impression of Severity Scale (CGI-S) Score at Week 18 (Open-label Extension Phase) |
-0.59 | <0.001 sig |
| SECONDARY Change From Baseline in Multiple Sclerosis Quality of Life-54 Instrument (MS-QOL-54) at Week 18 (Open-label Extension Phase) |
2.70; 1.97; 3.16; 2.24; 2.93; 0.50 | 0.002 sig |
| SECONDARY Number of Participants With Suicidal Behaviors, Ideations, and Acts Based on The Columbia Suicide Severity Rating Scale (C-SSRS) at Week 18 |
1; 0; 0 | — |
| SECONDARY Change in the Weekly Mean of the Night Pain Scores From Week 6 Through Week 18 (Open-label Extension Phase) |
-0.05; -0.31; -0.54; -0.62; -0.75; -0.89 | 0.524 |
| SECONDARY Change From Baseline in Beck Depression Inventory II (BDI-II), Question #9 at Week 18 (Open-label Extension Phase) |
-0.01 | 0.706 |
| SECONDARY Number of Participants Who Discontinued During the Open-label Extension Phase (by Week 18) |
34; 14; 7; 6; 4; 2 | — |
| SECONDARY Number of Participants With Treatment Emergent Adverse Events (TEAEs) During the Open-label Extension Phase |
130; 7 | — |
| SECONDARY Number of Participants With Adverse Events (AEs) Resulting in Discontinuation During the Open-label Extension Phase |
14; 2; 2; 1; 1; 1 | — |
| SECONDARY Change From Baseline in Blood Pressure at Week 18 (Open-label Extension Phase) |
-0.58; -1.22 | 0.320 |
| SECONDARY Change From Baseline in Pulse Rate at Week 18 (Open-label Extension Phase) |
1.47 | 0.032 sig |
| SECONDARY Change From Baseline in Weight at Week 18 (Open-label Extension Phase) |
-0.30 | 0.151 |
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
Data sourced from ClinicalTrials.gov (NCT00755807). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.