Central neuropathic pain due to Multiple sclerosis MedDRA version: 9.1 Level: LLT Classification code 10054095 Term: Neuropathic pain
Conditions
Sponsors
Eli Lilly and Company
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: [1] Present with central neuropathic pain due to MS based on the disease diagnostic criteria [2] Are male or female outpatients at least 18 years of age at the time of consent [3] Have a score of 4 or greater on the daily 24-hour average pain score (0- 10) for at least 4 of the 7 days prior to Visit 2 [4] Females must test negative for pregnancy at Visit 1. Females of childbearing potential must agree to utilize medically acceptable and reliable means of birth control as determined by the investigator during the study and for 1 month following the last dose of the study drug [5] Have an educational level and degree of understanding such that the patient can communicate intelligibly [6] Are judged to be reliable and agree to keep all appointments for clinic visits, tests, and procedures required by the protocol [7] Complete the daily diaries for at least 70% of the days between Visit 1 and Visit 2 [8] Patients may continue other prescription and non-prescription analgesic medications as long as the dose has been stable for 1 month prior to Visit 1, and they agree to maintain that stable dose throughout the study. Patients will NOT be allowed to change doses of concomitant analgesics during the study [9] Diagnosis of MS at least 1 year prior to Visit 1 as determined by MacDonald or Poser criteria. [10] Clinical stability as determined by an absence of MS exacerbation or change in disease modifying therapy for the 3 months prior to Visit 1. [11] Daily central neuropathic pain due to MS present for a minimum of 3 months prior to Visit 1 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: [12] Are investigator site personnel directly affiliated with this study and/or their immediate families [13] Are Lilly employees [14] Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of study entry [15] Are currently in a clinical trial of MS disease-modifying therapy [16] Have pain that cannot be clearly differentiated from causes other than MS [17] Have previously completed this study, withdrawn from any duloxetine study, or have been intolerant to previous duloxetine treatment. Note: Patients who have screen-failed for the reason of previous exposure to duloxetine may be reconsidered for this study. [18] Have previously demonstrated lack of response to an adequate trial of duloxetine per investigator opinion. [19] Are unwilling to comply with the use of a data collection device to directly record data from the patient. For those patients who do not have enough fine motor control to enter data directly into the device, a designated assistant may be used for data entry. The assistant must be the same person for all data entries. The designated assistant may not be site personnel or personnel affiliated with the study. [20] Any current or historical DSM-IV diagnosis of mania, bipolar disorder, psychosis, or schizoaffective disorder [21] History of DSM-IV-TR substance abuse or dependence within the 6 months immediately prior to Visit 1, excluding nicotine and caffeine. For purposes of this study, prior or current use (at Visit 1) of dronabinol (Saltivex) for MS or MS pain will not be considered to meet the DSm-IV criteria for substance abuse. However, use of this medication may be subject to other restrictions (see concomitant medication list for excluded medications). [22] Are taking any excluded medications that cannot be discontinued at Visit 1 (see concomitant medication list for excluded medications). [23] Have had treatment with a MAOI within 14 days of randomization or the potential need to use an MAOI during the study or within 5 days of discontinuation of study drug [24] Have a positive urine drug screen for any substance of abuse or excluded medication [25] Are pregnant or breast-feeding [26] Have serious cardiovascular, hepatic, renal, respiratory, or hematologic illness, or other medical or psychiatric condition that, in the opinion of the investigator, would compromise participation or be likely to lead to hospitalization during the course of the study. [27] Have elective surgery planned during the trial. [28] Have a history of recurrent seizures other than febrile seizures. [29] Are judged clinically by the investigator or are identified by the C-SSRS or BDI-II question 9 to be at suicidal risk prior to starting study drug. Patients will need to be evaluated by the investigator and/or a psychiatrist if they exhibit suicidality as assessed by the C-SSRS or BDI-II question 9 at any time after randomization. [30] Have uncontrolled narrow-angle glaucoma. [31] Have acute liver injury or severe cirrhosis [32] Have known hypersensitivity to duloxetine or any of the inactive ingredients [33] Have frequent or severe allergic reactions to multiple medications [34] Current DSM-IV-TR Axis I alcohol or eating disorders or PTSD as determined either by patient history or by diagnosis using specific modules of the MINI
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: to assess the efficacy of duloxetine 60 mg once daily (QD) compared with placebo on the reduction of central neuropathic pain severity as measured by the weekly mean of the daily 24-hour average pain scores in patients with central neuropathic pain due to MS assessed using an 11-point Likert scale and collected via daily patient diary at the end of 6 weeks of treatment.;Secondary Objective: • To evaluate response to treatment with duloxetine versus placebo using 2 response criteria, a 30% or 50% reduction, in the weekly 24-hour average pain scores described in the primary objective • To assess the efficacy of duloxetine versus placebo as measured by:PGI-Improvement scale,the weekly mean of the 24-hour worst, least, and night pain scores assessed using an 11-point Likert scale and collected via daily patient diary,BPI– Severity and Interference,CGI-Severity • To assess the impact of treatment with duloxetine versus placebo on patient-reported health outcomes, as measured by the MS-QOL-54 • To assess the safety of duloxetine versus placebo treatment-emergent adverse events, discontinuation adverse events, solicited questioning of suicide-related events, and suicide risk as assessed the C-SSRS, laboratory assessments, and vital signs.;Primary end point(s): The primary efficacy measure is the weekly mean of the 24-hour average pain severity assessed daily by each patient, via daily diary, using an 11-point Likert scale. | — |
Countries
Belgium
Outcome results
None listed