At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Duloxetine in Patients With Central Neuropathic Pain Due to Multiple Sclerosis.
In Brief
A Phase 3 clinical trial evaluating Duloxetine Hydrochloride (HCI) and Placebo for Multiple Sclerosis. Completed, enrolled 239 participants across 22 sites in 4 countries.
Detailed 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.
Study Details
Timeline
Interventions
Participants received 30 mg duloxetine (po, QD) for 1 week followed by 5 weeks at 60 mg in the acute placebo-controlled period. If the participant completes the double-blind portion of the trial, the participant will be offered the option to participate in the open-label extension period (given 60, 90, or 120 mg QD for 12 weeks).
Participants received placebo oral (po), once daily (QD) for 6 weeks (acute phase). If the participant completes the 6-week double-blind portion of the trial, the participant will be offered the option to participate in the open-label extension period (given 60, 90, or 120 milligrams \[mg\] QD for 12 weeks).