CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 40 enrolled
Drug / intervention
Milnacipran +1 moredrug
Likely dose
Milnacipran 100 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01225068
NCT01225068Phase 2Completed
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An Exploratory Randomized Placebo Controlled Trial of Milnacipran in Patients With Chronic Neuropathic Low Back Pain

Northwestern University·interventional·Posted Oct 20, 2010·Updated Jan 17, 2014

In Brief

A Phase 2 clinical trial evaluating Milnacipran and Placebo for Low Back Pain. Completed, enrolled 40 participants across 1 site.

Detailed Summary

Low back pain is a public health problem affecting between 70-85% of adults at some time in their life. This study is being done to study the safety and effectiveness of the drug Milnacipran in treating chronic low back pain.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLow Back Pain
CountriesUnited States
CollaboratorsForest Laboratories, Shirley Ryan AbilityLab, Best Practice

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedOct 20, 2010
Enrollment StartOct 1, 2010
Primary CompletionJan 1, 2012
Study CompletionApr 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 15.7 years ago

Interventions

Milnaciprandrug

Total of 100 mg (50 mg twice a day) for 6 weeks. Option to increase to 200 mg (100 mg twice a day) after two weeks of treatment. Includes gradual escalation and discontinuation for week 1 and after week 6.

Placebodrug

2 matching pills per day for 6 weeks. Option to increase dose after two weeks of treatment. Includes gradual escalation and discontinuation for week 1 and after week 6.