At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 402 enrolled
Drug / intervention
Nortriptyline +3 moredrug
Likely dose
Not stated in 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.
Patient Assisted Intervention for Neuropathy: Comparison of Treatment in Real Life Situations (PAIN-CONTRoLS)
In Brief
A Phase 4 clinical trial evaluating Nortriptyline, Duloxetine, and 2 other interventions for Cryptogenic Sensory Polyneuropathy. Completed, enrolled 402 participants across 46 sites in 2 countries.
Detailed Summary
The purpose of this large comparative effectiveness study led by Richard J. Barohn, MD, of the University of Kansas Medical Center, is to learn about the safety and effectiveness of nortriptyline, duloxetine, pregabalin and mexiletine in treating cryptogenic sensory polyneuropathy (CSPN).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCryptogenic Sensory Polyneuropathy
CountriesCanada, United States
CollaboratorsPatient-Centered Outcomes Research Institute
Timeline
Phase 4CompletedFinished
201520162017201820192020202120222023202420252026
Enrollment StartOct 2014
First PostedOct 2014
Primary CompletionSep 2017
TodayJul 2026
First PostedOct 9, 2014
Enrollment StartOct 1, 2014
Primary CompletionSep 1, 2017
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 11.7 years ago
Interventions
Nortriptylinedrug
Duloxetinedrug
Pregabalindrug
Mexiletinedrug