CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 9 enrolled
Drug / intervention
Alpha lipoic aciddrug
Likely dose
Alpha lipoic acid 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/NCT01313117
NCT01313117Phase 2Completed
CompareCT.gov

Dose Finding and Tolerability Study of Alpha-lipoic Acid in Patients at Risk for Paclitaxel Induced Peripheral Neuropathy

Northwestern University·interventional·Posted Mar 11, 2011·Updated Oct 2, 2014

In Brief

A Phase 2 clinical trial evaluating Alpha lipoic acid for Peripheral Neuropathy. Completed, enrolled 9 participants across 1 site.

Detailed Summary

This study is being done because peripheral neuropathy, a condition that interrupts sensation in your limbs, is a common side effect of paclitaxel. There is some evidence that alpha lipoic acid (ALA), an antioxidant compound, protects neurons after exposure to paclitaxel. The purpose of this study is to assess the safety and tolerability of ALA and to find the best dose of ALA in patients that receive chemotherapy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPeripheral Neuropathy
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedMar 11, 2011
Enrollment StartFeb 1, 2012
Primary CompletionAug 1, 2013
Study CompletionJan 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 15.3 years ago

Interventions

Alpha lipoic aciddrug

The baseline dose is 100 mg three times daily for four months. Dose escalation will occur until a maximum tolerated dose is found.