CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 131 enrolled
Drug / intervention
lamotrigine +1 moredrug
Likely dose
Not stated in record
Key inclusion· 7
  • ✓Diagnosis of cancer
  • ✓Received or currently receiving neurotoxic chemotherapy (taxanes, platinum compounds, or vinca alkaloids)
  • ✓Experiencing pain or symptoms of peripheral neuropathy for at least 1 month attributed to chemotherapy
  • ✓Average daily pain rating of at least 4 out of 10 OR peripheral neuropathy at least grade 1 out of 3 using ECOG sensory neuropathy rating
Key exclusion· 4
  • ✕Prior allergic reaction or intolerance to lamotrigine
  • ✕Extreme difficulty swallowing pills
  • ✕Other identified causes of painful paresthesia preceding chemotherapy, including radiation or malignant plexopathy, lumbar or cervical radiculopathy, or pre-existing peripheral neuropathy of another etiology
  • ✕Significant psychiatric illness (mania, psychosis, schizophrenia) that would preclude study participation

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

Search/NCT00068445
NCT00068445Phase 3Completed
CompareCT.gov

The Efficacy of Lamotrigine in the Management of Chemotherapy-Induced Peripheral Neuropathy: A Phase III Randomized, Double Blind, Placebo-Controlled Trial

Alliance for Clinical Trials in Oncology·interventional·Posted Sep 11, 2003·Updated May 4, 2018

In Brief

A Phase 3 clinical trial evaluating lamotrigine and Placebo for Neurotoxicity and 2 related conditions. Completed, enrolled 131 participants across 23 sites.

Detailed Summary

RATIONALE: Lamotrigine may be effective in reducing pain, numbness, tingling, and other symptoms of peripheral neuropathy. It is not yet known whether lamotrigine is effective in treating peripheral neuropathy caused by chemotherapy. PURPOSE: This randomized phase III trial is studying how well lamotrigine works in reducing pain, numbness, tingling, and other symptoms of peripheral neuropathy caused by chemotherapy in patients with cancer.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNeurotoxicity, Pain, Unspecified Adult Solid Tumor, Protocol Specific
CountriesUnited States
CollaboratorsNational Cancer Institute (NCI)

Timeline

Phase 3CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 11, 2003
Enrollment StartFeb 1, 2004
Primary CompletionMay 1, 2006
Study CompletionNov 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 22.8 years ago

Interventions

lamotriginedrug

Placeboother