Ignite Creation Date:
2024-05-05 @ 11:31 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00068445
Status:
COMPLETED
Last Update Posted:
2018-05-04
First Post:
2003-09-10
Brief Title:
Lamotrigine in Treating Peripheral Neuropathy Caused by Chemotherapy in Patients With Cancer
Sponsor:
Alliance for Clinical Trials in Oncology
Organization:
Alliance for Clinical Trials in Oncology
Study Overview
Official Title:
The Efficacy of Lamotrigine in the Management of Chemotherapy-Induced Peripheral Neuropathy A Phase III Randomized Double Blind Placebo-Controlled Trial
Status:
COMPLETED
Status Verified Date:
2018-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Detailed Description:
OBJECTIVES
Compare the efficacy of lamotrigine vs placebo in reducing pain and symptoms of chemotherapy-induced peripheral neuropathy in patients with cancer
Compare symptom distress mood states functional abilities and overall quality of life of patients treated with these agents
Determine the toxic effects of lamotrigine in these patients
OUTLINE This is a randomized placebo-controlled double-blind study Patients are stratified according to neurotoxic chemotherapy received taxanes vs platinum-based compounds vs vinca alkaloids vs combination vs other status of neurotoxic chemotherapy actively receiving therapy vs discontinued or completed and duration of pain or neuropathy symptoms 1-3 months vs 3-6 months vs more than 6 months Patients are randomized to 1 of 2 treatment arms
Compare the efficacy of lamotrigine vs placebo in reducing pain and symptoms of chemotherapy-induced peripheral neuropathy in patients with cancer
Compare symptom distress mood states functional abilities and overall quality of life of patients treated with these agents
Determine the toxic effects of lamotrigine in these patients
OUTLINE This is a randomized placebo-controlled double-blind study Patients are stratified according to neurotoxic chemotherapy received taxanes vs platinum-based compounds vs vinca alkaloids vs combination vs other status of neurotoxic chemotherapy actively receiving therapy vs discontinued or completed and duration of pain or neuropathy symptoms 1-3 months vs 3-6 months vs more than 6 months Patients are randomized to 1 of 2 treatment arms
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000322830 | REGISTRY | PDQ Physician Data Query | None |