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Anti-epileptic drug

Arm I - lamotrigine for Pain

Phase 3
Waitlist Available
Research Sponsored by Alliance for Clinical Trials in Oncology
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline to week 10
Awards & highlights

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.

Eligible Conditions
  • Pain
  • Solid Tumors
  • Neurotoxicity

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline to week 10
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to week 10 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Average Daily Pain Score as Measured Using a Pain Intensity Rating (NRS)
Change in Average Pain Score as Measured Using the European Cooperative Oncology Group (ECOG) Neuropathy Scale (ENS)
Secondary outcome measures
Change in Brief Pain Inventory (BPI) Average Pain Score [Week 10 Minus Baseline]
Change in Brief Pain Inventory (BPI) Least Pain Score [Week 10 Minus Baseline]
Change in Brief Pain Inventory (BPI) Pain Interference Score [Week 10 Minus Baseline]
+5 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Arm II - placeboExperimental Treatment1 Intervention
Patients receive oral placebo once daily for 2 weeks and then twice daily for 8 weeks. Treatment continues for 10 weeks in the absence of unacceptable toxicity. Quality of life, pain, mood states, and symptom distress are assessed at baseline and at 4, 6, 8, and 10 weeks. Patients are followed at 3-7 days.
Group II: Arm I - lamotrigineExperimental Treatment1 Intervention
Patients receive oral lamotrigine once daily for 2 weeks and then twice daily for 8 weeks. Treatment continues for 10 weeks in the absence of unacceptable toxicity. Quality of life, pain, mood states, and symptom distress are assessed at baseline and at 4, 6, 8, and 10 weeks. Patients are followed at 3-7 days.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lamotrigine
FDA approved

Find a Location

Who is running the clinical trial?

Alliance for Clinical Trials in OncologyLead Sponsor
512 Previous Clinical Trials
217,495 Total Patients Enrolled
10 Trials studying Pain
3,050 Patients Enrolled for Pain
National Cancer Institute (NCI)NIH
13,748 Previous Clinical Trials
40,959,270 Total Patients Enrolled
98 Trials studying Pain
17,598 Patients Enrolled for Pain
Ravi D. Rao, MD, MBBSStudy ChairMayo Clinic
3 Previous Clinical Trials
102 Total Patients Enrolled
~6 spots leftby Sep 2025
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