Clinical trial · Interventional
Lamotrigine in Treating Peripheral Neuropathy Caused by Chemotherapy in Patients With Cancer
The Efficacy of Lamotrigine in the Management of Chemotherapy-Induced Peripheral Neuropathy: A Phase III Randomized, Double Blind, Placebo-Controlled Trial
NCT00068445CI-TRIAL-00032775completedPhase 3Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neurotoxicity | — | UNRESOLVED | — |
| Pain | — | UNRESOLVED | — |
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| lamotrigine | Drug | — | UNRESOLVED |
| Placebo | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm I - lamotrigine
- description
- 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.
- interventionNames
- Drug: lamotrigine
- type
- OTHER
- label
- Arm II - placebo
- description
- 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.
- interventionNames
- Other: Placebo
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS:
* Diagnosis of cancer
* Received, or are currently receiving, neurotoxic chemotherapy, including any of the following:
* Taxanes (e.g., paclitaxel or docetaxel)
* Platinum-based compounds (e.g., carboplatin, cisplatin, or oxaliplatin)
* Vinca alkaloids (e.g., vincristine or vinblastine)
* 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
PATIENT CHARACTERISTICS:
Age
* 18 and over
Life expectancy
* At least 6 months
Hepatic
* Bilirubin \< 2 times upper limit of normal (ULN)
Renal
* Creatinine ≤ 1.5 times ULN
Other
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No prior allergic reaction or intolerance to lamotrigine
* No extreme difficulty swallowing pills
* No other identified causes of painful paresthesia preceding chemotherapy, including any of the following:
* Radiation or malignant plexopathy
* Lumbar or cervical radiculopathy
* Pre-existing peripheral neuropathy of another etiology, such as any of the following:
* Cyanocobalamin deficiency
* AIDS
* Monoclonal gammopathy
* Diabetes
* Heavy metal poisoning amyloidosis
* Syphilis
* Hyperthyroidism or hypothyroidism
* Inherited neuropathy
* No significant psychiatric illness (e.g., mania, psychosis, or schizophrenia) that would preclude study participation
* Able to complete questionnaires
PRIOR CONCURRENT THERAPY:
Chemotherapy
* See Disease Characteristics
* More than 7 days since prior methotrexate or other dihydrofolate inhibitors
Other
* More than 7 days since prior, and no concurrent use of any of the following:
* Tricyclic antidepressants (e.g., amitriptyline, nortriptyline, or desipramine)
* Concurrent selective serotonin reuptake inhibitors allowed
* Monoamine oxidase inhibitors
* Opioid analgesics
* Anticonvulsants (e.g., gabapentin, topiramate, valproic acid, or clonazepam)
* Adjuvant analgesics (e.g., mexiletine)
* Prior nonsteroidal anti-inflammatory drugs allowed
* Topical analgesics (e.g., lidocaine gel or patch) to the affected area
* Amifostine
* More than 30 days since prior investigational agents for pain control
* No other concurrent investigational agents for pain controlReferences
Publications (1)
- RESULTRao RD, Flynn PJ, Sloan JA, Wong GY, Novotny P, Johnson DB, Gross HM, Renno SI, Nashawaty M, Loprinzi CL. Efficacy of lamotrigine in the management of chemotherapy-induced peripheral neuropathy: a phase 3 randomized, double-blind, placebo-controlled trial, N01C3. Cancer. 2008 Jun 15;112(12):2802-8. doi: 10.1002/cncr.23482. PMID 18428211