Phase 3
Completed N=131
Lamotrigine in Treating Peripheral Neuropathy Caused by Chemotherapy in Patients With Cancer
Neurotoxicity · Postoperative Pain · Unspecified Adult Solid Tumor, Protocol Specific
Source: ClinicalTrials.gov NCT00068445 ↗
Enrolled (actual)
131
Serious AEs
0.0%
Results posted
May 2018
Primary outcomePrimary: Change in Average Daily Pain Score as Measured Using a Pain Intensity Rating (NRS) — -0.3; -0.5 units on a scale — p=0.56
◆ Published Evidence
Highly cited
194citations · ~11 / year
Efficacy of lamotrigine in the management of chemotherapy-induced peripheral neuropathy: a phase 3 randomized, double-blind, placebo-controlled trial, N01C3.
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.
Linked Publications
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Efficacy of lamotrigine in the management of chemotherapy-induced peripheral neuropathy: a phase 3 randomized, double-blind, placebo-controlled trial, N01C3.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Average Daily Pain Score as Measured Using a Pain Intensity Rating (NRS) |
-0.3; -0.5 | 0.56 |
| PRIMARY Change in Average Pain Score as Measured Using the European Cooperative Oncology Group (ECOG) Neuropathy Scale (ENS) |
-0.4; -0.3 | 0.36 |
| SECONDARY The Change in Overall Quality of Life as Measured by the Uniscale QOL From Baseline to Week 10 |
-4.3; 0.3 | 0.25 |
| SECONDARY Change in Brief Pain Inventory (BPI) Worst Pain Score [Week 10 Minus Baseline] |
0.1; -0.6 | 0.34 |
| SECONDARY Change in Brief Pain Inventory (BPI) Least Pain Score [Week 10 Minus Baseline] |
0.2; 0.1 | 0.53 |
| SECONDARY Change in Brief Pain Inventory (BPI) Average Pain Score [Week 10 Minus Baseline] |
-0.1; -0.8 | 0.22 |
| SECONDARY Change in Brief Pain Inventory (BPI) Pain Now Score [Week 10 Minus Baseline] |
-0.1; -0.3 | 0.33 |
| SECONDARY Change in Brief Pain Inventory (BPI) Pain Relief Score [Week 10 Minus Baseline] |
6.7; 0.4 | 0.07 |
| SECONDARY Change in Brief Pain Inventory (BPI) Pain Interference Score [Week 10 Minus Baseline] |
-0.5; -0.8 | 0.91 |
| SECONDARY Change in POMS Total Score [Week 10 Minus Baseline] |
1.4; 1.3 | 0.68 |
Eligibility Criteria
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 control
Data sourced from ClinicalTrials.gov (NCT00068445) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.