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CompletedNCT00068445Updated May 4, 2018Results posted

Lamotrigine in Treating Peripheral Neuropathy Caused by Chemotherapy in Patients With Cancer

A Phase 3 interventional study of lamotrigine and Placebo in Neurotoxicity, Pain and Unspecified Adult Solid Tumor, Protocol Specific, sponsored by Alliance for Clinical Trials in Oncology. Completed at 23 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-05-04.

Sponsored by Alliance for Clinical Trials in Oncology · Phase 3, Interventional, and Supportive care

Phase
Phase 3
Study type
Interventional
Enrollment
131
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Neurotoxicity
  • Pain
  • Unspecified Adult Solid Tumor, Protocol Specific

Keywords

  • neurotoxicity
  • pain
  • unspecified adult solid tumor, protocol specific
03

In context

Peripheral Nervous System Diseases

1,003 studies on the registry are indexed under Peripheral Nervous System Diseases; 177 are open to participants now.

This study's enrollment of 131 is above the median of 60 across 768 interventional studies indexed under Peripheral Nervous System Diseases.

Browse Peripheral Nervous System Diseases studies →

Lead sponsor

Alliance for Clinical Trials in Oncology is the lead sponsor of 499 studies on the registry; 27 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 6 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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
05

Study design

Phase
Phase 3
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
131 participants (actual)

Study arms

  • Experimental
    Arm I - lamotrigine

    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.

    Drug: lamotrigine

  • Other
    Arm II - placebo

    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.

    Other: Placebo

Interventions

  • Druglamotrigine
  • OtherPlacebo
06

What researchers measure

Primary outcomes

  1. Change in Average Daily Pain Score as Measured Using a Pain Intensity Rating (NRS)

    The change in mean score for average daily pain from baseline to week 10 using the Pain Intensity Rating (NRS) are reported below. The NRS scale ranges from 0 to 10 with higher scores corresponding to having more pain.

    Time frame: From baseline to week 10

  2. Change in Average Pain Score as Measured Using the European Cooperative Oncology Group (ECOG) Neuropathy Scale (ENS)

    The change in mean score for average daily pain from baseline to week 10 using the European Cooperative Oncology Group (ECOG) neuropathy scale (ENS) are reported below. The ENS scale goes from 0 to 3 with 0=none, 1=mild paresthesias, 2=mild or moderate sensory loss and/or moderate paresthesias, and 3=severe sensory loss or paresthesias that interfere with function.

    Time frame: From baseline to week 10

Secondary outcomes

  1. The Change in Overall Quality of Life as Measured by the Uniscale QOL From Baseline to Week 10

    The change in overall quality of life as measured by the Uniscale QOL (Week 10 minus Baseline) using the Wilcoxon test is reported for each arm below. The Uniscale is a score that ranges from 0 to 100, with 0 being QOL as bad as it can be and 100 being as good as it can be.

    Time frame: From baseline to week 10

  2. Change in Brief Pain Inventory (BPI) Worst Pain Score [Week 10 Minus Baseline]

    The average change in Brief Pain Inventory (BPI) Worst Pain scores between baseline and week 10 using Wilcoxon test are reported for each arm below. The BPI scales range from 0 to 10 with 0 meaning no pain and 10 meaning pain as bad as you can imagine.

    Time frame: From baseline to week 10

  3. Change in Brief Pain Inventory (BPI) Least Pain Score [Week 10 Minus Baseline]

    The average change in Brief Pain Inventory (BPI) Least Pain scores between baseline and week 10 using Wilcoxon test are reported for each arm below. The BPI scales range from 0 to 10 with 0 meaning no pain and 10 meaning pain as bad as you can imagine. Time Frame: Up to 1 week post-treatment

    Time frame: From baseline to week 10

  4. Change in Brief Pain Inventory (BPI) Average Pain Score [Week 10 Minus Baseline]

    The average change in Brief Pain Inventory (BPI) Average Pain scores between baseline and week 10 using Wilcoxon test are reported for each arm below. The BPI scales range from 0 to 10 with 0 meaning no pain and 10 meaning pain as bad as you can imagine.

    Time frame: From baseline to week 10

  5. Change in Brief Pain Inventory (BPI) Pain Now Score [Week 10 Minus Baseline]

    The average change in Brief Pain Inventory (BPI) Pain Now scores between baseline and week 10 using Wilcoxon test are reported for each arm below. The BPI scales range from 0 to 10 with 0 meaning no pain and 10 meaning pain as bad as you can imagine.

    Time frame: From baseline to week 10

  6. Change in Brief Pain Inventory (BPI) Pain Relief Score [Week 10 Minus Baseline]

    The average change in Brief Pain Inventory (BPI) Pain Relief scores between baseline and week 10 using Wilcoxon test are reported for each arm below. The BPI scales range from 0 to 10 with 0 meaning no pain and 10 meaning pain as bad as you can imagine.

    Time frame: From baseline to week 10

  7. Change in Brief Pain Inventory (BPI) Pain Interference Score [Week 10 Minus Baseline]

    The average change in Brief Pain Inventory (BPI) Pain Interference scores between baseline and week 10 using Wilcoxon test are reported for each arm below. The BPI scales range from 0 to 10 with 0 meaning no pain and 10 meaning pain as bad as you can imagine.

    Time frame: From baseline to week 10

  8. Change in POMS Total Score [Week 10 Minus Baseline]

    The average change in POMS Total scores between baseline and week 10 using Wilcoxon test are reported for each arm below. The POMS scales are calculated from patient responses on 30 questions asking how they have been feeling during the past week. The scores are all transformed so that 0 is the worst possible value and 100 is the best possible value.

    Time frame: From baseline to week 10

07

Results

Posted May 4, 2018

Participant flow

Randomization
Participant flow — Randomization
MilestoneArm I - LamotrigineArm II - Placebo
Started6566
Completed6362
Not completed24
Withdrew: Cancel13
Withdrew: Ineligible11
Treatment
Participant flow — Treatment
MilestoneArm I - LamotrigineArm II - Placebo
Started6362
Completed3446
Not completed2916
Withdrew: Refused further treatment1310
Withdrew: Adverse event71
Withdrew: Other (specifics not available)95

Outcome measures

PrimaryChange in Average Daily Pain Score as Measured Using a Pain Intensity Rating (NRS)

The change in mean score for average daily pain from baseline to week 10 using the Pain Intensity Rating (NRS) are reported below. The NRS scale ranges from 0 to 10 with higher scores corresponding to having more pain.

Time frame:
From baseline to week 10
Reported as:
Mean · units on a scale
Change in Average Daily Pain Score as Measured Using a Pain Intensity Rating (NRS)
units on a scaleArm I - LamotrigineArm II - Placebo
Change in Average Daily Pain Score as Measured Using a Pain Intensity Rating (NRS)-0.3 ± 2.76-0.5 ± 2.34
Statistical analysis
  • Arm I - Lamotrigine vs Arm II - Placebo · Wilcoxon (Mann-Whitney) · p = 0.56
PrimaryChange in Average Pain Score as Measured Using the European Cooperative Oncology Group (ECOG) Neuropathy Scale (ENS)

The change in mean score for average daily pain from baseline to week 10 using the European Cooperative Oncology Group (ECOG) neuropathy scale (ENS) are reported below. The ENS scale goes from 0 to 3 with 0=none, 1=mild paresthesias, 2=mild or moderate sensory loss and/or moderate paresthesias, and 3=severe sensory loss or paresthesias that interfere with function.

Time frame:
From baseline to week 10
Reported as:
Mean · units on a scale
Change in Average Pain Score as Measured Using the European Cooperative Oncology Group (ECOG) Neuropathy Scale (ENS)
units on a scaleArm I - LamotrigineArm II - Placebo
Change in Average Pain Score as Measured Using the European Cooperative Oncology Group (ECOG) Neuropathy Scale (ENS)-0.4 ± 0.73-0.3 ± 1.00
Statistical analysis
  • Arm I - Lamotrigine vs Arm II - Placebo · Wilcoxon (Mann-Whitney) · p = 0.36
SecondaryThe Change in Overall Quality of Life as Measured by the Uniscale QOL From Baseline to Week 10

The change in overall quality of life as measured by the Uniscale QOL (Week 10 minus Baseline) using the Wilcoxon test is reported for each arm below. The Uniscale is a score that ranges from 0 to 100, with 0 being QOL as bad as it can be and 100 being as good as it can be.

Time frame:
From baseline to week 10
Reported as:
Mean · units on a scale
The Change in Overall Quality of Life as Measured by the Uniscale QOL From Baseline to Week 10
units on a scaleArm I - LamotrigineArm II - Placebo
The Change in Overall Quality of Life as Measured by the Uniscale QOL From Baseline to Week 10-4.3 ± 25.150.3 ± 22.09
Statistical analysis
  • Arm I - Lamotrigine vs Arm II - Placebo · Wilcoxon (Mann-Whitney) · p = 0.25
SecondaryChange in Brief Pain Inventory (BPI) Worst Pain Score [Week 10 Minus Baseline]

The average change in Brief Pain Inventory (BPI) Worst Pain scores between baseline and week 10 using Wilcoxon test are reported for each arm below. The BPI scales range from 0 to 10 with 0 meaning no pain and 10 meaning pain as bad as you can imagine.

Time frame:
From baseline to week 10
Reported as:
Mean · units on a scale
Change in Brief Pain Inventory (BPI) Worst Pain Score [Week 10 Minus Baseline]
units on a scaleArm I - LamotrigineArm II - Placebo
Change in Brief Pain Inventory (BPI) Worst Pain Score [Week 10 Minus Baseline]0.1 ± 3.17-0.6 ± 2.31
Statistical analysis
  • Arm I - Lamotrigine vs Arm II - Placebo · Wilcoxon (Mann-Whitney) · p = 0.34
SecondaryChange in Brief Pain Inventory (BPI) Least Pain Score [Week 10 Minus Baseline]

The average change in Brief Pain Inventory (BPI) Least Pain scores between baseline and week 10 using Wilcoxon test are reported for each arm below. The BPI scales range from 0 to 10 with 0 meaning no pain and 10 meaning pain as bad as you can imagine. Time Frame: Up to 1 week post-treatment

Time frame:
From baseline to week 10
Reported as:
Mean · units on a scale
Change in Brief Pain Inventory (BPI) Least Pain Score [Week 10 Minus Baseline]
units on a scaleArm I - LamotrigineArm II - Placebo
Change in Brief Pain Inventory (BPI) Least Pain Score [Week 10 Minus Baseline]0.2 ± 2.120.1 ± 1.97
Statistical analysis
  • Arm I - Lamotrigine vs Arm II - Placebo · Wilcoxon (Mann-Whitney) · p = 0.53
SecondaryChange in Brief Pain Inventory (BPI) Average Pain Score [Week 10 Minus Baseline]

The average change in Brief Pain Inventory (BPI) Average Pain scores between baseline and week 10 using Wilcoxon test are reported for each arm below. The BPI scales range from 0 to 10 with 0 meaning no pain and 10 meaning pain as bad as you can imagine.

Time frame:
From baseline to week 10
Reported as:
Mean · units on a scale
Change in Brief Pain Inventory (BPI) Average Pain Score [Week 10 Minus Baseline]
units on a scaleArm I - LamotrigineArm II - Placebo
Change in Brief Pain Inventory (BPI) Average Pain Score [Week 10 Minus Baseline]-0.1 ± 2.15-0.8 ± 2.35
Statistical analysis
  • Arm I - Lamotrigine vs Arm II - Placebo · Wilcoxon (Mann-Whitney) · p = 0.22
SecondaryChange in Brief Pain Inventory (BPI) Pain Now Score [Week 10 Minus Baseline]

The average change in Brief Pain Inventory (BPI) Pain Now scores between baseline and week 10 using Wilcoxon test are reported for each arm below. The BPI scales range from 0 to 10 with 0 meaning no pain and 10 meaning pain as bad as you can imagine.

Time frame:
From baseline to week 10
Reported as:
Mean · units on a scale
Change in Brief Pain Inventory (BPI) Pain Now Score [Week 10 Minus Baseline]
units on a scaleArm I - LamotrigineArm II - Placebo
Change in Brief Pain Inventory (BPI) Pain Now Score [Week 10 Minus Baseline]-0.1 ± 2.77-0.3 ± 2.22
Statistical analysis
  • Arm I - Lamotrigine vs Arm II - Placebo · Wilcoxon (Mann-Whitney) · p = 0.33
SecondaryChange in Brief Pain Inventory (BPI) Pain Relief Score [Week 10 Minus Baseline]

The average change in Brief Pain Inventory (BPI) Pain Relief scores between baseline and week 10 using Wilcoxon test are reported for each arm below. The BPI scales range from 0 to 10 with 0 meaning no pain and 10 meaning pain as bad as you can imagine.

Time frame:
From baseline to week 10
Reported as:
Mean · units on a scale
Change in Brief Pain Inventory (BPI) Pain Relief Score [Week 10 Minus Baseline]
units on a scaleArm I - LamotrigineArm II - Placebo
Change in Brief Pain Inventory (BPI) Pain Relief Score [Week 10 Minus Baseline]6.7 ± 28.340.4 ± 30.34
Statistical analysis
  • Arm I - Lamotrigine vs Arm II - Placebo · Wilcoxon (Mann-Whitney) · p = 0.07
SecondaryChange in Brief Pain Inventory (BPI) Pain Interference Score [Week 10 Minus Baseline]

The average change in Brief Pain Inventory (BPI) Pain Interference scores between baseline and week 10 using Wilcoxon test are reported for each arm below. The BPI scales range from 0 to 10 with 0 meaning no pain and 10 meaning pain as bad as you can imagine.

Time frame:
From baseline to week 10
Reported as:
Mean · units on a scale
Change in Brief Pain Inventory (BPI) Pain Interference Score [Week 10 Minus Baseline]
units on a scaleArm I - LamotrigineArm II - Placebo
Change in Brief Pain Inventory (BPI) Pain Interference Score [Week 10 Minus Baseline]-0.5 ± 2.17-0.8 ± 2.19
Statistical analysis
  • Arm I - Lamotrigine vs Arm II - Placebo · Wilcoxon (Mann-Whitney) · p = 0.91
SecondaryChange in POMS Total Score [Week 10 Minus Baseline]

The average change in POMS Total scores between baseline and week 10 using Wilcoxon test are reported for each arm below. The POMS scales are calculated from patient responses on 30 questions asking how they have been feeling during the past week. The scores are all transformed so that 0 is the worst possible value and 100 is the best possible value.

Time frame:
From baseline to week 10
Reported as:
Mean · units on a scale
Change in POMS Total Score [Week 10 Minus Baseline]
units on a scaleArm I - LamotrigineArm II - Placebo
Change in POMS Total Score [Week 10 Minus Baseline]1.4 ± 10.671.3 ± 9.09
Statistical analysis
  • Arm I - Lamotrigine vs Arm II - Placebo · Wilcoxon (Mann-Whitney) · p = 0.68

Adverse events

Collected over Adverse events were collected over the 10 weeks of the study.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Arm I - Lamotrigine0/61 (0%)0/61 (0%)26/61 (42.6%)
Arm II - Placebo0/63 (0%)0/63 (0%)24/63 (38.1%)
Most frequent other events
Showing 10 of 30
Most frequent other events
EventArm I - LamotrigineArm II - Placebo
AtaxiaNervous system disorders14/618/63
DizzinessNervous system disorders6/6111/63
Rash desquamatingSkin and subcutaneous tissue disorders10/615/63
Depressed level of consciousnessNervous system disorders3/612/63
FatigueGeneral disorders2/613/63
DyspepsiaGastrointestinal disorders2/610/63
PruritusSkin and subcutaneous tissue disorders2/611/63
Muscle weaknessMusculoskeletal and connective tissue disorders0/612/63
HeadacheNervous system disorders0/612/63
NystagmusNervous system disorders1/612/63

Baseline characteristics

Age, Continuous
Age, Continuous(years)Arm I - LamotrigineArm II - PlaceboTotal
Mean62 (29 to 84)59 (34 to 82)61 (29 to 84)
Sex: Female, Male
Sex: Female, Male(Participants)Arm I - LamotrigineArm II - PlaceboTotal
Female363874
Male272451
Region of Enrollment
Region of Enrollment(Participants)Arm I - LamotrigineArm II - PlaceboTotal
United States6362125
08

Study locations

23 sites
  • Mayo Clinic Scottsdale
    Scottsdale, Arizona 85259, United States
  • Mayo Clinic - Jacksonville
    Jacksonville, Florida 32224, United States
  • CCOP - Atlanta Regional
    Atlanta, Georgia 30342-1701, United States
  • MBCCOP - Hawaii
    Honolulu, Hawaii 96813, United States
  • CCOP - Illinois Oncology Research Association
    Peoria, Illinois 61615-7828, United States
  • CCOP - Carle Cancer Center
    Urbana, Illinois 61801, United States
  • CCOP - Cedar Rapids Oncology Project
    Cedar Rapids, Iowa 52403-1206, United States
  • CCOP - Iowa Oncology Research Association
    Des Moines, Iowa 50309-1854, United States
  • Siouxland Hematology-Oncology Associates at June E. Nylen Cancer Center
    Sioux City, Iowa 51101-1733, United States
  • CCOP - Wichita
    Wichita, Kansas 67214-3882, United States
  • CCOP - Michigan Cancer Research Consortium
    Ann Arbor, Michigan 48106, United States
  • CCOP - Duluth
    Duluth, Minnesota 55805, United States
  • Mayo Clinic Cancer Center
    Rochester, Minnesota 55905, United States
  • Coborn Cancer Center
    Saint Cloud, Minnesota 56303, United States
  • CCOP - Metro-Minnesota
    Saint Louis Park, Minnesota 55416, United States
  • CCOP - Missouri Valley Cancer Consortium
    Omaha, Nebraska 68106, United States
  • Cancer Care Center at Medcenter One Hospital
    Bismarck, North Dakota 58501-5505, United States
  • CCOP - Dayton
    Dayton, Ohio 45429, United States
  • CCOP - Toledo Community Hospital
    Toledo, Ohio 43623-3456, United States
  • CCOP - Upstate Carolina
    Spartanburg, South Carolina 29303, United States
  • Rapid City Regional Hospital
    Rapid City, South Dakota 57709, United States
  • CCOP - Sioux Community Cancer Consortium
    Sioux Falls, South Dakota 57104, United States
  • CCOP - St. Vincent Hospital Cancer Center, Green Bay
    Green Bay, Wisconsin 54301, United States
09

References and documents

Publications

  • Rao 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. PubMed 18428211 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 4, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00068445
Lead sponsor
Alliance for Clinical Trials in Oncology
Collaborators
National Cancer Institute (NCI)
Responsible party
Sponsor
First posted
Sep 11, 2003
Start date
Feb 2004
Primary completion
May 2006
Completion
Nov 2013
Results posted
May 4, 2018
Last update
May 4, 2018

Study contacts

Ravi D. Rao, MD, MBBS
study chair · Mayo Clinic

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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