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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00068445
Recruitment Status : Completed
First Posted : September 11, 2003
Results First Posted : May 4, 2018
Last Update Posted : May 4, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Supportive Care
Conditions Neurotoxicity
Pain
Unspecified Adult Solid Tumor, Protocol Specific
Interventions Drug: lamotrigine
Other: Placebo
Enrollment 131
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Arm I - Lamotrigine Arm II - Placebo
Hide Arm/Group Description Patients receive oral lamotrigine (25 mg per pill) once daily for 2 weeks and then twice daily for 8 weeks. Treatment continues for 10 weeks total in the absence of unacceptable toxicity. Patients receive oral placebo once daily for 2 weeks and then twice daily for 8 weeks. Treatment continues for 10 weeks total in the absence of unacceptable toxicity.
Period Title: Randomization
Started 65 66
Completed 63 62
Not Completed 2 4
Reason Not Completed
Cancel             1             3
Ineligible             1             1
Period Title: Treatment
Started 63 62
Completed 34 46
Not Completed 29 16
Reason Not Completed
Refused Further Treatment             13             10
Adverse Event             7             1
Other (Specifics not available)             9             5
Arm/Group Title Arm I - Lamotrigine Arm II - Placebo Total
Hide Arm/Group Description Patients receive oral lamotrigine (25 mg per pill) once daily for 2 weeks and then twice daily for 8 weeks. Treatment continues for 10 weeks total in the absence of unacceptable toxicity. Patients receive oral placebo once daily for 2 weeks and then twice daily for 8 weeks. Treatment continues for 10 weeks total in the absence of unacceptable toxicity. Total of all reporting groups
Overall Number of Baseline Participants 63 62 125
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 63 participants 62 participants 125 participants
62
(29 to 84)
59
(34 to 82)
61
(29 to 84)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 63 participants 62 participants 125 participants
Female
36
  57.1%
38
  61.3%
74
  59.2%
Male
27
  42.9%
24
  38.7%
51
  40.8%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 63 participants 62 participants 125 participants
63
 100.0%
62
 100.0%
125
 100.0%
1.Primary Outcome
Title Change in Average Daily Pain Score as Measured Using a Pain Intensity Rating (NRS)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I - Lamotrigine Arm II - Placebo
Hide Arm/Group Description:
Patients receive oral lamotrigine (25 mg per pill) once daily for 2 weeks and then twice daily for 8 weeks. Treatment continues for 10 weeks total in the absence of unacceptable toxicity.
Patients receive oral placebo once daily for 2 weeks and then twice daily for 8 weeks. Treatment continues for 10 weeks total in the absence of unacceptable toxicity.
Overall Number of Participants Analyzed 34 46
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.3  (2.76) -0.5  (2.34)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I - Lamotrigine, Arm II - Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.56
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
2.Primary Outcome
Title Change in Average Pain Score as Measured Using the European Cooperative Oncology Group (ECOG) Neuropathy Scale (ENS)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Arm I - Lamotrigine Arm II - Placebo
Hide Arm/Group Description:
Patients receive oral lamotrigine (25 mg per pill) once daily for 2 weeks and then twice daily for 8 weeks. Treatment continues for 10 weeks total in the absence of unacceptable toxicity.
Patients receive oral placebo once daily for 2 weeks and then twice daily for 8 weeks. Treatment continues for 10 weeks total in the absence of unacceptable toxicity.
Overall Number of Participants Analyzed 34 46
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.4  (0.73) -0.3  (1.00)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I - Lamotrigine, Arm II - Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.36
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
3.Secondary Outcome
Title The Change in Overall Quality of Life as Measured by the Uniscale QOL From Baseline to Week 10
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with Uniscale QOL data at both time points available were assessed.
Arm/Group Title Arm I - Lamotrigine Arm II - Placebo
Hide Arm/Group Description:
Patients receive oral lamotrigine (25 mg per pill) once daily for 2 weeks and then twice daily for 8 weeks. Treatment continues for 10 weeks total in the absence of unacceptable toxicity.
Patients receive oral placebo once daily for 2 weeks and then twice daily for 8 weeks. Treatment continues for 10 weeks total in the absence of unacceptable toxicity.
Overall Number of Participants Analyzed 30 34
Mean (Standard Deviation)
Unit of Measure: units on a scale
-4.3  (25.15) 0.3  (22.09)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I - Lamotrigine, Arm II - Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.25
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
4.Secondary Outcome
Title Change in Brief Pain Inventory (BPI) Worst Pain Score [Week 10 Minus Baseline]
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with BPI Worst Pain data at both time points available were assessed.
Arm/Group Title Arm I - Lamotrigine Arm II - Placebo
Hide Arm/Group Description:
Patients receive oral lamotrigine (25 mg per pill) once daily for 2 weeks and then twice daily for 8 weeks. Treatment continues for 10 weeks total in the absence of unacceptable toxicity.
Patients receive oral placebo once daily for 2 weeks and then twice daily for 8 weeks. Treatment continues for 10 weeks total in the absence of unacceptable toxicity.
Overall Number of Participants Analyzed 27 36
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.1  (3.17) -0.6  (2.31)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I - Lamotrigine, Arm II - Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.34
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
5.Secondary Outcome
Title Change in Brief Pain Inventory (BPI) Least Pain Score [Week 10 Minus Baseline]
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with BPI Least Pain data at both time points available were assessed.
Arm/Group Title Arm I - Lamotrigine Arm II - Placebo
Hide Arm/Group Description:
Patients receive oral lamotrigine (25 mg per pill) once daily for 2 weeks and then twice daily for 8 weeks. Treatment continues for 10 weeks total in the absence of unacceptable toxicity.
Patients receive oral placebo once daily for 2 weeks and then twice daily for 8 weeks. Treatment continues for 10 weeks total in the absence of unacceptable toxicity.
Overall Number of Participants Analyzed 27 35
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.2  (2.12) 0.1  (1.97)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I - Lamotrigine, Arm II - Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.53
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
6.Secondary Outcome
Title Change in Brief Pain Inventory (BPI) Average Pain Score [Week 10 Minus Baseline]
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with BPI Average Pain data at both time points available were assessed.
Arm/Group Title Arm I - Lamotrigine Arm II - Placebo
Hide Arm/Group Description:
Patients receive oral lamotrigine (25 mg per pill) once daily for 2 weeks and then twice daily for 8 weeks. Treatment continues for 10 weeks total in the absence of unacceptable toxicity.
Patients receive oral placebo once daily for 2 weeks and then twice daily for 8 weeks. Treatment continues for 10 weeks total in the absence of unacceptable toxicity.
Overall Number of Participants Analyzed 29 35
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.1  (2.15) -0.8  (2.35)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I - Lamotrigine, Arm II - Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.22
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
7.Secondary Outcome
Title Change in Brief Pain Inventory (BPI) Pain Now Score [Week 10 Minus Baseline]
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with BPI Pain Now data at both time points available were assessed.
Arm/Group Title Arm I - Lamotrigine Arm II - Placebo
Hide Arm/Group Description:
Patients receive oral lamotrigine (25 mg per pill) once daily for 2 weeks and then twice daily for 8 weeks. Treatment continues for 10 weeks total in the absence of unacceptable toxicity.
Patients receive oral placebo once daily for 2 weeks and then twice daily for 8 weeks. Treatment continues for 10 weeks total in the absence of unacceptable toxicity.
Overall Number of Participants Analyzed 30 35
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.1  (2.77) -0.3  (2.22)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I - Lamotrigine, Arm II - Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.33
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
8.Secondary Outcome
Title Change in Brief Pain Inventory (BPI) Pain Relief Score [Week 10 Minus Baseline]
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with BPI Pain Relief data at both time points available were assessed.
Arm/Group Title Arm I - Lamotrigine Arm II - Placebo
Hide Arm/Group Description:
Patients receive oral lamotrigine (25 mg per pill) once daily for 2 weeks and then twice daily for 8 weeks. Treatment continues for 10 weeks total in the absence of unacceptable toxicity.
Patients receive oral placebo once daily for 2 weeks and then twice daily for 8 weeks. Treatment continues for 10 weeks total in the absence of unacceptable toxicity.
Overall Number of Participants Analyzed 21 25
Mean (Standard Deviation)
Unit of Measure: units on a scale
6.7  (28.34) 0.4  (30.34)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I - Lamotrigine, Arm II - Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.07
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
9.Secondary Outcome
Title Change in Brief Pain Inventory (BPI) Pain Interference Score [Week 10 Minus Baseline]
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with BPI Pain Interference data at both time points available were assessed.
Arm/Group Title Arm I - Lamotrigine Arm II - Placebo
Hide Arm/Group Description:
Patients receive oral lamotrigine (25 mg per pill) once daily for 2 weeks and then twice daily for 8 weeks. Treatment continues for 10 weeks total in the absence of unacceptable toxicity.
Patients receive oral placebo once daily for 2 weeks and then twice daily for 8 weeks. Treatment continues for 10 weeks total in the absence of unacceptable toxicity.
Overall Number of Participants Analyzed 30 35
Mean (Standard Deviation)
Unit of Measure: units on a scale
-0.5  (2.17) -0.8  (2.19)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I - Lamotrigine, Arm II - Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.91
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
10.Secondary Outcome
Title Change in POMS Total Score [Week 10 Minus Baseline]
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with POMS scales data at both time points available were assessed.
Arm/Group Title Arm I - Lamotrigine Arm II - Placebo
Hide Arm/Group Description:
Patients receive oral lamotrigine (25 mg per pill) once daily for 2 weeks and then twice daily for 8 weeks. Treatment continues for 10 weeks total in the absence of unacceptable toxicity.
Patients receive oral placebo once daily for 2 weeks and then twice daily for 8 weeks. Treatment continues for 10 weeks total in the absence of unacceptable toxicity.
Overall Number of Participants Analyzed 27 34
Mean (Standard Deviation)
Unit of Measure: units on a scale
1.4  (10.67) 1.3  (9.09)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm I - Lamotrigine, Arm II - Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.68
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Time Frame Adverse events were collected over the 10 weeks of the study.
Adverse Event Reporting Description Each CTCAE term is a unique representation of a specific event used for medical documentation/scientific analysis and is a single MedDRA Lowest Level Term (LLT). All AEs are reported below for patients who reported AEs for cycle >0 and grade >0.Serious AE (SAE) reports may include any secondary serious or non-serious events considered related to the primary event (the reason for filing an expedited report); collectively, these events are referred to as Expedited AEs, and appear in the SAE table.
 
Arm/Group Title Arm I - Lamotrigine Arm II - Placebo
Hide Arm/Group Description Patients receive oral lamotrigine (25 mg per pill) once daily for 2 weeks and then twice daily for 8 weeks. Treatment continues for 10 weeks total in the absence of unacceptable toxicity. Patients receive oral placebo once daily for 2 weeks and then twice daily for 8 weeks. Treatment continues for 10 weeks total in the absence of unacceptable toxicity.
All-Cause Mortality
Arm I - Lamotrigine Arm II - Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/61 (0.00%)      0/63 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Arm I - Lamotrigine Arm II - Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/61 (0.00%)      0/63 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm I - Lamotrigine Arm II - Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   26/61 (42.62%)      24/63 (38.10%)    
Cardiac disorders     
Arrhythmia supraventricular  1  1/61 (1.64%)  1 0/63 (0.00%)  0
Eye disorders     
Vision blurred  1  1/61 (1.64%)  1 0/63 (0.00%)  0
Gastrointestinal disorders     
Abdominal pain  1  0/61 (0.00%)  0 1/63 (1.59%)  1
Constipation  1  0/61 (0.00%)  0 1/63 (1.59%)  1
Diarrhea  1  1/61 (1.64%)  1 1/63 (1.59%)  1
Dyspepsia  1  2/61 (3.28%)  2 0/63 (0.00%)  0
Flatulence  1  0/61 (0.00%)  0 1/63 (1.59%)  1
Nausea  1  0/61 (0.00%)  0 1/63 (1.59%)  1
Vomiting  1  0/61 (0.00%)  0 1/63 (1.59%)  1
General disorders     
Fatigue  1  2/61 (3.28%)  3 3/63 (4.76%)  4
General symptom  1  1/61 (1.64%)  3 0/63 (0.00%)  0
Pain  1  1/61 (1.64%)  1 1/63 (1.59%)  1
Pain due to radiation  1  0/61 (0.00%)  0 1/63 (1.59%)  1
Infections and infestations     
Infection without neutropenia  1  1/61 (1.64%)  1 0/63 (0.00%)  0
Metabolism and nutrition disorders     
Blood glucose increased  1  0/61 (0.00%)  0 1/63 (1.59%)  1
Dehydration  1  0/61 (0.00%)  0 1/63 (1.59%)  1
Musculoskeletal and connective tissue disorders     
Arthralgia  1  1/61 (1.64%)  1 0/63 (0.00%)  0
Muscle weakness  1  0/61 (0.00%)  0 2/63 (3.17%)  2
Nervous system disorders     
Ataxia  1  14/61 (22.95%)  54 8/63 (12.70%)  24
Depressed level of consciousness  1  3/61 (4.92%)  3 2/63 (3.17%)  3
Dizziness  1  6/61 (9.84%)  11 11/63 (17.46%)  30
Extrapyramidal disorder  1  0/61 (0.00%)  0 1/63 (1.59%)  1
Headache  1  0/61 (0.00%)  0 2/63 (3.17%)  5
Nystagmus  1  1/61 (1.64%)  1 2/63 (3.17%)  2
Peripheral sensory neuropathy  1  0/61 (0.00%)  0 1/63 (1.59%)  3
Psychiatric disorders     
Insomnia  1  0/61 (0.00%)  0 2/63 (3.17%)  2
Renal and urinary disorders     
Dysuria (painful urination)  1  0/61 (0.00%)  0 1/63 (1.59%)  1
Respiratory, thoracic and mediastinal disorders     
Dyspnea (shortness of breath)  1  1/61 (1.64%)  1 0/63 (0.00%)  0
Skin and subcutaneous tissue disorders     
Pruritus  1  2/61 (3.28%)  2 1/63 (1.59%)  1
Rash desquamating  1  10/61 (16.39%)  11 5/63 (7.94%)  13
1
Term from vocabulary, MedDRA 6
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Charles L. Loprinzi, M.D.
Organization: Mayo Clinic
Phone: 507-284-3731
EMail: cloprinzi@mayo.edu
Publications of Results:
Renno SI, Rao RD, Sloan J, et al.: The efficacy of lamotrigine in the management of chemotherapy-induced peripheral neuropathy: a phase III randomized, double blind, placebo-controlled NCCTG trial, N01C3. [Abstract] J Clin Oncol 24 (Suppl 18): A-8530, 475s, 2006.
Layout table for additonal information
Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00068445     History of Changes
Other Study ID Numbers: NCCTG-N01C3
CDR0000322830 ( Registry Identifier: PDQ (Physician Data Query) )
First Submitted: September 10, 2003
First Posted: September 11, 2003
Results First Submitted: February 6, 2018
Results First Posted: May 4, 2018
Last Update Posted: May 4, 2018