Trial · NCT00068445
Lamotrigine in Treating Peripheral Neuropathy Caused by Chemotherapy in Patients With Cancer
NCT00068445, Phase 3, Completed, Alliance for Clinical Trials in Oncology; results first posted 2018-05-04
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Lamotrigine in Treating Peripheral Neuropathy Caused by Chemotherapy in Patients With Cancer. Trials, record NCT00068445. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00068445
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Lamotrigine in Treating Peripheral Neuropathy Caused by Chemotherapy in Patients With Cancer
- NCT number
- NCT00068445
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 131 participants, actual
- Lead sponsor
- Alliance for Clinical Trials in Oncology
- Conditions
- Neurotoxicity, Pain, Unspecified Adult Solid Tumor, Protocol Specific
- Interventions
- lamotrigine, Placebo
- First posted
- 2003-09-11
- Last updated
- 2018-05-04
- Results first posted
- 2018-05-04
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Average Daily Pain Score as Measured Using a Pain Intensity Rating (NRS) | From baseline to week 10 | 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. |
| Primary | Change in Average Pain Score as Measured Using the European Cooperative Oncology Group (ECOG) Neuropathy Scale (ENS) | From baseline to week 10 | 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. |
| Secondary | The Change in Overall Quality of Life as Measured by the Uniscale QOL From Baseline to Week 10 | 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. |
| Secondary | Change in Brief Pain Inventory (BPI) Worst Pain Score [Week 10 Minus Baseline] | From baseline to week 10 | 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. |
| Secondary | Change in Brief Pain Inventory (BPI) Least Pain Score [Week 10 Minus Baseline] | From baseline to week 10 | 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 |
| Secondary | Change in Brief Pain Inventory (BPI) Average Pain Score [Week 10 Minus Baseline] | From baseline to week 10 | 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. |
| Secondary | Change in Brief Pain Inventory (BPI) Pain Now Score [Week 10 Minus Baseline] | From baseline to week 10 | 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. |
| Secondary | Change in Brief Pain Inventory (BPI) Pain Relief Score [Week 10 Minus Baseline] | From baseline to week 10 | 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. |
| Secondary | Change in Brief Pain Inventory (BPI) Pain Interference Score [Week 10 Minus Baseline] | From baseline to week 10 | 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. |
| Secondary | Change in POMS Total Score [Week 10 Minus Baseline] | From baseline to week 10 | 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. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Average Daily Pain Score as Measured Using a Pain Intensity Rating (NRS) | From baseline to week 10 | units on a scale | MEAN | |
| PRIMARY | Change in Average Pain Score as Measured Using the European Cooperative Oncology Group (ECOG) Neuropathy Scale (ENS) | From baseline to week 10 | units on a scale | MEAN | |
| SECONDARY | The Change in Overall Quality of Life as Measured by the Uniscale QOL From Baseline to Week 10 | From baseline to week 10 | Participants with Uniscale QOL data at both time points available were assessed. | units on a scale | MEAN |
| SECONDARY | Change in Brief Pain Inventory (BPI) Worst Pain Score [Week 10 Minus Baseline] | From baseline to week 10 | Participants with BPI Worst Pain data at both time points available were assessed. | units on a scale | MEAN |
| SECONDARY | Change in Brief Pain Inventory (BPI) Least Pain Score [Week 10 Minus Baseline] | From baseline to week 10 | Participants with BPI Least Pain data at both time points available were assessed. | units on a scale | MEAN |
| SECONDARY | Change in Brief Pain Inventory (BPI) Average Pain Score [Week 10 Minus Baseline] | From baseline to week 10 | Participants with BPI Average Pain data at both time points available were assessed. | units on a scale | MEAN |
| SECONDARY | Change in Brief Pain Inventory (BPI) Pain Now Score [Week 10 Minus Baseline] | From baseline to week 10 | Participants with BPI Pain Now data at both time points available were assessed. | units on a scale | MEAN |
| SECONDARY | Change in Brief Pain Inventory (BPI) Pain Relief Score [Week 10 Minus Baseline] | From baseline to week 10 | Participants with BPI Pain Relief data at both time points available were assessed. | units on a scale | MEAN |
| SECONDARY | Change in Brief Pain Inventory (BPI) Pain Interference Score [Week 10 Minus Baseline] | From baseline to week 10 | Participants with BPI Pain Interference data at both time points available were assessed. | units on a scale | MEAN |
| SECONDARY | Change in POMS Total Score [Week 10 Minus Baseline] | From baseline to week 10 | Participants with POMS scales data at both time points available were assessed. | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Average Daily Pain Score as Measured Using a Pain Intensity Rating (NRS) | Arm I - Lamotrigine | -0.3 | Standard Deviation 2.76 | units on a scale | |
| Change in Average Daily Pain Score as Measured Using a Pain Intensity Rating (NRS) | Arm II - Placebo | -0.5 | Standard Deviation 2.34 | units on a scale | |
| Change in Average Pain Score as Measured Using the European Cooperative Oncology Group (ECOG) Neuropathy Scale (ENS) | Arm I - Lamotrigine | -0.4 | Standard Deviation 0.73 | units on a scale | |
| Change in Average Pain Score as Measured Using the European Cooperative Oncology Group (ECOG) Neuropathy Scale (ENS) | Arm II - Placebo | -0.3 | Standard Deviation 1.00 | units on a scale | |
| The Change in Overall Quality of Life as Measured by the Uniscale QOL From Baseline to Week 10 | Arm I - Lamotrigine | -4.3 | Standard Deviation 25.15 | units on a scale | |
| The Change in Overall Quality of Life as Measured by the Uniscale QOL From Baseline to Week 10 | Arm II - Placebo | 0.3 | Standard Deviation 22.09 | units on a scale | |
| Change in Brief Pain Inventory (BPI) Worst Pain Score [Week 10 Minus Baseline] | Arm I - Lamotrigine | 0.1 | Standard Deviation 3.17 | units on a scale | |
| Change in Brief Pain Inventory (BPI) Worst Pain Score [Week 10 Minus Baseline] | Arm II - Placebo | -0.6 | Standard Deviation 2.31 | units on a scale | |
| Change in Brief Pain Inventory (BPI) Least Pain Score [Week 10 Minus Baseline] | Arm I - Lamotrigine | 0.2 | Standard Deviation 2.12 | units on a scale | |
| Change in Brief Pain Inventory (BPI) Least Pain Score [Week 10 Minus Baseline] | Arm II - Placebo | 0.1 | Standard Deviation 1.97 | units on a scale |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Randomization | STARTED | Arm I - Lamotrigine | 65 | |
| Randomization | STARTED | Arm II - Placebo | 66 | |
| Randomization | COMPLETED | Arm I - Lamotrigine | 63 | |
| Randomization | COMPLETED | Arm II - Placebo | 62 | |
| Randomization | NOT COMPLETED | Arm I - Lamotrigine | 2 | |
| Randomization | NOT COMPLETED | Arm II - Placebo | 4 | |
| Treatment | STARTED | Arm I - Lamotrigine | 63 | |
| Treatment | STARTED | Arm II - Placebo | 62 | |
| Treatment | COMPLETED | Arm I - Lamotrigine | 34 | |
| Treatment | COMPLETED | Arm II - Placebo | 46 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events60
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Arrhythmia supraventricular | Cardiac disorders | Arm I - Lamotrigine | 1 | 61 | 1 |
| other | Arrhythmia supraventricular | Cardiac disorders | Arm II - Placebo | 0 | 63 | 0 |
| other | Vision blurred | Eye disorders | Arm I - Lamotrigine | 1 | 61 | 1 |
| other | Vision blurred | Eye disorders | Arm II - Placebo | 0 | 63 | 0 |
| other | Abdominal pain | Gastrointestinal disorders | Arm I - Lamotrigine | 0 | 61 | 0 |
| other | Abdominal pain | Gastrointestinal disorders | Arm II - Placebo | 1 | 63 | 1 |
| other | Constipation | Gastrointestinal disorders | Arm I - Lamotrigine | 0 | 61 | 0 |
| other | Constipation | Gastrointestinal disorders | Arm II - Placebo | 1 | 63 | 1 |
| other | Diarrhea | Gastrointestinal disorders | Arm I - Lamotrigine | 1 | 61 | 1 |
| other | Diarrhea | Gastrointestinal disorders | Arm II - Placebo | 1 | 63 | 1 |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Arm I - Lamotrigine | 0 | 61 |
| Total, all-cause mortality | Arm II - Placebo | 0 | 63 |
| Total, other adverse events | Arm I - Lamotrigine | 26 | 61 |
| Total, other adverse events | Arm II - Placebo | 24 | 63 |
| Total, serious adverse events | Arm I - Lamotrigine | 0 | 61 |
| Total, serious adverse events | Arm II - Placebo | 0 | 63 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 18428211 | RESULT |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Arm I - Lamotrigine vs Arm II - Placebo: deaths from any cause | Trial comparisons |
| Arm I - Lamotrigine vs Arm II - Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00068445
GET https://conductscience.org/api/trials/v1/NCT00068445/events?page=2