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NCT00068445 · ClinicalTrials.gov registry record · Phase 3
Lamotrigine in Treating Peripheral Neuropathy Caused by Chemotherapy in Patients With Cancer
A Phase 3 study, sponsored by Alliance for Clinical Trials in Oncology.
- Completed
- Registry status
- Phase 3
- Development phase
- 131
- Enrollment target
NCT00068445: Completed Phase 3 study, sponsored by Alliance for Clinical Trials in Oncology.
NCT00068445 is a Phase 3 study that has completed, run by Alliance for Clinical Trials in Oncology. The registered enrollment target is 131 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00068445, a Phase 3 study, has completed, sponsored by Alliance for Clinical Trials in Oncology.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 131 participants
- Enrollment target
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.
Primary Outcome
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.
Interventions
- OTHER Placebo
- DRUG lamotrigine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 131 participants |
| Start Date | 2004-02 |
| Est. Completion | 2013-11 |
| Phase | Phase 3 |
What the finished NCT00068445 record still lists
NCT00068445 is an interventional study that assigns participants to a tested intervention. The registered 131 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT00068445 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00068445 about?
NCT00068445 is a clinical study titled "Lamotrigine in Treating Peripheral Neuropathy Caused by Chemotherapy in Patients With Cancer". 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 lam...
What is the current status of trial NCT00068445?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 131 participants. The study started on 2004-02. Estimated completion is 2013-11.
What interventions are being tested in trial NCT00068445?
The interventions under investigation include: Placebo (OTHER), lamotrigine (DRUG).
Who is sponsoring clinical trial NCT00068445?
This trial is sponsored by Alliance for Clinical Trials in Oncology, which has 446 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00068445's enrollment target sits among peer trials
131 1593rd of 2000 higher than 407 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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