Trial · NCT00203229
Research Study to Test Safety and Effectiveness of Investigational Drug in Patients With Trigeminal Neuralgia
NCT00203229, Not applicable, Completed, Thomas Jefferson University; results first posted 2014-06-03
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Research Study to Test Safety and Effectiveness of Investigational Drug in Patients With Trigeminal Neuralgia. Trials, record NCT00203229. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00203229
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Research Study to Test Safety and Effectiveness of Investigational Drug in Patients With Trigeminal Neuralgia
- NCT number
- NCT00203229
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 20 participants, actual
- Lead sponsor
- Thomas Jefferson University
- Conditions
- Trigeminal Neuralgia
- Interventions
- lamotrigine, Placebo
- First posted
- 2005-09-20
- Last updated
- 2014-06-03
- Results first posted
- 2014-06-03
- Limitations and caveats
- Limited enrollment due to fear of placebo and high drop out rate.
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Average Number of Pain Attacks | Day 150 Visit #7 | The average number of attacks daily experienced between Visit #1 and Visit #2 (baseline diary) was compared to the average daily number of attacks recorded between Visit #5 and Visit #7 after the patient has titrated the drug to the maximum tolerated dose. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Average Number of Pain Attacks | Day 150 Visit #7 | Pain attacks | MEAN |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Average Number of Pain Attacks | Placebo | 3.3533 | Standard Deviation 1.1209 | Pain attacks | |
| Average Number of Pain Attacks | Lamotrigine | 3.1807 | Standard Deviation 0.7713 | Pain attacks |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 10 | |
| Overall Study | STARTED | Lamotrigine | 10 | |
| Overall Study | COMPLETED | Placebo | 7 | |
| Overall Study | COMPLETED | Lamotrigine | 7 | |
| Overall Study | NOT COMPLETED | Placebo | 3 | |
| Overall Study | NOT COMPLETED | Lamotrigine | 3 |
Source ClinicalTrials.gov
Adverse events2
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 | ataxia | Nervous system disorders | Placebo | 0 | 7 | 0 |
| other | ataxia | Nervous system disorders | Lamotrigine | 2 | 7 | 2 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Lamotrigine | ||
| Total, other adverse events | Placebo | 0 | 7 |
| Total, other adverse events | Lamotrigine | 2 | 7 |
| Total, serious adverse events | Placebo | 0 | 7 |
| Total, serious adverse events | Lamotrigine | 0 | 7 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Lamotrigine vs Placebo: serious adverse events |
Source 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/NCT00203229
GET https://conductscience.org/api/trials/v1/NCT00203229/registered