Trial · NCT00438451
Study on the Treatment of Elderly Patients With Older and Newer Antiepileptic Drugs
NCT00438451, Phase 4, Completed, Johannes Gutenberg University Mainz; results first posted 2013-02-28
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study on the Treatment of Elderly Patients With Older and Newer Antiepileptic Drugs. Trials, record NCT00438451. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00438451
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study on the Treatment of Elderly Patients With Older and Newer Antiepileptic Drugs
- NCT number
- NCT00438451
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 361 participants, actual
- Lead sponsor
- Johannes Gutenberg University Mainz
- Conditions
- Focal Epilepsy
- Interventions
- Levetiracetam, Carbamazepine, Lamotrigine
- First posted
- 2007-02-22
- Last updated
- 2013-02-28
- Other registries' IDs
- eudract:2005-003324-19, isrctn:ISRCTN94839639
- Results first posted
- 2013-02-28
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 58-week Retention Rate Measured by the Number of Drop Outs Due to Adverse Events or Seizures From Day 1 of Treatment | 58 weeks | |
| Secondary | Time to Drop Out | 58 weeks | number of days between randomization and premature discontinuation of the study |
| Secondary | Percentage of Patients Remaining Seizure-free at Week 30 (Visit 4) | Week 30 | Percentage of patients experiencing no seizures until week 30 (Visit 4) and did not discontinue the study until week 30. |
| Secondary | Percentage of Patients Remaining Seizure Free at Week 58 (Visit 6) | week 58 | Percentage of patients experiencing no seizures until week 58 (Visit 6) and did not discontinue the study until week 58. |
| Secondary | The Time (in Days) to First Break-through Seizure (From Day 1 of Treatment) | over the whole duration of 58 weeks | |
| Secondary | The Absolute Seizure Frequency During the Maintenance Phase (Weeks 7 - 58) | over 52 weeks | Seizure frequency was assessed by investigators in the CRF at the Visits V3, V4, V5 and V6. The absolute seizure frequency during the maintenance phase was defined as the sum of those entries. |
| Secondary | Proportion of Seizure-free Days During the Maintenance Phase for Subjects Who Enter the Maintenance Phase | 52 weeks | |
| Secondary | QOLIE-31 (Quality Of Life In Epilepsy) Results at V6 | 58 weeks, final visit | The QOLIE-31 is a 31 item score that measures the quality of life in epilepsy (each item with a range of 0 to 100). There are 7 sub-scores seizure worry (items 11,21,22,23,25), overall quality of life (items 1,14), emotional well-being (items 3,4,5,7,9), energy/fatigue (items 2,6,8,10), cognitive functioning (items 12,15,16,17,18,26), medication effects (items 24,29,30) and social functioning (13,19,20,27,28). These scores were combined to a total score by Total score = seizure worry\*0.08 + overall quality of life\*0.14 + emotional well-being\*0.15 + energy/fatigue\*0.12 + cognitive functioning\*0.27 + medication effects\*0.03 + social functioning\*0.21 For all scores, higher values indicate better quality of life. Each score has a possible range from 0 to 100. |
| Secondary | Portland Neurotoxicity Scale (PNS) at V6 | at week 58 | The PNS is a 15-item scale. Each item can be scored from 1 to 9. There are a total score (includes all items, range:15 to 135) and two subscores: The cognitive toxicity subscore (10 items: Energy Level, Memory, Interest, Concentration, Forgetfulness, Sleepliness, Moodiness, Alertness, Attention Span, Motivation, range:10 to 90) and the somatomoto subscore (5 items: Vision, Walking, Coordination, Tremor, Speech, range:5-45). The score is calculated by taking the mean of all non-missing values times the number of items. Lower values indicate better quality of life. |
| Secondary | Results of Cognitive Testing (EpiTrack© by UCB) - Score at V6 | week 58 | EPITrack-Score shows the performance of attention and executive functions. Higher values indicate a better performance. The results of EPITrack Score ranges between 7 and 45. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 58-week Retention Rate Measured by the Number of Drop Outs Due to Adverse Events or Seizures From Day 1 of Treatment | 58 weeks | ITT population:~All randomized patients were included in the Intention-to-Treat (ITT) population except patients that were not evaluable for efficacy e.g. patients without epilepsy or patients not able to comply with the study requirements. | proportion of participants | MEAN |
| SECONDARY | Time to Drop Out | 58 weeks | ITT population:~All randomized patients were included in the Intention-to-Treat (ITT) population except patients that were not evaluable for efficacy e.g. patients without epilepsy or patients not able to comply with the study requirements. | days | MEDIAN |
| SECONDARY | Percentage of Patients Remaining Seizure-free at Week 30 (Visit 4) | Week 30 | ITT population:~All randomized patients were included in the Intention-to-Treat (ITT) population except patients that were not evaluable for efficacy e.g. patients without epilepsy or patients not able to comply with the study requirements. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Patients Remaining Seizure Free at Week 58 (Visit 6) | week 58 | ITT population:~All randomized patients were included in the Intention-to-Treat (ITT) population except patients that were not evaluable for efficacy e.g. patients without epilepsy or patients not able to comply with the study requirements. | percentage of participants | NUMBER |
| SECONDARY | The Time (in Days) to First Break-through Seizure (From Day 1 of Treatment) | over the whole duration of 58 weeks | ITT population:~All randomized patients were included in the Intention-to-Treat (ITT) population except patients that were not evaluable for efficacy e.g. patients without epilepsy or patients not able to comply with the study requirements. | days | MEDIAN |
| SECONDARY | The Absolute Seizure Frequency During the Maintenance Phase (Weeks 7 - 58) | over 52 weeks | Completer population:~The completer population comprises all patients still being in the study at week 58 (This definition deviates minimally from the protocol. It could not be assessed from the CRF data, if patients were on treatment). | number of seizures | NUMBER |
| SECONDARY | Proportion of Seizure-free Days During the Maintenance Phase for Subjects Who Enter the Maintenance Phase | 52 weeks | Patients of ITT population who reached the maintenance phase | proportion of seizure-free days | NUMBER |
| SECONDARY | QOLIE-31 (Quality Of Life In Epilepsy) Results at V6 | 58 weeks, final visit | Patients of ITT population who filled out QOLIE-31 at V6 | units on a scale | MEAN |
| SECONDARY | Portland Neurotoxicity Scale (PNS) at V6 | at week 58 | Patients of ITT population who filled out PNS at V6 | units on a scale | MEAN |
| SECONDARY | Results of Cognitive Testing (EpiTrack© by UCB) - Score at V6 | week 58 | Patients of ITT population who had data at V6 | units on a scale | MEAN |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group78
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 58-week Retention Rate Measured by the Number of Drop Outs Due to Adverse Events or Seizures From Day 1 of Treatment | Levetiracetam | 0.61 | 95% Confidence Interval 0.53 to 0.70 | proportion of participants | |
| 58-week Retention Rate Measured by the Number of Drop Outs Due to Adverse Events or Seizures From Day 1 of Treatment | Carbamazepine | 0.46 | 95% Confidence Interval 0.37 to 0.55 | proportion of participants | |
| 58-week Retention Rate Measured by the Number of Drop Outs Due to Adverse Events or Seizures From Day 1 of Treatment | Lamotrigine | 0.56 | 95% Confidence Interval 0.47 to 0.65 | proportion of participants | |
| Time to Drop Out | Levetiracetam | NA | 95% Confidence Interval NA to NA | days | |
| Time to Drop Out | Carbamazepine | 265 | 95% Confidence Interval 119 to NA | days | |
| Time to Drop Out | Lamotrigine | NA | 95% Confidence Interval 270 to NA | days | |
| Percentage of Patients Remaining Seizure-free at Week 30 (Visit 4) | Levetiracetam | 48 | percentage of participants | ||
| Percentage of Patients Remaining Seizure-free at Week 30 (Visit 4) | Carbamazepine | 39 | percentage of participants | ||
| Percentage of Patients Remaining Seizure-free at Week 30 (Visit 4) | Lamotrigine | 49 | percentage of participants | ||
| Percentage of Patients Remaining Seizure Free at Week 58 (Visit 6) | Levetiracetam | 43 | percentage of participants |
1 to 10 of 78Source ClinicalTrials.gov
See all 78 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Levetiracetam | 122 | |
| Overall Study | STARTED | Carbamazepine | 121 | |
| Overall Study | STARTED | Lamotrigine | 118 | |
| Overall Study | Safety Population | Levetiracetam | 122 | |
| Overall Study | Safety Population | Carbamazepine | 121 | |
| Overall Study | Safety Population | Lamotrigine | 117 | |
| Overall Study | ITT Population | Levetiracetam | 122 | |
| Overall Study | ITT Population | Carbamazepine | 120 | |
| Overall Study | ITT Population | Lamotrigine | 117 | |
| Overall Study | Maintenance Phase (Week 7-58) | Levetiracetam | 93 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events435
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 | Constipation | Gastrointestinal disorders | Levetiracetam | 2 | 122 | 2 |
| other | Constipation | Gastrointestinal disorders | Carbamazepine | 15 | 121 | 16 |
| other | Constipation | Gastrointestinal disorders | Lamotrigine | 5 | 117 | 5 |
| other | Diarrhoea | Gastrointestinal disorders | Levetiracetam | 9 | 122 | 11 |
| other | Diarrhoea | Gastrointestinal disorders | Carbamazepine | 13 | 121 | 14 |
| other | Diarrhoea | Gastrointestinal disorders | Lamotrigine | 14 | 117 | 17 |
| other | Dry mouth | Gastrointestinal disorders | Levetiracetam | 1 | 122 | 1 |
| other | Dry mouth | Gastrointestinal disorders | Carbamazepine | 5 | 121 | 5 |
| other | Dry mouth | Gastrointestinal disorders | Lamotrigine | 7 | 117 | 8 |
| other | Nausea | Gastrointestinal disorders | Levetiracetam | 11 | 122 | 15 |
1 to 10 of 435Source ClinicalTrials.gov
See all 435 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Levetiracetam | ||
| Total, all-cause mortality | Carbamazepine | ||
| Total, all-cause mortality | Lamotrigine | ||
| Total, other adverse events | Levetiracetam | 108 | 122 |
| Total, other adverse events | Carbamazepine | 108 | 121 |
| Total, other adverse events | Lamotrigine | 110 | 117 |
| Total, serious adverse events | Levetiracetam | 33 | 122 |
| Total, serious adverse events | Carbamazepine | 36 | 121 |
| Total, serious adverse events | Lamotrigine | 32 | 117 |
Source ClinicalTrials.gov
Papers3
The papers the trial lists on ClinicalTrials.gov.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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.
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