Trial · NCT03048084
Seizure Treatment in Glioma
NCT03048084, Phase 4, Recruiting, Leiden University Medical Center
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Seizure Treatment in Glioma. Trials, record NCT03048084. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03048084
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Seizure Treatment in Glioma
- NCT number
- NCT03048084
- Status
- Recruiting
- Phases
- Phase 4
- Enrollment
- 120 participants, estimated
- Lead sponsor
- Leiden University Medical Center
- Conditions
- Glioma
- Interventions
- Levetiracetam, Valproic Acid
- First posted
- 2017-02-09
- Last updated
- 2026-08-26
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Ongoing seizure freedom at 6 months | 6 months | The percentage of patients with ongoing seizure freedom at 6 months |
| Secondary | Cumulative incidence of treatment failure for any reason | 36 months | Cumulative incidence function of time to treatment failure for any reason of ASM treatment using competing risk models with death as a competing event. |
| Secondary | Cumulative incidence of treatment failure for specific reasons | 36 months | Cumulative incidence function of time to treatment failure for specific reasons of ASM treatment using competing risk models with death and non-applicable reasons of failure as competing events. Reasons of failure: uncontrolled seizures, adverse effects, other reasons of treatment failure, and death |
| Secondary | Cumulative incidence of a first recurrent seizure | 36 months | Cumulative incidence function of time to occurrence of a first recurrent seizure after ASM initiation using competing risk models with death as a competing event. |
| Secondary | Adverse effects of the treatment | 0, 1, 3, 6, 9, 12, 15, 18, 21, 24, 30 and 36 months or 0, 1, 6, 12, 18, 24 and 30 months, depending on a 3-monthly or 6-monthly follow-up schedule respectively | Severity of adverse effects of the treatment, defined as severity (grade 1-5) of intolerable adverse effects leading to ASM discontinuation according to the Common Terminology Criteria for Adverse- Events (CTCAE) version 5.0 |
| Secondary | Hospitalisation rate | 0, 1, 3, 6, 9, 12, 15, 18, 21, 24, 30 and 36 months or 0, 1, 6, 12, 18, 24 and 30 months, depending on a 3-monthly or 6-monthly follow-up schedule respectively | hospitalization rate due to treatment failure |
| Secondary | Health-related quality of life | 0, 3, 6, 9, 12, 15, 18, 21, 24, 30 and 36 months or 0, 6, 12, 18, 24 and 30 months, depending on a 3-monthly or 6-monthly follow-up schedule respectively | Health-related quality of life |
| Secondary | Cognitive complaints | 0, 3, 6, 9, 12, 15, 18, 21, 24, 30 and 36 months or 0, 6, 12, 18, 24 and 30 months, depending on a 3-monthly or 6-monthly follow-up schedule respectively | Cognitive complaints using MOS-CFS scores |
| Secondary | Mood | 0, 3, 6, 9, 12, 15, 18, 21, 24, 30 and 36 months or 0, 6, 12, 18, 24 and 30 months, depending on a 3-monthly or 6-monthly follow-up schedule respectively | Anxiety and depression using HADS scale scores |
| Secondary | Performance Status | 0, 3, 6, 9, 12, 15, 18, 21, 24, 30 and 36 months or 0, 6, 12, 18, 24 and 30 months, depending on a 3-monthly or 6-monthly follow-up schedule respectively | Karnofsky Performance Status Score |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers2
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.
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/NCT03048084
GET https://conductscience.org/api/trials/v1/NCT03048084/registered