Trial · NCT05450822
Precision Medicine in the Treatment of Epilepsy
NCT05450822, Recruiting, Gitte Moos Knudsen
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Precision Medicine in the Treatment of Epilepsy. Trials, record NCT05450822. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05450822
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Precision Medicine in the Treatment of Epilepsy
- NCT number
- NCT05450822
- Status
- Recruiting
- Enrollment
- 550 participants, estimated
- Lead sponsor
- Gitte Moos Knudsen
- Conditions
- Epilepsy
- Interventions
- Levetiracetam, Levetiracetam Tablets, Lamotrigine tablet
- First posted
- 2022-07-11
- Last updated
- 2024-04-11
Source ClinicalTrials.gov
Registered outcomes64
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Categorical effect of anti-seizure medication (ASM) on treatment outcome (Cohort II-III). | As change over time from the ASM evaluation period (after 4-7 weeks titration period) to six months, one, three and five years after for patients in cohort II-III. | 1\) Seizure-free within six months after starting ASM treatment and remained seizure-free for at least one year (last observed seizure within the six months after starting ASM treatment); 2) Seizure-free more than six months after starting ASM treatment and the seizure-free period lasts at least one year; 3) Fluctuations with both seizure-freedom and seizure-relapse; or 4) Never seizure-free for a year at the third- and fifth-year follow-up timepoint. |
| Primary | Categorical effect of a second seizure/epilepsy diagnosis for patients in Cohort I. | As change over time of epilepsy diagnosis at six months, one, three and five years after inclusion of patients in Cohort I. | The proportion of patients in Cohort I with one epileptic seizure who become diagnosed with epilepsy. |
| Secondary | Continuous treatment outcome using a seizure severity index (Cohort II-III). | As a monthly change over time from the ASM evaluation period (after 4-7 weeks titration period) to one, three and five years after for patients in cohort II-III. | Treatment outcome as percentage change in the Seizure Severity Questionnaire (SSQ). |
| Secondary | Continuous treatment outcome rating adverse events (Cohort II-III). | As a monthly change over time from baseline and one, three and five years after inclusion for patients in cohort II-III. | Treatment outcome as percentage change in the Liverpool Adverse Event Profile (LAEP). |
| Secondary | Continuous treatment outcome rating impression of change (Cohort II-III). | As a monthly change over time from the ASM evaluation period (after 4-7 weeks titration period) to one, three and five years after for patients in cohort II-III. | Treatment outcome as percentage change in in Patient's Global Impression of Change (PGIC). |
| Secondary | A continuous rating of depression diagnosis (Cohort I-III and healthy). | At baseline between groups (HCs and patients) and as change over time from baseline to one, three and five years after inclusion for patients in cohort I-III. | Percentage change in Major Depression Inventory (MDI). |
| Secondary | A continuous rating of depressive symptoms (Cohort I-III and healthy). | At baseline between groups (HCs and patients) and as change over time from baseline to one, three and five years after inclusion for patients in cohort I-III. | Percentage change in Inventory of Depressive Symptomatology (IDS-SR30). |
| Secondary | A continuous rating of specific depressive symptoms associated with neurological disease (Cohort I-III and healthy). | At baseline between groups (HCs and patients) and as a monthly change over time from baseline to one, three and five years after inclusion for patients in cohort I-III. | Percentage change in the Neurological Disorders Depression Inventory for Epilepsy (NDDI-E). |
| Secondary | Categorical outcome of psychiatric symptoms (Cohort I-III and healthy). | At baseline between groups (HCs and patients) and as change over time from baseline to one, three and five years after inclusion for patients in cohort I-III. | Psychopathology assessed by WHO International Classification of Diseases 10 (ICD-10) diagnostic classification and a semi-structured psychiatric, clinical interview. |
| Secondary | A continuous rating of symptoms of anxiety (Cohort I-III and healthy). | At baseline between groups (HCs and patients) and as a monthly change over time from baseline to one, three and five years after inclusion for patients in cohort I-III. | Percentage change in the Generalized Anxiety Disorder 7-item (GAD-7). |
1 to 10 of 64Source ClinicalTrials.gov
See all 64 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.
Papers193
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.
Tests6
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Complex Figure Copy and Recall | Secondary outcome | ConductCognition |
| Picture Naming Test | Secondary outcome | ConductCognition |
| Trail Making Test A | Secondary outcome | ConductCognition |
| Trail Making Test B | Secondary outcome | ConductCognition |
| Verbal Fluency | Secondary outcome | ConductCognition |
| Verbal Learning | Secondary outcome | ConductCognition |
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/NCT05450822
GET https://conductscience.org/api/trials/v1/NCT05450822/registered?page=2