Trial · NCT02429596
A Trial of Generic Substitution of Antiepileptic Drugs
NCT02429596, Phase 4, Unknown, IRCCS National Neurological Institute "C. Mondino" Foundation
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Trial of Generic Substitution of Antiepileptic Drugs. Trials, record NCT02429596. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02429596
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Trial of Generic Substitution of Antiepileptic Drugs
- NCT number
- NCT02429596
- Status
- Unknown
- Phases
- Phase 4
- Enrollment
- 200 participants, estimated
- Lead sponsor
- IRCCS National Neurological Institute "C. Mondino" Foundation
- Conditions
- Epilepsy
- Interventions
- Experimental
- First posted
- 2015-04-29
- Last updated
- 2015-04-29
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Serum drug concentration (25% change in serum drug concentration) | After six months | The primary outcome endpoint will be the proportion of patients who post-randomization show a greater than 25% change in serum drug concentration compared with baseline. When comparing differences in serum concentration between post-randomization and baseline, the mean of the two values (post-absorptive and trough) measured on each occasion will be used because this provides a more accurate estimate of relative bioavailability. |
| Secondary | Serum drug concentration (15% change in mean serum drug concentration) | After six months | proportion of patients who post-randomization will show a greater than 15% change in mean serum drug concentration compared with baseline |
| Secondary | Serum drug concentration (50% change in mean serum drug concentration) | After six months | proportion of patients who post-randomization will show a greater than 50% change in mean serum drug concentration compared with baseline |
| Secondary | Serum drug concentration (5, 25% and 50% change in either post-absorptive or trough serum drug concentration) | After six months | proportion of patients who will show a greater than 15, 25% and 50% change in either post-absorptive or trough serum drug concentration compared with baseline |
| Secondary | Serum drug concentration (distribution in individual serum drug concentrations) | After six months | distribution in individual serum drug concentrations post-randomization compared with baseline |
| Secondary | Serum drug concentration (mean percent change (and %CV) in serum drug concentration) | After six months | mean percent change (and %CV) in serum drug concentration post-randomization compared with baseline |
| Secondary | adverse events | After three years | proportion of patients with adverse events |
| Secondary | adverse events | After three years | adverse event (AEP) scores |
| Secondary | first seizure after randomization | After three years | interval elapsed between randomization and the first seizure |
| Secondary | products (by type of AED, specific product utilized, and type of switch (brand to generic and generic to generic) | After three years | the above outcome measures, by type of AED, specific product utilized, and type of switch (brand to generic and generic to generic). |
Source ClinicalTrials.gov
Outcomes0
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.
Papers13
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/NCT02429596
GET https://conductscience.org/api/trials/v1/NCT02429596/registered