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NCT01898676: Epilepsy
An Open Label, Randomized, Four-period, Two-sequence, Fully Replicated, Single-dose, Crossover Study of the Relative Bioavailability of Two Formulations of Extended-release Divalproex Sodium Tablets in Fed Patients With Stable Epilepsy.
Phase 1 trial testing Divalproex Sodium Extended-release 250mg in Epilepsy in 16 participants. Status unknown.
1 August 2013
Quick facts
| Lead sponsor | Vince & Associates Clinical Research, Inc. |
|---|---|
| Phase | Phase 1 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | diagnostic |
| Enrollment | 16 |
| Start date | 1 July 2013 |
| Primary completion | 1 August 2013 |
| Estimated completion | 1 December 2013 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Divalproex Sodium Extended-release 250mg — full drug profile →
- DEPAKOTE 250mg — full drug profile →
Conditions studied
- Epilepsy — all drugs for Epilepsy →
Sponsor
Vince & Associates Clinical Research, Inc.
Who can join
Adults 18 to 55, any sex, with Epilepsy. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Evaluate generic divalproex sodium extended release to Depakote ER
Time frame: Approximately 2.5 months
This is an open-label, randomized, two-sequence, two-treatment, single dose, four-period, fully replicated crossover study in which 16 subjects will receive one of the two study drugs, Depakote ER or a generic equivalent, during each treatment period. Subjects will be patients with epilepsy who are otherwise healthy and who are stable on anti-epileptic therapy, not including any formulation of div
Sponsor's own description
A study in stable epilepsy patients comparing levels of valproic acid after administration of brand and generic divalproex sodium extended release tablets.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT01898676
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Epilepsy
Currently open trials in the same condition.
- NCT07095933 — The Safety and Efficacy Evaluation of Everolimus as an Adjunctive Treatment for Focal Refractory Epilepsy · EARLY_PHASE1 · recruiting
- NCT07224191 — Hippocampal Oscillations During Exploration · NA · recruiting
- NCT07219407 — A Long-term Study of the Safety and Effectiveness of RAP-219 in Adults With Focal Onset Seizures · Phase 2 · recruiting
- NCT07417280 — LIFUS For Neurological Disorders · NA · recruiting
- NCT07490769 — Levetiracetam Three Times Daily in Epilepsy · Phase 3 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01898676 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Vince & Associates Clinical Research, Inc.
- Last refreshed: 9 July 2013
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01898676.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing