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NCT01749046
Double-blind, Placebo-controlled Clinical Study to Evaluate the Efficacy, Safety and Tolerability of a Fixed Dose of Remegal as Adjunctive Therapy in Patients With Partial Seizures
Phase 3 trial testing Remegal in Epilepsy in 224 participants. Completed in 1 December 2013.
1 October 2013
Quick facts
| Lead sponsor | Valexfarm |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 224 |
| Start date | 1 March 2012 |
| Primary completion | 1 October 2013 |
| Estimated completion | 1 December 2013 |
| Sites | 9 locations across Russia |
Drugs / interventions tested
- Remegal — full drug profile →
Conditions studied
- Epilepsy — all drugs for Epilepsy →
- Simple Partial Seizures — all drugs for Simple Partial Seizures →
- Complex Partial Seizures — all drugs for Complex Partial Seizures →
- Partial Seizures With Secondary Generalization — all drugs for Partial Seizures With Secondary Generalization →
Sponsor
Valexfarm — full company profile →
Who can join
Adults 18 to 65, any sex, with Epilepsy or Simple Partial Seizures. 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.
-
Seizure Frequency Reduction
Time frame: 12 weeks
The assessment of efficacy will be based on the reduction of total partial seizure frequency reported in the patient's diary during the Treatment phase.
Sponsor's own description
The purpose of this study is to determine weather Remegal in fixed dosage 1500 mg/daily is effictive and safe in patients with epilepsy with partial seizures
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Developing a Conceptual Disease Model of Patient Experiences and Identifying Patient-Reported Clinical Outcome Assessments for Use in Trials of Treatments for Focal Onset Seizures.
Oberdhan D, Bacci E, Hill JN, Palsgrove A, et al · · 2022 · cited 2× · PMID 35345602 · DOI 10.2147/ndt.s354031
Verify or expand the search:
- PubMed search for NCT01749046
- 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 NCT01749046 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Valexfarm
- Last refreshed: 10 May 2017
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/NCT01749046.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing