NCT01179854 is a Phase 2 clinical trial of Remegal in Drug Safety, sponsored by Valexfarm.

Who is sponsoring NCT01179854?

NCT01179854 is sponsored by Valexfarm.

What drugs are being tested in NCT01179854?

Interventions in NCT01179854: Remegal.

What condition does NCT01179854 study?

NCT01179854 studies Drug Safety, Normal Drug Tolerance, Self Efficacy.

Is NCT01179854 still recruiting?

NCT01179854 is currently completed. Last updated 10 May 2017.

Last reviewed 2017-05-10 · How we verify

NCT01179854

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Phase 2 Double-blind,Placebo-controlled Study for Evaluation of Efficiency, Safety,Tolerance and Pharmacokinetics of Different Doses of Remegal in Additional Therapy for Patients With Refractory Partial Seizures

Completed Phase 2 Last updated 10 May 2017

What this trial tests

Phase 2 trial testing Remegal in Drug Safety in 60 participants. Completed in 1 September 2011.

Timeline

1 September 2009

Primary endpoint
1 November 2010

1 September 2011

Quick facts

Lead sponsor	Valexfarm
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	60
Start date	1 September 2009
Primary completion	1 November 2010
Estimated completion	1 September 2011
Sites	4 locations across Russia

Drugs / interventions tested

Remegal — full drug profile →

Conditions studied

Drug Safety — all drugs for Drug Safety →
Normal Drug Tolerance — all drugs for Normal Drug Tolerance →
Self Efficacy — all drugs for Self Efficacy →

Sponsor

Valexfarm — full company profile →

Who can join

Adults 18 to 65, any sex, with Drug Safety or Normal Drug Tolerance. 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.

safety and tolerability
Time frame: Jan 2010 - Dec 2010
The primary objective of the study is to evaluate the safety and tolerability of Remegal administered concomitantly with 1 - 3 antiepileptic drugs (AEDs) in subjects who currently have uncontrolled partial seizures with or without secondary generalization.

Sponsor's own description

The purpose of this study is to determine weather different doses of Remegal are effective,safety and tolerant in Additional Therapy for Patients With Refractory Partial Seizures and pharmacokinetics definition

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01179854 (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 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/NCT01179854.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing