Study of Rufinamide in Pediatric Subjects 1 to Less Than 4 Years of Age With Lennox-Gastaut Syndrome Inadequately Controlled With Other Anti-epileptic Drugs

PHASE3CompletedINTERVENTIONAL
Enrollment

37

Participants

Timeline

Start Date

June 16, 2011

Primary Completion Date

November 2, 2015

Study Completion Date

November 2, 2015

Conditions
Lennox-Gastaut Syndrome
Interventions
DRUG

Rufinamide

Rufinamide up to 45 mg/kg/day, in 2 divided doses, administered as oral suspension (40 mg/mL) as an add-on to the subject's existing regimen of 1-3 antiepileptic drugs (AEDs)

DRUG

Any other approved Antiepileptic Drug

Any other approved AED: any other approved AED of the investigator's choice as an add-on to the subject's existing regimen of 1-3 anti-epileptic drugs (AEDs)

Trial Locations (47)

14642

Rochester

15224

Pittsburgh

19104

Philadelphia

20010

Washington D.C.

23510

Norfolk

30912

Augusta

32561

Gulf Breeze

33414

Wellington

33609

Tampa

40536

Lexington

43205

Columbus

44308

Akson

46100

Mantova

60637

Chicago

71103

Shreveport

78258

San Antonio

78723

Austin

80045

Aurora

84131

Salerno

92123

San Diego

Unknown

Miami

Akron

Bron

Marseille

Paris

Ambelokipi Athens

Pátrai

Pendeli Athens

Thessaloniki

Mantova

Calambrone

Pisa

Pavia

Elblag

Gdansk

Kielce

Poznan

Warsaw

Cape Town

03756

Lebanon

08026

Gibbsboro

T2T 5C7

Calgary

T6G 2B7

Edmonton

M2K 2W2

Toronto

S7N 0W8

Saskatoon

'00165

Roma

35-301

Rzeszów

All Listed Sponsors
lead

Eisai Inc.

INDUSTRY

NCT01405053 - Study of Rufinamide in Pediatric Subjects 1 to Less Than 4 Years of Age With Lennox-Gastaut Syndrome Inadequately Controlled With Other Anti-epileptic Drugs | Biotech Hunter | Biotech Hunter