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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	EUCTR
Last refreshed on:	28 August 2014
Main ID:	EUCTR2009-017904-95-ES
Date of registration:	26/05/2010
Prospective Registration:	Yes
Primary sponsor:	Upsher-Smith Laboratories, Inc.
Public title:	Estudio abierto de extensión para evaluar la seguridad de USL255 como terapia adyuvante en pacientes con crisis de inicio parcial refractarias que habían participado en el P09-004, un estudio en fase 3 aleatorizado, multicéntrico, doble ciego, controlado con placebo y de grupos paralelos. Open-Label Extension Study to Evaluate the Safety of USL255 as Adjunctive Therapy in Patients with Refractory Partial-Onset Seizures who had Participated in P09-004, a Randomized, Multicenter, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study
Scientific title:	Estudio abierto de extensión para evaluar la seguridad de USL255 como terapia adyuvante en pacientes con crisis de inicio parcial refractarias que habían participado en el P09-004, un estudio en fase 3 aleatorizado, multicéntrico, doble ciego, controlado con placebo y de grupos paralelos. Open-Label Extension Study to Evaluate the Safety of USL255 as Adjunctive Therapy in Patients with Refractory Partial-Onset Seizures who had Participated in P09-004, a Randomized, Multicenter, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Study
Date of first enrolment:	22/07/2010
Target sample size:	172
Recruitment status:	Not Recruiting
URL:	https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-017904-95
Study type:	Interventional clinical trial of medicinal product
Study design:	Controlled: no Randomised: Open: Single blind: Double blind: Parallel group: Cross over: Other: If controlled, specify comparator, Other Medicinial Product: Placebo: Other:
Phase:

Countries of recruitment
Belgium	Germany	Greece	Hungary	Spain

Contacts

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Key inclusion & exclusion criteria

Inclusion criteria:
? Los sujetos han completado el período de mantenimiento del estudio P09-004, salvo que el promotor apruebe lo contrario.
? Los sujetos siguen en tratamiento con una dosis estable de 1 a un máximo de 3 AE concomitantes aprobados.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
No aplica.

Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Crisis de inicio parcial refractarias con o sin generalización secundaria. Refractory partial-onset seizures with or without secondary generalization.
MedDRA version: 12.1 Level: LLT Classification code 10034090 Term: Partial seizures, complex
MedDRA version: 12.1 Level: LLT Classification code 10034091 Term: Partial seizures, simple
MedDRA version: 12.1 Level: LLT Classification code 10040703 Term: Simple partial seizures
MedDRA version: 12.1 Level: PT Classification code 10056209 Term: Partial seizures with secondary generalisation
MedDRA version: 12.1 Level: LLT Classification code 10010145 Term: Complex partial seizures
MedDRA version: 12.1 Level: LLT Classification code 10048674 Term: Partial seizures with secondary generalization

Intervention(s)

Product Name: Topiramato de liberación prolongada
Product Code: USL225
Pharmaceutical Form: Capsule*
INN or Proposed INN: Topiramato
CAS Number: 97240-79-4
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use

Product Name: Topiramato de liberación prolongada
Product Code: USL225
Pharmaceutical Form: Capsule*
INN or Proposed INN: Topiramato
CAS Number: 97240-79-4
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 200-
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use

Product Name: Topiramato de liberación prolongada
Product Code: USL225
Pharmaceutical Form: Capsule*
INN or Proposed INN: Topiramato
CAS Number: 97240-79-4
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-

Primary Outcome(s)

Secondary Objective: El objetivo secundario es valorar la frecuencia de las crisis en sujetos con crisis de inicio parcial refractarias con o sin generalización secundaria que reciben USL255 en régimen abierto

Main Objective: El objetivo principal es evaluar la seguridad y la tolerabilidad de USL255 (hasta 400 mg/día) administrado como terapia adyuvante en sujetos con crisis de inicio parcial refractarias con o sin generalización secundaria.

Primary end point(s): No aplica.

Secondary Outcome(s)

Secondary ID(s)

2009-017904-95-BE

P09-005

Source(s) of Monetary Support

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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