Follow on study for participants involved in the P09- 004 Study which examines if USL255 is safe in patients with refractory partial-onset seizures

• Register: EUCTR
• Last refreshed on: 21 August 2017
• Main ID: EUCTR2009-017904-95-BE
• Date of registration: 13/04/2010
• Prospective Registration: Yes
• Primary sponsor: Upsher-Smith Laboratories, Inc.
• Public title: Follow on study for participants involved in the P09- 004 Study which examines if USL255 is safe in patients with refractory partial-onset seizures
• Scientific title: 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: 28/06/2010
• Target sample size: 275
• 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: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: no Number of treatment arms in the trial: 1
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

Argentina, Australia, Belgium, Canada, Chile, Germany, Greece, Hungary, India, Israel, New Zealand, Poland, Russian Federation, South Africa, Spain, United States

Contacts

• Name: Clinical Development
• Affiliation: Upsher-Smith Laboratories, Inc.

• Name: Clinical Development
• Affiliation: Upsher-Smith Laboratories, Inc.

Key inclusion & exclusion criteria

Inclusion criteria:
• Have completed the maintenance period of the P09-004 study, unless otherwise approved by the sponsor.
• Continue to be treated with a stable dose of 1 to a maximum of 3 approved concomitant AEDs.

Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 227
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 48

Exclusion criteria:
n/a


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

Health Condition(s) or Problem(s) studied

Refractory partial-onset seizures with or without secondary generalization
MedDRA version: 14.0 Level: PT Classification code 10056209 Term: Partial seizures with secondary generalisation System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 14.0 Level: LLT Classification code 10034090 Term: Partial seizures, complex System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 14.0 Level: PT Classification code 10040703 Term: Simple partial seizures System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 14.0 Level: LLT Classification code 10048674 Term: Partial seizures with secondary generalization System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 14.0 Level: PT Classification code 10010145 Term: Complex partial seizures System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 14.0 Level: LLT Classification code 10034091 Term: Partial seizures, simple System Organ Class: 10029205 - Nervous system disorders

Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Intervention(s)

Product Name: Topiramate extended-release
Product Code: USL255
Pharmaceutical Form: Capsule
INN or Proposed INN: Topiramate
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: Topiramate extended-release
Product Code: USL255
Pharmaceutical Form: Capsule
INN or Proposed INN: Topiramate
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: Topiramate extended-release
Product Code: USL255
Pharmaceutical Form: Capsule
INN or Proposed INN: Topiramate
CAS Number: 97240-79-4
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-

Primary Outcome(s)

Primary end point(s):

Main Objective: The primary objective is to evaluate the safety and tolerability of USL255 (up to 400mg/day) given as adjunctive treatment in subjects with refractory partial-onset seizures with or without secondary generalization.

Secondary Objective: The secondary objective is to assess seizure frequency in subjects with refractory partial-onset seizures with or without secondary generalization receiving open-label USL255.

Secondary ID(s)

NCT01191086

P09-005

Source(s) of Monetary Support

Upsher-Smith Laboratories, Inc.