Study to Evaluate the Safety and Effectiveness of USL255 in Patients With Refractory Partial-onset Seizures

U

Upsher-Smith Laboratories

Status and phase

Completed
Phase 3

Conditions

Epilepsy

Treatments

Drug: USL255
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01142193
P09-004
2009-016996-31 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study is to examine the safety and effectiveness of USL255 as adjunctive therapy in patients with refractory partial onset-seizures.

Enrollment

249 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Subject has a confirmed diagnosis of partial-onset seizures with or without secondary generalization for at least 12 months prior to Visit 1.
  • Currently on a stable dosing regimen of 1 to 3 AEDs for at least 4-weeks prior to Visit 1 (12 weeks for phenobarbital and primidone).
  • Have a minimum of 8 partial-onset seizures and no more than 21 consecutive seizure free days, during the 8-week baseline.

Exclusion criteria

  • Have a history of seizure episodes lasting less than 30 minutes in which several seizures occur with such frequency that the initiation and completion of each individual seizure cannot be distinguished, within 3 months prior to Visit 1.
  • Have a history of pseudoseizures, or status epilepticus, within 3 months prior to Visit 1.
  • Have a history of metabolic acidosis, nephrolithiasis, ureterolithiasis, or narrow angle glaucoma.
  • Have a history of suicidal attempts, suicidal ideation, or uncontrolled psychiatric illness within 2 years of Visit 1.
  • Currently taking, or have taken felbamate within the past 18 months, or have taken vigabatrin in the past.
  • Have taken topiramate within the past 6 months.

Trial design

249 participants in 2 patient groups, including a placebo group

USL255
Experimental group
Treatment:
Drug: USL255
Placebo
Placebo Comparator group
Treatment:
Drug: Placebo

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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