Trial to Evaluate the Safety and Efficacy of Keppra After Conversion to Mono-therapy in Subjects With Partial Epilepsy

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UCB

Status and phase

Completed
Phase 4

Conditions

Epilepsy

Treatments

Drug: Levetiracetam (Keppra)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00630357
N01037

Details and patient eligibility

About

A cohort of patients who became seizure-free during add-on treatment to one standard AED with Keppra in a previous trial (N01031) were followed to assess whether seizure freedom was maintained. Tolerability was documented.

Enrollment

14 patients

Sex

All

Ages

16+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Diagnosis of epilepsy with partial seizures;
  • having completed the trial N01031 of Keppra as adjunctive therapy (SKATE);
  • seizure-free over the last 3 months prior to protocol Visit 1;
  • 1 concomitant marketed AED at the time of trial entry and throughout the previous trial N01031;
  • on the clinical judgment of the Investigator, progressive withdrawal of the concomitant AED and conversion to monotherapy with Keppra can be attempted.

Exclusion criteria

  • History of suicide attempt, current suicidal ideation, or other serious psychiatric disorders requiring or having required hospitalization or medication within the previous 5 years;
  • presence of known pseudoseizures within the last year;
  • presence or history of allergy to the components of Keppra (levetiracetam, lactose, cornstarch, and excipients) or other pyrrolidine derivatives;
  • felbamate with less than 18 months exposure;
  • vigabatrin, without visual field assessment as per recommendation of the manufacturer, i.e., every 6 months;
  • uncountable seizures (clusters) or history of convulsive status epilepticus within the last 5 years.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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