Follow up Trial for Keppra (Levetiracetam) as Monotherapy in Patients With Newly Diagnosed Epilepsy Coming From N01175 (NCT00175903).

UCB Pharma130 enrolled

Overview

For ethical reasons to give opportunity for adult subjects (≥16 or 18 years) suffering from newly diagnosed epilepsy who completed the therapeutic confirmatory, open-label trial N01175 (NCT00175903) conducted with levetiracetam in monotherapy and who benefited from the treatment, to receive treatment with levetiracetam until the monotherapy indication for levetiracetam is granted in Europe. To continue to assess safety of levetiracetam as per adverse event reporting and observation of weight changes.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

130

Conditions

Epilepsy

Interventions

LevetiracetamDRUG

500 mg oral tablets,1000 - 3000 mg/day, twice a day (BID), duration of the study

Eligibility

Sex: ALLMin age: 16 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Male/female adult subjects (≥ 16 or 18 years) * Diagnosis of epilepsy (all types of seizures may be included) * Subjects who completed N01175 (NCT00175903) trial and benefited from levetiracetam monotherapy Other inclusion criteria may apply Exclusion Criteria: * Subjects withdrawn from N01175 (NCT00175903) trial for any reason * Subjects who received treatment other than levetiracetam in N01175 (NCT00175903) trial * Subject requiring add-on antiepileptic treatment * Subjects from countries where levetiracetam is authorized for use as monotherapy in epilepsy treatment * Sexually active woman with childbearing potential who is not using a medically accepted birth control method

Locations (35)

Unnamed facility

Bruges, Belgium

Unnamed facility

Edegem, Belgium

Outcomes

Primary Outcomes

Assessment of Safety of Levetiracetam as Per Adverse Event (AE) Reporting in Open-label Therapy Phase

Summarization for occurrence of adverse events like number of subjects with any adverse events or drug related adverse events is provided (see categories).

Time frame: during open-label therapy phase of 18 months

Secondary Outcomes

Change From Baseline in Body Weight to Withdrawal or End of Study After 18 Months

Time frame: Start of open-label therapy (Baseline) to withdrawal or end of study after 18 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.