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

Phase 3

Completed

• Conditions: Epilepsy
• Interventions: Drug: Levetiracetam

• Registration Number: NCT00291655
• Lead Sponsor: UCB Pharma

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-02-10
• Study First Submitted QC: 2006-02-10
• Study First Posted: 2006-02-14
• Study Start: 2006-06
• Primary Completion: 2008-04
• Study Completion: 2008-04
• Results First Submitted: 2009-08-25
• Results First Submitted QC: 2009-10-09
• Results First Posted: 2009-11-13
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-29
• Last Update Posted: 2015-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

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• Subjects withdrawn from N01175 (NCT00175903) trial for any reason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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Levetiracetam (LEV)	Levetiracetam	-

Primary Outcome Measures

Name	Time	Method
Assessment of Safety of Levetiracetam as Per Adverse Event (AE) Reporting in Open-label Therapy Phase	during open-label therapy phase of 18 months	Summarization for occurrence of adverse events like number of subjects with any adverse events or drug related adverse events is provided (see categories).

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Body Weight to Withdrawal or End of Study After 18 Months	Start of open-label therapy (Baseline) to withdrawal or end of study after 18 months