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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Bruges, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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Subjects withdrawn from N01175 (NCT00175903) trial for any reason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

Treatment and study plan

Levetiracetam

Drug

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

Primary outcomes

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

Time frame: 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 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

Sponsors and collaborators

Lead sponsor

UCB Pharma

Industry

Registry information

Official study title

A Multicenter, Open-label, Follow-up Trial Evaluating the Long-term Safety of Levetiracetam, for Patients Suffering From Epilepsy and Coming From the Study N01175 (NCT00175903).

Important dates

Study start: 2006
Primary completion: 2008
Study completion: 2008
First posted: Feb 14, 2006
Registry last updated: May 18, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed