Monotherapy With Levetiracetam in Patients Suffering From Epilepsy.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00150813
Recruitment Status : Completed
First Posted : September 8, 2005
Last Update Posted : December 6, 2013
Information provided by:
UCB Pharma

Brief Summary:
An open-label follow-up trial assessing the long term safety of levetiracetam as per adverse events reporting.

Condition or disease Intervention/treatment Phase
Epilepsy, Tonic-clonic Drug: LEVETIRACETAM Phase 3

Study Type : Interventional  (Clinical Trial)
Enrollment : 70 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Open-label, Follow-up Trial Evaluating the Long-term Safety of Levetiracetam Individualized Dose From 1000 to 3000 mg/Day (Oral Tablets of 500 mg b.i.d.), Used as Monotherapy in Subjects (≥ 16 Years) Suffering From Epilepsy and Coming From the N01061 or the N01093 Trials.
Study Start Date : August 2005
Actual Primary Completion Date : May 2007
Actual Study Completion Date : May 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy
U.S. FDA Resources

Primary Outcome Measures :
  1. Around 4 years of Safety assessment of levetiracetam via Adverse Events reporting,

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Subjects with a confirmed diagnosis of epilepsy.
  • Subjects having experienced in the past unprovoked partial seizures (IA, IB, IC with clear focal origin),or generalized tonic-clonic seizures (without clear focal origin), that are classifiable according to the International Classification of Epileptic Seizures
  • Subjects having participated in the previous double-blind monotherapy trial (N01061 or N01093).
  • Male/female subjects (≥ 16 years).

Exclusion Criteria:

  • Need for an additional AED.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00150813

Czech Republic
Beroun, Czech Republic
Brno, Czech Republic
Ceske Budejovice, Czech Republic
Praha 1, Czech Republic
Praha 5, Czech Republic
Rychnov nad Kneznou, Czech Republic
Budapest, Hungary
Debrecen, Hungary
Pécs, Hungary
Szeged, Hungary
Białystok, Poland
Gdańsk, Poland
Katowice, Poland
Lublin, Poland
Szczecin, Poland
Warszawa, Poland
Łódź, Poland
Göteborg, Sweden
Helsingborg, Sweden
Huddinge, Sweden
Karlstad, Sweden
Uppsala, Sweden
Sponsors and Collaborators
UCB Pharma
Study Director: UCB Clinical Trial Call Center UCB Pharma

Additional Information: Identifier: NCT00150813     History of Changes
Other Study ID Numbers: N01127
First Posted: September 8, 2005    Key Record Dates
Last Update Posted: December 6, 2013
Last Verified: September 2009

Keywords provided by UCB Pharma:
Monotherapy, epilepsy
Keppra, levetiracetam

Additional relevant MeSH terms:
Epilepsy, Generalized
Epilepsy, Tonic-Clonic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Nootropic Agents
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs