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Monotherapy With Levetiracetam in Patients Suffering From Epilepsy.

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00150813
First Posted: September 8, 2005
Last Update Posted: December 6, 2013
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.
Information provided by:
UCB Pharma
  Purpose
An open-label follow-up trial assessing the long term safety of levetiracetam as per adverse events reporting.

Condition Intervention Phase
Epilepsy, Tonic-clonic Drug: LEVETIRACETAM Phase 3

Study Type: Interventional
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by UCB Pharma:

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

Estimated Enrollment: 70
Study Start Date: August 2005
Study Completion Date: May 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
  Eligibility

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
Criteria

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.
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00150813


Locations
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
Hungary
Budapest, Hungary
Debrecen, Hungary
Pécs, Hungary
Szeged, Hungary
Poland
Białystok, Poland
Gdańsk, Poland
Katowice, Poland
Lublin, Poland
Szczecin, Poland
Warszawa, Poland
Łódź, Poland
Sweden
Göteborg, Sweden
Helsingborg, Sweden
Huddinge, Sweden
Karlstad, Sweden
Uppsala, Sweden
Sponsors and Collaborators
UCB Pharma
Investigators
Study Director: UCB Clinical Trial Call Center UCB Pharma
  More Information

Additional Information:
ClinicalTrials.gov Identifier: NCT00150813     History of Changes
Other Study ID Numbers: N01127
First Submitted: September 6, 2005
First Posted: September 8, 2005
Last Update Posted: December 6, 2013
Last Verified: September 2009

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

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