Monotherapy With Levetiracetam in Patients Suffering From Epilepsy.

This study has been completed.
Sponsor:
Information provided by:
UCB, Inc.
ClinicalTrials.gov Identifier:
NCT00150813
First received: September 6, 2005
Last updated: December 5, 2013
Last verified: September 2009
  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: 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, Inc.:

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

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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, Inc.
Investigators
Study Director: UCB Clinical Trial Call Center UCB, Inc.
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00150813     History of Changes
Other Study ID Numbers: N01127
Study First Received: September 6, 2005
Last Updated: December 5, 2013
Health Authority: Czech Republic: State Institute for Drug Control
Hungary: National Institute of Pharmacy
Poland: Ministry of Health
Sweden: Medical Products Agency

Keywords provided by UCB, Inc.:
Monotherapy, epilepsy
Keppra, levetiracetam

Additional relevant MeSH terms:
Epilepsy
Epilepsy, Tonic-Clonic
Epilepsy, Generalized
Stress, Psychological
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Behavioral Symptoms
Etiracetam
Piracetam
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Nootropic Agents
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 01, 2014