Back to resultsMonotherapy With Levetiracetam in Patients Suffering From Epilepsy.
Primary Purpose
Epilepsy, Tonic-clonic
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Levetiracetam
Sponsored by
About this trial
This is an interventional treatment trial for Epilepsy, Tonic-clonic focused on measuring Monotherapy, Epilepsy, Keppra, Levetiracetam
Eligibility 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 [NCT00150735] or N01093 [NCT00150787]). Male/female subjects (>= 16 years). Exclusion Criteria: - Need for an additional Antiepileptic Drug (AED).
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Levetiracetam
Arm Description
Subjects received open-label Levetiracetam.
Outcomes
Primary Outcome Measures
Percentage Participants With Treatment Emergent Adverse Events
An Adverse Event (AE) is any untoward medical occurrence (eg, noxious or pathological changes) in a subject or clinical investigation subject compared with pre-existing conditions, that occurs during any period of a clinical trial. An AE is defined as being independent of assumption of any causality (eg, to study or concomitant medication, primary or concomitant disease, or study design).
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00150813
Brief Title
Monotherapy With Levetiracetam in Patients Suffering From Epilepsy.
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 Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
August 10, 2005 (Actual)
Primary Completion Date
May 29, 2007 (Actual)
Study Completion Date
May 29, 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UCB Pharma SA
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
An open-label follow-up trial assessing the long term safety of levetiracetam as per adverse events reporting.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy, Tonic-clonic
Keywords
Monotherapy, Epilepsy, Keppra, Levetiracetam
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
66 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Levetiracetam
Arm Type
Experimental
Arm Description
Subjects received open-label Levetiracetam.
Intervention Type
Drug
Intervention Name(s)
Levetiracetam
Other Intervention Name(s)
Keppra
Intervention Description
Pharmaceutical form: oral tablets Route of administration: Oral use
Primary Outcome Measure Information:
Title
Percentage Participants With Treatment Emergent Adverse Events
Description
An Adverse Event (AE) is any untoward medical occurrence (eg, noxious or pathological changes) in a subject or clinical investigation subject compared with pre-existing conditions, that occurs during any period of a clinical trial. An AE is defined as being independent of assumption of any causality (eg, to study or concomitant medication, primary or concomitant disease, or study design).
Time Frame
From the Entry Visit until up to 2 weeks after the last drug intake, up to 93 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility 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 [NCT00150735] or N01093 [NCT00150787]).
Male/female subjects (>= 16 years).
Exclusion Criteria:
- Need for an additional Antiepileptic Drug (AED).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
UCB Cares
Organizational Affiliation
001 844 599 2273 (UCB)
Official's Role
Study Director
Facility Information:
City
Beroun
Country
Czechia
City
Brno
Country
Czechia
City
Ceske Budejovice
Country
Czechia
City
Praha 1
Country
Czechia
City
Praha 5
Country
Czechia
City
Rychnov nad Kneznou
Country
Czechia
City
Budapest
Country
Hungary
City
Debrecen
Country
Hungary
City
Pécs
Country
Hungary
City
Szeged
Country
Hungary
City
Białystok
Country
Poland
City
Gdańsk
Country
Poland
City
Katowice
Country
Poland
City
Lublin
Country
Poland
City
Szczecin
Country
Poland
City
Warszawa
Country
Poland
City
Łódź
Country
Poland
City
Göteborg
Country
Sweden
City
Helsingborg
Country
Sweden
City
Huddinge
Country
Sweden
City
Karlstad
Country
Sweden
City
Uppsala
Country
Sweden
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
http://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
Description
FDA Safety Alerts and Recalls
Learn more about this trial
Monotherapy With Levetiracetam in Patients Suffering From Epilepsy.
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