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Monotherapy With Levetiracetam in Patients Suffering From Epilepsy.

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ClinicalTrials.gov Identifier: NCT00150813
Recruitment Status : Completed
First Posted : September 8, 2005
Results First Posted : October 1, 2018
Last Update Posted : November 21, 2018
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB Pharma SA )

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 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.
Actual Study Start Date : August 10, 2005
Actual Primary Completion Date : May 29, 2007
Actual Study Completion Date : May 29, 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy

Arm Intervention/treatment
Experimental: Levetiracetam
Subjects received open-label Levetiracetam.
Drug: Levetiracetam
Pharmaceutical form: oral tablets Route of administration: Oral use
Other Name: Keppra




Primary Outcome Measures :
  1. Percentage Participants With Treatment Emergent Adverse Events [ Time Frame: From the Entry Visit until up to 2 weeks after the last drug intake, up to 93 weeks ]
    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).



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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
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 [NCT00150735] or N01093 [NCT00150787]).
  • Male/female subjects (>= 16 years).

Exclusion Criteria:

- Need for an additional Antiepileptic Drug (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 ClinicalTrials.gov identifier (NCT number): NCT00150813


Locations
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Czechia
Beroun, Czechia
Brno, Czechia
Ceske Budejovice, Czechia
Praha 1, Czechia
Praha 5, Czechia
Rychnov nad Kneznou, Czechia
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 SA
Investigators
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Study Director: UCB Cares 001 844 599 2273 (UCB)

Additional Information:
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Responsible Party: UCB Pharma SA
ClinicalTrials.gov Identifier: NCT00150813     History of Changes
Other Study ID Numbers: N01127
First Posted: September 8, 2005    Key Record Dates
Results First Posted: October 1, 2018
Last Update Posted: November 21, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by UCB Pharma ( UCB Pharma SA ):
Monotherapy
Epilepsy
Keppra
Levetiracetam
Additional relevant MeSH terms:
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Epilepsy
Epilepsy, Tonic-Clonic
Epilepsy, Generalized
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Levetiracetam
Anticonvulsants
Nootropic Agents