Monotherapy With Levetiracetam in Patients Suffering From Epilepsy.

Epilepsy, Tonic-clonic Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00150813
• Other study ID #: N01127
• Status: Completed
• Phase: Phase 3
• Start date: August 10, 2005
• Est. completion date: May 29, 2007

Study information

• Verified date: October 2018
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: May 29, 2007
• Est. primary completion date: May 29, 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Epilepsy
• Epilepsy, Generalized
• Epilepsy, Tonic-clonic

Intervention

Drug:
• Levetiracetam
Pharmaceutical form: oral tablets Route of administration: Oral use

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
UCB Pharma SA

Countries where clinical trial is conducted

Czechia,  Hungary,  Poland,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	From the Entry Visit until up to 2 weeks after the last drug intake, up to 93 weeks

External Links

•   Clinical Study Summary on UCB.com
•   FDA Safety Alerts and Recalls