Monotherapy With Levetiracetam or Carbamazepine in Patients Suffering From Epilepsy.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-07-31

Study Completion Date

2005-11-30

Brief Summary

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A double-blind follow-up trial assessing the long term safety of Levetiracetam as per adverse events reporting, physical and neurological examination and vital signs

Detailed Description

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Conditions

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Epilepsy, Tonic-clonic

Keywords

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Monotherapy, epilepsy Levetiracetam Keppra

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

DOUBLE

Interventions

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LEVETIRACETAM

Intervention Type DRUG

Eligibility Criteria

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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 coming from the N01061 monotherapy trial and for whom double-blind continuation of investigational product is beneficial.

Exclusion Criteria

* Need for an additional AED.

Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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UCB Clinical Trial Call Center

Role: STUDY_DIRECTOR

UCB Pharma

References

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Brodie MJ, Perucca E, Ryvlin P, Ben-Menachem E, Meencke HJ; Levetiracetam Monotherapy Study Group. Comparison of levetiracetam and controlled-release carbamazepine in newly diagnosed epilepsy. Neurology. 2007 Feb 6;68(6):402-8. doi: 10.1212/01.wnl.0000252941.50833.4a.

Reference Type RESULT

PMID: 17283312 (View on PubMed)

Other Identifiers

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N01093

Identifier Type: -

Identifier Source: org_study_id