Monotherapy With Levetiracetam in Newly Diagnosed 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

580 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-06-30

Study Completion Date

2005-07-31

Brief Summary

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A double-blind trial comparing the efficacy and safety of levetiracetam to carbamazepine used as monotherapy in subjects (≥ 16 years) newly or recently diagnosed as suffering from epilepsy, and experiencing partial or generalized tonic-clonic seizures.

Detailed Description

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Conditions

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Generalized Epilepsy

Keywords

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Monotherapy, epilepsy, Levetiracetam, Keppra.

Study Design

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Allocation Method

NON_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 newly or recently diagnosed epilepsy having experienced 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. The discrimination between IC and IIE is not requested for inclusion.
* Subjects with at least 2 unprovoked seizures separated by a minimum of 48 hours in the year preceding randomization out of which at least 1 unprovoked seizure in the 3 months preceding randomization.
* Subjects with a confirmed diagnosis of epilepsy.
* Male/female subjects (≥16 years).

Exclusion Criteria

* History or presence of seizures of other types than partial (IA, IB, IC, with clear focal origin) and generalized tonic-clonic (without clear focal origin) seizures.
* History or presence of seizures occurring only in clustered patterns, defined as repeated seizures occurring over a short period of time, i.e. \< 20 minutes, with or without function regained between 2 ictal events.
* History, clinical or EEG finding suggestive of idiopathic generalized epilepsy (IGE) at randomization.

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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N01061

Identifier Type: -

Identifier Source: org_study_id