ClinicalTrials.gg
CompletedNCT00150787Updated Nov 26, 2013

Monotherapy With Levetiracetam or Carbamazepine in Patients Suffering From Epilepsy.

A Phase 3 interventional study of LEVETIRACETAM in Epilepsy, Tonic-clonic, sponsored by UCB Pharma. Completed. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2013-11-26.

Sponsored by UCB Pharma (part of UCB S.A.) · Phase 3 and Interventional

Phase
Phase 3
Study type
Interventional
Enrollment
250
Allocation
Randomized
Ages
16 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Epilepsy, Tonic-clonic

Keywords

  • Monotherapy, epilepsy
  • Levetiracetam
  • Keppra
03

In context

Epilepsy, Tonic-Clonic

23 studies on the registry are indexed under Epilepsy, Tonic-Clonic; 3 are open to participants now.

This study's enrollment of 250 is above the median of 94 across 20 interventional studies indexed under Epilepsy, Tonic-Clonic.

Browse Epilepsy, Tonic-Clonic studies →

Lead sponsor

UCB Pharma is the lead sponsor of 242 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years and older
Sexes eligible
All

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 product is beneficial.

Exclusion criteria

Exclusion Criteria:

  • Need for an additional AED.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Phase 3
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
250 participants

Interventions

06

What researchers measure

Primary outcomes

  1. Around 2 years of Safety assessment of levetiracetam via Adverse Events reporting, physical and neurological examination and vital signs

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • 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. PubMed 17283312 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jul 2003, a primary completion of Nov 2005 and a completion of Nov 2005. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 6, 2005
First posted
Sep 8, 2005
Start
Jul 2003
Primary completionActual
Nov 2005
CompletionActual
Nov 2005
Last update
Nov 26, 2013
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 26, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00150787
Lead sponsor
UCB Pharma
First posted
Sep 8, 2005
Start date
Jul 2003
Primary completion
Nov 2005
Completion
Nov 2005
Last update
Nov 26, 2013

Study contacts

UCB Clinical Trial Call Center
study director · UCB Pharma
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2009. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Levetiracetam

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