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CompletedNCT00150748Updated Jul 29, 2020

Long Term Follow up Treatment With Levetiracetam in Subjects of 4 Years and Older With Generalized Epilepsy

A Phase 3 interventional study of Levetiracetam 166 mg and Levetiracetam 250 mg in Generalized Epilepsy, sponsored by UCB Pharma SA. Completed. Open to participants aged 4 Years to 64 Years. Per ClinicalTrials.gov, last updated 2020-07-29.

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

Phase
Phase 3
Study type
Interventional
Enrollment
217
Allocation
Not applicable
Ages
4 Years to 64 Years
Sex
All
01

Study summary

An open-label, follow-up study to evaluate the safety and efficacy of levetiracetam (LEV), in children (≥ 4 years old), adolescents and adults suffering from primary generalized seizures.

02

Conditions studied

  • Generalized Epilepsy

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Keywords

  • Generalized Epilepsy, Primary Generalized Seizures
  • Keppra, Levetiracetam
03

In context

Epilepsy, Generalized

39 studies on the registry are indexed under Epilepsy, Generalized; 4 are open to participants now.

This study's enrollment of 217 is above the median of 75 across 25 interventional studies indexed under Epilepsy, Generalized.

Browse Epilepsy, Generalized studies →

Lead sponsor

UCB Pharma SA is the lead sponsor of 28 studies on the registry; none are open to participants now.

Browse UCB Pharma studies →All UCB S.A. studies →

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

04

Who can participate

Ages eligible
4 Years to 64 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

  • Male or female children, adolescents and adults having completed the final visit of a previous study with levetiracetam (LEV)
  • Subjects who were/are suffering from primary generalized (type II) epileptic seizures
  • Subjects for whom the Investigator believes a reasonable benefit (efficacy or tolerability) from the long-term administration of LEV may be expected

Exclusion criteria

Exclusion Criteria:

  • Known acute or chronic illness, for example: cardiac, renal or hepatic dysfunction, etc., which may impair reliable participation in the trial or necessitate the use of medication not allowed by protocol
  • Concomitant use of any drug with possible central nervous system effects unless at a stable dose
  • Concomitant use of any drug (other than hormonal treatment and the subject's normal anti-epileptic drugs (AEDs) that may influence the metabolism of the concomitant AED(s), except if the dose has been stable before entry in the study for sufficient length of time
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.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
217 participants (actual)

Study arms

  • Experimental
    Levetiracetam

    Subjects received treatment up to 1764 days during the Evaluation Period. Up to 4000 mg/day (or 80 mg/kg/day for children and adolescents less than 50 kg). Oral tablets of 166, 250, or 500 mg Levetiracetam twice daily (b.i.d.).

    Drug: Levetiracetam 166 mg · Drug: Levetiracetam 250 mg · Drug: Levetiracetam 500 mg

Interventions

  • DrugLevetiracetam 166 mg

    * Active Substance: Levetiracetam * Pharmaceutical Form: Tablet * Concentration: 166 mg * Route of Administration: Oral use

  • DrugLevetiracetam 250 mg

    * Active Substance: Levetiracetam * Pharmaceutical Form: Tablet * Concentration: 250 mg * Route of Administration: Oral use

  • DrugLevetiracetam 500 mg

    * Active Substance: Levetiracetam * Pharmaceutical Form: Tablet * Concentration: 500 mg * Route of Administration: Oral use

06

What researchers measure

Primary outcomes

  1. Number of subjects having at least 6 months of seizure freedom at any time during the Evaluation Period

    Time frame: Evaluation Period

  2. Percentage of subjects having at least 6 months of seizure freedom at any time during the Evaluation Period

    Time frame: Evaluation Period

Secondary outcomes

  1. Number of subjects remaining seizure-free, for the All intent-to-treat (ITT) population, and Tonic-Clonic, Myoclonic, and Absence subpopulations since the beginning of this study N167 (Visit 1) during the Evaluation Period

    Time frame: From Visit 1 to the end of the Evaluation Period

  2. Percentage of subjects remaining seizure-free, for the All intent-to-treat (ITT) population, and Tonic-Clonic, Myoclonic, and Absence subpopulations since the beginning of this study N167 (Visit 1) during the Evaluation Period

    Time frame: From Visit 1 to the end of the Evaluation Period

  3. Reduction from N01057 or N166 Baseline to the Evaluation Period in seizure frequency per week for Tonic-Clonic subpopulation seizures types

    Time frame: From N01057 or N166 Baseline to the Evaluation Period

  4. Percentage reduction from N01057 or N166 Baseline to the Evaluation Period in seizure frequency per week for Tonic-Clonic subpopulation seizures types

    Time frame: From N01057 or N166 Baseline to the Evaluation Period

  5. Reduction from N01057 or N166 Baseline to the Evaluation Period in seizure days per week for the ITT population, and Absence and Myoclonic subpopulations

    Time frame: From N01057 or N166 Baseline to the Evaluation Period

  6. Percentage reduction from N01057 or N166 Baseline to the Evaluation Period in seizure days per week for the ITT population, and Absence and Myoclonic subpopulations

    Time frame: From N01057 or N166 Baseline to the Evaluation Period

  7. Categorical percentage reduction from Baseline to the Evaluation Period in seizure days per week for the ITT population, and Absence and Myoclonic subpopulations

    Time frame: Evaluation Period

  8. Categorical percentage reduction from Baseline to the Evaluation Period in seizure frequency per week for Tonic-Clonic subpopulation seizures types

    Time frame: Evaluation Period

07

Study locations

No study locations are listed for this record.

08

References and documents

Publications

  • Delanty N, Jones J, Tonner F. Adjunctive levetiracetam in children, adolescents, and adults with primary generalized seizures: open-label, noncomparative, multicenter, long-term follow-up study. Epilepsia. 2012 Jan;53(1):111-9. doi: 10.1111/j.1528-1167.2011.03300.x. Epub 2011 Nov 2. PubMed 22050371 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 29, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00150748
Lead sponsor
UCB Pharma SA
Responsible party
Sponsor
First posted
Sep 8, 2005
Start date
Nov 2001
Primary completion
Jul 2007
Completion
Jul 2007
Last update
Jul 29, 2020

Study contacts

UCB Clinical Trial Call Center
study director · +1 877-822-9493

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.

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