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

NCT ID: NCT00150748

Last Updated: 2020-07-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 217 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-11-30
• Study Completion Date: 2007-07-31

Brief 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.

Conditions

Generalized Epilepsy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.).

Group Type: EXPERIMENTAL

Levetiracetam 166 mg

Intervention Type: DRUG

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

Levetiracetam 250 mg

Intervention Type: DRUG

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

Levetiracetam 500 mg

Intervention Type: DRUG

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

Interventions

Levetiracetam 166 mg

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

Intervention Type: DRUG

Levetiracetam 250 mg

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

Intervention Type: DRUG

Levetiracetam 500 mg

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

Intervention Type: DRUG

Eligibility Criteria

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

• Known clinically significant 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

• Minimum Eligible Age: 4 Years
• Maximum Eligible Age: 64 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

UCB Pharma SA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

UCB Clinical Trial Call Center

Role: STUDY_DIRECTOR

+1 877-822-9493

References

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.

Reference Type: DERIVED

PMID: 22050371 (View on PubMed)

Other Identifiers

2004-001997-13

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

N167

Identifier Type: -

Identifier Source: org_study_id