A Study Of The Safety And Efficacy Of Levetiracetam (Keppra®) (Ucb L059) In Children With Epilepsy

NCT00150709 | Completed Phase 3 Results FDA Drug

• 1 other identifier: N157
• Study Type: interventional
• Target: 223
• Locations: 0 countries
• Sites: N/A

Brief Summary

Open-label study to allow pediatric patients who have participated in prior Levetiracetam (Keppra®) studies to continue their treatment with adequate monitoring and standardized follow-up care until Levetiracetam (Keppra®) is approved for use in children or until the completion of the development program for pediatrics.

Conditions

Epilepsy, Partial

Keywords

Epilepsy; Pediatric; Partial onset epilepsy; Levetiracetam; Keppra

Outcome Measures

Primary Outcomes (2)

• Percentage Change From Baseline in Partial Onset (Type I) Seizure Frequency Per Week Over Time During the Treatment Period

  Percentage change from Baseline of partial onset (Type I) seizure frequency over the Treatment Period standardized to 1 week Period. According to the ILAE 1981 classification, seizures can be classified into one of the following three groups: Type I (partial onset seizures), Type II (generalized seizures) and Type III (unclassified seizures). Negative values indicate an improvement from Baseline.

  During the Treatment Period (an average of 2 years), compared to Baseline

• Percentage Change From Baseline in Total (Type I, II, III) Seizure Frequency Per Week Over Time During the Treatment Period

  Percentage change from Baseline in total (type I, II, III) seizure frequency over the Treatment Period standardized to 1 week Period. Seizures were categorized in Type I (partial onset seizures), Type II (generalized seizures) and Type III (unclassified seizures) according to the ILAE 1981 classification. Negative values indicate an improvement from Baseline.

  During the Treatment Period (an average of 2 years), compared to Baseline

Secondary Outcomes (89)

• Absolute Change From Baseline in Partial Onset (Type I) Seizure Frequency Over Time During the Treatment Period

  During the Treatment Period (an average of 2 years), compared to Baseline

• Absolute Change From Baseline in Total (Type I, II, III) Seizure Frequency Per Week Over Time During the Treatment Period

  During the Treatment Period (an average of 2 years), compared to Baseline

• At Least 50% Responder Rate in Partial Onset (Type I) Seizure Frequency From Baseline Per Week During the Treatment Period

  During the Treatment Period (an average of 2 years), compared to Baseline

• At Least 50% Responder Rate in Total (Type I, II, III) Seizure Frequency From Baseline Per Week During the Treatment Period

  During the Treatment Period (an average of 2 years), compared to Baseline

• Number of Subjects Who Are Seizure-free for at Least 7 Days During the Treatment Period

  During the Treatment Period (an average of 2 years)

Study Arms (4)

N159 PBO/LEV

EXPERIMENTAL

Subjects had previously participated in study N159 in which they had received Placebo (PBO).

Drug: Levetiracetam

N159 LEV/LEV

EXPERIMENTAL

Subjects had previously participated in study N159 in which they had received Levetiracetam (LEV).

Drug: Levetiracetam

N01010+N151 LEV/LEV

EXPERIMENTAL

Subjects had previously participated in study N01010 or study N151 in which they had received Levetiracetam (LEV).

Drug: Levetiracetam

N01052 LEV/LEV

EXPERIMENTAL

Subjects had previously participated in study N01052 in which they had received Levetiracetam (LEV).

Drug: Levetiracetam

Interventions

Levetiracetam DRUG

* Pharmaceutical form: Oral tablets and oral solution * Route of administration: Oral use

Also known as: Keppra

N01010+N151 LEV/LEV; N01052 LEV/LEV; N159 LEV/LEV; N159 PBO/LEV

Eligibility Criteria

• Age: Up to 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Have completed Study N151, or any other applicable pediatric trials of Levetiracetam (Keppra®)
• Be a patient for whom the treatment of Levetiracetam (Keppra®) would be of potential benefit such that the patient/parent(s)/legal guardian and the Investigator agree to continue treatment.

You may not qualify if:

• Not be on a ketogenic diet (during the course of this study).
• Not have seizures too close together to accurately count (i.e., the patient's seizures must be countable).

Sponsors & Collaborators

• UCB Pharma: lead

Related Links

• FDA Safety Alerts and Recalls

MeSH Terms

Conditions

Epilepsies, Partial; Epilepsy

Interventions

Levetiracetam

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids; Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: UCB
• Organization: Cares

UCBCares@ucb.com

001 844 599 2273

Study Officials

• UCB Cares

  001 844 599 2273 (UCB)

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2005
• First Posted: September 8, 2005
• Study Start: January 26, 1998
• Primary Completion: January 25, 2006
• Study Completion: January 25, 2006
• Last Updated: February 9, 2024
• Results First Posted: February 9, 2024

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share