Follow-up Study of L059 (Levetiracetam) in Epileptic Patients With Partial Onset Seizures by Open Label Method

NCT00160615 | Completed Phase 3 Results FDA Drug

• 1 other identifier: N01020
• Study Type: interventional
• Target: 154
• Locations: 0 countries
• Sites: N/A

Brief Summary

The safety and efficacy of L059 was evaluated in patients who completed "N165 Clinical Trial of L059". They received L059 at a daily dose from 1,000 mg to 3,000 mg in addition to their standard concomitant AEDs

Conditions

Epilepsy, Partial

Keywords

Epilepsy, partial; Keppra; Levetiracetam

Outcome Measures

Primary Outcomes (4)

• Partial (Type I) Seizure Frequency Per Week by Analysis Visit

  Number of Partial (Type I) seizures over the treatment period standardized to 1 week period.

  From Baseline up to 54 months

• Partial (Type IA) Seizure Frequency Per Week by Analysis Visit

  Number of Partial (Type IA) seizures over the treatment period standardized to 1 week period.

  From Baseline up to 54 months

• Partial (Type IB) Seizure Frequency Per Week by Analysis Visit

  Number of Partial (Type IB) seizures over the treatment period standardized to 1 week period.

  From Baseline up to 54 months

• Partial (Type IC) Seizure Frequency Per Week by Analysis Visit

  Number of Partial (Type IC) seizures over the treatment period standardized to 1 week period.

  From Baseline up to 54 months

Secondary Outcomes (4)

• Percentage Change From Baseline of Partial Onset Seizure Frequency (Type I Overall) Per Week by Analysis Visit

  From Baseline up to 54 months

• Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IA) Per Week by Analysis Visit

  From Baseline up to 54 months

• Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IB) Per Week by Analysis Visit

  From Baseline up to 54 months

• Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IC) Per Week by Analysis Visit

  From Baseline up to 54 months

Study Arms (1)

Levetiracetam

EXPERIMENTAL

Subjects received oral tablets of Levetiracetam. This study N01020 (NCT00160615) was designed as a single group assignment study and as follow-up study, open for patients from N165 (NCT00600509). The differentiation into placebo and Levetiracetam in the results reporting section is based on the treatment of the previously conducted study N165 (NCT00600509).

Drug: Levetiracetam

Interventions

Levetiracetam DRUG

* Pharmaceutical form: Film-coating tablets * Concentration: 250 mg/ 500 mg * Route of administration: oral use

Also known as: Keppra

Levetiracetam

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who completed the evaluation period (Week 16) of N165 Clinical Trial of L059
• Patients/the parent or guardian wish to continue treatment with L059 and to enter N165 Follow-up Study, and also the investigator admit the necessity of the repeated intake of the investigational drug for the patients.

You may not qualify if:

• Patients who had not participate in N165 Clinical Trial of L059.
• Patients who had participated in N165 Clinical Trial of L059 with no intention of entering the follow-up study taking the same medication.
• Patients had not been in compliance with requirements of Protocol for N165 Clinical Trial of L059 in the course of the study.

Sponsors & Collaborators

• UCB Japan Co. Ltd.: lead

Related Links

• FDA Safety Alerts and Recalls

MeSH Terms

Conditions

Epilepsies, Partial

Interventions

Levetiracetam

Condition Hierarchy (Ancestors)

Epilepsy; 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

+1844 599

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

Model Details: This study N01020 (NCT00160615) was designed as a single group assignment study and as follow-up study, open for patients from N165 (NCT00600509). The differentiation into placebo and Levetiracetam in the results reporting section is based on the treatment of the previously conducted study N165 (NCT00600509).

Study Record Dates

• First Submitted: September 8, 2005
• First Posted: September 12, 2005
• Study Start: September 12, 2001
• Primary Completion: January 17, 2007
• Study Completion: January 17, 2007
• Last Updated: June 10, 2019
• Results First Posted: June 10, 2019

Record last verified: 2019-03