We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT00160615
Previous Study | Return to List | Next Study

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00160615
Recruitment Status : Completed
First Posted : September 12, 2005
Results First Posted : June 10, 2019
Last Update Posted : June 10, 2019
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB Japan Co. Ltd. )

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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

Condition or disease Intervention/treatment Phase
Epilepsy, Partial Drug: Levetiracetam Phase 3

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 154 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: 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).
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Follow-up Study of L059 (Levetiracetam) in Epileptic Patients With Partial Onset Seizures by Open Label Method
Actual Study Start Date : September 12, 2001
Actual Primary Completion Date : January 17, 2007
Actual Study Completion Date : January 17, 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy Seizures

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Levetiracetam
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
  • Pharmaceutical form: Film-coating tablets
  • Concentration: 250 mg/ 500 mg
  • Route of administration: oral use
Other Name: Keppra


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Partial (Type I) Seizure Frequency Per Week by Analysis Visit [ Time Frame: From Baseline up to 54 months ]
    Number of Partial (Type I) seizures over the treatment period standardized to 1 week period.

  2. Partial (Type IA) Seizure Frequency Per Week by Analysis Visit [ Time Frame: From Baseline up to 54 months ]
    Number of Partial (Type IA) seizures over the treatment period standardized to 1 week period.

  3. Partial (Type IB) Seizure Frequency Per Week by Analysis Visit [ Time Frame: From Baseline up to 54 months ]
    Number of Partial (Type IB) seizures over the treatment period standardized to 1 week period.

  4. Partial (Type IC) Seizure Frequency Per Week by Analysis Visit [ Time Frame: From Baseline up to 54 months ]
    Number of Partial (Type IC) seizures over the treatment period standardized to 1 week period.


Secondary Outcome Measures :
  1. Percentage Change From Baseline of Partial Onset Seizure Frequency (Type I Overall) Per Week by Analysis Visit [ Time Frame: From Baseline up to 54 months ]

    Percentage change from baseline of of Partial (Type I) seizure frequency over the treatment period standardized to 1 week period.

    Negative values indicate improvement from Baseline.


  2. Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IA) Per Week by Analysis Visit [ Time Frame: From Baseline up to 54 months ]

    Percentage change from baseline of of Partial (Type IA) seizure frequency over the treatment period standardized to 1 week period.

    Negative values indicate improvement from Baseline.


  3. Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IB) Per Week by Analysis Visit [ Time Frame: From Baseline up to 54 months ]

    Percentage change from baseline of of Partial (Type IB) seizure frequency over the treatment period standardized to 1 week period.

    Negative values indicate improvement from Baseline.


  4. Percentage Change From Baseline of Partial Onset Seizure Frequency (Subtype IC) Per Week by Analysis Visit [ Time Frame: From Baseline up to 54 months ]

    Percentage change from baseline of of Partial (Type IC) seizure frequency over the treatment period standardized to 1 week period.

    Negative values indicate improvement from Baseline.



Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00160615


Sponsors and Collaborators
UCB Japan Co. Ltd.
Investigators
Layout table for investigator information
Study Director: UCB Cares 001 844 599 2273 (UCB)
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Layout table for additonal information
Responsible Party: UCB Japan Co. Ltd.
ClinicalTrials.gov Identifier: NCT00160615    
Other Study ID Numbers: N01020
First Posted: September 12, 2005    Key Record Dates
Results First Posted: June 10, 2019
Last Update Posted: June 10, 2019
Last Verified: March 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by UCB Pharma ( UCB Japan Co. Ltd. ):
Epilepsy, partial
Keppra
Levetiracetam
Additional relevant MeSH terms:
Layout table for MeSH terms
Epilepsy
Seizures
Epilepsies, Partial
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Neurologic Manifestations
Levetiracetam
Anticonvulsants
Nootropic Agents