An Open Label Study of Levetiracetam Monotherapy in Newly Diagnosed Epilepsy With Partial Onset Seizure

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB Japan Co. Ltd. )
ClinicalTrials.gov Identifier:
NCT01506882
First received: January 5, 2012
Last updated: May 21, 2014
Last verified: May 2014
  Purpose

The purpose of this study is to evaluate the efficacy of Levetiracetam (LEV) used as monotherapy, with efficacy measured as 6-month seizure freedom at the last evaluated dose in the LEV 1000 mg/day to 2000 mg/day group, in newly or recently diagnosed Epilepsy subjects.


Condition Intervention Phase
Epilepsy
Partial Onset Seizures
Drug: Levetiracetam (LEV)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Open-label, Randomized, Multicenter Study to Evaluate the Efficacy and Safety of Levetiracetam Used as Monotherapy in Newly or Recently Diagnosed Epilepsy Patients Aged Older Than or Equal to 16 Years With Partial Seizures

Resource links provided by NLM:


Further study details as provided by UCB Pharma:

Primary Outcome Measures:
  • Percentage of subjects in the Levetiracetam (LEV) 1000 mg/day to 2000 mg/day group who are seizure free for 26 consecutive weeks of treatment during the Evaluation Period [ Time Frame: From the end of the 1-week Stabilization Period over the 26-weeks Evaluation Period ] [ Designated as safety issue: No ]
    Subjects in the LEV 1000 mg/day to 2000 mg/day group receive the initial dose of LEV 1000 mg/day for the 1-week Stabilization Period and enter the Evaluation Period. Unless a seizure occurs during the Evaluation Period, the subjects will continue LEV 1000 mg/day for 26 weeks. If a seizure occurs during the Evaluation Period, the dose will be increased to 2000 mg/day and a restart of stabilization on LEV 2000 mg/day for 1 week is required prior to restarting the 26-weeks Evaluation Period on LEV 2000 mg/day.


Secondary Outcome Measures:
  • Percentage of subjects in the Levetiracetam (LEV) 1000 mg/day to 2000 mg/day group who are seizure free for 52 consecutive weeks of treatment during the Evaluation Period and the Maintenance Period [ Time Frame: From entry in the 26-weeks Evaluation Period to the end of the 26-weeks Maintenance Period ] [ Designated as safety issue: No ]
    Subjects who complete the 26-weeks Evaluation Period without having a seizure will continue receiving the same dose of LEV as in the Evaluation Period during the 26-weeks Maintenance Period unless a seizure occurs.

  • Percentage of subjects in the Levetiracetam (LEV) 3000 mg/day group who are seizure free for 26 consecutive weeks of treatment during the Evaluation Period [ Time Frame: From the end of the 1-week Stabilization Period over the 26-weeks Evaluation Period ] [ Designated as safety issue: No ]
    Unless a seizure occurs, the subjects will continue LEV 3000 mg/day for 26 weeks.

  • Percentage of subjects in the Levetiracetam (LEV) 3000 mg/day group who are seizure free for 52 consecutive weeks of treatment during the Evaluation Period and the Maintenance Period [ Time Frame: From entry in the 26-weeks Evaluation Period to the end of the 26-weeks Maintenance Period ] [ Designated as safety issue: No ]
    Subjects who complete the 26-weeks Evaluation Period without having a seizure will continue receiving LEV 3000 mg/day during the 26-weeks Maintenance Period unless a seizure occurs.

  • Time to first seizure at the last evaluated dose in subjects in the Levetiracetam (LEV) 1000 mg/day to 2000 mg/day group during 51 months [ Time Frame: 51 months during Evaluation, Maintenance and Safety Follow Up Period after 1-week Stabilization Period ] [ Designated as safety issue: No ]
    Median time to first seizure will be estimated from the Kaplan-Meier curve.

  • Time to withdrawal at the last evaluated dose in subjects in the Levetiracetam (LEV) 1000 mg/day to 2000 mg/day group during 51 months [ Time Frame: 51 months during Evaluation, Maintenance and Safety Follow Up Period after 1-week Stabilization Period ] [ Designated as safety issue: No ]
    Median time to withdrawal will be estimated from the Kaplan-Meier curve.

  • Time to first seizure in subjects in the Levetiracetam (LEV) 3000 mg/day group during 51 months [ Time Frame: 51 months during Evaluation, Maintenance and Safety Follow Up Period after 1-week Stabilization Period ] [ Designated as safety issue: No ]
    Median time to first seizure will be estimated from the Kaplan-Meier curve.

  • Time to withdrawal in subjects in the Levetiracetam (LEV) 3000 mg/day group during 51 months [ Time Frame: 51 months during Evaluation, Maintenance and Safety Follow Up Period after 1-week Stabilization Period ] [ Designated as safety issue: No ]
    Median time to withdrawal will be estimated from the Kaplan-Meier curve.


Enrollment: 71
Study Start Date: December 2011
Estimated Study Completion Date: June 2015
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Levetiracetam 1000 mg/day to 2000 mg/day group Drug: Levetiracetam (LEV)

Formulation: Tablet

Strength: LEV 250 mg, LEV 500 mg

Dosage: First study dose is 1000 mg/day and if new seizure occurs, the dose will be increased to 2000 mg/day. Max dose in the Follow Up Period is 3000 mg/day.

Frequency: Twice daily

Other Name: Keppra, E Keppra
Experimental: Levetiracetam 3000 mg/day group Drug: Levetiracetam (LEV)

Formulation: Tablet

Strength: LEV 250 mg, LEV 500 mg

Dosage: 1000 mg/day for first two weeks, then 2000 mg/day for two weeks then 3000 mg/day by the end of the trial.

Frequency: Twice daily

Other Name: Keppra, E Keppra

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subject is male or female and aged ≥ 16 years at Visit 1
  • Subjects with newly or recently diagnosed Epilepsy having experienced unprovoked Partial Seizures (IA, IB, IC), that are classifiable according to the International League Against Epilepsy (ILAE) classification of Epileptic Seizures
  • Subjects with at least 2 unprovoked seizures separated by a minimum of 48 hours in the year prior to Visit 1, of which, at least 1 unprovoked seizure occurred in the 3 months prior to Visit 1
  • Minimum body weight of 40 kg at Visit 1

Exclusion Criteria:

  • Subject has a history or presence of seizure types other than partial (IA, IB, IC)
  • Subject has an experience of any type of brain surgery in the consecutive 2 years prior to Visit 1
  • Subject has a history or presence of known Pseudo-Seizures
  • Subject has been treated for Epilepsy with any Antiepileptic Drug (AED) within the 6 months prior to Visit 1. However, acute and sub-acute seizure treatments are accepted for a maximum use of 2 weeks, if the treatments are stopped for the week prior to Visit 1
  • Subject has a known clinically significant acute or chronic illness, such as but not restricted to: cardiac, renal, hepatic dysfunction, endocrinological, or psychiatric illness, and that may impair reliable participation in the study or necessitate the use of medication not allowed by the protocol
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01506882

Locations
Japan
19
Aomori, Japan
33
Asaka, Japan
21
Daito, Japan
12
Fujisawa, Japan
14
Hamamatsu, Japan
11
Himeji, Japan
30
Hirosaki, Japan
8
Kagoshima, Japan
20
Kamakura, Japan
17
Kawasaki, Japan
3
Kitakyusyu, Japan
26
Kodaira, Japan
9
Kokubunji, Japan
32
Kyoto, Japan
25
Miyakonojo, Japan
5
Nagoya Aichi, Japan
4
Nara, Japan
22
Okayama, Japan
15
Osaka, Japan
27
Osaka, Japan
24
Osakasayama, Japan
13
Saitama, Japan
1
Sakai, Japan
29
Sapporo, Japan
2
Toyonaka, Japan
7
Ube, Japan
18
Yamagata, Japan
Sponsors and Collaborators
UCB Japan Co. Ltd.
Investigators
Study Director: UCB Clinical Trial Call Center +1 877 822 9493 (UCB)
  More Information

No publications provided

Responsible Party: UCB Pharma ( UCB Japan Co. Ltd. )
ClinicalTrials.gov Identifier: NCT01506882     History of Changes
Other Study ID Numbers: N01375
Study First Received: January 5, 2012
Last Updated: May 21, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by UCB Pharma:
Levetiracetam
Monotherapy
Epilepsy
Partial Onset Seizures
Japan

Additional relevant MeSH terms:
Epilepsy
Seizures
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Etiracetam
Piracetam
Anticonvulsants
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Nootropic Agents
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 16, 2014