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

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ClinicalTrials.gov Identifier: NCT00150748
Recruitment Status : Completed
First Posted : September 8, 2005
Last Update Posted : March 25, 2015
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB Pharma SA )

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.

Condition or disease Intervention/treatment Phase
Generalized Epilepsy Drug: Levetiracetam 166 mg Drug: Levetiracetam 250 mg Drug: Levetiracetam 500 mg Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 217 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label, Multicenter, Follow-up Study to Evaluate the Safety and Efficacy of Levetiracetam (LEV) (Oral Tablets of 166, 250 or 500 mg b.i.d.), at Individualized Doses up to a Maximum of 4000 mg/Day (or 80 mg/kg/Day for Children and Adolescents Less Than 50 kg), in Children (≥ 4 Years Old), Adolescents and Adults Suffering From Primary Generalized Seizures
Study Start Date : November 2001
Primary Completion Date : July 2007
Study Completion Date : July 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy Seizures
U.S. FDA Resources

Arm Intervention/treatment
Experimental: 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.).
Drug: Levetiracetam 166 mg
  • Active Substance: Levetiracetam
  • Pharmaceutical Form: Tablet
  • Concentration: 166 mg
  • Route of Administration: Oral use
Drug: Levetiracetam 250 mg
  • Active Substance: Levetiracetam
  • Pharmaceutical Form: Tablet
  • Concentration: 250 mg
  • Route of Administration: Oral use
Drug: Levetiracetam 500 mg
  • Active Substance: Levetiracetam
  • Pharmaceutical Form: Tablet
  • Concentration: 500 mg
  • Route of Administration: Oral use



Primary Outcome Measures :
  1. Number of subjects having at least 6 months of seizure freedom at any time during the Evaluation Period [ Time Frame: Evaluation Period ]
  2. Percentage of subjects having at least 6 months of seizure freedom at any time during the Evaluation Period [ Time Frame: Evaluation Period ]

Secondary Outcome Measures :
  1. Number of subjects remaining seizure-free, for the All intent-to-treat (ITT) population, and Tonic-Clonic, Myoclonic, and Absence subpopulations since the beginning of this study N167 (Visit 1) during the Evaluation Period [ Time Frame: From Visit 1 to the end of the Evaluation Period ]
  2. Percentage of subjects remaining seizure-free, for the All intent-to-treat (ITT) population, and Tonic-Clonic, Myoclonic, and Absence subpopulations since the beginning of this study N167 (Visit 1) during the Evaluation Period [ Time Frame: From Visit 1 to the end of the Evaluation Period ]
  3. Reduction from N01057 or N166 Baseline to the Evaluation Period in seizure frequency per week for Tonic-Clonic subpopulation seizures types [ Time Frame: From N01057 or N166 Baseline to the Evaluation Period ]
  4. Percentage reduction from N01057 or N166 Baseline to the Evaluation Period in seizure frequency per week for Tonic-Clonic subpopulation seizures types [ Time Frame: From N01057 or N166 Baseline to the Evaluation Period ]
  5. Reduction from N01057 or N166 Baseline to the Evaluation Period in seizure days per week for the ITT population, and Absence and Myoclonic subpopulations [ Time Frame: From N01057 or N166 Baseline to the Evaluation Period ]
  6. Percentage reduction from N01057 or N166 Baseline to the Evaluation Period in seizure days per week for the ITT population, and Absence and Myoclonic subpopulations [ Time Frame: From N01057 or N166 Baseline to the Evaluation Period ]
  7. Categorical percentage reduction from Baseline to the Evaluation Period in seizure days per week for the ITT population, and Absence and Myoclonic subpopulations [ Time Frame: Evaluation Period ]
  8. Categorical percentage reduction from Baseline to the Evaluation Period in seizure frequency per week for Tonic-Clonic subpopulation seizures types [ Time Frame: Evaluation Period ]


Information from the National Library of Medicine

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Ages Eligible for Study:   4 Years to 64 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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): NCT00150748


Sponsors and Collaborators
UCB Pharma SA
Investigators
Study Director: UCB Clinical Trial Call Center +1 877-822-9493

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: UCB Pharma SA
ClinicalTrials.gov Identifier: NCT00150748     History of Changes
Other Study ID Numbers: N167
2004-001997-13 ( EudraCT Number )
First Posted: September 8, 2005    Key Record Dates
Last Update Posted: March 25, 2015
Last Verified: March 2015

Keywords provided by UCB Pharma ( UCB Pharma SA ):
Generalized Epilepsy, Primary Generalized Seizures
Keppra, Levetiracetam

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