Trial record 3 of 58 for:    "Epilepsy, Generalized"

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
UCB Pharma ( UCB Pharma SA )
ClinicalTrials.gov Identifier:
NCT00150748
First received: September 6, 2005
Last updated: March 24, 2015
Last verified: March 2015
  Purpose

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 Intervention Phase
Generalized Epilepsy
Drug: Levetiracetam 166 mg
Drug: Levetiracetam 250 mg
Drug: Levetiracetam 500 mg
Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by UCB Pharma:

Primary Outcome Measures:
  • Number of subjects having at least 6 months of seizure freedom at any time during the Evaluation Period [ Time Frame: Evaluation Period ] [ Designated as safety issue: No ]
  • Percentage of subjects having at least 6 months of seizure freedom at any time during the Evaluation Period [ Time Frame: Evaluation Period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Categorical percentage reduction from Baseline to the Evaluation Period in seizure frequency per week for Tonic-Clonic subpopulation seizures types [ Time Frame: Evaluation Period ] [ Designated as safety issue: No ]

Enrollment: 217
Study Start Date: November 2001
Study Completion Date: July 2007
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   4 Years to 64 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00150748

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

Additional Information:
No publications provided by UCB Pharma

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: UCB Pharma ( UCB Pharma SA )
ClinicalTrials.gov Identifier: NCT00150748     History of Changes
Other Study ID Numbers: N167, 2004-001997-13
Study First Received: September 6, 2005
Last Updated: March 24, 2015
Health Authority: Austria: Federal Ministry for Health and Women
Belgium: Federal Agency for Medicines and Health Products, FAMHP
Canada: Health Canada
Estonia: The State Agency of Medicine
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Ireland: Irish Medicines Board
Italy: Ministry of Health
Mexico: Federal Commission for Protection Against Health Risks
New Zealand: Food Safety Authority
Poland: Ministry of Health
Russia: Pharmacological Committee, Ministry of Health
Spain: Ministry of Health and Consumption
Sweden: Medical Products Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Food and Drug Administration

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

Additional relevant MeSH terms:
Epilepsy, Generalized
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Etiracetam
Piracetam
Anticonvulsants
Central Nervous System Agents
Neuroprotective Agents
Nootropic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 30, 2015