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

• ClinicalTrials.gov Identifier: NCT00150748
• Recruitment Status: Completed
• First Posted: September 8, 2005
• Last Update Posted: July 29, 2020
• Sponsor: UCB Pharma SA
• Information provided by (Responsible Party): UCB Pharma ( UCB Pharma SA )

Study Description

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 217 participants
• Allocation: N/A
• 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
• Actual Primary Completion Date: July 2007
• Actual Study Completion Date: July 2007

Arms and Interventions

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

Outcome Measures

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 ]

Eligibility Criteria

• 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

Contacts and Locations

Sponsors and Collaborators

UCB Pharma SA

Investigators

• Study Director: UCB Clinical Trial Call Center; +1 877-822-9493

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Delanty N, Jones J, Tonner F. Adjunctive levetiracetam in children, adolescents, and adults with primary generalized seizures: open-label, noncomparative, multicenter, long-term follow-up study. Epilepsia. 2012 Jan;53(1):111-9. doi: 10.1111/j.1528-1167.2011.03300.x. Epub 2011 Nov 2.

• Responsible Party: UCB Pharma SA
• ClinicalTrials.gov Identifier: NCT00150748
• Other Study ID Numbers: N167; 2004-001997-13 ( EudraCT Number )
• First Posted: September 8, 2005
• Last Update Posted: July 29, 2020
• Last Verified: July 2020

Keywords provided by UCB Pharma ( UCB Pharma SA ):

Generalized Epilepsy, Primary Generalized Seizures; Keppra, Levetiracetam

Additional relevant MeSH terms:

Epilepsy; Epilepsy, Generalized; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Levetiracetam; Anticonvulsants; Nootropic Agents