Efficacy and Safety of Levetiracetam in Partial Seizures Control, With or Without Secondary Generalization

NCT01392768 | Completed Phase 3

• 1 other identifier: ACH-LPT-03(09/10)
• Study Type: interventional
• Target: 126
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study is to determine whether levetiracetam as adjunctive therapy is effective in the treatment of partial seizures, with or without secondary generalization, associated with refractory focal epilepsy.

Conditions

Epilepsy; Partial Seizures

Keywords

Epilepsy; Partial; Seizures; Adjunctive

Outcome Measures

Primary Outcomes (1)

• Partial onset seizure frequency per week.

  Collection of seizure count throughout the whole study

  From baseline to week 24

Secondary Outcomes (5)

• Safety descriptive about occurence of adverse events, evaluation of results of clinical/physical examination and ECG and laboratory tests results.

  From baseline to week 30

• Proportions of response between the groups of treatment. (Responders defined as number of patients with at least 50% reduction in the number of weekly partial seizures)

  From baseline to week 24

• Percentage reduction from baseline in partial seizure frequency of days a week.

  From baseline to week 24

• Proportion of response between the groups of treatment. (Responders defined as number of subjects with at least 50% reduction in the number of days per week with partial seizures)

  From baseline to week 24

• Proportion between the groups of treatment without any kind of seizures. (seizure free)

  12 weeks after the titration period (period with stable regimen of the drug)

Study Arms (2)

Levetiracetam

EXPERIMENTAL

Drug: Levetiracetam

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Levetiracetam DRUG

Oral solution (Each mL contains 100mg of levetiracetam) or immediate-release tablets (Tablets containing 500mg or 1000mg of levetiracetam)

Levetiracetam

Placebo DRUG

Placebo, properly standardized to suit the characteristics of each dosage form (oral solution and tablets) of levetiracetam

Placebo

Eligibility Criteria

• Age: 4 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients of both sexes, aged between 04 and 65 years, remaining the feasibility of a legal guardian in accordance with need, able to understand and provide written informed consent and able to allow compliance at the treatment and the requirements of the protocol;
• Patient´s weight ≥ 20kg;
• Consistent diagnosis of refractory focal epilepsy, with or without secondary generalization;
• Patient with onset of seizures for at least 02 years preceding the screening visit;
• Presence at least 12 partial seizures during the 03 months preceding the screening visit (04 seizures per month);
• Only seizures that generate motor manifestation will be recorded in this study.
• Absence of brain injury progressive or expansive, previously documented by CT scan, MRI or other imaging test applicable (in the last 05 years;
• Patient with electroencephalogram performed up to 02 years before this visit;
• Subject with stable regimen (minimum of 01 month) from one to three antiepileptic drugs.
• Vagus nerve stimulation for 04 weeks prior to V1, or use of benzodiazepines for more than 07 consecutive days will be considered as concomitant epileptic drugs)

You may not qualify if:

• Patients with:
• Seizures of non epileptic origin;
• Pseudoseizures;
• Seizures occurring in clustered patterns (03 or more seizures in 30 minutes), in the 03 months preceding the screening visit (V1);
• History of status epilepticus while taking antiepileptic drugs during the 03 months that preceding the screening visit (V1).
• Epileptic syndromes that occurs with cognitive deficits or secondary epilepsy evolving from some brain disease;
• History of schizophrenia or suicide attempt;
• Patients with psychiatric ill ongoing;
• Presence of severe mental retardation of any etiology;
• Previous exposure to levetiracetam;
• Women of childbearing age who had tested positive for pregnancy, or who do not use acceptable contraceptive method, or do not agree to practice reliable contraception during the study;
• Woman in pregnancy or lactation period;
• Diagnosis of renal or hepatic failure;
• Patients with genetic syndromes;
• Patient that is taking any prohibited medication (Item 9.3);

Sponsors & Collaborators

• Ache Laboratorios Farmaceuticos S.A.: lead

MeSH Terms

Conditions

Epilepsy; Seizures

Interventions

Levetiracetam

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids; Pyrrolidinones; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Elza M Yacubian

  Federal University of São Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2011
• First Posted: July 13, 2011
• Study Start: January 1, 2013
• Primary Completion: July 1, 2015
• Study Completion: August 1, 2015
• Last Updated: October 31, 2016

Record last verified: 2016-10