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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by Ache Laboratorios Farmaceuticos S.A..
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Ache Laboratorios Farmaceuticos S.A.
ClinicalTrials.gov Identifier:
NCT01392768
First received: July 6, 2011
Last updated: July 12, 2011
Last verified: July 2011
  Purpose

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.


Condition Intervention Phase
Epilepsy
Partial Seizures
Drug: Levetiracetam
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-blind, Phase III, Multicenter, Randomized, Placebo-controlled Study to Evaluate the Efficacy and Safety of Levetiracetam as Adjunctive Therapy, in Partial Seizures Control Associated With Refractory Focal Epilepsy

Resource links provided by NLM:


Further study details as provided by Ache Laboratorios Farmaceuticos S.A.:

Primary Outcome Measures:
  • Partial onset seizure frequency per week. [ Time Frame: From baseline to week 24 ] [ Designated as safety issue: No ]
    Collection of seizure count throughout the whole study


Secondary Outcome Measures:
  • Safety descriptive about occurence of adverse events, evaluation of results of clinical/physical examination and ECG and laboratory tests results. [ Time Frame: From baseline to week 30 ] [ Designated as safety issue: Yes ]
    Collection of safety data throughout the whole study period

  • 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) [ Time Frame: From baseline to week 24 ] [ Designated as safety issue: No ]
    Comparative between baseline and treatment periods

  • Percentage reduction from baseline in partial seizure frequency of days a week. [ Time Frame: From baseline to week 24 ] [ Designated as safety issue: No ]
    Comparative between baseline and treatment periods

  • 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) [ Time Frame: From baseline to week 24 ] [ Designated as safety issue: No ]
    Comparative between baseline and treatment periods

  • Proportion between the groups of treatment without any kind of seizures. (seizure free) [ Time Frame: 12 weeks after the titration period (period with stable regimen of the drug) ] [ Designated as safety issue: No ]
    During the evaluation period of treatment, without the titration period


Estimated Enrollment: 200
Study Start Date: December 2011
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Levetiracetam Drug: Levetiracetam
Oral solution (Each mL contains 100mg of levetiracetam) or immediate-release tablets (Tablets containing 500mg or 1000mg of levetiracetam)
Placebo Comparator: Placebo Drug: Placebo
Placebo, properly standardized to suit the characteristics of each dosage form (oral solution and tablets) of levetiracetam

  Eligibility

Ages Eligible for Study:   4 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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);
  • Participation in last one year of clinical protocols, unless it can be direct benefit to subject;
  • Relatives of sponsor´s or study site´s employee;
  • Current evidence of clinically significant diseases: hematopoietic, gastrointestinal, cardiovascular, hepatic, renal, neurological, endocrine, psychiatric, autoimmune, pulmonary, or another disease that block the subject participation;
  • Any finding of clinical observation (anamnesis and physical exam) laboratory abnormality (e.g., blood glucose, blood count), disease (for example, liver, cardiovascular system, lung) or therapy that, in opinion of the investigator, may endanger the subject or interfere with the endpoints of study.
  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: NCT01392768

Contacts
Contact: Carla R Peron, Physician +55 11 2608-8680 carla.peron@ache.com.br

Sponsors and Collaborators
Ache Laboratorios Farmaceuticos S.A.
Investigators
Principal Investigator: Elza M Yacubian Federal University of São Paulo
  More Information

No publications provided

Responsible Party: Ache Laboratorios Farmaceuticos S.A.
ClinicalTrials.gov Identifier: NCT01392768     History of Changes
Other Study ID Numbers: ACH-LPT-03(09/10)
Study First Received: July 6, 2011
Last Updated: July 12, 2011
Health Authority: Brazil: Ethics Committee
Brazil: Ministry of Health

Keywords provided by Ache Laboratorios Farmaceuticos S.A.:
Epilepsy
Partial
Seizures
Adjunctive

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
Neuroprotective Agents
Nootropic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014