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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01392768
Recruitment Status : Completed
First Posted : July 13, 2011
Last Update Posted : October 31, 2016
Information provided by (Responsible Party):
Ache Laboratorios Farmaceuticos S.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.

Condition or disease Intervention/treatment Phase
Epilepsy Partial Seizures Drug: Levetiracetam Drug: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 126 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : January 2013
Actual Primary Completion Date : July 2015
Actual Study Completion Date : August 2015

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Partial onset seizure frequency per week. [ Time Frame: From baseline to week 24 ]
    Collection of seizure count throughout the whole study

Secondary Outcome Measures :
  1. 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 ]
    Collection of safety data throughout the whole study period

  2. 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 ]
    Comparative between baseline and treatment periods

  3. Percentage reduction from baseline in partial seizure frequency of days a week. [ Time Frame: From baseline to week 24 ]
    Comparative between baseline and treatment periods

  4. 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 ]
    Comparative between baseline and treatment periods

  5. 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) ]
    During the evaluation period of treatment, without the titration period

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Ages Eligible for Study:   4 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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 identifier (NCT number): NCT01392768

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

Responsible Party: Ache Laboratorios Farmaceuticos S.A. Identifier: NCT01392768     History of Changes
Other Study ID Numbers: ACH-LPT-03(09/10)
First Posted: July 13, 2011    Key Record Dates
Last Update Posted: October 31, 2016
Last Verified: October 2016

Keywords provided by Ache Laboratorios Farmaceuticos S.A.:

Additional relevant MeSH terms:
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Nootropic Agents
Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs