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

Epilepsy Clinical Trial

— Mozart  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01392768
• Other study ID #: ACH-LPT-03(09/10)
• Status: Completed
• Phase: Phase 3
• First received: July 6, 2011
• Last updated: October 27, 2016
• Start date: January 2013
• Est. completion date: August 2015

Study information

• Verified date: October 2016
• Source: Ache Laboratorios Farmaceuticos S.A.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics CommitteeBrazil: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: August 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Epilepsy
• Partial Seizures
• Seizures

Intervention

Drug:
• Levetiracetam
Oral solution (Each mL contains 100mg of levetiracetam) or immediate-release tablets (Tablets containing 500mg or 1000mg of levetiracetam)
• Placebo
Placebo, properly standardized to suit the characteristics of each dosage form (oral solution and tablets) of levetiracetam

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ache Laboratorios Farmaceuticos S.A.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Partial onset seizure frequency per week.	Collection of seizure count throughout the whole study	From baseline to week 24	No
Secondary	Safety descriptive about occurence of adverse events, evaluation of results of clinical/physical examination and ECG and laboratory tests results.	Collection of safety data throughout the whole study period	From baseline to week 30	Yes
Secondary	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)	Comparative between baseline and treatment periods	From baseline to week 24	No
Secondary	Percentage reduction from baseline in partial seizure frequency of days a week.	Comparative between baseline and treatment periods	From baseline to week 24	No
Secondary	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)	Comparative between baseline and treatment periods	From baseline to week 24	No
Secondary	Proportion between the groups of treatment without any kind of seizures. (seizure free)	During the evaluation period of treatment, without the titration period	12 weeks after the titration period (period with stable regimen of the drug)	No