EpilepsyPhase 3MozartNCT01392768
Efficacy and Safety of Levetiracetam in Partial Seizures Control, With or Without Secondary Generalization
A Phase 3 study testing Levetiracetam in people with Epilepsy and Partial Seizures, run by Ache Laboratorios Farmaceuticos S.A..
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. Read more about this study
- Who is it for?
- Ages 4 to 65 years
- Conditions the study is for
- Epilepsy, Partial Seizures
- What is being tested?
- Levetiracetam
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 126 participants
- Where
- No sites listed yet
- Study dates
- Jan 2013to Aug 2015
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Show all 10Show fewer
- 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)
Who cannot join
- 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;
Show all 19Show fewer
- 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.
About this study
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
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
- Being tested
- Levetiracetam, Placebo
- Keywords
- Epilepsy, Partial, Seizures, Adjunctive
- Medical subject headings
- Epilepsy, Seizures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LevetiracetamDrug
Oral solution (Each mL contains 100mg of levetiracetam) or immediate-release tablets (Tablets containing 500mg or 1000mg of levetiracetam)
PlaceboDrug
Placebo, properly standardized to suit the characteristics of each dosage form (oral solution and tablets) of levetiracetam
| Study group | Role | What they receive |
|---|---|---|
| Levetiracetam | Experimental | Not described Receives: Drug: Levetiracetam |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Partial onset seizure frequency per week.
Collection of seizure count throughout the whole study
Measured: 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.
Collection of safety data throughout the whole study period
Measured: 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)
Comparative between baseline and treatment periods
Measured: From baseline to week 24
Percentage reduction from baseline in partial seizure frequency of days a week.
Comparative between baseline and treatment periods
Measured: 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)
Comparative between baseline and treatment periods
Measured: From baseline to week 24
Proportion between the groups of treatment without any kind of seizures. (seizure free)
During the evaluation period of treatment, without the titration period
Measured: 12 weeks after the titration period (period with stable regimen of the drug)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2011 (estimated)
- Study startJan 2013
- Primary completionJul 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ache Laboratorios Farmaceuticos S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Elza M Yacubian, Principal investigator, Federal University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01392768
- Sponsor's protocol ID
- ACH-LPT-03(09/10)
- Acronym
- Mozart
- Status last verified
- Oct 2016
- First submitted
- 6 Jul 2011
- Last updated
- 31 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01392768
- Acronym / sponsor ID
- Mozart / ACH-LPT-03(09/10)
- Conditions
- Epilepsy, Partial Seizures
- Keywords
- Epilepsy, Partial, Seizures, Adjunctive
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Ache Laboratorios Farmaceuticos S.A.Industry (pharma, biotech, devices)
- Study start
- Jan 2013
- Primary completion
- Jul 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 13 Jul 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Levetiracetam | Experimental | Drug: Levetiracetam |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 4 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- 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);
Key exclusion criteria (19 listed)
- Patients with:
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LevetiracetamOral solution (Each mL contains 100mg of levetiracetam) or immediate-release tablets (Tablets containing 500mg or 1000mg of levetiracetam) | Drug | Levetiracetam |
| PlaceboPlacebo, properly standardized to suit the characteristics of each dosage form (oral solution and tablets) of levetiracetam | Drug | Placebo |
Primary outcome
Partial onset seizure frequency per week.
Time frame: From baseline to week 24
Collection of seizure count throughout the whole study
5 secondary outcomes
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
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
Percentage reduction from baseline in partial seizure frequency of days a week.
Time frame: 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)
Time frame: From baseline to week 24
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2016.
Related trials for Epilepsy
Not yet recruiting
Clinical Trial of SEEG for Drug-resistant Epilepsy
Drug-Resistant Epilepsy
RecruitingPhase 3
Investigate Efficacy and Safety of Carisbamate as Adjunctive Treatment for Seizures Associated With LGS in Children and Adults
Seizures, Lennox Gastaut Syndrome
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures
Focal Seizure, Epilepsy
Active, not recruitingObservational study
Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)
Traumatic Brain Injury, Post-traumatic Epilepsy
RecruitingPhase 3
Study Evaluating the Efficacy and Safety of RAP-219 in Adult Participants With Focal Seizures FOCUS-1
Focal Seizure, Epilepsy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elza M Yacubian principal investigator
Federal University of São Paulo
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Levetiracetam in people with Epilepsy and Partial Seizures, run by Ache Laboratorios Farmaceuticos S.A..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Partial onset seizure frequency per week. (time frame: From baseline to week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2016.