EpilepsyNCT04132063
Generic Substitution of Original Levetiracetam in Thai Epilepsy Patients
An observational study of Epilepsy, run by Mahidol University at 1 site in Thailand.
Trial summary
The retrospective pre-post observational study was conducted to evaluate the real-world evidence of efficacy and tolerability of generic levetiracetam (oral tablet) which was switched from original levetiracetam (oral tablet) in patients with epilepsy at the national hospital for neurology and neurosurgery in… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Epilepsy
- What is being tested?
- Generic levetiracetam
- Type of treatment
- Pill or oral medicine
- How many people
- 75 participants
- Where
- 1 siteThailand
- Study dates
- 1 Nov 2018to 30 May 2019
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Any epileptic patients who received generic substitution to original levetiracetam from February 2016 to May 2018
Who may be able to join
- Diagnosis of epilepsy for at least 6 months prior to generic levetiracetam substitution;
- Same dosage form and strength of generic substitution to original levetiracetam;
- Stable dose of original levetiracetam and stable seizure frequency prior to generic levetiracetam substitution;
- Stable dose of generic levetiracetam after generic levetiracetam substitution
Who cannot join
- Absence seizure with levetiracetam monotherapy;
- Original levetiracetam in dosage form of oral solution or intravenous solution prior to generic levetiracetam substitution;
- Poor compliance;
- Death or loss of follow up;
- Unavailable data for evaluation of outcomes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of Generic Substitution of Original Levetiracetam in Patients With Epilepsy
The retrospective pre-post observational study was conducted to evaluate the real-world evidence of efficacy and tolerability of generic levetiracetam (oral tablet) which was switched from original levetiracetam (oral tablet) in patients with epilepsy at the national hospital for neurology and neurosurgery in Thailand. Epilepsy patients who received generic substitution to original levetiracetam at the same dose and had stable conditions of seizure were only included. In the period of 6 months, the investigators assessed the change of seizure frequency, the incidence of hospitalization due to breakthrough seizure, the incidence of adverse events and the incidence of composite outcomes related to dosage adjustment of antiepileptic drugs.
- Conditions
- Epilepsy
- Being tested
- Generic levetiracetam
- Keywords
- Epilepsy, Generic, Levetiracetam, Therapeutic equivalency
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Generic levetiracetamDrug
Generic levetiracetam tablet as the same dose as original levetiracetam tablet at the switching date
| Study group | Role | What they receive |
|---|---|---|
| Generic levetiracetam | Not described Receives: Drug: Generic levetiracetam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline seizure frequency
Change from baseline seizure frequency per month at 3 and 6 months
Measured: At baseline, 3 and 6 months after generic levetiracetam substitution
Secondary outcomes (3)
Hospitalization
Incidence of hospitalization due to breakthrough seizure
Measured: During 6 months of generic levetiracetam substitution
Adverse events
Incidence of adverse events after generic levetiracetam substitution
Measured: During 6 months of generic levetiracetam substitution
Composite outcomes
Incidence of composite outcomes related to dosage adjustment of antiepileptic drugs such as
- Switching back to original levetiracetam due to experiencing an uncontrolled seizure or adverse drug reactions,
- The incremental dose of generic levetiracetam due to experiencing an uncontrolled seizure,
- The decremental dose of generic levetiracetam due to experiencing adverse events,
- Add-on other antiepileptic drugs due to experiencing an uncontrolled seizure,
- The incremental dose of concurrent antiepileptic drugs due to experiencing an uncontrolled seizure.
Measured: During 6 months of generic levetiracetam substitution
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2019
- Study start1 Nov 2018
- Primary completion30 May 2019
- Study completion30 May 2019
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.
- More trials run by Mahidol UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jannapas Tharavichitkun, Principal investigator, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04132063
- Sponsor's protocol ID
- 2018/PY119
- Status last verified
- Oct 2019
- First submitted
- 15 Oct 2019
- Last updated
- 18 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Generic Substitution of Original Levetiracetam in Patients With Epilepsy
- ClinicalTrials.gov ID
- NCT04132063
- Acronym / sponsor ID
- 2018/PY119
- Conditions
- Epilepsy
- Keywords
- Epilepsy, Generic, Levetiracetam, Therapeutic equivalency
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 30 May 2019 (actual)
- Study completion
- 30 May 2019 (actual)
- First posted
- 18 Oct 2019 (actual)
- 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 retrospective pre-post observational study was conducted to evaluate the real-world evidence of efficacy and tolerability of generic levetiracetam (oral tablet) which was switched from original levetiracetam (oral tablet) in patients with epilepsy at the national hospital for neurology and neurosurgery in Thailand. Epilepsy patients who received generic substitution to original levetiracetam at the same dose and had stable conditions of seizure were only included. In the period of 6 months, the investigators assessed the change of seizure frequency, the incidence of hospitalization due to breakthrough seizure, the incidence of adverse events and the incidence of composite outcomes related to dosage adjustment of antiepileptic drugs.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Generic levetiracetam | – | Drug: Generic levetiracetam |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Any epileptic patients who received generic substitution to original levetiracetam from February 2016 to May 2018
Key inclusion criteria (4 listed)
- Diagnosis of epilepsy for at least 6 months prior to generic levetiracetam substitution;
- Same dosage form and strength of generic substitution to original levetiracetam;
- Stable dose of original levetiracetam and stable seizure frequency prior to generic levetiracetam substitution;
- Stable dose of generic levetiracetam after generic levetiracetam substitution
Key exclusion criteria (5 listed)
- Absence seizure with levetiracetam monotherapy;
- Original levetiracetam in dosage form of oral solution or intravenous solution prior to generic levetiracetam substitution;
- Poor compliance;
- Death or loss of follow up;
- Unavailable data for evaluation of outcomes
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 |
|---|---|---|
| Generic levetiracetamGeneric levetiracetam tablet as the same dose as original levetiracetam tablet at the switching date | Drug | Generic levetiracetam |
Primary outcome
Change from baseline seizure frequency
Time frame: At baseline, 3 and 6 months after generic levetiracetam substitution
Change from baseline seizure frequency per month at 3 and 6 months
3 secondary outcomes
Hospitalization
Time frame: During 6 months of generic levetiracetam substitution
Adverse events
Time frame: During 6 months of generic levetiracetam substitution
Composite outcomes
Time frame: During 6 months of generic levetiracetam substitution
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 18 Oct 2019.
- Individual participant dataSharing planned: No
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.
Jannapas Tharavichitkun principal investigator
Mahidol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epilepsy, run by Mahidol University at 1 site in Thailand.
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 4 inclusion and 5 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 18 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Change from baseline seizure frequency (time frame: At baseline, 3 and 6 months after generic levetiracetam substitution). 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 18 Oct 2019.