Epilepsies, PartialPhase 4STANDLOWNCT03689114
Low vs. Standard Daily Doses of Antiepileptic Drugs in Newly Diagnosed, Previously Untreated Epilepsy(STANDLOW)
A Phase 4 study testing Low dose carbamazepine, Standard dose carbamazepine and Low dose levetiracetam in people with Epilepsies, Partial, run by Mario Negri Institute for Pharmacological Research at 1 site in Italy.
Trial summary
There are no guidelines on the first maintenance daily dose of antiepileptic drugs (AEDs) in newly diagnosed, previously untreated epilepsy. Original trials and Cochrane reviews show that seizure remission can be achieved with differing daily doses. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epilepsies, Partial
- What is being tested?
- Low dose carbamazepine, Standard dose carbamazepine and Low dose levetiracetam
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteItaly
- Study dates
- 10 May 2021to 30 Jun 2024
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older;
- Newly diagnosed previously untreated epilepsy, defined according to the ILAE definition (Fisher et al, 2014);
- Having experienced focal seizures, defined according to the ILAE criteria (Commission, 1981);
- Able to understand and comply with the study requirements and release a written informed consent.
Who cannot join
- A patient will be excluded if at least one of the following criteria will be met:
- Age less than 18 years;
- Having experienced primarily or secondarily generalized tonic and/or clonic seizures, or other (non-focal) seizure types;
- Previous exposure to AEDs;
- Requiring low or standard doses on account of individual needs;
- Inability to understand the aims or modalities of the study;
Show all 12Show fewer
- Current pregnancy or planning to become pregnant during the study period (e.g. who are not post-menopausal, surgically sterile, or using inadequate birth control). A postmenopausal state is defined as no menses for 12 months without an alternative medical cause;
- Previous treatment with an antiepileptic drug;
- Men unable to practice contraception for the duration of the treatment.
- Poor compliance with assigned treatments;
- Refusal to release written informed consent;
- The study investigators will receive the summary of product characteristics (SPC) available for each study drug. Patients cannot be enrolled in the study if the contraindications/warnings described in the SPC are met.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Tolerability of Low vs. Standard Daily Doses of Antiepileptic Drugs in Newly Diagnosed, Previously Untreated Epilepsy (STANDLOW). A Multicenter, Randomized, Single-blind, Parallel-group Trial
There are no guidelines on the first maintenance daily dose of antiepileptic drugs (AEDs) in newly diagnosed, previously untreated epilepsy. Original trials and Cochrane reviews show that seizure remission can be achieved with differing daily doses. In clinical practice, the first maintenance dose varies significantly. In contrast, the risk of adverse treatment effects increases with dosage. There is thus the need to identify the lowest effective dose for treatment start. This background prompted us to undertake a randomized multicenter pragmatic non-inferiority trial comparing standard to low daily doses of AEDs to demonstrate that low doses are at least as effective as standard doses (as indicated by the national formulary) but are better tolerated and are associated with a better quality of life. If proven as effective as the standard dose, a low daily dose of AEDs is a benefit to the patient in terms of tolerability and safety and a source of savings for the National Health System.
- Conditions
- Epilepsies, Partial
- Being tested
- Low dose carbamazepine, Standard dose carbamazepine, Low dose levetiracetam, Standard dose levetiracetam, Low dose valproate
- Keywords
- epilepsy, antiepileptic drugs, low dose, standard dose, new diagnosis
- Medical subject headings
- Epilepsies, Partial, Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low dose carbamazepineDrug
Also called low carbamazepine
Carbamazepine, 300 mg/die
Standard dose carbamazepineDrug
Also called Standard carbamazepine
Carbamazepine 600 mg/die
Low dose levetiracetamDrug
Also called Low levetiracetam
Levetiracetam 500 mg/die
Standard dose levetiracetamDrug
Also called Standard levetiracetam
Levetiracetam 1000 mg/die
Low dose valproateDrug
Also called Low valproate
Valproate 300 mg/die
Standard dose valproateDrug
Also called Standard valproate
Valproate 600 mg/die
Low dose zonisamideDrug
Also called Low zonisamide
Zonisamide 150 mg/die
Standard dose zonisamideDrug
Also called Standard zonisamide
Zonisamide 300 mg/die
Low dose oxcarbazepineDrug
Also called Low oxcarbazepine
Oxcarbazepine 600 mg/die
Standard dose oxcarbazepineDrug
Also called Standard oxcarbazepine
Oxcarbazepine 1200 mg/die
Low dose topiramateDrug
Also called Low topiramate
Topiramate 100 mg/die
Standard dose topiramateDrug
Also called Standard topiramate
Topiramate 200 mg/die
Low dose lamotrigineDrug
Also called Low lamotrigine
Lamotrigine 100 mg/die
Standard dose lamotrigineDrug
Also called Standard lamotrigine
Lamotrigine 200 mg/die
Low dose gabapentinDrug
Also called Low gabapentin
Gabapentin 450 mg/die
Standard dose gabapentinDrug
Also called Standard gabapentin
Gabapentin 900 mg/die
| Study group | Role | What they receive |
|---|---|---|
| Low dose | Experimental | Dosage is in mg: low dose carbamazepine, 300 ; low dose levetiracetam, 500; low dose valproate, 300; low dose zonisamide, 150; low dose oxcarbazepine, 600; low dose topiramate, 100; low dose lamotrigine, 100; low dose gabapentin, 450. Study drugs are in form of tablets for daily administration. Study drug administration duration is 12 months. The choice of the drug is left to the caring physician's discretion but it must be limited to the AEDs marketed for monotherapy use. All the study drugs will be used according to the respective SPCs, which will be sent by the promoter to all the study investigators. Receives: Drug: Low dose carbamazepine; Drug: Low dose levetiracetam; Drug: Low dose valproate; Drug: Low dose zonisamide; Drug: Low dose oxcarbazepine; Drug: Low dose topiramate; Drug: Low dose lamotrigine; Drug: Low dose gabapentin |
| Standard dose | Active comparator | Dosage is in mg: standard dose carbamazepine 600; standard dose levetiracetam 1000; standard dose valproate, 600; standard dose zonisamide 300; standard dose oxcarbazepine 1200; standard dose topiramate, 200; standard dose lamotrigine, 200; standard dose gabapentin 900. Study drugs are in form of tablets for daily administration. Study drug administration duration is 12 months. The choice of the drug is left to the caring physician's discretion but it must be limited to the AEDs marketed for monotherapy use. All the study drugs will be used according to the respective SPCs, which will be sent by the promoter to all the study investigators. Receives: Drug: Standard dose carbamazepine; Drug: Standard dose levetiracetam; Drug: Standard dose valproate; Drug: Standard dose zonisamide; Drug: Standard dose oxcarbazepine; Drug: Standard dose topiramate; Drug: Standard dose lamotrigine; Drug: Standard dose gabapentin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment Failure
The proportion of patients experiencing a treatment failure motivated by the need to change the assigned dose or the assigned drug for seizure relapse during the follow-up.
All proportions are reported as percentages.
Measured: 12 months
Secondary outcomes (4)
Drug-related Adverse Events
the proportion of patients experiencing a treatment failure motivated by intolerable drug-related adverse events during the follow-up;
Measured: 12 months
PSQ-18, Italian Version
The score of the seven Patients Satisfaction Questionnaire 18 items (PSQ-18) subscales (general satisfaction, technical quality, interpersonal manner, communication, financial aspects, time spent with doctor, accessibility and convenience) at the last visit; the score of each subscale ranges from 1 (worst) to 5 (best).
Measured: 12 months
QoLIE-31, Italian Version
QoLIE-31 measures the quality of life of patients with epilepsy (range 0-100, where 0 corresponds to the worst quality of life and 100 corresponds to the best), at the end of study visit.
Measured: 12 months
Health Care Resources Utilization.
The mean daily patient's cost of health care resources consumed for the management of epilepsy during the first 12 months of the study.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2018
- Study start10 May 2021
- Primary completion30 Jun 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Epilepsies, PartialStudies of the same condition, open and under way.
- More trials run by Mario Negri Institute for Pharmacological ResearchThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a multicenter randomized pragmatic parallel-group single-blind non-inferiority trial.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Azienda Ospedaliera San Gerardo di Monza, Ministry of Health, Italy
- Responsible party
- Sponsor
- Investigators
- Ettore Beghi, MD, Principal investigator, Istituto Di Ricerche Farmacologiche Mario Negri
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03689114
- Sponsor's protocol ID
- STANDLOW
- Acronym
- STANDLOW
- Status last verified
- Jul 2025
- First submitted
- 27 Sep 2018
- Last updated
- 8 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Abimbola S, Martiniuk AL, Hackett ML, Anderson CS. The influence of design and definition on the proportion of general epilepsy cohorts with remission and intractability. Neuroepidemiology. 2011;36(3):204-12. doi: 10.1159/000327497. Epub 2011 May 24.
PubMed 21606654Beghi E, Niero M, Roncolato M. Validity and reliability of the Italian version of the Quality-of-Life in Epilepsy Inventory (QOLIE-31). Seizure. 2005 Oct;14(7):452-8. doi: 10.1016/j.seizure.2005.07.008. Epub 2005 Aug 10.
PubMed 16098770Proposal for revised clinical and electroencephalographic classification of epileptic seizures. From the Commission on Classification and Terminology of the International League Against Epilepsy. Epilepsia. 1981 Aug;22(4):489-501. doi: 10.1111/j.1528-1157.1981.tb06159.x. No abstract available.
PubMed 6790275Fisher RS, Acevedo C, Arzimanoglou A, Bogacz A, Cross JH, Elger CE, Engel J Jr, Forsgren L, French JA, Glynn M, Hesdorffer DC, Lee BI, Mathern GW, Moshe SL, Perucca E, Scheffer IE, Tomson T, Watanabe M, Wiebe S. ILAE official report: a practical clinical definition of epilepsy. Epilepsia. 2014 Apr;55(4):475-82. doi: 10.1111/epi.12550. Epub 2014 Apr 14.
PubMed 24730690Gilliam F. Optimizing health outcomes in active epilepsy. Neurology. 2002 Apr 23;58(8 Suppl 5):S9-20. doi: 10.1212/wnl.58.8_suppl_5.s9.
PubMed 11971128Maguire M, Marson AG, Ramaratnam S. Epilepsy (partial). BMJ Clin Evid. 2010 Jun 28;2010:1214.
PubMed 21429248Perucca P, Jacoby A, Marson AG, Baker GA, Lane S, Benn EK, Thurman DJ, Hauser WA, Gilliam FG, Hesdorffer DC. Adverse antiepileptic drug effects in new-onset seizures: a case-control study. Neurology. 2011 Jan 18;76(3):273-9. doi: 10.1212/WNL.0b013e318207b073.
PubMed 21242496
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Tolerability of Low vs. Standard Daily Doses of Antiepileptic Drugs in Newly Diagnosed, Previously Untreated Epilepsy (STANDLOW). A Multicenter, Randomized, Single-blind, Parallel-group Trial
- ClinicalTrials.gov ID
- NCT03689114
- Acronym / sponsor ID
- STANDLOW / STANDLOW
- Conditions
- Epilepsies, Partial
- Keywords
- epilepsy, antiepileptic drugs, low dose, standard dose, new diagnosis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Mario Negri Institute for Pharmacological ResearchUniversity, hospital or other
- Collaborators
- Azienda Ospedaliera San Gerardo di Monza, Ministry of Health, Italy
- Study start
- 10 May 2021 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 28 Sep 2018 (actual)
- Results
- Posted 8 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
There are no guidelines on the first maintenance daily dose of antiepileptic drugs (AEDs) in newly diagnosed, previously untreated epilepsy. Original trials and Cochrane reviews show that seizure remission can be achieved with differing daily doses. In clinical practice, the first maintenance dose varies significantly. In contrast, the risk of adverse treatment effects increases with dosage. There is thus the need to identify the lowest effective dose for treatment start. This background prompted us to undertake a randomized multicenter pragmatic non-inferiority trial comparing standard to low daily doses of AEDs to demonstrate that low doses are at least as effective as standard doses (as indicated by the national formulary) but are better tolerated and are associated with a better quality of life. If proven as effective as the standard dose, a low daily dose of AEDs is a benefit to the patient in terms of tolerability and safety and a source of savings for the National Health System.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This is a multicenter randomized pragmatic parallel-group single-blind non-inferiority trial.
| Arm | Type | Receives |
|---|---|---|
| Low dose | Experimental | Drug: Low dose carbamazepine, Drug: Low dose levetiracetam, Drug: Low dose valproate, Drug: Low dose zonisamide, Drug: Low dose oxcarbazepine, Drug: Low dose topiramate, Drug: Low dose lamotrigine, Drug: Low dose gabapentinDosage is in mg: low dose carbamazepine, 300 ; low dose levetiracetam, 500; low dose valproate, 300; low dose zonisamide, 150; low dose oxcarbazepine, 600; low dose topiramate, 100; low dose lamotrigine, 100; low dose gabapentin, 450. Study drugs are in form of tablets for daily administration. Study drug administration duration is 12 months. The choice of the drug is left to the caring physician's discretion but it must be limited to the AEDs marketed for monotherapy use. All the study drugs will be used according to the respective SPCs, which will be sent by the promoter to all the study investigators. |
| Standard dose | Active comparator | Drug: Standard dose carbamazepine, Drug: Standard dose levetiracetam, Drug: Standard dose valproate, Drug: Standard dose zonisamide, Drug: Standard dose oxcarbazepine, Drug: Standard dose topiramate, Drug: Standard dose lamotrigine, Drug: Standard dose gabapentinDosage is in mg: standard dose carbamazepine 600; standard dose levetiracetam 1000; standard dose valproate, 600; standard dose zonisamide 300; standard dose oxcarbazepine 1200; standard dose topiramate, 200; standard dose lamotrigine, 200; standard dose gabapentin 900. Study drugs are in form of tablets for daily administration. Study drug administration duration is 12 months. The choice of the drug is left to the caring physician's discretion but it must be limited to the AEDs marketed for monotherapy use. All the study drugs will be used according to the respective SPCs, which will be sent by the promoter to all the study investigators. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 years or older;
- Newly diagnosed previously untreated epilepsy, defined according to the ILAE definition (Fisher et al, 2014);
- Having experienced focal seizures, defined according to the ILAE criteria (Commission, 1981);
- Able to understand and comply with the study requirements and release a written informed consent.
Key exclusion criteria (12 listed)
- Age less than 18 years;
- Having experienced primarily or secondarily generalized tonic and/or clonic seizures, or other (non-focal) seizure types;
- Previous exposure to AEDs;
- Requiring low or standard doses on account of individual needs;
- Inability to understand the aims or modalities of the study;
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 |
|---|---|---|
| Low dose carbamazepineAlso: low carbamazepineCarbamazepine, 300 mg/die | Drug | Low dose |
| Standard dose carbamazepineAlso: Standard carbamazepineCarbamazepine 600 mg/die | Drug | Standard dose |
| Low dose levetiracetamAlso: Low levetiracetamLevetiracetam 500 mg/die | Drug | Low dose |
| Standard dose levetiracetamAlso: Standard levetiracetamLevetiracetam 1000 mg/die | Drug | Standard dose |
| Low dose valproateAlso: Low valproateValproate 300 mg/die | Drug | Low dose |
| Standard dose valproateAlso: Standard valproateValproate 600 mg/die | Drug | Standard dose |
| Low dose zonisamideAlso: Low zonisamideZonisamide 150 mg/die | Drug | Low dose |
| Standard dose zonisamideAlso: Standard zonisamideZonisamide 300 mg/die | Drug | Standard dose |
| Low dose oxcarbazepineAlso: Low oxcarbazepineOxcarbazepine 600 mg/die | Drug | Low dose |
| Standard dose oxcarbazepineAlso: Standard oxcarbazepineOxcarbazepine 1200 mg/die | Drug | Standard dose |
| Low dose topiramateAlso: Low topiramateTopiramate 100 mg/die | Drug | Low dose |
| Standard dose topiramateAlso: Standard topiramateTopiramate 200 mg/die | Drug | Standard dose |
| Low dose lamotrigineAlso: Low lamotrigineLamotrigine 100 mg/die | Drug | Low dose |
| Standard dose lamotrigineAlso: Standard lamotrigineLamotrigine 200 mg/die | Drug | Standard dose |
| Low dose gabapentinAlso: Low gabapentinGabapentin 450 mg/die | Drug | Low dose |
| Standard dose gabapentinAlso: Standard gabapentinGabapentin 900 mg/die | Drug | Standard dose |
Primary outcome
Treatment Failure
Time frame: 12 months
The proportion of patients experiencing a treatment failure motivated by the need to change the assigned dose or the assigned drug for seizure relapse during the follow-up. All proportions are reported as percentages.
4 secondary outcomes
Drug-related Adverse Events
Time frame: 12 months
PSQ-18, Italian Version
Time frame: 12 months
QoLIE-31, Italian Version
Time frame: 12 months
Health Care Resources Utilization.
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 21606654Abimbola S, Martiniuk AL, Hackett ML, Anderson CS. The influence of design and definition on the proportion of general epilepsy cohorts with remission and intractability. Neuroepidemiology. 2011;36(3):204-12. doi: 10.1159/000327497. Epub 2011 May 24.
- Background: PubMed 16098770Beghi E, Niero M, Roncolato M. Validity and reliability of the Italian version of the Quality-of-Life in Epilepsy Inventory (QOLIE-31). Seizure. 2005 Oct;14(7):452-8. doi: 10.1016/j.seizure.2005.07.008. Epub 2005 Aug 10.
- Background: PubMed 6790275Proposal for revised clinical and electroencephalographic classification of epileptic seizures. From the Commission on Classification and Terminology of the International League Against Epilepsy. Epilepsia. 1981 Aug;22(4):489-501. doi: 10.1111/j.1528-1157.1981.tb06159.x. No abstract available.
- Background: PubMed 24730690Fisher RS, Acevedo C, Arzimanoglou A, Bogacz A, Cross JH, Elger CE, Engel J Jr, Forsgren L, French JA, Glynn M, Hesdorffer DC, Lee BI, Mathern GW, Moshe SL, Perucca E, Scheffer IE, Tomson T, Watanabe M, Wiebe S. ILAE official report: a practical clinical definition of epilepsy. Epilepsia. 2014 Apr;55(4):475-82. doi: 10.1111/epi.12550. Epub 2014 Apr 14.
- Background: PubMed 11971128Gilliam F. Optimizing health outcomes in active epilepsy. Neurology. 2002 Apr 23;58(8 Suppl 5):S9-20. doi: 10.1212/wnl.58.8_suppl_5.s9.
- Background: PubMed 21429248Maguire M, Marson AG, Ramaratnam S. Epilepsy (partial). BMJ Clin Evid. 2010 Jun 28;2010:1214.
- Background: PubMed 21242496Perucca P, Jacoby A, Marson AG, Baker GA, Lane S, Benn EK, Thurman DJ, Hauser WA, Gilliam FG, Hesdorffer DC. Adverse antiepileptic drug effects in new-onset seizures: a case-control study. Neurology. 2011 Jan 18;76(3):273-9. doi: 10.1212/WNL.0b013e318207b073.
- Individual participant dataSharing planned: No
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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.
Ettore Beghi, MD principal investigator
Istituto Di Ricerche Farmacologiche Mario Negri
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Low dose carbamazepine, Standard dose carbamazepine and Low dose levetiracetam in people with Epilepsies, Partial, run by Mario Negri Institute for Pharmacological Research at 1 site in Italy.
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 12 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 8 Jul 2025. 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 Italy. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Treatment Failure (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03689114, which also lists 7 linked publications.
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 8 Jul 2025.