Low vs. Standard Daily Doses of Antiepileptic Drugs in Newly Diagnosed, Previously Untreated Epilepsy(STANDLOW)
NCT ID: NCT03689114
Last Updated: 2025-07-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
58 participants
INTERVENTIONAL
2021-05-10
2024-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Low dose
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.
Low dose carbamazepine
Carbamazepine, 300 mg/die
Low dose levetiracetam
Levetiracetam 500 mg/die
Low dose valproate
Valproate 300 mg/die
Low dose zonisamide
Zonisamide 150 mg/die
Low dose oxcarbazepine
Oxcarbazepine 600 mg/die
Low dose topiramate
Topiramate 100 mg/die
Low dose lamotrigine
Lamotrigine 100 mg/die
Low dose gabapentin
Gabapentin 450 mg/die
Standard dose
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.
Standard dose carbamazepine
Carbamazepine 600 mg/die
Standard dose levetiracetam
Levetiracetam 1000 mg/die
Standard dose valproate
Valproate 600 mg/die
Standard dose zonisamide
Zonisamide 300 mg/die
Standard dose oxcarbazepine
Oxcarbazepine 1200 mg/die
Standard dose topiramate
Topiramate 200 mg/die
Standard dose lamotrigine
Lamotrigine 200 mg/die
Standard dose gabapentin
Gabapentin 900 mg/die
Interventions
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Low dose carbamazepine
Carbamazepine, 300 mg/die
Standard dose carbamazepine
Carbamazepine 600 mg/die
Low dose levetiracetam
Levetiracetam 500 mg/die
Standard dose levetiracetam
Levetiracetam 1000 mg/die
Low dose valproate
Valproate 300 mg/die
Standard dose valproate
Valproate 600 mg/die
Low dose zonisamide
Zonisamide 150 mg/die
Standard dose zonisamide
Zonisamide 300 mg/die
Low dose oxcarbazepine
Oxcarbazepine 600 mg/die
Standard dose oxcarbazepine
Oxcarbazepine 1200 mg/die
Low dose topiramate
Topiramate 100 mg/die
Standard dose topiramate
Topiramate 200 mg/die
Low dose lamotrigine
Lamotrigine 100 mg/die
Standard dose lamotrigine
Lamotrigine 200 mg/die
Low dose gabapentin
Gabapentin 450 mg/die
Standard dose gabapentin
Gabapentin 900 mg/die
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Newly diagnosed previously untreated epilepsy, defined according to the ILAE definition (Fisher et al, 2014);
3. Having experienced focal seizures, defined according to the ILAE criteria (Commission, 1981);
4. Able to understand and comply with the study requirements and release a written informed consent.
Exclusion Criteria
1. Age less than 18 years;
2. Having experienced primarily or secondarily generalized tonic and/or clonic seizures, or other (non-focal) seizure types;
3. Previous exposure to AEDs;
4. Requiring low or standard doses on account of individual needs;
5. Inability to understand the aims or modalities of the study;
6. 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;
7. Previous treatment with an antiepileptic drug;
8. Men unable to practice contraception for the duration of the treatment.
9. Poor compliance with assigned treatments;
10. Refusal to release written informed consent;
11. 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.
18 Years
ALL
No
Sponsors
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Azienda Ospedaliera San Gerardo di Monza
OTHER
Ministry of Health, Italy
OTHER_GOV
Mario Negri Institute for Pharmacological Research
OTHER
Responsible Party
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Principal Investigators
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Ettore Beghi, MD
Role: PRINCIPAL_INVESTIGATOR
Istituto Di Ricerche Farmacologiche Mario Negri
Locations
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ASST Monza Ospedale San Gerardo
Monza, , Italy
Countries
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References
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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.
Beghi 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.
Proposal 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.
Fisher 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.
Gilliam 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.
Maguire M, Marson AG, Ramaratnam S. Epilepsy (partial). BMJ Clin Evid. 2010 Jun 28;2010:1214.
Perucca 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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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STANDLOW
Identifier Type: -
Identifier Source: org_study_id
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