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Trial record 72 of 83 for:    CARBAMAZEPINE AND Cytochrome P-450 CYP3A Inducers

Low vs. Standard Daily Doses of Antiepileptic Drugs in Newly Diagnosed, Previously Untreated Epilepsy(STANDLOW) (STANDLOW)

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ClinicalTrials.gov Identifier: NCT03689114
Recruitment Status : Not yet recruiting
First Posted : September 28, 2018
Last Update Posted : September 27, 2019
Sponsor:
Collaborators:
Azienda Ospedaliera San Gerardo di Monza
Ministry of Health, Italy
Information provided by (Responsible Party):
Mario Negri Institute for Pharmacological Research

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Epilepsies, Partial Drug: Low dose carbamazepine Drug: Standard dose carbamazepine Drug: Low dose levetiracetam Drug: Standard dose levetiracetam Drug: Low dose valproate Drug: Standard dose valproate Drug: Low dose zonisamide Drug: Standard dose zonisamide Drug: Low dose oxcarbazepine Drug: Standard dose oxcarbazepine Drug: Low dose topiramate Drug: Standard dose topiramate Drug: Low dose lamotrigine Drug: Standard dose lamotrigine Drug: Low dose gabapentin Drug: Standard dose gabapentin Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 374 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is a multicenter randomized pragmatic parallel-group single-blind non-inferiority trial.
Masking: Single (Participant)
Primary Purpose: Treatment
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
Estimated Study Start Date : January 7, 2020
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : December 2021


Arm Intervention/treatment
Experimental: 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.
Drug: Low dose carbamazepine
Carbamazepine, 300 mg/die
Other Name: low carbamazepine

Drug: Low dose levetiracetam
Levetiracetam 500 mg/die
Other Name: Low levetiracetam

Drug: Low dose valproate
Valproate 300 mg/die
Other Name: Low valproate

Drug: Low dose zonisamide
Zonisamide 150 mg/die
Other Name: Low zonisamide

Drug: Low dose oxcarbazepine
Oxcarbazepine 600 mg/die
Other Name: Low oxcarbazepine

Drug: Low dose topiramate
Topiramate 100 mg/die
Other Name: Low topiramate

Drug: Low dose lamotrigine
Lamotrigine 100 mg/die
Other Name: Low lamotrigine

Drug: Low dose gabapentin
Gabapentin 450 mg/die
Other Name: Low gabapentin

Active Comparator: 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.
Drug: Standard dose carbamazepine
Carbamazepine 600 mg/die
Other Name: Standard carbamazepine

Drug: Standard dose levetiracetam
Levetiracetam 1000 mg/die
Other Name: Standard levetiracetam

Drug: Standard dose valproate
Valproate 600 mg/die
Other Name: Standard valproate

Drug: Standard dose zonisamide
Zonisamide 300 mg/die
Other Name: Standard zonisamide

Drug: Standard dose oxcarbazepine
Oxcarbazepine 1200 mg/die
Other Name: Standard oxcarbazepine

Drug: Standard dose topiramate
Topiramate 200 mg/die
Other Name: Standard topiramate

Drug: Standard dose lamotrigine
Lamotrigine 200 mg/die
Other Name: Standard lamotrigine

Drug: Standard dose gabapentin
Gabapentin 900 mg/die
Other Name: Standard gabapentin




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Drug-related adverse events [ Time Frame: 12 months ]
    the proportion of patients experiencing a treatment failure motivated by intolerable drug-related adverse events during the follow-up;

  2. Quality of life in epilepsy scale 31 items(QOLIE-31), italian version [ Time Frame: 12 months ]
    QOLIE-31 total score at baseline and last visit. Maximum total score is 100 (best quality of life possible) and the minimum is 0 (worst quality of life possible).

  3. Patients health care's satisfaction (PSQ-18) scale, 18 items [ Time Frame: 12 months ]
    The score of the seven PSQ-18 subscales (general satisfaction, technical quality, interpersonal manner, communication, financial aspects, time spent with doctor, accessibility and convenience) at baseline and last visit. Possible scores of each subscale range from 1 (worst satisfaction) to 5 (better satisfaction). There is no total score for this scale.

  4. Health care resources utilization. [ Time Frame: 12 months ]
    The mean daily patient's cost of health care resources consumed for the management of epilepsy during the first 12 months of the study.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 18 years or older;
  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:

A patient will be excluded if at least one of the following criteria will be met:

  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03689114


Contacts
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Contact: Ettore Beghi, MD 0239014542 ettore.beghi@marionegri.it
Contact: Giorgia Giussani, PhD 0239014604 giorgia.giussani@marionegri.it

Sponsors and Collaborators
Mario Negri Institute for Pharmacological Research
Azienda Ospedaliera San Gerardo di Monza
Ministry of Health, Italy
Investigators
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Principal Investigator: Ettore Beghi, MD Istituto di Ricerche Farmacologiche Mario Negri IRCCS

Publications:

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Responsible Party: Mario Negri Institute for Pharmacological Research
ClinicalTrials.gov Identifier: NCT03689114     History of Changes
Other Study ID Numbers: STANDLOW
First Posted: September 28, 2018    Key Record Dates
Last Update Posted: September 27, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mario Negri Institute for Pharmacological Research:
epilepsy
antiepileptic drugs
low dose
standard dose
new diagnosis
Additional relevant MeSH terms:
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Carbamazepine
Cytochrome P-450 CYP3A Inducers
Cytochrome P-450 Enzyme Inducers
Epilepsy
Epilepsies, Partial
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Topiramate
Lamotrigine
Zonisamide
Oxcarbazepine
Gabapentin
Levetiracetam
Valproic Acid
Anticonvulsants
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antimanic Agents
Hypoglycemic Agents