Trial · NCT03689114

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

NCT03689114, Phase 4, Completed, Mario Negri Institute for Pharmacological Research; results first posted 2025-07-08

3 sourcestrials-2026-11-12-0.4.0

Cite this record

ConductScience Library. Low vs. Standard Daily Doses of Antiepileptic Drugs in Newly Diagnosed, Previously Untreated Epilepsy(STANDLOW). Trials, record NCT03689114. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03689114

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Low vs. Standard Daily Doses of Antiepileptic Drugs in Newly Diagnosed, Previously Untreated Epilepsy(STANDLOW)
NCT number: NCT03689114
Status: Completed
Phases: Phase 4
Enrollment: 58 participants, actual
Lead sponsor: Mario Negri Institute for Pharmacological Research
Conditions: Epilepsies, Partial
Interventions: Low dose carbamazepine, Standard dose carbamazepine, Low dose levetiracetam, Standard dose levetiracetam, Low dose valproate, Standard dose valproate, Low dose zonisamide, Standard dose zonisamide, Low dose oxcarbazepine, Standard dose oxcarbazepine, Low dose topiramate, Standard dose topiramate, Low dose lamotrigine, Standard dose lamotrigine, Low dose gabapentin, Standard dose gabapentin
First posted: 2018-09-28
Last updated: 2025-07-08
Results first posted: 2025-07-08

Source ClinicalTrials.gov

Registered outcomes5

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Treatment Failure	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.
Secondary	Drug-related Adverse Events	12 months	the proportion of patients experiencing a treatment failure motivated by intolerable drug-related adverse events during the follow-up;
Secondary	PSQ-18, Italian Version	12 months	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).
Secondary	QoLIE-31, Italian Version	12 months	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.
Secondary	Health Care Resources Utilization.	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.

Source ClinicalTrials.gov

Outcomes5

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Treatment Failure	12 months	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Drug-related Adverse Events	12 months	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	PSQ-18, Italian Version	12 months	units on a scale	MEDIAN
SECONDARY	QoLIE-31, Italian Version	12 months	units on a scale	MEDIAN
SECONDARY	Health Care Resources Utilization.	12 months	euro	MEDIAN

Source ClinicalTrials.gov

Results by group22

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Treatment Failure	Low Dose		11		Participants
Treatment Failure	Standard Dose		11		Participants
Drug-related Adverse Events	Low Dose		3		Participants
Drug-related Adverse Events	Standard Dose		3		Participants
PSQ-18, Italian Version	Low Dose	General satisfaction	4.5	Inter-Quartile Range 3 to 5	units on a scale
PSQ-18, Italian Version	Standard Dose	General satisfaction	4	Inter-Quartile Range 3 to 4	units on a scale
PSQ-18, Italian Version	Low Dose	Technical quality	4	Inter-Quartile Range 3.5 to 5	units on a scale
PSQ-18, Italian Version	Standard Dose	Technical quality	4	Inter-Quartile Range 4 to 4	units on a scale
PSQ-18, Italian Version	Low Dose	Interpersonal manner	5	Inter-Quartile Range 4 to 5	units on a scale
PSQ-18, Italian Version	Standard Dose	Interpersonal manner	4	Inter-Quartile Range 3 to 5	units on a scale

1 to 10 of 22Source ClinicalTrials.gov

See all 22 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Low Dose	29
Overall Study	STARTED	Standard Dose	29
Overall Study	COMPLETED	Low Dose	27
Overall Study	COMPLETED	Standard Dose	25
Overall Study	NOT COMPLETED	Low Dose	2
Overall Study	NOT COMPLETED	Standard Dose	4

Source ClinicalTrials.gov

Adverse events18

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	IRRITABILITY	Psychiatric disorders	Low Dose	1	29	1
other	IRRITABILITY	Psychiatric disorders	Standard Dose	2	29	2
other	Fatigue	Nervous system disorders	Low Dose	2	29	2
other	Fatigue	Nervous system disorders	Standard Dose	3	29	3
other	Dizziness	Nervous system disorders	Low Dose	2	29	2
other	Dizziness	Nervous system disorders	Standard Dose	0	29	0
other	rash maculo-papular	Eye disorders	Low Dose	0	29	0
other	rash maculo-papular	Eye disorders	Standard Dose	2	29	2
other	Somnolence	Nervous system disorders	Low Dose	4	29	4
other	Somnolence	Nervous system disorders	Standard Dose	4	29	4

1 to 10 of 18Source ClinicalTrials.gov

See all 18 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Low Dose	0	29
Total, all-cause mortality	Standard Dose	0	29
Total, other adverse events	Low Dose	9	29
Total, other adverse events	Standard Dose	11	29
Total, serious adverse events	Low Dose	2	29
Total, serious adverse events	Standard Dose	1	29

Source ClinicalTrials.gov

Papers7

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
6790275	BACKGROUND	PubMed
11971128	BACKGROUND	PubMed
16098770	BACKGROUND	PubMed
21242496	BACKGROUND	PubMed
21429248	BACKGROUND	PubMed
21606654	BACKGROUND	PubMed
24730690	BACKGROUND	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons4

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Low Dose vs Standard Dose: Drug-related Adverse Events	Trial comparisons
Low Dose vs Standard Dose: Treatment Failure	Trial comparisons
Low Dose vs Standard Dose: deaths from any cause	Trial comparisons
Low Dose vs Standard Dose: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT03689114

GET https://conductscience.org/api/trials/v1/NCT03689114/results?page=2

API reference For AI assistants