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Clinical efficacy of the addition of fenofibrate to standard therapy in the treatment of therapy-resistant nocturnal frontal lobe epilepsy

PHASE II OPEN STUDY ABOUT THE EFFECTIVENESS OF FENOFIBRATE AS ADD ON THERAPY FOR DRUG RESISTANT NOCTURNAL FRONTAL LOBE EPILEPSY (FNLE) . - ADFNLE

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2011-005433-39-IT
Enrollment
Unknown
Registered
2012-01-31
Start date
2012-03-22
Completion date
Unknown
Last updated
2014-03-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Drug resistant nocturnal frontal lobe epilepsy MedDRA version: 14.1 Level: PT Classification code 10049424 Term: Frontal lobe epilepsy System Organ Class: 10029205 - Nervous system disorders

Interventions

Pharmaceutical Form: Capsule, hard INN or Proposed INN: FENOFIBRATE CAS Number: 49562-28-9 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 200-

Sponsors

AZIENDA OSPEDALIERO UNIVERSITARIA DI CAGLIARI
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients of both sexes aged between 18 and 65 years with nocturnal frontal lobe epilepsy in particular in its autosomal dominant form resistant to conventional therapies May be included in the study patients concurrently treated with anticoagulants, oral hypoglycemic agents or insulin only if the dosage of these drugs will initially be halved Women of childbearing age who use contraceptives Signing the informed consent Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Patients with hepatic, renal, severe peptic ulcer patients. Patients treated with statins Subjects with hypersensitivity to the components Women who are pregnant or breastfeeding

Design outcomes

Primary

MeasureTime frame
Main Objective: verify the clinical efficacy of adjunctive therapy with fenofibrate in patients with nocturnal frontal lobe epilepsy;Secondary Objective: To examine changes in the EEG signal, describe the modulation, the dynamics and the change in density of cortical neuronal nicotinic receptor for acetylcholine (nAChR) through the use of brain SPECT.;Primary end point(s): verify the clinical efficacy of adjunctive therapy with fenofibrate in patients with nocturnal frontal lobe epilepsy;Timepoint(s) of evaluation of this end point: 6 months—

Secondary

MeasureTime frame
Secondary end point(s): To examine changes in the EEG signal, describe the modulation, the dynamics and the change in density of cortical neuronal nicotinic receptor for acetylcholine (nAChR) through the use of brain SPECT.;Timepoint(s) of evaluation of this end point: 6 months—

Countries

Italy

Contacts

Public ContactNeurologia e Neurofisiopatologia

AZIENDA OSPEDALIERO UNIVERSITARIA DI CAGLIARI

marrosu@unica.it070 6754953

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026