Clinical trials: Antiepileptic Drugs
Bio-equivalence Study, Fed Conditions
Fed Bioequivalence Study of CBZ Formulations
Controlled release Carbamazepine (CBZ) is a antiepileptic, antineuralgic and mood stabilizer drug. The CR formulation of CBZ is slowly absorbed and the elimination half life varies with time due to metabolism autoinduction.
- Trial name
- NCT02132897
- Testing
- Auration CR Tablets 400 Single Dose-Tegretol CR 400 Single Dose, Tegretol CR 400 Single Dose-Auration CR 400 Single Dose
- Where
- Uruguay
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Center for Clinical Pharmacology Research Bdbeq S.A.
Epilepsy
Premenstrual Dysphoric Disorder and Antiepileptic Drugs
This study is being done to determine if there are differences in mood during the menstrual cycle among women with epilepsy who take various different antiepileptic drugs and women without epilepsy.
- Trial name
- NCT00612235
- Testing
- Lamotrigine, Levetiracetam, Carbamazepine
- Where
- 3 sites in United States
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Beth Israel Deaconess Medical Center
Neutropenia, Thrombocytopenia
Effects of Levetiracetam Monotherapy on Various Hematological Parameters in Adult Patients Suffering of Epilepsy
Low therapeutic index of established antiepileptic drugs (AEDs) coupled with better understanding of the pathophysiology of seizure has encouraged the development of several novel AEDs.
- Conditions
- Neutropenia, Thrombocytopenia, Aplastic Anemia, Anemia
- Trial name
- NCT06491303
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- Assiut University
Healthy
Effect of Talampanel (an AMPA Receptor Blocker) on Brain Activity
This study will use transcranial magnetic stimulation (TMS) and electroencephalography (EEG) to test the safety of an experimental anti-epileptic drug called Talampanel and learn how it affects brain activity.
- Trial name
- NCT00057460
- Testing
- Talampanel
- Where
- United States
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)
Bariatric Surgery Candidate
Pharmacokinetics of Paracetamol and Antiepileptic Drugs After Sleeve Gastrectomy
Sleeve gastrectomy may affect drug pharmacokinetics in several potential ways. We will measure pharmakokinetics of paracetamol and antiepileptic drugs before and 6 months after sleeve gastrectomy.
- Trial name
- NCT03161509
- Testing
- Paracetamol, Antiepileptic (either carbamazepine, lamotrigine, phenytoin or valproic acid)
- Where
- Israel
- Volunteers
- 2 people, healthy volunteers welcome
- Sponsor
- Rambam Health Care Campus
Refractory Epilepsy
Efficacy of Ketamine Infusion Compared With Traditional Anti-epileptic Agents in Refractory Status Epilepticus
The study will investigate the efficacy of the N-methyl-D-aspartate receptor antagonist ketamine as a first line agent in refractory status epilepticus versus traditional general anesthetic agents used for burst suppression that…
- Trial name
- NCT03115489
- Testing
- Traditional Treatment (Group T), Ketamine Infusion (Group K)
- Where
- United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- University of Alabama at Birmingham
Epilepsy, Pregnancy
Maternal Outcomes and Neurodevelopmental Effects of Antiepileptic Drugs (MONEAD)
Epilepsy is one of the most common neurological disorders affecting women of childbearing age. Poor pregnancy outcomes are increased in these women and their children.
- Trial name
- MONEAD (NCT01730170)
- Where
- 20 sites in United States
- Volunteers
- 565 people, healthy volunteers welcome
- Sponsor
- Stanford University
Dravet Syndrome, Epilepsy
Bioavailability of Stiripentol After Single Oral Dose of Capsule vs Suspension in Healthy Subjects (STILIQ)
This is a Phase I, open-label, randomized, single-center, two-way cross-over study evaluating the relative bioavailability, pharmacokinetics, safety, and palatability of two formulations of stiripentol (Diacomit®), indicated in…
- Conditions
- Dravet Syndrome, Epilepsy, Childhood, Epileptic Encephalopathy
- Trial name
- STILIQ (NCT07176832)
- Testing
- Stiripentol capsule (Diacomit®), Stiripentol oral suspension (Diacomit®)
- Where
- 2 sites in France
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Biocodex
Seizure
Study of Predictors of Response to Anti Epilepsy in Epilepsy
Pharmacoresistant epilepsy remains around 30% despite the development of 25 anti epileptic drugs. Of course, this can be explained by pharmacoresistant epileptic brain diseases, as exemplified by some genetic diseases.
- Trial name
- RESISTANT (NCT02883712)
- Where
- France
- Volunteers
- 155 people, healthy volunteers welcome
- Sponsor
- University Hospital, Lille
Alveolar Bone Loss
Bone Mineral Density and Periodontal Status in Patients on Antiepileptic Drug
Assessment of bone mineral density and periodontal parameters in patients with epilepsy. Comparative evaluation of bone mineral density and levels of marginal alveolar bone in patients with epilepsy on monotherapy, combination…
- Trial name
- NCT04262999
- Testing
- effect of sodium valproate on alveolar bone level, effect of levetiracetam on alveolar bone level, effect of sodium valproate+levetiracetam on alveolar bone level
- Where
- India
- Volunteers
- 140 people, healthy volunteers welcome
- Sponsor
- Postgraduate Institute of Dental Sciences Rohtak
Epilepsy, Neuropathy
HLA Screening in Reducing the Risk of Antiepileptic Drug-induced Cutaneous Adverse Reactions
Cutaneous adverse drug reactions (cADRs) include mild maculopapular exanthema (MPE) and severe cutaneous reactions such as hypersensitivity syndrome, Stevens-Johnson syndrome (SJS), and toxic epidermal necrolysis (TEN).
- Conditions
- Epilepsy, Neuropathy, Psychiatric Illness, Blepharospasm
- Trial name
- NCT03184597
- Testing
- HLA screening before commencing aromatic AEDs
- Where
- China
- Volunteers
- 4,000 people, healthy volunteers welcome
- Sponsor
- Second Affiliated Hospital of Guangzhou Medical University
Autism, Developmental Delay
Developmental Delay in Children Exposed During Pregnancy to Either Lamotrigine,Sodium Valproate, or Carbamazepine
This study is investigating the neurodevelopmental effects of prenatal exposure to lamotrigine (LTG), sodium valproate (VPA), or carbamazepine (CBZ) monotherapies. The hypotheses to be tested include: 1.
- Conditions
- Autism, Developmental Delay, Birth Defects
- Trial name
- NCT01097720
- Where
- United States
- Volunteers
- 298 people, healthy volunteers welcome
- Sponsor
- Massachusetts General Hospital
Epilepsy
Clinical Study in Healthy Volunteers to Investigate the Neurocognitive Effects of a New Antiepileptic Drug: Brivaracetam
The primary objective of the study is to evaluate the neurocognitive effects of brivaracetam
- Trial name
- NCT00736931
- Testing
- Brivaracetam, levetiracetam, lorazepam
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- UCB Pharma
Epilepsy
Balance and Anti-Epileptic Drugs
Patients with epilepsy exercise less than the general population. A barrier to exercise may be the effect of antiepileptic drugs on balance and reaction time.
- Trial name
- AEDs (NCT03338478)
- Testing
- Wii Balance Board
- Where
- United States
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Erik J. Kobylarz
Contraception, Drug Interactions
Effect of Anti-epileptic Drugs on Etonogestrel-releasing Implant Pharmacokinetics in Women With Epilepsy
Data on the interaction between the etonogestrel (ENG) implant and antiepileptic drug (AED) regimen are scarce. We will evaluated the effect of 2 AED regimens (1 including carbamazepine and the other topiramate) on the…
- Trial name
- NCT03307863
- Testing
- Carbamazepine-Implant, Topiramate-Implant, Implant
- Where
- Brazil
- Volunteers
- 69 people, healthy volunteers welcome
- Sponsor
- University of Sao Paulo
Syndrome of Inappropriate ADH-secretion
Urinary Aquaporine 2 in Patients With Syndrome of Inappropriate ADH-secretion Caused by Treatment With Antiepileptic Medicine
Patients treated with the antiepileptic drug Oxcarbazepine often develop syndrome of inappropriate secretion of antidiuretic hormone(SIADH)We want to test the hypothesis, that these patients have a higher reabsorption of water…
- Trial name
- NCT00298753
- Testing
- fluid restriction for 14 days (15ml fluid per kg weight)
- Where
- Denmark
- Volunteers
- healthy volunteers welcome
- Sponsor
- Regional Hospital Holstebro
Healthy
Bioequivalence Study of Two Formulations of Pregabalin Capsules 150 mg
The present study was conducted to find out whether the bioavailability of 150 mg pregabalin capsules produced by Dexa Medica was equivalent to the reference products (Lyrica® capsule 150 mg, Pfizer Manufacturing Deutschland…
- Trial name
- NCT02233777
- Testing
- Pregabalin capsules 150 mg of Dexa Medica, Pregabalin capsules 150 mg of Pfizer Manufacturing Deutschland
- Where
- Indonesia
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Dexa Medica Group
Epilepsy
Study of Antiepileptic Drug Effects on Child Development
The specific aim of this study is to determine if in utero exposure produces differential antiepileptic drug (AED) effects on subsequent cognitive abilities and behavioral abnormalities in children
- Trial name
- NCT00353886
- Testing
- TONI-3, WRAT-3, Connor's Rating Scales PRS & TRS
- Where
- 10 sites in United States, United Kingdom
- Volunteers
- 81 people, healthy volunteers welcome
- Sponsor
- Augusta University
Healthy
Effect of Ginkgo Biloba on Phenytoin Elimination
This study will examine how the herbal remedy ginkgo biloba may affect the body's elimination of other medicines. Many people take ginkgo biloba to improve memory, mental alertness and overall feeling of well being.
- Trial name
- NCT00011063
- Testing
- Ginkgo Biloba
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- National Institutes of Health Clinical Center (CC)
Focal Epilepsy
TMS Combined With EEG/EMG as a Biomarker Predicting Antiepileptic Drug Response
Ιn the present study (BIOEPI), the following three hypotheses will be investigated: 1. The proposed TMS-EEG / EMG protocol (which includes software for calculating the cerebral cortex stimulation threshold) in combination with…
- Trial name
- BIOEPI (NCT05278221)
- Testing
- Software EstimLT
- Where
- Greece
- Volunteers
- 42 people, healthy volunteers welcome
- Sponsor
- Aristotle University Of Thessaloniki