Clinical trials: Antiepileptic Drugs
Epilepsy, Complex Partial
A Treatment Use Protocol for Subjects Continuing on From the Open-label Extension 0601
This study is designed to provide ganaxolone to those patients deriving significant benefit from current treatment in protocol 1042-0601.
- Trial name
- 0602 (NCT01002820)
- Testing
- ganaxolone
- Where
- 7 sites in United States
- Volunteers
- 11 people
- Sponsor
- Marinus Pharmaceuticals
Epilepsy
eValuation of the Efficacy and toleRability of Vimpat When Added to lEvetiracetam
The main purpose of this study is to evaluate the effectiveness of the study drug lacosamide (200-600 mg/day) when added to a stable dose of levetiracetam (1000-3000 mg/day) with withdrawal of the concomitant sodium channel…
- Trial name
- VERVE (NCT01484977)
- Testing
- Lacosamide
- Where
- 54 sites in United States, Australia and 7 more
- Volunteers
- 120 people
- Sponsor
- UCB Pharma
Focal Epilepsy
Study on the Treatment of Elderly Patients With Older and Newer Antiepileptic Drugs
In this clinical trial patients with newly diagnosed focal epilepsy aged 60 years or older receive three different antiepileptic drugs in a double-blind, randomized design over a period of 58 weeks.
- Trial name
- STEP-ONE (NCT00438451)
- Testing
- Levetiracetam, Carbamazepine, Lamotrigine
- Where
- Germany
- Volunteers
- 361 people
- Sponsor
- Johannes Gutenberg University Mainz
Drug Resistant Partial Onset Seizure
A Two-year Open-label Extension Study of Ganaxolone in Patients With Drug-resistant Partial-onset Seizures
A follow-on, two-year open-label extension study of ganaxolone as add-on therapy in adult patients with drug-resistant partial-onset seizures
- Trial name
- NCT02519439
- Testing
- ganaxolone
- Where
- 5 sites in United States
- Volunteers
- 26 people
- Sponsor
- Marinus Pharmaceuticals
Epilepsy, Generalized Tonic-clonic Seizures
A Study of Levetiracetam in Japanese Pediatric Patients With Generalized Tonic-clonic Seizures
To evaluate the efficacy and safety of Levetiracetam dry syrup at doses up to 60 mg/kg/day or 3000 mg/day used as adjunctive therapy in Japanese pediatric patients aged ≥4 to <16 years with uncontrolled Generalized Tonic-Clonic…
- Trial name
- NCT01292837
- Testing
- Levetiracetam
- Where
- 26 sites in Japan
- Volunteers
- 13 people
- Sponsor
- UCB Japan Co. Ltd.
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
Epilepsy, Bone Loss
Antiepileptic Drugs and Osteoporotic Prevention Trial
Study Design: (e.g., Controlled, Double-Blind, Randomized, Parallel): Randomized, double-blind, placebo controlled of a bisphosphonate in the prevention of bone loss associated with the use of antiepileptic drugs.
- Conditions
- Epilepsy, Bone Loss, Osteoporosis, Fractures
- Trial name
- ADOPT (NCT00869622)
- Testing
- Risedronate
- Where
- United States
- Volunteers
- 80 people
- Sponsor
- Boston VA Research Institute, Inc.
Neonatal Seizures
Prophylactic Phenobarbital After Neonatal Seizures
The treatment of infants with medications after their seizures have stopped is very variable. No one knows if continuing treatment with phenobarbital for up to several months is helpful or harmful.
- Trial name
- PROPHENO (NCT01089504)
- Testing
- phenobarbital
- Where
- 18 sites in United States
- Volunteers
- 13 people
- Sponsor
- University of Rochester
Epilepsy, Contraception
Women With Epilepsy: a Pilot Study of PK and PD Anti-epileptic Drug Effects in Levonorgestrel Intrauterine System Users
The investigators will conduct a prospective, seven-month pilot study to explore pharmacokinetic (PK) and pharmacodynamic (PD) effects among women with epilepsy using the levonorgestrel intrauterine system (LNG IUS) for…
- Trial name
- WESAIL (NCT02362373)
- Testing
- levonorgestrel IUS
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Columbia University
Partial Epilepsies, Partial Onset Seizures
Study to Assess the Long-term Safety of Oral Lacosamide in Subjects With Partial-onset Seizures
The purpose of this study is to allow eligible subjects from the parent study, SP925 [NCT00655551] to continue lacosamide and to obtain additional long-term safety data
- Trial name
- NCT00655486
- Testing
- lacosamide
- Where
- 7 sites in United States
- Volunteers
- 97 people
- Sponsor
- UCB BIOSCIENCES, Inc.
Epilepsy, Partial Seizures
An Open Label Study of Levetiracetam in Japanese Pediatric Patients With Partial Seizures
Objective of the First Period: To evaluate the efficacy of Levetiracetam dry syrup at doses up to a maximum of 60 mg/kg/day or 3000 mg/day used as an adjunctive therapy in Japanese pediatric patients (4 to 16 years) with…
- Trial name
- NCT01063764
- Testing
- Levetiracetam
- Where
- 29 sites in Japan
- Volunteers
- 73 people
- Sponsor
- UCB Japan Co. Ltd.
Brain Tumor Related Epilepsy (BTRE)
Study of Lacosamide as an Adjunctive Drug Treatment for Epilepsy in Patients With Brain Tumors
This study is being conducted to find out whether lacosamide (a drug to treat epilepsy) is effective in routine clinical practice for patients with epilepsy caused by a brain tumor.
- Trial name
- VIBES (NCT02276053)
- Where
- 24 sites in France, Germany and 4 more
- Volunteers
- 93 people
- Sponsor
- UCB BIOSCIENCES GmbH
15q Duplication Syndrome, CDKL5 Deficiency Disease
A Multicenter, Open-label, Pilot Study of Soticlestat (TAK-935/OV935) in Participants With 15Q Duplication Syndrome (Dup 15q) or Cyclin-Dependent Kinase-Like 5 (CDKL5) Deficiency Disorder (ARCADE STUDY)
The purpose of this study is to investigate the effect of soticlestat on the frequency of motor seizures for participants with Dup15q or CDD during the Maintenance Period.
- Trial name
- NCT03694275
- Testing
- Soticlestat
- Where
- 8 sites in United States
- Volunteers
- 20 people
- Sponsor
- Takeda
Epilepsy, Dravet Syndrome
Antiepileptic Efficacy Study of GWP42003-P in Children and Young Adults With Dravet Syndrome (GWPCARE1)
To investigate the potential antiepileptic effects of cannabidiol (GWP42003-P) in children and young adults with Dravet syndrome.
- Trial name
- NCT02091375
- Testing
- GWP42003-P 20 mg/kg/day Dose
- Where
- 22 sites in United States, France and 2 more
- Volunteers
- 120 people
- Sponsor
- Jazz Pharmaceuticals
Epilepsy
Clinical and Economic Burden of Uncontrolled Epilepsy: Analyses From a Medicaid Database and a Private Health Plan Database
Antiepileptic drugs (AEDs) are the main therapeutic option for patients with epilepsy; however, complete seizure control remains elusive for many patients.
- Trial name
- NCT01390909
- Testing
- Anti-epileptic drug (AED)
- Volunteers
- 12,386 people
- Sponsor
- GlaxoSmithKline
Status Epilepticus
Paramedic Treatment of Prolonged Seizures by Intramuscular Versus Intravenous Anticonvulsant Medications
The goal of this non-inferiority trial is to determine which type of routine care is the best for paramedics to stop someone from seizing.
- Trial name
- RAMPART (NCT00809146)
- Testing
- Intramuscular route of active treatment, Intravenous route of active treatment
- Where
- 17 sites in United States
- Volunteers
- 1,023 people
- Sponsor
- Robert Silbergleit
Brain and Central Nervous System Tumors
Celecoxib in Patients With Newly Diagnosed GBM Who Are Receiving Anticonvulsant Drugs and Undergoing RT
RATIONALE: Celecoxib may stop the growth of tumor cells by blocking the enzymes necessary for their growth. It is not yet known whether the effectiveness of celecoxib in treating glioblastoma multiforme is decreased in patients…
- Trial name
- NCT00068770
- Testing
- radiation therapy, Celecoxib
- Where
- 7 sites in United States
- Volunteers
- 35 people
- Sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Refractory Epilepsy
Thalidomide Low Threshold in Epilepsy
The purpose of this study is to determine whether thalidomide is effective in the refractory epilepsy treatment.
- Trial name
- NCT01061866
- Testing
- 3-phthalimidoglutarimide (Thalidomide)
- Volunteers
- 7 people
- Sponsor
- National Institute of Neurology and Neurosurgery, Mexico
Epilepsy With Simple or Complex Partial Onset Seizures
Safety and Efficacy of Eslicarbazepine Acetate Monotherapy in Subjects With Partial Epilepsy Not Well Controlled by Current Antiepileptic Drugs
This is an 18-week, double-blind, multicenter study with gradual conversion from previous antiepileptic therapy to eslicarbazepine acetate monotherapy in subjects with partial epilepsy.
- Trial name
- NCT00866775
- Testing
- Eslicarbazepine acetate
- Where
- 106 sites in United States, Canada
- Volunteers
- 193 people
- Sponsor
- Sumitomo Pharma America, Inc.
Focal Epilepsy
A Prospective, Observational Study On The Effectiveness Of New Antiepileptic Drugs As First Bitherapy In The Daily Clinical Practice
Assessment of the efficacy under daily clinical conditions of the new antiepileptic drugs (AEDs) gabapentin, lamotrigine, levetiracetam, oxcarbazepine, pregabalin, tiagabine and topiramate, used as first-choice combination…
- Trial name
- NCT00855738
- Testing
- Gabapentin, Lamotrigine, Levetiracetam, Pregabalin, Oxcarbacepine, Tiagabine, Topiramate, Zonisamide
- Volunteers
- 111 people
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.