Clinical trials: Antiepileptic Drugs
Brain Neoplasms, Brain Cancer
1 Week Versus 6 Weeks of Levetiracetam in Surgical Brain Tumor Patients
The purpose of this study is to see if there are any differences in patient reported neurotoxicity between patients who receive Levetiracetam tablets for one week after surgery to remove a brain tumor versus those who receive…
- Conditions
- Brain Neoplasms, Brain Cancer, Brain Tumors, Cancer of the Brain
- Trial name
- NCT02334722
- Testing
- Levetiracetam
- Where
- United States
- Volunteers
- 81 people
- Sponsor
- University of Florida
Epilepsies, Partial
Low vs. Standard Daily Doses of Antiepileptic Drugs in Newly Diagnosed, Previously Untreated Epilepsy(STANDLOW)
There are no guidelines on the first maintenance daily dose of antiepileptic drugs (AEDs) in newly diagnosed, previously untreated epilepsy.
- Trial name
- STANDLOW (NCT03689114)
- Testing
- Low dose carbamazepine, Standard dose carbamazepine, Low dose levetiracetam
- Where
- Italy
- Volunteers
- 58 people
- Sponsor
- Mario Negri Institute for Pharmacological Research
Drug Resistant Partial Onset Seizure
Phase 3 Study of Adjunctive Ganaxolone in Adults With Drug-resistant Partial Onset Seizures and Open-label Extension
The study will evaluate the effectiveness and safety of an investigational drug-ganaxolone - on partial seizure frequency in adults with epilepsy taking a maximum of 3 antiepileptic medications (AEDs).
- Trial name
- NCT01963208
- Testing
- ganaxolone
- Where
- 71 sites in United States, Australia and 4 more
- Volunteers
- 405 people
- Sponsor
- Marinus Pharmaceuticals
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, Partial
Study With Seletracetam (Ucb 44212) in Adult Subjects (18 to 65 Years) With Partial Onset Seizures
This trial will evaluate the efficacy and safety of ucb 44212 as add on therapy in subjects with focal epilepsy.
- Trial name
- NCT00152451
- Testing
- Seletracetam (ucb 44212)
- Where
- 7 sites in United States
- Volunteers
- 31 people
- Sponsor
- UCB S.A. - Pharma Sector
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.
Partial Epilepsies
Trial to Assess Optimized Dosage of Lacosamide as add-on Therapy in Patients With Partial Onset Seizure
To evaluate if a flexible dose escalation of lacosamide, up to the maximum approved dose of 400 mg/day, or to a clinically effective lower dose for an individual patient, improves the tolerability and safety of lacosamide (200 mg…
- Trial name
- SELF (NCT01235403)
- Testing
- Lacosamide
- Where
- 32 sites in France
- Volunteers
- 100 people
- Sponsor
- UCB Pharma
Epilepsy
Trial to Assess Vagus Nerve Stimulation Therapy vs. Anti-Epileptic Drug (AED) Treatment in Children With Refractory Seizures
This is a randomized study designed to compare long-term treatment outcomes in pediatric patients with refractory seizures treated with VNS (Vagus Nerve Stimulation) Therapy versus anti-epileptic drugs (AEDs).
- Trial name
- NCT01118455
- Testing
- Vagus Nerve Stimulation (VNS) Therapy, Anti-Epileptic Drug (AED)
- Where
- 19 sites in Austria, Belgium and 3 more
- Volunteers
- 134 people
- Sponsor
- Cyberonics, Inc.
Lumbar Spinal Fusions
Pregabalin for the Treatment of Pain After Posterior Spinal Fusions
Acute pain management is challenging in patients after spinal fusions, particularly since most have taken analgesics for prolonged periods before choosing the surgical alternative.
- Trial name
- NCT01366196
- Testing
- Pregabalin 150 mg
- Where
- United States
- Volunteers
- 86 people
- Sponsor
- Hospital for Special Surgery, New York
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
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
Recurrent Glioblastoma Multiforme (GBM)
Efficacy and Safety of Imatinib Mesylate Plus Hydroxyurea (HU) in Patients With Recurrent Glioblastoma Multiforme (GBM)
This was an investigational study to assess the objective overall response (OOR) rate (complete response [CR] + partial response [PR]) of imatinib mesylate and hydroxyurea (hydroxycarbamide) combination therapy in patients with…
- Trial name
- NCT00290771
- Testing
- Imatinib tablets, Hydroxyurea capsules
- Where
- United States
- Volunteers
- 231 people
- Sponsor
- Novartis
Epilepsy
Diazepam Buccal Film (DBF) - Diastat Rectal Gel (DRG) Crossover Study
This was a multiple centers, single-dose, open-label, randomized two-sequence crossover, two-period study to evaluate the pharmacokinetics (PK) of single doses of Diazepam Buccal Film (DBF) compared with Diastat® Rectal Gel (DRG)…
- Trial name
- NCT03953820
- Testing
- Diazepam Buccal Film, Diastat® Rectal Gel (Valeant Pharmaceuticals USA)
- Where
- 3 sites in United States
- Volunteers
- 31 people
- Sponsor
- Aquestive Therapeutics
Epilepsy
A Study to Assess the Safety and Efficacy of Lacosamide Versus Placebo (a Pill Without Active Medication) in Patients With Idiopathic Generalised Epilepsy Who Are Already Taking Anti-epileptic Medications
Evaluating efficacy \& safety of lacosamide versus Placebo in a blinded fashion as add-on Therapy for Primary Generalized Tonic-clonic (PGTC) seizures in subject 4 years of age or greater with idiopathic generalized epilepsy…
- Trial name
- VALOR (NCT02408523)
- Testing
- Lacosamide Tablet, Lasosamide Oral Solution
- Where
- 115 sites in United States, Australia and 20 more
- Volunteers
- 242 people
- Sponsor
- UCB BIOSCIENCES, Inc.
Subarachnoid Hemorrhage
Antiepileptic Drugs and Vascular Risk Markers
The purpose of this study is to determine if certain seizure medications raise levels of cholesterol and other blood components which could increase the risk of heart attacks and strokes.
- Trial name
- NCT00774306
- Testing
- phenytoin, valproate, levetiracetam
- Volunteers
- 52 people
- Sponsor
- Thomas Jefferson University
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.
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
Epilepsy
Characterization of Epilepsy Patients BEEP 2b
Some epilepsy patients are described as GB when they have worsened seizures or side effects related to switching between brand name and generic, or between generic antiepileptic drug (AED) products.
- Trial name
- BEEP2b (NCT02707965)
- Testing
- Oxcarbazepine (brand name vs generic drugs), Divalproex Sodium (brand name vs generic drugs), Carbamazepine (brand name vs generic drugs)
- Where
- United States
- Volunteers
- 21 people
- Sponsor
- Food and Drug Administration (FDA)
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
Partial Epilepsy
Efficacy and Safety Study of BIA 2-093 in Combination With Other Anti-Epileptic Drugs to Treat Partial Epilepsy
The primary objective of the study is to evaluate the efficacy of eslicarbazepine acetate once-daily at doses of 400 mg, 800 mg and 1200 mg compared with placebo as adjunctive therapy in patients with refractory partial epilepsy…
- Trial name
- NCT00957047
- Testing
- eslicarbazepine acetate, ESL - Part II
- Where
- Portugal
- Volunteers
- 395 people
- Sponsor
- Bial - Portela C S.A.