| 1 |
NCT02834793 |
Recruiting |
Study of Perampanel as Adjunctive Treatment for Inadequately Controlled Seizures Associated With Lennox-Gastaut Syndrome |
- Lennox-Gastaut Syndrome (LGS)
|
- Drug: Perampanel
- Drug: Placebo
|
Interventional |
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Median percent change in drop seizure frequency per 28 days during double-blind treatment (Titration Period and Maintenance Period) relative to the Prerandomization Phase
- Median percent change in total seizure frequency per 28 days during double-blind treatment (Titration Period and Maintenance Period) relative to the Prerandomization Phase
- Number of participants with 50% responder rate in the Maintenance Period of the double-blind treatment phase relative to the Prerandomization Phase for drop seizures
- (and 7 more...)
|
142 |
All |
2 Years and older (Child, Adult, Senior) |
NCT02834793 |
E2007-G000-338 |
|
December 2016 |
September 2019 |
October 2020 |
July 15, 2016 |
November 21, 2017 |
|
- Banner - University Medical Center Phoenix
Phoenix, Arizona, United States - University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States - Stanford University
Palo Alto, California, United States - (and 28 more...)
|
| 2 |
NCT02731300 |
Completed
Has Results |
Transcranial Direct Current Stimulation, Treatment of Childhood Drug-Resistant Lennox-Gastaut Syndrome, A Pilot Study |
|
|
Interventional |
Phase 4 |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Number of Seizure After Treatment by tDCS
- Number of Epileptic Discharge After Treatment by tDCS
|
22 |
All |
6 Years to 15 Years (Child) |
NCT02731300 |
tDCSLennox |
|
August 2010 |
December 2013 |
December 2013 |
April 7, 2016 |
June 29, 2016 |
June 29, 2016 |
|
| 3 |
NCT01991041 |
Completed |
European Registry of Anti-Epileptic Drug Use in Patients With Lennox-Gastaut Syndrome (LGS) |
|
|
Observational |
|
|
Industry |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Safety during the use of rufinamide and other anti-epileptic drugs
- Long term use of rufinamide, and other anti-epileptic drugs
|
109 |
All |
4 Years and older (Child, Adult, Senior) |
NCT01991041 |
E2080-E044-401 |
|
June 2008 |
October 2015 |
November 2015 |
November 25, 2013 |
May 4, 2016 |
|
- Graz, Austria
- Innsbruck, Austria
- Linz, Austria
- (and 47 more...)
|
| 4 |
NCT03355209 |
Recruiting |
A Study to Investigate the Efficacy and Safety of ZX008 (Fenfluramine Hydrochloride) as an Adjunctive Therapy in Children and Adults With Lennox-Gastaut Syndrome |
|
- Drug: ZX008 02 and 0.8 mg/kg/day
- Other: Placebo
|
Interventional |
Phase 3 |
- Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc.
- Zogenix, Inc.
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Part 1: Change from baseline in frequency of seizures that result in drops in subjects receiving ZX008 compared to placebo
- Part 2: Adverse events and related safety parameters in subjects receiving ZX008 compared to placebo
|
225 |
All |
2 Years to 35 Years (Child, Adult) |
NCT03355209 |
ZX008-1601 |
|
November 27, 2017 |
December 2019 |
December 2019 |
November 28, 2017 |
April 17, 2018 |
|
- Center for Neurosciences
Tucson, Arizona, United States - Children's Hospital of Orange County
Orange, California, United States - University of California San Francisco
San Francisco, California, United States - (and 20 more...)
|
| 5 |
NCT01370486 |
Unknown † |
Melatonin Versus Placebo in the Lennox-Gastaut Syndrome: Neurophysiological and Neuropsychological Effects |
|
- Drug: melatonin
- Drug: placebo
|
Interventional |
Phase 4 |
|
Other |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- diminution of at least 50% of the nocturnal interictal discharges and tonic seizures with the melatonin treatment
- augmentation of at least 15% of the amount of deep slow sleep with the melatonin treatment
|
6 |
All |
18 Years to 55 Years (Adult) |
NCT01370486 |
25/10 |
|
August 2011 |
January 2012 |
January 2012 |
June 10, 2011 |
June 10, 2011 |
|
- Institution de Lavigny
Lavigny, Vaud, Switzerland
|
| 6 |
NCT02318537 |
Withdrawn |
Cannabidiol Oral Solution as an Adjunctive Therapy for Treatment of Participants With Inadequately Controlled Lennox-Gastaut Syndrome |
|
- Drug: Cannabidiol Oral Solution
- Drug: Placebo Solution
|
Interventional |
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Treatment
|
- Percent change from baseline in the frequency of motor seizures involving the trunk or extremities [tonic, atonic, generalized tonic-clonic (GTC), focal seizures with motor components (FSMC)]
- Percent change from baseline in severity of motor seizures involving the trunk or extremities (tonic, clonic, GTC, FSMC)
- Percent change from baseline in frequency of all seizure activity independent of seizure type
- (and 6 more...)
|
0 |
All |
2 Years to 30 Years (Child, Adult) |
NCT02318537 |
INS011-14-024 |
|
December 30, 2017 |
June 30, 2018 |
June 30, 2018 |
December 17, 2014 |
January 4, 2018 |
|
|
| 7 |
NCT01146951 |
Completed
Has Results |
A Placebo-Controlled, Double-Blind Comparative Study of E2080 in Lennox-Gastaut Syndrome Patients (Study E2080-J081-304) |
|
- Drug: Rufinamide (E2080)
- Drug: Placebo
|
Interventional |
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Percent Change in Tonic-Atonic Seizure Frequency From Baseline (Per 28 Days)
- Number of Participants Achieving a 50% Reduction in Tonic-atonic Seizure Frequency
- Percent Change in Total Seizure Frequency (Per 28 Days)
- (and 2 more...)
|
66 |
All |
4 Years to 30 Years (Child, Adult) |
NCT01146951 |
E2080-J081-304 |
|
June 2010 |
August 2011 |
August 2011 |
June 22, 2010 |
January 24, 2018 |
November 21, 2013 |
- Nagoya-shi, Aichi, Japan
- Matsuyama-shi, Ehime, Japan
- Fukuoka-shi, Fukuoka, Japan
- (and 20 more...)
|
| 8 |
NCT01405053 |
Completed |
Study of Rufinamide in Pediatric Subjects 1 to Less Than 4 Years of Age With Lennox-Gastaut Syndrome Inadequately Controlled With Other Anti-epileptic Drugs |
|
- Drug: Rufinamide
- Drug: Any other approved AED
|
Interventional |
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Change in Child Behavior Checklist (CBCL) Total Problems Score
- Time to withdrawal from rufinamide or other AED
- Percent change in total seizure frequency and in frequency by individual type per 28 days
- (and 4 more...)
|
37 |
All |
1 Year to 3 Years (Child) |
NCT01405053 |
E2080-G000-303 |
|
June 2011 |
October 2015 |
November 2015 |
July 29, 2011 |
March 23, 2016 |
|
- Washington, District of Columbia, United States
- Tampa, Florida, United States
- Wellington, Florida, United States
- (and 19 more...)
|
| 9 |
NCT02224690 |
Completed |
A Study to Investigate the Efficacy and Safety of Cannabidiol (GWP42003-P; CBD) as Adjunctive Treatment for Seizures Associated With Lennox-Gastaut Syndrome in Children and Adults |
- Epilepsy
- Lennox-Gastaut Syndrome
|
- Drug: GWP42003-P
- Drug: Placebo Control
|
Interventional |
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Percentage change from baseline in number of drop seizures (average per 28 days) during the treatment period.
- Percentage change from baseline in number of drop seizures (average per 28 days).
- Number of subjects considered treatment responders, defined as those with a ≥25%, ≥50%, ≥75%, or 100% reduction in drop seizures from baseline.
- (and 7 more...)
|
171 |
All |
2 Years to 55 Years (Child, Adult) |
NCT02224690 |
GWEP1423
2014-002941-23 |
GWPCARE4 |
March 2015 |
February 2016 |
June 2016 |
August 25, 2014 |
February 23, 2017 |
|
- GW Investigational Site
Chicago, Illinois, United States
|
| 10 |
NCT02224560 |
Completed |
A Study to Investigate the Efficacy and Safety of Cannabidiol (GWP42003-P; CBD) as Adjunctive Treatment for Seizures Associated With Lennox-Gastaut Syndrome in Children and Adults |
- Epilepsy
- Lennox-Gastaut Syndrome
|
- Drug: GWP42003-P
- Drug: Placebo control
|
Interventional |
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Percentage change from baseline in number of drop seizures (average per 28 days) during the treatment period.
- Percentage change from baseline in number of drop seizures (average per 28 days).
- Number of subjects considered treatment responders, defined as those with a ≥25%, ≥50%, ≥75%, or 100% reduction in drop seizures from baseline. Summaries will be presented overall and four-weekly.
- (and 7 more...)
|
225 |
All |
2 Years to 55 Years (Child, Adult) |
NCT02224560 |
GWEP1414
2014-002940-42 |
GWPCARE3 |
March 2015 |
May 2016 |
September 2016 |
August 25, 2014 |
October 17, 2017 |
|
- GW Investigational Site
Columbus, Ohio, United States
|
| 11 |
NCT01160770 |
Completed
Has Results |
Safety and Effectiveness of Open-Label Clobazam in Subjects With Lennox-Gastaut Syndrome |
|
|
Interventional |
Phase 3 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Median Percent Reduction in Average Weekly Rate of Drop Seizures Based on the 7-day Assessment
- Median Percent Reduction in Average Weekly Rate of Drop Seizures Based on the Last 30-day Assessment
- Percent of Patients Considered Treatment Responders Defined as Those With a ≥25%, ≥50%, ≥75%, 100% Reduction in Drop Seizures Based on the 7-day Assessment
- (and 3 more...)
|
267 |
All |
2 Years to 60 Years (Child, Adult) |
NCT01160770 |
13109A
OV1004 |
LGS |
December 2005 |
February 2012 |
February 2012 |
July 12, 2010 |
March 21, 2018 |
May 6, 2013 |
|
| 12 |
NCT02224573 |
Enrolling by invitation |
GWPCARE5 - An Open Label Extension Study of Cannabidiol (GWP42003-P) in Children and Young Adults With Dravet or Lennox-Gastaut Syndromes |
- Epilepsy
- Dravet Syndrome
- Lennox-Gastaut Syndrome
|
|
Interventional |
Phase 3 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- The incidence of adverse events and other assessments as measure of subject safety.
- Mean change in quality of life, relative to the pre-randomization baseline of the Core Study, if assessed during the Core Study.
- Changes in the Caregiver Global Impression of Change (CGIC) or Subject Global Impression of Change score, relative to the pre-randomization baseline of the Core Study, if assessed during the Core Study.
- (and 8 more...)
|
680 |
All |
2 Years and older (Child, Adult, Senior) |
NCT02224573 |
GWEP1415
2014-001834-27 |
|
June 2015 |
June 2019 |
June 2019 |
August 25, 2014 |
October 24, 2017 |
|
|
| 13 |
NCT02632149 |
Recruiting |
Trial to Assess Vagus Nerve Stimulation Therapy in Children With Lennox-Gastaut Syndrome |
|
- Device: PINS Vagus Nerve Stimulator
|
Interventional |
Early Phase 1 |
- Beijing Pins Medical Co., Ltd
- Qilu Hospital of Shandong University
- Qingdao University
- (and 2 more...)
|
Industry / Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Changes in seizure frequency from baseline to the seizure count evaluation period 6 month
- Changes in seizure frequency from baseline to the seizure count evaluation period
- Change from Baseline in the Engel and McHugh description
- Overall WISC Score in Patients from Baseline
|
31 |
All |
3 Years to 14 Years (Child) |
NCT02632149 |
PINS-017 |
|
October 2016 |
October 2017 |
|
December 16, 2015 |
October 11, 2016 |
|
- Qilu Hospital of Shandong University
Jinan, Shandong, China - JiNing First People's Hospital
JiNing, Shandong, China - Linyi People's Hospital
Linyi, Shandong, China - (and 2 more...)
|
| 14 |
NCT00004776 |
Completed |
Phase III Randomized, Double-Blind, Placebo-Controlled Study of Oral Topiramate for Lennox-Gastaut Syndrome |
|
|
Interventional |
Phase 3 |
- National Center for Research Resources (NCRR)
- University of California, Los Angeles
- Office of Rare Diseases (ORD)
|
NIH / Other |
- Allocation: Randomized
- Masking: Double
- Primary Purpose: Treatment
|
|
10 |
All |
4 Years to 30 Years (Child, Adult) |
NCT00004776 |
199/11821
UCLA-567 |
|
November 1993 |
|
|
February 25, 2000 |
June 24, 2005 |
|
|
| 15 |
NCT00518713 |
Completed
Has Results |
Clobazam in Patients With Lennox-Gastaut Syndrome |
- Epilepsy
- Epilepsy, Generalized
- Seizures
|
- Drug: Clobazam Low Dose
- Drug: Clobazam Medium Dose
- Drug: Clobazam High Dose
- Drug: Placebo
|
Interventional |
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Treatment
|
- Percent Reduction in Number of Drop Seizures (12-week Maintenance Period).
- Percent Reduction in Number of Drop Seizures (First 4 Weeks of the 12-week Maintenance Period).
- Percent Reduction in Number of Drop Seizures (Middle 4 Weeks of the 12-week Maintenance Period).
- (and 8 more...)
|
238 |
All |
2 Years to 60 Years (Child, Adult) |
NCT00518713 |
13110A
OV1012 |
|
August 2007 |
December 2009 |
April 2010 |
August 21, 2007 |
February 9, 2012 |
February 9, 2012 |
- University of Alabama at Birmingham
Huntsville, Alabama, United States - St. Joseph's Hospital and Medical Center
Phoenix, Arizona, United States - Phoenix Children's Hospital
Phoenix, Arizona, United States - (and 50 more...)
|
| 16 |
NCT00236756 |
Completed |
A Study of the Efficacy and Safety of Topiramate as an add-on Therapy in the Treatment of Epilepsy Patients With Lennox-Gastaut Syndrome |
|
|
Interventional |
Phase 3 |
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double
- Primary Purpose: Treatment
|
- Percent reduction from baseline in seizure rates (all types of seizures) in the double-blind phase. Percent reduction in drop attacks (tonic-clonic) and parent/guardian global evaluation at end of study
- Percent treatment responders all types of seizures. Percent treatment responders drop attacks (tonic-clonic seizures). Safety evaluations conducted throughout the study.
|
100 |
All |
12 Months to 30 Years (Child, Adult) |
NCT00236756 |
CR005464 |
|
August 1993 |
|
February 2001 |
October 12, 2005 |
June 3, 2011 |
|
|
| 17 |
NCT00162981 |
Completed
Has Results |
Clobazam in Subjects With Lennox-Gastaut Syndrome |
- Epilepsy
- Epilepsy, Generalized
- Seizures
|
- Drug: Clobazam Low Dose
- Drug: Clobazam High Dose
|
Interventional |
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Treatment
|
- Percent Reduction in Number of Drop Seizures.
- A Comparison of the High Dose Group to Low Dose Group of the Percent Reduction in Number of Drop Seizures.
- Percent of Patients Considered Treatment Responders Defined as Those With a >= 25%, >= 50%, >= 75%, and 100% Reduction in Drop Seizures.
- Parent/Caregiver Global Evaluations of the Patient's Overall Change in Symptoms.
|
68 |
All |
2 Years to 30 Years (Child, Adult) |
NCT00162981 |
13108A
OV1002 |
|
October 2005 |
August 2006 |
October 2006 |
September 13, 2005 |
February 9, 2012 |
February 9, 2012 |
- Barrow Neurological Institute
Phoenix, Arizona, United States - Childrens Hospital Los Angeles
Los Angeles, California, United States - Children's National Medical Center
Washington, District of Columbia, United States - (and 11 more...)
|
| 18 |
NCT02175173 |
Active, not recruiting |
Post-marketing Surveillance of Long-term Administration of Inovelon Tablets in Patients With Lennox-Gastaut Syndrome |
|
|
Observational |
|
- Eisai Co., Ltd.
- Eisai Inc.
|
Industry |
- Observational Model: Other
- Time Perspective: Retrospective
|
- Investigations on adverse events and adverse drug reactions
- Frequency of attacks
- Overall assessments of the improvement in the seriousness of seizures
|
715 |
All |
Child, Adult, Senior |
NCT02175173 |
INO01T |
|
June 13, 2013 |
April 2018 |
April 2018 |
June 26, 2014 |
February 23, 2017 |
|
|
| 19 |
NCT01151540 |
Completed |
A Long Term Extension Study of E2080 in Lennox-Gastaut Patients |
|
|
Interventional |
Phase 3 |
- Eisai Co., Ltd.
- Eisai Inc.
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Number of patients with adverse events as a measure of Safety and Tolerability.
- Change in the number of seizures of Epilepsy (tonic seizure or cataplexy)
|
54 |
All |
Child, Adult, Senior |
NCT01151540 |
E2080-J081-305 |
|
November 2010 |
August 2013 |
October 2013 |
June 28, 2010 |
February 21, 2014 |
|
- Nagoyashi, Aichi, Japan
- Matsuyama, Ehime, Japan
- Fukuoka-shi, Fukuoka, Japan
- (and 20 more...)
|
| 20 |
NCT02910297 |
Withdrawn |
The Pharmacokinetics of Cannabidiol (CBD) and Its Effects in Children With Severe Epilepsy |
- Dravet Syndrome
- Lennox Gastaut Syndrome
|
|
Observational |
|
- Gillette Children's Specialty Healthcare
- University of Minnesota - Clinical and Translational Science Institute
|
Other |
- Observational Model: Case-Crossover
- Time Perspective: Prospective
|
- Reduction in seizures
- Cannabidiol concentration
|
0 |
All |
2 Years to 30 Years (Child, Adult) |
NCT02910297 |
CBD-PK-1 |
|
September 2016 |
December 31, 2017 |
December 31, 2017 |
September 22, 2016 |
February 21, 2018 |
|
|
| 21 |
NCT01668654 |
Terminated
Has Results |
Long-term, Open-label Safety Extension Study of Retigabine/Ezogabine in Pediatric Subjects (>= 12 Years Old) With POS or LGS |
|
- Drug: retigabine/ezogabine
|
Interventional |
Phase 3 |
- GlaxoSmithKline
- Valeant Pharmaceuticals International, Inc.
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Number of Participants (Par.) With Any Adverse Event (AE) or Serious Adverse Event (SAE) During the Treatment Period
- Number of Participants With AEs Leading to Withdrawal
- Number of Participants With Vital Signs Outside the Pre-determined Clinically Important Findings or Outside the Normal Ranges at Any Time During the Study
- (and 34 more...)
|
4 |
All |
12 Years to 29 Years (Child, Adult) |
NCT01668654 |
113388 |
|
September 2012 |
June 2013 |
June 2013 |
August 20, 2012 |
January 9, 2017 |
August 4, 2014 |
- GSK Investigational Site
Los Angeles, California, United States - GSK Investigational Site
Gulf Breeze, Florida, United States - GSK Investigational Site
Port Charlotte, Florida, United States - (and 6 more...)
|
| 22 |
NCT03467113 |
Enrolling by invitation |
A Study to Assess the Safety and Tolerability of ZX008 in Children and Young Adults With DS or LGS Currently Taking CBD |
- Dravet Syndrome
- Lennox Gastaut Syndrome
|
- Drug: ZX008 02 and 0.8 mg/kg/day
|
Interventional |
Phase 1
Phase 2 |
- Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc.
- Zogenix, Inc.
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Adverse events
- Change in heart rate
- Change in blood pressure
- (and 8 more...)
|
25 |
All |
2 Years to 18 Years (Child, Adult) |
NCT03467113 |
ZX008-1602 |
|
January 19, 2018 |
February 2019 |
February 2019 |
March 15, 2018 |
March 15, 2018 |
|
- PANDA Neurology/CIRCA
Atlanta, Georgia, United States - MultiCare Institute for Research & Innovation
Tacoma, Washington, United States
|
| 23 |
NCT00297349 |
Completed |
A Study of the Safety of Topiramate Given in Combination With Other Medications in Adults and Children With Seizures |
|
|
Observational |
|
- Janssen Cilag Pharmaceutica S.A.C.I., Greece
|
Industry |
- Time Perspective: Prospective
|
- Evaluation of the safety of oral topiramate as adjuvant therapy for focal epilepsy, Lennox-Gastaut syndrome epileptic seizures and the generalized tonoclonic seizures in adults and children aged 2 years and older.
- Safety & tolerability evaluation will be performed by reporting AEs & Clinical labs.
- Evaluation of efficacy will be performed with the aid of descriptive statistics.
- Overall assessments of the improvement in the seriousness of seizures will be performed.
|
153 |
All |
2 Years and older (Child, Adult, Senior) |
NCT00297349 |
CR003472 |
|
November 2003 |
|
June 2005 |
February 28, 2006 |
April 27, 2010 |
|
|
| 24 |
NCT02815540 |
Not yet recruiting |
The Effects of Cannabidiol (CBD) on Electrical and Autonomic Cardiac Function in Children With Severe Epilepsy |
- Lennox-Gastaut Syndrome
- Dravet Syndrome
|
- Procedure: 15-Lead ECG
- Drug: Cannabadiol
|
Interventional |
Not Applicable |
- Gillette Children's Specialty Healthcare
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Diagnostic
|
- ECG parameters
- Holter heart rate parameters
- Seizure frequency
- Dysautonomia signs and symptoms
|
25 |
All |
2 Years to 30 Years (Child, Adult) |
NCT02815540 |
CBD-001 |
CBD1 |
June 2016 |
June 2017 |
December 2017 |
June 28, 2016 |
June 28, 2016 |
|
- Gillette Children's Specialty Healthcare
St.Paul, Minnesota, United States
|
| 25 |
NCT02655198 |
Active, not recruiting |
Add-on Therapy With Low Dose Fenfluramine in Lennox Gastaut Epilepsy |
- Epilepsy
- Lennox Gastaut Syndrome
|
|
Interventional |
Phase 2 |
- Katholieke Universiteit Leuven
- Zogenix, Inc.
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Efficacy of add-on FFA in Lennox Gastaut epilepsy: Number of responders and seizure free patients at each FFA dosage (0,2 or 0,4 or 0,8 mg/kg/day)
- Seizure frequency change per patient and per major seizure type (Tonic Clonic Seizures (TCS), Tonic Seizures (TS), Atonic Seizures (AS), Focal Seizures (FS))
- Adverse events (cardiac and general)
- (and 2 more...)
|
13 |
All |
3 Years to 18 Years (Child, Adult) |
NCT02655198 |
S58545 |
FFA-LGS |
January 2016 |
December 2017 |
December 2017 |
January 13, 2016 |
October 13, 2017 |
|
- University Hospitals UZ Leuven
Leuven, Belgium
|
| 26 |
NCT01494584 |
Terminated
Has Results |
Study in Pediatric Subjects With Epilepsy |
|
- Drug: ezogabine/retigabine
|
Interventional |
Phase 2 |
- GlaxoSmithKline
- Valeant Pharmaceuticals International, Inc.
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- The Area Under the Plasma Concentration-time Curve Over the Dosing Interval (AUC[0-tau]) Following Oral Administration of Ezogabine/Retigabine
- Apparent Clearance (CL/F) Following Oral Administration of Ezogabine/Retigabine
- Maximum Observed Concentration (Cmax) and Pre-dose (Trough) Concentration at the End of the Dosing Interval (Ctau) Following Oral Administration of Ezogabine/Retigabine
- (and 23 more...)
|
5 |
All |
12 Years to 17 Years (Child) |
NCT01494584 |
113284 |
|
July 25, 2012 |
April 29, 2013 |
April 29, 2013 |
December 19, 2011 |
May 25, 2017 |
September 4, 2014 |
- GSK Investigational Site
Los Angeles, California, United States - GSK Investigational Site
Gulf Breeze, Florida, United States - GSK Investigational Site
Port Charlotte, Florida, United States - (and 6 more...)
|
| 27 |
NCT00004729 |
Completed |
Ketogenic Diet for Child Epilepsy and Seizure Control |
- Epilepsy
- Seizures
- Lennox-Gastaut Syndrome
|
- Behavioral: Ketogenic diet
|
Interventional |
Not Applicable |
- National Institute of Neurological Disorders and Stroke (NINDS)
|
NIH |
- Allocation: Randomized
- Masking: Double
- Primary Purpose: Treatment
|
|
|
All |
1 Year to 10 Years (Child) |
NCT00004729 |
R01NS035980 |
|
July 1997 |
|
|
February 28, 2000 |
December 22, 2006 |
|
- Johns Hopkins Hospital
Baltimore, Maryland, United States
|
| 28 |
NCT02318602 |
Completed |
Cannabidiol Oral Solution as an Adjunctive Treatment for Treatment-resistant Seizure Disorder |
|
- Drug: Cannabidiol Oral Solution
|
Interventional |
Phase 3 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Percentage of participants with adverse events
- Percentage of participants with severe adverse events
- Percentage of participants with clinically significant change from baseline in safety parameters
- (and 7 more...)
|
53 |
All |
1 Year to 30 Years (Child, Adult) |
NCT02318602 |
INS011-14-030 |
|
January 2016 |
June 22, 2017 |
June 22, 2017 |
December 17, 2014 |
February 5, 2018 |
|
- University of California San Francisco Medical Center
San Francisco, California, United States - Miami Children's Hospital
Miami, Florida, United States - Child Neurology Center - NW F
Pensacola, Florida, United States - (and 8 more...)
|
| 29 |
NCT03254680 |
Not yet recruiting |
Turmeric as Treatment in Epilepsy |
- Epilepsy
- Dravet Syndrome
- Lennox-Gastaut Syndrome
- (and 2 more...)
|
- Dietary Supplement: Turmeric
|
Interventional |
Not Applicable |
- New York University School of Medicine
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Number of epilepsy patients enrolled in study
- Number of epilepsy seizures post epilepsy treatment with turmeric
|
20 |
All |
1 Year to 70 Years (Child, Adult, Senior) |
NCT03254680 |
17-00750 |
|
March 2018 |
November 2018 |
November 2018 |
August 18, 2017 |
November 14, 2017 |
|
- New York University School of Medicine
New York, New York, United States
|
| 30 |
NCT00233012 |
Completed |
A Study of the Pharmacokinetics, Safety and Tolerability of Topiramate in Infants (Age 1-24 Months) With Refractory Partial-onset Seizures |
|
|
Interventional |
Phase 1 |
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
|
Industry |
|
- Individual (each patient) and mean (each treatment) topiramate plasma concentration-time profiles.
- Incidence of adverse events throughout the study. Changes from pretreatment to the end of posttreatment phase in take-home records, clinical laboratory results, physical & neurologic examination results, ECGs, renal ultrasounds, vital sign measurements
|
16 |
All |
1 Month to 24 Months (Child) |
NCT00233012 |
CR002236 |
|
June 2005 |
|
October 2007 |
October 5, 2005 |
May 25, 2010 |
|
|
| 31 |
NCT00187928 |
Completed |
Study to Determine the Efficacy and Safety of Adjunctive Topiramate in the Treatment of Obsessive-Compulsive Disorder |
- Obsessive-Compulsive Disorder
|
|
Interventional |
Phase 3 |
- University of Florida
- Ortho-McNeil Pharmaceutical
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Single Group Assignment
- Masking: Double
- Primary Purpose: Treatment
|
|
96 |
All |
18 Years to 65 Years (Adult) |
NCT00187928 |
CAPSS-217 |
|
January 2003 |
March 2006 |
March 2006 |
September 16, 2005 |
October 5, 2011 |
|
- UF Health Science Center
Gainesville, Florida, United States
|
| 32 |
NCT01863602 |
Completed |
Special Drug Use Investigation for LAMICTAL® (Long Term) |
|
- Drug: Lamotrigine tablets
|
Observational |
|
|
Industry |
- Time Perspective: Prospective
|
- The incidence of adverse drug reactions
- Occurrence of skin disorder after the start of treatment
- Overall improvement of subjects' symptoms
|
850 |
All |
Child, Adult, Senior |
NCT01863602 |
112728 |
|
April 2009 |
July 2016 |
July 2016 |
May 29, 2013 |
November 9, 2016 |
|
|
| 33 |
NCT00552045 |
Unknown † |
Epilepsy Phenome/Genome Project |
- Epilepsy
- Localization-related Epilepsy
- Infantile Spasms
- (and 3 more...)
|
|
Observational |
|
- University of California, San Francisco
- National Institute of Neurological Disorders and Stroke (NINDS)
|
Other / NIH |
- Observational Model: Case Control
- Time Perspective: Prospective
|
- EPGP will recruit persons with specific forms of epilepsy. DNA will be isolated from participants' blood and genetic variants associated with common forms of epilepsy will be identified.
|
4150 |
All |
up to 60 Years (Child, Adult) |
NCT00552045 |
1R01NS053998-01A1
CRC
1R01NS053998 |
EPGP |
November 2007 |
December 2013 |
April 2014 |
November 1, 2007 |
January 16, 2014 |
|
- University of Alabama at Birmingham, Epilepsy Center, 1719 6th Ave S, CIRC, Ste 312
Birmingham, Alabama, United States - Mayo Clinic College of Medicine Arizona
Phoenix, Arizona, United States - University of California, San Francisco, 400 Parnassus, Room 847
San Francisco, California, United States - (and 22 more...)
|
| 34 |
NCT03024827 |
Recruiting |
Cannabidiol in Children With Refractory Epileptic Encephalopathy |
|
|
Interventional |
Phase 1 |
- University of Saskatchewan
- University of Alberta
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Heart Rate
- Blood Pressure
- Weight
- (and 19 more...)
|
30 |
All |
1 Year to 10 Years (Child) |
NCT03024827 |
CARE-E-01 |
CARE-E |
April 26, 2017 |
September 2018 |
December 2018 |
January 19, 2017 |
February 5, 2018 |
|
- University of Alberta
Edmonton, Alberta, Canada - University of British Columbia
Vancouver, British Columbia, Canada - University of Manitoba
Winnipeg, Manitoba, Canada - (and 2 more...)
|
| 35 |
NCT00001325 |
Completed |
Metabolic Abnormalities in Children With Epilepsy |
- Generalized Epilepsy
- Infantile Spasms
- Metabolic Disease
- (and 2 more...)
|
|
Observational |
|
- National Institute of Neurological Disorders and Stroke (NINDS)
- National Institutes of Health Clinical Center (CC)
|
NIH |
|
|
80 |
All |
Child, Adult, Senior |
NCT00001325 |
920175
92-N-0175 |
|
April 1992 |
|
June 2004 |
November 4, 1999 |
March 4, 2008 |
|
- National Institute of Neurological Disorders and Stroke (NINDS)
Bethesda, Maryland, United States
|
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