| 1 |
NCT01533506 |
No longer available |
Stiripentol in Dravet Syndrome |
|
|
Expanded Access
|
|
|
Other |
|
|
|
Female |
11 Years and older (Child, Adult, Older Adult) |
NCT01533506 |
12-000690 |
|
February 2012 |
February 2013 |
February 2013 |
February 15, 2012 |
February 28, 2013 |
|
- Mayo Clinic in Rochester
Rochester, Minnesota, United States
|
|
| 2 |
NCT03299842 |
Enrolling by invitation |
A Study to Assess the Usability of the Embrace Seizure Detection Watch in Children and Young Adults With Dravet Syndrome |
|
- Drug: ZX008 (Fenfluramine Hydrochloride)
|
Interventional
|
Phase 3 |
- Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc.
- Zogenix, Inc.
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Usability of the Empatica Embrace Seizure Detection watch system (Embrace) in outpatients with Dravet syndrome
- Overall Usability of the Empatica Embrace Seizure Detection watch system (Embrace) in outpatients with Dravet syndrome
- Compare objective convulsive seizure count, as captured by the Embrace, to convulsive seizure count captured manually in the Embrace electronic seizure diary
|
20 |
All |
Child, Adult, Older Adult |
NCT03299842 |
ZX008-1503-SS01 |
|
August 23, 2017 |
December 31, 2018 |
December 31, 2018 |
October 3, 2017 |
October 3, 2017 |
|
- University of California San Francisco
San Francisco, California, United States
|
|
| 3 |
NCT02823145 |
Enrolling by invitation |
An Open-Label Extension Trial to Assess the Long-Term Safety of ZX008 (Fenfluramine Hydrochloride HCl) Oral Solution in Children and Young Adults With Dravet Syndrome |
|
- Drug: ZX008 (Fenfluramine Hydrochloride)
|
Interventional
|
Phase 3 |
- Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc.
- Zogenix, Inc.
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Long-term safety and tolerability as measured by treatment emergent adverse events, including clinical labs, vital signs, and examination findings.
- Proportion of subjects who achieve reduction from baseline in convulsive seizure frequency
- The longest interval between convulsive seizures will be calculated for each subject over the entire open-label treatment period.
|
210 |
All |
2 Years to 18 Years (Child, Adult) |
NCT02823145 |
ZX008-1503 |
|
June 2016 |
December 2018 |
December 2018 |
July 6, 2016 |
February 22, 2018 |
|
- Center for Neurosciences - Tucson
Tucson, Arizona, United States - Collaborative Neuroscience Network
Long Beach, California, United States - Children's Hospital Los Angeles
Los Angeles, California, United States - (and 46 more...)
|
|
| 4 |
NCT01983722 |
Available |
Treatment Plan to Provide Expanded Access to Stiripentol for Patients With Dravet Syndrome |
|
|
Expanded Access
|
|
- Children's Hospital Medical Center, Cincinnati
|
Other |
|
|
|
All |
6 Months and older (Child, Adult, Older Adult) |
NCT01983722 |
2013-5518 |
|
|
|
|
November 14, 2013 |
August 23, 2017 |
|
- Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
|
|
| 5 |
NCT01835314 |
Available |
Compassionate Use of Stiripentol in Dravet Syndrome |
|
|
Expanded Access
|
|
- University of Colorado, Denver
|
Other |
|
|
|
All |
1 Year to 21 Years (Child, Adult) |
NCT01835314 |
12-0315 |
|
|
|
|
April 18, 2013 |
May 10, 2018 |
|
- Children's Hospital Colorado
Aurora, Colorado, United States
|
|
| 6 |
NCT02926898 |
Active, not recruiting |
A Two-Part Study to Investigate the Dose-Ranging Safety and Pharmacokinetics, Followed by the Efficacy and Safety of ZX008 (Fenfluramine Hydrochloride) Oral Solution as an Adjunctive Therapy in Children ≥2 Years Old and Young Adults With Dravet Syndrome |
|
- Drug: ZX008 - 0.2 mg/kg/day
- Drug: ZX008 - 0.4 mg/kg/day
- Drug: ZX008 - 20 mg/day maximum dose
- Drug: Matching 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
|
- Change from baseline in frequency of convulsive seizures in subjects receiving ZX008 0.2 mg/kg/day as adjunctive therapy compared to placebo
- Change from baseline in frequency of convulsive seizures in subjects receiving ZX008 0.4 mg/kg/day as adjunctive therapy compared to placebo
- Proportion of subjects achieving a ≥40% or ≥50% reduction from baseline in convulsive seizure frequency and longest seizure-free interval in subjects receiving ZX008 0.2 and 0.4 mg/kg/day as adjunctive therapy compared to placebo
|
100 |
All |
2 Years to 18 Years (Child, Adult) |
NCT02926898 |
ZX008-1504 |
|
September 2016 |
June 2018 |
June 2018 |
October 6, 2016 |
January 8, 2018 |
|
- University of California San Francisco
San Francisco, California, United States - The Children'S Hospital Colorado
Aurora, Colorado, United States - Ann & Robert Lurie Children'S Hospital of Chicago
Chicago, Illinois, United States - (and 25 more...)
|
|
| 7 |
NCT02187809 |
Terminated
Has Results |
Safety and Tolerability of Clobazam as Adjunctive Therapy in Paediatric Patients Aged ≥1 to ≤16 Years With Dravet Syndrome |
|
|
Interventional
|
Phase 3 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Number of Participants With Adverse Events as a Measure of Safety and Tolerability
- Number of Participants With Adverse Events of Special Interest as a Measure of Safety and Tolerability Based on Dose
- Columbia Suicide Severity Rating Scale (C-SSRS), Categorisation Based on Columbia Classification Algorithm of Suicide Assessment (C-CASA) Categories (1, 2, 3, 4 and 7) for Patients Aged ≥ 6 Years
- (and 4 more...)
|
3 |
All |
1 Year to 16 Years (Child) |
NCT02187809 |
14362B |
|
March 2015 |
October 2015 |
October 2015 |
July 11, 2014 |
March 27, 2017 |
February 15, 2017 |
- US010
Los Angeles, California, United States - US012
Orange, California, United States - US001
Orlando, Florida, United States - (and 6 more...)
|
|
| 8 |
NCT02174094 |
Withdrawn |
Clobazam as Adjunctive Therapy in Paediatric Patients Aged ≥1 to ≤16 Years With Dravet Syndrome |
|
- Drug: Clobazam
- Drug: Placebo
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Treatment
|
- Percent change from baseline to study completion/withdrawal in seizure rate for combined tonic-clonic and clonic seizure rates, based upon a calculation of seizure frequency determined from daily seizure diary counts
- Percent change from baseline to study completion/withdrawal in seizure rate for combined tonic-clonic and clonic seizure rates, based upon a calculation of seizure frequency determined from daily seizure diary counts during 4 weeks of maintenance
- Percent change in seizure rate for myoclonic seizures determined from daily seizure diary counts
- (and 12 more...)
|
0 |
All |
1 Year to 16 Years (Child) |
NCT02174094 |
14362A |
|
March 2015 |
August 2015 |
August 2015 |
June 25, 2014 |
September 24, 2015 |
|
- US010
Los Angeles, California, United States - US001
Orlando, Florida, United States - US003
Rochester, Minnesota, United States - (and 6 more...)
|
|
| 9 |
NCT02826863 |
Recruiting |
A Trial of Two Fixed Doses of ZX008 (Fenfluramine HCl) as an Adjunctive Therapy in Children and Young Adults With Dravet Syndrome |
|
- Drug: ZX008 - 0.8 mg/kg/day
- Drug: ZX008 - 0.2 mg/kg/day
- Drug: 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
|
- Change from baseline in frequency of convulsive seizures in subjects receiving ZX008 0.8mg/kg/day compared to placebo
- Change from baseline in frequency of convulsive seizures for subjects receiving ZX008 0.2mg/kg/day compared to placebo
- Proportion of subjects achieving a ≥40% or ≥50% reduction from baseline in convulsive seizure frequency and longest seizure-free interval in subjects receiving ZX008 0.2 and 0.8 mg/kg/day compared to placebo
- (and 2 more...)
|
130 |
All |
2 Years to 18 Years (Child, Adult) |
NCT02826863 |
ZX008-1502 |
|
July 15, 2016 |
December 2018 |
December 2018 |
July 11, 2016 |
May 14, 2018 |
|
- Melbourne Brain Centre Austin Hospital
Melbourne, Australia - Princes Margaret Hospital
Perth, Australia - Children's Health Queensland Hospital and Health Service at Lady Cilento Children's Hospital
South Brisbane, Australia - (and 28 more...)
|
|
| 10 |
NCT02239276 |
Available |
Expanded Access Use of Stiripentol in Dravet Syndrome or Sodium Channel Mutation Epileptic Encephalopathies |
- Dravet Syndrome
- Epileptic Encephalopathies Associated With SCN1A Mutations
|
|
Expanded Access
|
|
- M. Scott Perry
- Cook Children's Health Care System
|
Other |
|
|
|
All |
6 Months to 18 Years (Child, Adult) |
NCT02239276 |
2014-047 |
|
|
|
|
September 12, 2014 |
January 25, 2018 |
|
- Cook Children's Medical Center
Fort Worth, Texas, United States
|
|
| 11 |
NCT01607073 |
Completed |
Verapamil as Therapy for Children and Young Adults With Dravet Syndrome |
|
|
Interventional
|
Phase 2 |
- Beverly S. Wical, M.D.
- Mayo Clinic
- Ann & Robert H Lurie Children's Hospital of Chicago
- (and 2 more...)
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Seizure Frequency
- Frequency of myoclonic/absence/atypical absence seizures
|
2 |
All |
2 Years to 25 Years (Child, Adult) |
NCT01607073 |
IND 113666 |
|
April 2012 |
January 2015 |
January 2015 |
May 28, 2012 |
March 25, 2015 |
|
- Children's Memorial Hospital
Chicago, Illinois, United States - Mayo Clinic
Rochester, Minnesota, United States - Gillette Children's Specialty Healthcare
St. Paul, Minnesota, United States - Mary Hitchcock Memorial Hospital
Lebanon, New Hampshire, United States
|
|
| 12 |
NCT02318563 |
Withdrawn |
Cannabidiol Oral Solution as an Adjunctive Therapy for Treatment of Participants With Inadequately Controlled Dravet 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 in the frequency of tonic-clonic, clonic, and focal seizures with motor components
- Percent change from baseline in the severity of tonic-clonic, clonic, and focal seizures with motor components
- Percent change from baseline in the duration of tonic-clonic, clonic, and focal seizures with motor components
- (and 5 more...)
|
0 |
All |
1 Year to 30 Years (Child, Adult) |
NCT02318563 |
INS011-14-025 |
|
December 30, 2017 |
June 17, 2018 |
June 17, 2018 |
December 17, 2014 |
January 4, 2018 |
|
|
|
| 13 |
NCT02896608 |
Recruiting |
Neuronal Excitability of HCN1 Channel Mutations in Dravet Syndrome |
|
- Device: measure of neuronal excitability
|
Observational
|
|
- Fondation Ophtalmologique Adolphe de Rothschild
|
Other |
- Observational Model: Other
- Time Perspective: Cross-Sectional
|
- hyperpolarizing electrotonus
- hyperpolarizing threshold current
|
90 |
All |
15 Years and older (Child, Adult, Older Adult) |
NCT02896608 |
AGN_2015_11 |
EXCIDRAH |
October 2015 |
December 2018 |
December 2018 |
September 12, 2016 |
February 7, 2018 |
|
- Fondation Ophtalmologique Adolphe de Rothschild
Paris, France
|
|
| 14 |
NCT02224703 |
Recruiting |
GWPCARE2 A Study to Investigate the Efficacy and Safety of Cannabidiol (GWP42003-P) in Children and Young Adults With Dravet 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 convulsive seizure frequency during the treatment period.
- Number of subjects considered treatment responders, defined as those with a ≥25%, ≥50% or ≥75% reduction in convulsive seizures from baseline.
- Number of subjects who are convulsive seizure free.
- (and 5 more...)
|
150 |
All |
2 Years to 18 Years (Child, Adult) |
NCT02224703 |
GWEP1424
2014-002939-34 |
|
March 2015 |
May 2017 |
June 2017 |
August 25, 2014 |
October 12, 2016 |
|
- Sutter Neuroscience Institute
Sacramento, California, United States - Miami Children's Hospital
Miami, Florida, United States - McFarland Clinic
Ames, Iowa, United States - (and 7 more...)
|
|
| 15 |
NCT02091375 |
Completed |
Antiepileptic Efficacy Study of GWP42003-P in Children and Young Adults With Dravet Syndrome (GWPCARE1) |
|
- 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 convulsive seizure frequency during the treatment period.
- Number of subjects considered treatment responders, defined as those with a ≥25%, ≥50% or ≥75% reduction in convulsive seizures from baseline.
- Number of subjects who are convulsive seizure free.
- (and 5 more...)
|
120 |
All |
2 Years to 18 Years (Child, Adult) |
NCT02091375 |
GWEP1332 Part B |
|
March 2015 |
November 2015 |
February 2016 |
March 19, 2014 |
September 28, 2016 |
|
- NYU Comprehensive Epilepsy Center
NY, New York, United States
|
|
| 16 |
NCT02091206 |
Completed |
A Dose-ranging Pharmacokinetics and Safety Study of GWP42003-P in Children With Dravet Syndrome (GWPCARE1) |
|
- Drug: GWP42003-P
- Drug: Placebo control
|
Interventional
|
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- The incidence of adverse events as measure of subject safety
- The plasma concentration time curves for cannabidiol and its major metabolite following single and multiple doses of GWP42003-P
- Plasma concentrations of clobazam and N-desmethylclobazam, if taken concomitantly with GWP42003-P, prior to single and multiple doses of GWP42003-P
|
34 |
All |
4 Years to 10 Years (Child) |
NCT02091206 |
GWEP1332 Part A |
|
October 2014 |
February 2015 |
November 2015 |
March 19, 2014 |
September 28, 2016 |
|
- Houston, Texas, United States
|
|
| 17 |
NCT02682927 |
Active, not recruiting |
A Trial of Two Fixed Doses of ZX008 (Fenfluramine HCl) in Children and Young Adults With Dravet Syndrome |
- Dravet Syndrome
- Seizure Disorder
|
- Drug: ZX008 (Fenfluramine Hydrochloride)
- Drug: Matching 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
|
- Change in mean convulsive seizure frequency comparing the baseline with the combined titration and maintenance period for ZX008 0.8mg/kg/day group compared with placebo group.
- Proportion of subjects in each ZX008 treatment arm compared with placebo who were considered treatment responders, defined as those with a ≥40% and ≥50%, reduction in convulsive seizures from baseline.
- Comparison of subjects' longest seizure-free interval in each ZX008 treatment arm compared with placebo
- (and 2 more...)
|
130 |
All |
2 Years to 18 Years (Child, Adult) |
NCT02682927 |
ZX008-1501 |
|
January 2016 |
June 2018 |
June 2018 |
February 17, 2016 |
March 12, 2018 |
|
- Phoenix Children's
Phoenix, Arizona, United States - Center for Neurosciences - Tucson
Tucson, Arizona, United States - Rady Children's Hospital San Diego
San Diego, California, United States - (and 19 more...)
|
|
| 18 |
NCT02415686 |
Recruiting |
Cardiac Arrhythmias in Dravet Syndrome |
|
|
Observational
|
|
- Stichting Epilepsie Instellingen Nederland
- Epilepsiefonds
|
Other |
- Observational Model: Case-Control
- Time Perspective: Other
|
- Ictal asystole (sinus arrest ≥ 3 s) or ictal bradycardia (< 2nd heart rate percentile for age)
- Ictal QT lengthening or shortening
|
60 |
All |
6 Years and older (Child, Adult, Older Adult) |
NCT02415686 |
NL48765.058.15 |
|
June 2015 |
August 2018 |
August 2018 |
April 14, 2015 |
November 8, 2017 |
|
- Universität Bonn
Bonn, North Rhine-Westphalia, Germany - Stichting Epilepsie Instellingen Nederland (SEIN)
Heemstede, Achterweg 5, Netherlands - Great Ormond Street Hospital
London, South East, United Kingdom
|
|
| 19 |
NCT02229032 |
Completed |
Genetic Analysis Between Charlotte's Web Responders Versus Non- Responders in a Dravet Population |
|
|
Observational
|
|
- University of Colorado, Denver
- Denver Health Medical Center
|
Other |
- Observational Model: Cohort
- Time Perspective: Cross-Sectional
|
- genetic differences between patients with Dravet Syndrome (SCN1A gene mutation) who appear to respond to high concentration cannabidiol (CBD) oil therapy versus those who do not.
|
19 |
All |
up to 50 Years (Child, Adult) |
NCT02229032 |
14-0294 |
|
August 2014 |
July 2017 |
July 2017 |
August 29, 2014 |
December 15, 2017 |
|
- Denver Health Medical Center
Denver, Colorado, United States
|
|
| 20 |
NCT02758626 |
Recruiting |
Ataluren for Nonsense Mutation in CDKL5 and Dravet Syndrome |
|
- Drug: ataluren
- Drug: Placebo
|
Interventional
|
Phase 2 |
- New York University School of Medicine
- PTC Therapeutics
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Number of adverse events and serious adverse events related to ataluren
- Seizure frequency from baseline after ataluren treatment in patients w/ CDKL5 or Dravet from daily seizure diary.
|
16 |
All |
2 Years to 12 Years (Child) |
NCT02758626 |
15-00426 |
|
November 2016 |
December 2018 |
December 2019 |
May 2, 2016 |
November 9, 2017 |
|
- New York University School of Medicine
New York, New York, United States
|
|
| 21 |
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
|
|
| 22 |
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 |
|
|
|
| 23 |
NCT02815540 |
Unknown † |
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
|
|
| 24 |
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...)
|
|
| 25 |
NCT03254680 |
Withdrawn |
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
|
0 |
All |
1 Year to 70 Years (Child, Adult, Older Adult) |
NCT03254680 |
17-00750 |
|
March 2018 |
November 2018 |
November 2018 |
August 18, 2017 |
April 30, 2018 |
|
- New York University School of Medicine
New York, New York, United States
|
|
| 26 |
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, Older Adult) |
NCT02224573 |
GWEP1415
2014-001834-27 |
|
June 2015 |
June 2019 |
June 2019 |
August 25, 2014 |
October 24, 2017 |
|
|
|
| 27 |
NCT02983695 |
Active, not recruiting |
Cannabinoid Therapy for Pediatric Epilepsy |
|
|
Interventional
|
Phase 1 |
- The Hospital for Sick Children
- Tilray
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Establishment of tolerability of TIL-TC150 by measuring the number of participants with adverse events and / or abnormal laboratory values that are related to treatment
- Establishment of tolerability of TIL-TC150 by standardised side effects questionnaire -pediatric epilepsy side effects questionnaire (PESQ)
- The impact of therapy on quality of life using the Quality of Life in Childhood Epilepsy (QOLCE) questionnaire
- (and 2 more...)
|
20 |
All |
1 Year to 18 Years (Child, Adult) |
NCT02983695 |
1000047417 |
|
February 2, 2017 |
August 30, 2018 |
December 30, 2018 |
December 6, 2016 |
May 30, 2018 |
|
- The Hospital for Sick Children
Toronto, Ontario, Canada
|
|
| 28 |
NCT01858285 |
Recruiting |
Genetics of Severe Early Onset Epilepsies |
- Epilepsy
- Epileptic Encephalopathy
- Ohtahara Syndrome
- (and 5 more...)
|
|
Observational
|
|
- Boston Children’s Hospital
- Dravet Syndrome Foundation
|
Other |
- Observational Model: Cohort
- Time Perspective: Cross-Sectional
|
- Identify new or existing causative mutations through whole exome sequencing of epilepsy patients
|
500 |
All |
Child, Adult, Older Adult |
NCT01858285 |
X10-04-0197 |
|
November 2010 |
December 2020 |
|
May 21, 2013 |
August 25, 2017 |
|
- Boston Children's Hospital
Boston, Massachusetts, United States
|
|
| 29 |
NCT01662453 |
Recruiting |
Risk Factors for Sudden Unexplained Death in Epilepsy |
|
|
Observational
|
|
- New York University School of Medicine
|
Other |
- Observational Model: Case-Control
- Time Perspective: Retrospective
|
- - Incidence of SUDEP - Risk factors for SUDEP.
|
400 |
All |
Child, Adult, Older Adult |
NCT01662453 |
11-01664 |
SUDEP |
June 2011 |
December 2018 |
December 2018 |
August 10, 2012 |
March 29, 2018 |
|
- NYU Comprehensive Epilepsy Center
New York, New York, United States
|
|
| 30 |
NCT02286986 |
Active, not recruiting |
Cannabidiol (CBD) to 27 Patients (Aged 2 Years - 19 Years) With Drug Resistant Epilepsy |
|
|
Interventional
|
Phase 1 |
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Seizure Frequency
- Drug Plasma Levels of Cannabidiol
|
25 |
All |
2 Years to 25 Years (Child, Adult) |
NCT02286986 |
IND 70871 |
|
September 2014 |
June 2018 |
December 2018 |
November 10, 2014 |
April 12, 2017 |
|
- University of Utah School of Medicine
Salt Lake City, Utah, United States
|
|
| 31 |
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 |
May 8, 2018 |
|
- University of British Columbia
Vancouver, British Columbia, Canada - University of Manitoba
Winnipeg, Manitoba, Canada - Universite de Montreal
Montreal, Quebec, Canada - University of Saskatchewan
Saskatoon, Saskatchewan, Canada
|
|
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