| 1 |
NCT03777059 |
Recruiting |
To Evaluate the Safety and Tolerability of Atogepant 10mg, 30 mg and 60 mg Once a Day for the Prevention of Migraine in Participants With Episodic Migraine |
|
- Drug: Atogepant 30 mg
- Drug: Atogepant 60 mg
- Drug: Placebo
- Drug: Atogepant 10 mg
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Prevention
|
- Change from baseline in mean monthly migraine days across the 12-week treatment period
- Change from baseline in mean monthly headache days across the 12-week treatment period.
- Change from baseline in mean monthly acute medication use days across the 12-week treatment period.
- (and 3 more...)
|
872 |
All |
18 Years to 80 Years (Adult, Older Adult) |
NCT03777059 |
3101-301-002 |
|
December 14, 2018 |
February 5, 2020 |
February 5, 2020 |
December 17, 2018 |
January 25, 2019 |
|
- Barrow Neurological Institute
Phoenix, Arizona, United States - Mayo Clinic Scottsdale
Scottsdale, Arizona, United States - Orange Grove Family Practice
Tucson, Arizona, United States - (and 85 more...)
|
|
| 2 |
NCT03732638 |
Recruiting |
Efficacy and Safety Trial of Rimegepant for Migraine Prevention in Adults |
|
- Drug: Rimegepant
- Drug: Placebo
|
Interventional
|
Phase 2
Phase 3 |
- Biohaven Pharmaceuticals, Inc.
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Prevention
|
- Change from baseline in mean number of migraine days per month
- Achievement of at least a 50% reduction from baseline in mean monthly migraine days.
- The mean number of rescue medication days per month.
- (and 4 more...)
|
1200 |
All |
18 Years and older (Adult, Older Adult) |
NCT03732638 |
BHV3000-305 |
|
November 14, 2018 |
September 30, 2019 |
February 15, 2020 |
November 6, 2018 |
January 9, 2019 |
|
- MedPharmics, LLC
Phoenix, Arizona, United States - Tucson Neuroscience Research
Tucson, Arizona, United States - Baptist Health Center for Clinical Research
Little Rock, Arkansas, United States - (and 72 more...)
|
|
| 3 |
NCT03836040 |
Not yet recruiting
New |
Efficacy and Safety of Erenumab in Pediatric Subjects With Episodic Migraine |
|
- Drug: Erenumab Dose 1
- Drug: Erenumab Dose 2
- Drug: Erenumab Dose 3
- Other: Placebo
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Change from baseline in monthly migraine days (MMDs)
- Change in monthly headache days from baseline
- Proportion of subjects with at least 50% reduction in monthly migraine days (MMDs) from baseline
- (and 4 more...)
|
456 |
All |
6 Years to 17 Years (Child) |
NCT03836040 |
20150125
2017-002397-39 |
OASIS (EM) |
June 6, 2019 |
November 4, 2022 |
June 28, 2023 |
February 11, 2019 |
February 11, 2019 |
|
- Research site
Aurora, Colorado, United States - Research site
Colorado Springs, Colorado, United States - Research site
Washington, District of Columbia, United States - (and 55 more...)
|
|
| 4 |
NCT03832998 |
Not yet recruiting
New |
Efficacy and Safety of Erenumab in Pediatric Subjects With Chronic Migraine |
|
- Drug: Erenumab Dose 1
- Drug: Erenumab Dose 2
- Drug: Erenumab Dose 3
- Other: Placebo
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Change from baseline in monthly migraine days (MMDs)
- Change in monthly headache days from baseline
- Proportion of subjects with at least 50% reduction in monthly migraine days (MMDs) from baseline
- (and 4 more...)
|
286 |
All |
6 Years to 17 Years (Child) |
NCT03832998 |
20160354
2017-002399-23 |
OASIS (CM) |
June 6, 2019 |
January 17, 2024 |
September 25, 2024 |
February 6, 2019 |
February 8, 2019 |
|
- Research site
Aurora, Colorado, United States - Research site
Colorado Springs, Colorado, United States - Research site
Washington, District of Columbia, United States - (and 51 more...)
|
|
| 5 |
NCT03275922 |
Recruiting |
Efficacy & Safety Of Zomig Nasal Spray For Acute Migraine Treatment In Subjects 6 To 11 Years, With OLE |
|
- Drug: Placebo ZNS
- Drug: ZNS
|
Interventional
|
Phase 3 |
- IMPAX Laboratories, Inc.
- AstraZeneca
|
Industry |
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Pain-free status at 2 hours post treatment
- Proportion of subjects who achieve pain-free status at 24 hours post-dose
- Headache response at 24 hours post-dose
- Sustained headache response at 24 hours post-dose
|
426 |
All |
6 Years to 11 Years (Child) |
NCT03275922 |
IPX229-B16-01 |
|
December 4, 2017 |
April 2020 |
May 2020 |
September 8, 2017 |
February 15, 2019 |
|
- Arkansas Children's Hospital (109)
Little Rock, Arkansas, United States - Advanced Research Center, Inc (134)
Anaheim, California, United States - Sierra Medical Research (124)
Fresno, California, United States - (and 41 more...)
|
|
| 6 |
NCT03557333 |
Recruiting |
Safety and Tolerability of POD-DHE (INP104) in Migraine (STOP-301) |
|
- Combination Product: INP104
|
Interventional
|
Phase 3 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Serious treatment emergent adverse events (SAEs)
- Non-serious treatment emergent adverse events (AEs)
- Change in nasal mucosa
- Change in olfactory function
|
240 |
All |
18 Years to 65 Years (Adult, Older Adult) |
NCT03557333 |
INP104-301 |
|
July 13, 2018 |
October 18, 2019 |
October 18, 2019 |
June 15, 2018 |
December 7, 2018 |
|
- Synexus - Clinical Research Advantage, Inc. - Southview Medical Group, PC., 833 Saint Vincent's Drive, Suite 300
Birmingham, Alabama, United States - Synexus - Clinical Research Advantage, Inc. - Simon Williamson Clinical, PC., 832 Princeton Avenue Southwest
Birmingham, Alabama, United States - Alabama Clinical Therapeutics, LLC., 52 Medical Park East Drive, Suite 203
Birmingham, Alabama, United States - (and 35 more...)
|
|
| 7 |
NCT02729480 |
Recruiting |
Clinical Trial of Wireless CranioFacial Nerve Stimulation (CFNS) for the Treatment of CranioFacial Neuropathic Pain |
|
- Device: Halo Craniofacial Nerve Stimulator System
|
Interventional
|
Not Applicable |
- StimRelieve, LLC
- Goodman Campbell Brain and Spine, Indiana University, Indianapolis, Indiana, USA
- International Spine, Pain and Performance Center, Washington DC, USA
- (and 5 more...)
|
Industry / Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Pain Score
- Incidence and severity of adverse events
- Percentage change from baseline in VAS for facial pain
- (and 5 more...)
|
65 |
All |
18 Years and older (Adult, Older Adult) |
NCT02729480 |
30-00208 |
|
February 1, 2017 |
December 2018 |
December 2019 |
April 6, 2016 |
April 19, 2018 |
|
- International Spine, Pain & Performance Center
Washington, District of Columbia, United States - Goodman Campbell Brain and Spine, Indiana University
Indianapolis, Indiana, United States - Prizm Pain Management
Canton, Michigan, United States - (and 4 more...)
|
|
| 8 |
NCT01431326 |
Recruiting |
Pharmacokinetics of Understudied Drugs Administered to Children Per Standard of Care |
- Adenovirus
- Anesthesia
- Anxiety
- (and 47 more...)
|
- Drug: The POPS study is collecting PK data on children prescribed the following drugs of interest per standard of care:
|
Observational
|
|
- Daniel Benjamin
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- The EMMES Corporation
- Duke University
|
Other / NIH / Industry |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Composite of pharmacokinetic outcomes for understudied drugs in children
- Composite pharmacodynamic outcomes of understudied drugs in children
- Biomarkers associated with understudied drugs in children
|
10000 |
All |
up to 21 Years (Child, Adult) |
NCT01431326 |
Pro00029638
IND 113645
IND 114369
IND 114531
IND 118358
HHSN20100006
HHSN27500020
HHSN27500027
HHSN27500043
HHSN27500049 |
PTN_POPS |
November 2011 |
February 2020 |
February 2020 |
September 9, 2011 |
April 4, 2018 |
|
- Alaska Native Medical Center
Anchorage, Alaska, United States - Arkansas Children's Hospital
Little Rock, Arkansas, United States - University of California at San Diego Medical Center
La Jolla, California, United States - (and 51 more...)
|
|
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