Efficacy & Safety Of Zomig Nasal Spray For Acute Migraine Treatment In Subjects 6 To 11 Years, With OLE
NCT ID: NCT03275922
Last Updated: 2021-01-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
374 participants
INTERVENTIONAL
2017-11-27
2020-09-28
Brief Summary
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Part 1: Approximately 20 weeks (includes screening and double-blind treatment).
* Screening will be performed based on the inclusion exclusion criteria specified in the study protocol.
* Randomize approximately 288 subjects into the double-blind crossover phase.
Part 2: Approximately 100 subjects who complete the double-blind crossover phase will enter part 2, a 6 month open-label safety extension (OLE).
Efficacy will be evaluated in the double-blind part of the trial. Safety will be evaluated in both the double-blind and the OLE.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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Run-in - ZNS - Placebo - OLE
After Run-in period, subjects will be randomized to ZNS followed by placebo ZNS. Upon successful completion of Part 1, subjects may enroll into OLE (Part 2).
Placebo ZNS
Placebo Zolmitriptan Nasal Spray
ZNS
Zolmitriptan Nasal Spray
Run-in - Placebo - ZNS - OLE
After Run-in period, subjects will be randomized to placebo ZNS followed by ZNS. Upon successful completion of Part 1, subjects may enroll into OLE (Part 2).
Placebo ZNS
Placebo Zolmitriptan Nasal Spray
ZNS
Zolmitriptan Nasal Spray
Interventions
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Placebo ZNS
Placebo Zolmitriptan Nasal Spray
ZNS
Zolmitriptan Nasal Spray
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Subjects ages 6 to 11 years throughout the double-blind portion of the studyAn established diagnosis of migraine
3. By history, average migraine frequency of ≥ 2 attacks per month lasting on average ≥ 3 hours per attack
4. By history, experiences at least 16 headache-free days per month on average
Exclusion Criteria
2. Any medical condition, including severe hepatic impairment, which, in the opinion of the investigator, may put the subject at increased risk with exposure to zolmitriptan, or may interfere with the safety or efficacy assessments.
3. Had an unacceptable adverse experience following previous use of any 5HT1B/1D agonist drug (in the opinion of the investigator).
4. Had not experienced satisfactory relief from migraine pain during prior treatment with 2 or more adequate courses of triptans.
5. Prior use of any nasal spray (triptan or dihydroergotamine \[DHE\]) for the acute treatment of migraine
6. Disease or anatomic abnormalities of the nasal cavity precluding or complicating the use of ZNS.
6 Years
11 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Impax Laboratories, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Impax Study Director
Role: STUDY_DIRECTOR
Impax Laboratories, LLC
Locations
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Phoenix Children's Hospital (149)
Phoenix, Arizona, United States
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
Shailesh M. Asaikar, MD. Inc. DBA Child and Adolescent Neurology Consultatns (119)
Sacramento, California, United States
Children's Hospital Colorado (154)
Aurora, Colorado, United States
Blue Sky Neurology (106)
Englewood, Colorado, United States
IMMUNOe Research Centers (150)
Thornton, Colorado, United States
Ki Health Partners, LLC dba New England INstitute for Clinical Research (128)
Stamford, Connecticut, United States
Children's National Health System (141)
Washington D.C., District of Columbia, United States
NW Florida Clinical Research Group, LLC (122)
Gulf Breeze, Florida, United States
Clinical Neuroscience Solutions, Inc. (127)
Jacksonville, Florida, United States
Axcess Medical Research (126)
Loxahatchee Groves, Florida, United States
Biotech Pharmaceutical Group (138)
Miami, Florida, United States
Sanitas Medical and Dental Institute/dba Sanitas Research, LLC (142)
Miami, Florida, United States
Laszlo J. Mate, M.D., P.A. (153)
North Palm Beach, Florida, United States
Clincial Neuroscience Solutions, Inc. (136)
Orlando, Florida, United States
Pediatric Neurology, PA (125)
Orlando, Florida, United States
East Florida Research (143)
Port Saint Lucie, Florida, United States
Pedatric Epilepsy & Neurology Specialists (157)
Tampa, Florida, United States
Premiere Research Institute @ Palm Beach Neurology, PA (105)
West Palm Beach, Florida, United States
Clinical Integrative Research Center of Atlanta (121)
Atlanta, Georgia, United States
NuDirections Clinical Research, LLC (159)
Atlanta, Georgia, United States
iResearch Atlanta, LLC (146)
Decatur, Georgia, United States
Meridian Clinical Research, LLC (130)
Savannah, Georgia, United States
Josephson Wallack Munshower Neurology P.C. (114)
Indianapolis, Indiana, United States
Kosair Charities Pediatric Clinical Research Unit (120)
Louisville, Kentucky, United States
Michigan Head-Pain and Neurological Institute (103)
Ann Arbor, Michigan, United States
Mercy Research (116)
St Louis, Missouri, United States
Clinical Research Center of NJ (123)
Voorhees Township, New Jersey, United States
Dent Neurosciences Research Center (129)
Amherst, New York, United States
OnSite Clinical Solutions, LLC (155)
Charlotte, North Carolina, United States
Headache Wellness Center (Site 152)
Greensboro, North Carolina, United States
Raleigh Neurology Associates, PA (113)
Raleigh, North Carolina, United States
Akron Children's Hospital (site 139)
Akron, Ohio, United States
Cincinnati Children's Hospital (140)
Cincinnati, Ohio, United States
Preferred Primary Care Physicians, Inc. (115)
Pittsburgh, Pennsylvania, United States
Access Clinical Trials, Inc. (151)
Nashville, Tennessee, United States
Texas Neurology, P.A. (110)
Dallas, Texas, United States
Children's Medical Center Dallas (147)
Dallas, Texas, United States
J. Lewis Research Inc. Foothill Family Clinic (107)
Salt Lake City, Utah, United States
Primary Children's Hospital Outpatient Services (117)
Salt Lake City, Utah, United States
Granger Medical Holladay (111)
Salt Lake City, Utah, United States
Pediatric Research of Charlottesville, LLC (104)
Charlottesville, Virginia, United States
Northwest Clinical Research Center (132)
Bellevue, Washington, United States
Multicare Health System- Mary Bridge Pediatrics- Tacoma (158)
Tacoma, Washington, United States
Marshfield Clinic (145)
Marshfield, Wisconsin, United States
Countries
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Other Identifiers
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IPX229-B16-01
Identifier Type: -
Identifier Source: org_study_id
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