Efficacy & Safety Of Zomig Nasal Spray For Acute Migraine Treatment In Subjects 6 To 11 Years, With OLE
- Conditions
- Migraine
- Interventions
- Drug: Placebo ZNSDrug: ZNS
- Registration Number
- NCT03275922
- Lead Sponsor
- Impax Laboratories, LLC
- Brief Summary
To evaluate the efficacy and safety of zolmitriptan nasal spray (ZNS) in the acute treatment of migraine headache in subjects ages 6 to 11 years.
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 374
Not provided
- History of ischemic or vasospastic heart disease, arrhythmias associated with accessory conduction pathways (eg, Wolff-Parkinson-White syndrome), cerebrovascular disease, hemiplegic or basilar artery migraine, peripheral vascular disease, ischemic bowel disease, uncontrolled hypertension, recent (within 24 hours) or use of another 5HT1 agonist, ergots or ergotamine-containing medications.
- 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.
- Had an unacceptable adverse experience following previous use of any 5HT1B/1D agonist drug (in the opinion of the investigator).
- Had not experienced satisfactory relief from migraine pain during prior treatment with 2 or more adequate courses of triptans.
- Prior use of any nasal spray (triptan or dihydroergotamine [DHE]) for the acute treatment of migraine
- Disease or anatomic abnormalities of the nasal cavity precluding or complicating the use of ZNS.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Run-in - Placebo - ZNS - OLE Placebo ZNS 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). Run-in - ZNS - Placebo - OLE Placebo ZNS 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). Run-in - ZNS - Placebo - OLE ZNS 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). Run-in - Placebo - ZNS - OLE ZNS 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).
- Primary Outcome Measures
Name Time Method Pain-free status at 2 hours post treatment 2 hours post-dose Headache pain intensity is assessed by the subjects immediately prior to treatment and 2 hours post-dose using a 4-point headache pain intensity scale (severe = 3, moderate = 2, mild = 1, or none = 0).
- Secondary Outcome Measures
Name Time Method Proportion of subjects who achieve pain-free status at 24 hours post-dose 24 hours post-dose The headache pain intensity is assessed by the subjects using a 4-point headache pain intensity scale (severe = 3, moderate = 2, mild = 1, or none = 0).
Sustained headache response at 24 hours post-dose 24 hours post-dose Sustained headache response is defined as a reduction in migraine headache pain intensity from severe or moderate to mild or none at 2 hours which is then maintained (without a return to moderate or severe pain) at 24 hours with no use of rescue medication prior to the 24 hour assessment.
Headache response at 24 hours post-dose 24 hours post-dose The subject diary captures the headache severity using a 4-point headache pain intensity scale (severe = 3, moderate = 2, mild = 1, or none = 0). Headache response is defined as a reduction in moderate (2) or severe (3) pain to mild (1) or no (0) pain at 24 hour post-dose.
Trial Locations
- Locations (47)
Clinical Integrative Research Center of Atlanta (121)
🇺🇸Atlanta, Georgia, United States
iResearch Atlanta, LLC (146)
🇺🇸Decatur, Georgia, United States
Akron Children's Hospital (site 139)
🇺🇸Akron, Ohio, United States
Biotech Pharmaceutical Group (138)
🇺🇸Miami, Florida, United States
Sanitas Medical and Dental Institute/dba Sanitas Research, LLC (142)
🇺🇸Miami, Florida, United States
Josephson Wallack Munshower Neurology P.C. (114)
🇺🇸Indianapolis, Indiana, United States
Preferred Primary Care Physicians, Inc. (115)
🇺🇸Pittsburgh, Pennsylvania, United States
Cincinnati Children's Hospital (140)
🇺🇸Cincinnati, Ohio, United States
Phoenix Children's Hospital (149)
🇺🇸Phoenix, Arizona, United States
Access Clinical Trials, Inc. (151)
🇺🇸Nashville, Tennessee, 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
Arkansas Children's Hospital (109)
🇺🇸Little Rock, Arkansas, United States
Children's National Health System (141)
🇺🇸Washington, District of Columbia, United States
Ki Health Partners, LLC dba New England INstitute for Clinical Research (128)
🇺🇸Stamford, Connecticut, United States
Clinical Research Center of NJ (123)
🇺🇸Voorhees, New Jersey, United States
Advanced Research Center, Inc (134)
🇺🇸Anaheim, California, United States
Sierra Medical Research (124)
🇺🇸Fresno, California, United States
Blue Sky Neurology (106)
🇺🇸Englewood, Colorado, United States
IMMUNOe Research Centers (150)
🇺🇸Thornton, Colorado, United States
Clinical Neuroscience Solutions, Inc. (127)
🇺🇸Jacksonville, Florida, United States
NW Florida Clinical Research Group, LLC (122)
🇺🇸Gulf Breeze, Florida, United States
Axcess Medical Research (126)
🇺🇸Loxahatchee Groves, Florida, United States
Laszlo J. Mate, M.D., P.A. (153)
🇺🇸North Palm Beach, Florida, United States
East Florida Research (143)
🇺🇸Port Saint Lucie, Florida, United States
NuDirections Clinical Research, LLC (159)
🇺🇸Atlanta, Georgia, United States
Premiere Research Institute @ Palm Beach Neurology, PA (105)
🇺🇸West Palm Beach, Florida, United States
Meridian Clinical Research, LLC (130)
🇺🇸Savannah, Georgia, United States
Headache Wellness Center (Site 152)
🇺🇸Greensboro, North Carolina, United States
Mercy Research (116)
🇺🇸Saint Louis, Missouri, United States
OnSite Clinical Solutions, LLC (155)
🇺🇸Charlotte, North Carolina, United States
Dent Neurosciences Research Center (129)
🇺🇸Amherst, New York, United States
Raleigh Neurology Associates, PA (113)
🇺🇸Raleigh, North Carolina, United States
Texas Neurology, P.A. (110)
🇺🇸Dallas, Texas, United States
Children's Medical Center Dallas (147)
🇺🇸Dallas, Texas, United States
Pediatric Research of Charlottesville, LLC (104)
🇺🇸Charlottesville, Virginia, United States
Northwest Clinical Research Center (132)
🇺🇸Bellevue, Washington, United States
Marshfield Clinic (145)
🇺🇸Marshfield, Wisconsin, United States
Multicare Health System- Mary Bridge Pediatrics- Tacoma (158)
🇺🇸Tacoma, Washington, 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
Clincial Neuroscience Solutions, Inc. (136)
🇺🇸Orlando, Florida, United States
Pediatric Neurology, PA (125)
🇺🇸Orlando, Florida, United States
Pedatric Epilepsy & Neurology Specialists (157)
🇺🇸Tampa, Florida, 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