Efficacy & Safety Of Zomig Nasal Spray For Acute Migraine Treatment In Subjects 6 To 11 Years, With OLE

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Crossover Study To Evaluate The Efficacy And Safety Of Zolmitriptan Nasal Spray For The Treatment Of Acute Migraine In Subjects Ages 6 To 11 Years, With An Open-Label Extension

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.

Study Overview

• Status: Completed
• Conditions: Migraine
• Intervention / Treatment: Drug: Placebo ZNS; Drug: ZNS

• Study Type: Interventional
• Enrollment (Actual): 374
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85016
      • Phoenix Children's Hospital (149)
  • Arkansas
    • Little Rock, Arkansas, United States, 72202
      • Arkansas Children's Hospital (109)
  • California
    • Anaheim, California, United States, 92805
      • Advanced Research Center, Inc (134)
    • Fresno, California, United States, 17601
      • Sierra Medical Research (124)
    • Sacramento, California, United States, 95815
      • Shailesh M. Asaikar, MD. Inc. DBA Child and Adolescent Neurology Consultatns (119)
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Children's Hospital Colorado (154)
    • Englewood, Colorado, United States, 80113
      • Blue Sky Neurology (106)
    • Thornton, Colorado, United States, 80233
      • IMMUNOe Research Centers (150)
  • Connecticut
    • Stamford, Connecticut, United States, 06905
      • Ki Health Partners, LLC dba New England INstitute for Clinical Research (128)
  • District of Columbia
    • Washington, District of Columbia, United States, 20010
      • Children's National Health System (141)
  • Florida
    • Gulf Breeze, Florida, United States, 32561
      • NW Florida Clinical Research Group, LLC (122)
    • Jacksonville, Florida, United States, 32256
      • Clinical Neuroscience Solutions, Inc. (127)
    • Loxahatchee Groves, Florida, United States, 33470
      • Axcess Medical Research (126)
    • Miami, Florida, United States, 33155
      • Biotech Pharmaceutical Group (138)
    • Miami, Florida, United States, 33155
      • Sanitas Medical and Dental Institute/dba Sanitas Research, LLC (142)
    • North Palm Beach, Florida, United States, 33408
      • Laszlo J. Mate, M.D., P.A. (153)
    • Orlando, Florida, United States, 32801
      • Clincial Neuroscience Solutions, Inc. (136)
    • Orlando, Florida, United States, 32819
      • Pediatric Neurology, PA (125)
    • Port Saint Lucie, Florida, United States, 34983
      • East Florida Research (143)
    • Tampa, Florida, United States, 17601
      • Pedatric Epilepsy & Neurology Specialists (157)
    • West Palm Beach, Florida, United States, 33407
      • Premiere Research Institute @ Palm Beach Neurology, PA (105)
  • Georgia
    • Atlanta, Georgia, United States, 30328
      • Clinical Integrative Research Center of Atlanta (121)
    • Atlanta, Georgia, United States, 30350
      • NuDirections Clinical Research, LLC (159)
    • Decatur, Georgia, United States, 30030
      • iResearch Atlanta, LLC (146)
    • Savannah, Georgia, United States, 31406
      • Meridian Clinical Research, LLC (130)
  • Indiana
    • Indianapolis, Indiana, United States, 46256
      • Josephson Wallack Munshower Neurology P.C. (114)
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Kosair Charities Pediatric Clinical Research Unit (120)
  • Michigan
    • Ann Arbor, Michigan, United States, 48104
      • Michigan Head-Pain and Neurological Institute (103)
  • Missouri
    • Saint Louis, Missouri, United States, 63141
      • Mercy Research (116)
  • New Jersey
    • Voorhees, New Jersey, United States, 08043
      • Clinical Research Center of NJ (123)
  • New York
    • Amherst, New York, United States, 14226
      • Dent Neurosciences Research Center (129)
  • North Carolina
    • Charlotte, North Carolina, United States, 28277
      • OnSite Clinical Solutions, LLC (155)
    • Greensboro, North Carolina, United States, 27405
      • Headache Wellness Center (Site 152)
    • Raleigh, North Carolina, United States, 27607
      • Raleigh Neurology Associates, PA (113)
  • Ohio
    • Akron, Ohio, United States, 44308
      • Akron Children's Hospital (site 139)
    • Cincinnati, Ohio, United States, 45229
      • Cincinnati Children's Hospital (140)
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15236
      • Preferred Primary Care Physicians, Inc. (115)
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Access Clinical Trials, Inc. (151)
  • Texas
    • Dallas, Texas, United States, 75214
      • Texas Neurology, P.A. (110)
    • Dallas, Texas, United States, 75235
      • Children's Medical Center Dallas (147)
  • Utah
    • Salt Lake City, Utah, United States, 84109
      • J. Lewis Research Inc. Foothill Family Clinic (107)
    • Salt Lake City, Utah, United States, 84113
      • Primary Children's Hospital Outpatient Services (117)
    • Salt Lake City, Utah, United States, 84117
      • Granger Medical Holladay (111)
  • Virginia
    • Charlottesville, Virginia, United States, 22902
      • Pediatric Research of Charlottesville, LLC (104)
  • Washington
    • Bellevue, Washington, United States, 98007
      • Northwest Clinical Research Center (132)
    • Tacoma, Washington, United States, 98405
      • Multicare Health System- Mary Bridge Pediatrics- Tacoma (158)
  • Wisconsin
    • Marshfield, Wisconsin, United States, 54449
      • Marshfield Clinic (145)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 11 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria

1. Parent or legal guardian is able to provide written informed consent and subject is able to provide assent.
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:

1. 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.
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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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).	Drug: Placebo ZNS; Placebo Zolmitriptan Nasal Spray; Other Names: Placebo; Drug: ZNS; Zolmitriptan Nasal Spray
Other: 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).	Drug: Placebo ZNS; Placebo Zolmitriptan Nasal Spray; Other Names: Placebo; Drug: ZNS; Zolmitriptan Nasal Spray

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain-free status at 2 hours post treatment	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).	2 hours post-dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of subjects who achieve pain-free status at 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).	24 hours post-dose
Headache response at 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.	24 hours post-dose
Sustained headache response at 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.	24 hours post-dose

Collaborators and Investigators

• Sponsor: Impax Laboratories, LLC
• Collaborators: AstraZeneca

Study record dates

Study Major Dates

• Study Start (Actual): November 27, 2017
• Primary Completion (Actual): July 2, 2020
• Study Completion (Actual): September 28, 2020

Study Registration Dates

• First Submitted: September 6, 2017
• First Submitted That Met QC Criteria: September 6, 2017
• First Posted (Actual): September 8, 2017

Study Record Updates

• Last Update Posted (Actual): January 11, 2021
• Last Update Submitted That Met QC Criteria: January 8, 2021
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Pain; Efficacy; Pediatric; Migraine; Headache
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders
• Other Study ID Numbers: IPX229-B16-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No