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

Sponsor
Impax Laboratories, LLC (Industry)
Overall Status
Completed
CT.gov ID
NCT03275922
Collaborator
AstraZeneca (Industry)
374
Enrollment
47
Locations
2
Arms
34
Actual Duration (Months)
8
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
374 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
A Multicenter, Randomized, Double-blind, Placebo-controlled, Crossover StudyA Multicenter, Randomized, Double-blind, Placebo-controlled, Crossover Study
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
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
Actual Study Start Date :
Nov 27, 2017
Actual Primary Completion Date :
Jul 2, 2020
Actual Study Completion Date :
Sep 28, 2020

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. 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).

    2. 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.

    3. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    6 Years to 11 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    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.

    Contacts and Locations

    Locations

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

    Sponsors and Collaborators

    • Impax Laboratories, LLC
    • AstraZeneca

    Investigators

    • Study Director: Impax Study Director, Impax Laboratories, LLC

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Impax Laboratories, LLC
    ClinicalTrials.gov Identifier:
    NCT03275922
    Other Study ID Numbers:
    • IPX229-B16-01
    First Posted:
    Sep 8, 2017
    Last Update Posted:
    Jan 11, 2021
    Last Verified:
    Jul 1, 2020
    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
    Keywords provided by Impax Laboratories, LLC
    Migraine
    Headache
    Pain
    Efficacy
    Pediatric
    Additional relevant MeSH terms:
    Migraine Disorders

    Study Results

    No Results Posted as of Jan 11, 2021