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

Primary Purpose

Migraine

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Placebo ZNS
ZNS
Sponsored by
Impax Laboratories, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine focused on measuring Migraine, Headache, Pain, Efficacy, Pediatric

Eligibility Criteria

6 Years - 11 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Phoenix Children's Hospital (149)
  • Arkansas Children's Hospital (109)
  • Advanced Research Center, Inc (134)
  • Sierra Medical Research (124)
  • Shailesh M. Asaikar, MD. Inc. DBA Child and Adolescent Neurology Consultatns (119)
  • Children's Hospital Colorado (154)
  • Blue Sky Neurology (106)
  • IMMUNOe Research Centers (150)
  • Ki Health Partners, LLC dba New England INstitute for Clinical Research (128)
  • Children's National Health System (141)
  • NW Florida Clinical Research Group, LLC (122)
  • Clinical Neuroscience Solutions, Inc. (127)
  • Axcess Medical Research (126)
  • Biotech Pharmaceutical Group (138)
  • Sanitas Medical and Dental Institute/dba Sanitas Research, LLC (142)
  • Laszlo J. Mate, M.D., P.A. (153)
  • Clincial Neuroscience Solutions, Inc. (136)
  • Pediatric Neurology, PA (125)
  • East Florida Research (143)
  • Pedatric Epilepsy & Neurology Specialists (157)
  • Premiere Research Institute @ Palm Beach Neurology, PA (105)
  • Clinical Integrative Research Center of Atlanta (121)
  • NuDirections Clinical Research, LLC (159)
  • iResearch Atlanta, LLC (146)
  • Meridian Clinical Research, LLC (130)
  • Josephson Wallack Munshower Neurology P.C. (114)
  • Kosair Charities Pediatric Clinical Research Unit (120)
  • Michigan Head-Pain and Neurological Institute (103)
  • Mercy Research (116)
  • Clinical Research Center of NJ (123)
  • Dent Neurosciences Research Center (129)
  • OnSite Clinical Solutions, LLC (155)
  • Headache Wellness Center (Site 152)
  • Raleigh Neurology Associates, PA (113)
  • Akron Children's Hospital (site 139)
  • Cincinnati Children's Hospital (140)
  • Preferred Primary Care Physicians, Inc. (115)
  • Access Clinical Trials, Inc. (151)
  • Texas Neurology, P.A. (110)
  • Children's Medical Center Dallas (147)
  • J. Lewis Research Inc. Foothill Family Clinic (107)
  • Primary Children's Hospital Outpatient Services (117)
  • Granger Medical Holladay (111)
  • Pediatric Research of Charlottesville, LLC (104)
  • Northwest Clinical Research Center (132)
  • Multicare Health System- Mary Bridge Pediatrics- Tacoma (158)
  • Marshfield Clinic (145)

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Run-in - ZNS - Placebo - OLE

Run-in - Placebo - ZNS - OLE

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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).
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.
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.

Full Information

First Posted
September 6, 2017
Last Updated
January 8, 2021
Sponsor
Impax Laboratories, LLC
Collaborators
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT03275922
Brief Title
Efficacy & Safety Of Zomig Nasal Spray For Acute Migraine Treatment In Subjects 6 To 11 Years, With OLE
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
November 27, 2017 (Actual)
Primary Completion Date
July 2, 2020 (Actual)
Study Completion Date
September 28, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Impax Laboratories, LLC
Collaborators
AstraZeneca

4. Oversight

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
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine
Keywords
Migraine, Headache, Pain, Efficacy, Pediatric

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Model Description
A Multicenter, Randomized, Double-blind, Placebo-controlled, Crossover Study
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
374 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Run-in - ZNS - Placebo - OLE
Arm Type
Other
Arm Description
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).
Arm Title
Run-in - Placebo - ZNS - OLE
Arm Type
Other
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
Placebo ZNS
Other Intervention Name(s)
Placebo
Intervention Description
Placebo Zolmitriptan Nasal Spray
Intervention Type
Drug
Intervention Name(s)
ZNS
Intervention Description
Zolmitriptan Nasal Spray
Primary Outcome Measure Information:
Title
Pain-free status at 2 hours post treatment
Description
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).
Time Frame
2 hours post-dose
Secondary Outcome Measure Information:
Title
Proportion of subjects who achieve pain-free status at 24 hours post-dose
Description
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).
Time Frame
24 hours post-dose
Title
Headache response at 24 hours post-dose
Description
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.
Time Frame
24 hours post-dose
Title
Sustained headache response at 24 hours post-dose
Description
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.
Time Frame
24 hours post-dose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria Parent or legal guardian is able to provide written informed consent and subject is able to provide assent. Subjects ages 6 to 11 years throughout the double-blind portion of the studyAn established diagnosis of migraine By history, average migraine frequency of ≥ 2 attacks per month lasting on average ≥ 3 hours per attack By history, experiences at least 16 headache-free days per month on average Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Impax Study Director
Organizational Affiliation
Impax Laboratories, LLC
Official's Role
Study Director
Facility Information:
Facility Name
Phoenix Children's Hospital (149)
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Facility Name
Arkansas Children's Hospital (109)
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72202
Country
United States
Facility Name
Advanced Research Center, Inc (134)
City
Anaheim
State/Province
California
ZIP/Postal Code
92805
Country
United States
Facility Name
Sierra Medical Research (124)
City
Fresno
State/Province
California
ZIP/Postal Code
17601
Country
United States
Facility Name
Shailesh M. Asaikar, MD. Inc. DBA Child and Adolescent Neurology Consultatns (119)
City
Sacramento
State/Province
California
ZIP/Postal Code
95815
Country
United States
Facility Name
Children's Hospital Colorado (154)
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Blue Sky Neurology (106)
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80113
Country
United States
Facility Name
IMMUNOe Research Centers (150)
City
Thornton
State/Province
Colorado
ZIP/Postal Code
80233
Country
United States
Facility Name
Ki Health Partners, LLC dba New England INstitute for Clinical Research (128)
City
Stamford
State/Province
Connecticut
ZIP/Postal Code
06905
Country
United States
Facility Name
Children's National Health System (141)
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
NW Florida Clinical Research Group, LLC (122)
City
Gulf Breeze
State/Province
Florida
ZIP/Postal Code
32561
Country
United States
Facility Name
Clinical Neuroscience Solutions, Inc. (127)
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Axcess Medical Research (126)
City
Loxahatchee Groves
State/Province
Florida
ZIP/Postal Code
33470
Country
United States
Facility Name
Biotech Pharmaceutical Group (138)
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Facility Name
Sanitas Medical and Dental Institute/dba Sanitas Research, LLC (142)
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Facility Name
Laszlo J. Mate, M.D., P.A. (153)
City
North Palm Beach
State/Province
Florida
ZIP/Postal Code
33408
Country
United States
Facility Name
Clincial Neuroscience Solutions, Inc. (136)
City
Orlando
State/Province
Florida
ZIP/Postal Code
32801
Country
United States
Facility Name
Pediatric Neurology, PA (125)
City
Orlando
State/Province
Florida
ZIP/Postal Code
32819
Country
United States
Facility Name
East Florida Research (143)
City
Port Saint Lucie
State/Province
Florida
ZIP/Postal Code
34983
Country
United States
Facility Name
Pedatric Epilepsy & Neurology Specialists (157)
City
Tampa
State/Province
Florida
ZIP/Postal Code
17601
Country
United States
Facility Name
Premiere Research Institute @ Palm Beach Neurology, PA (105)
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
Facility Name
Clinical Integrative Research Center of Atlanta (121)
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
NuDirections Clinical Research, LLC (159)
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30350
Country
United States
Facility Name
iResearch Atlanta, LLC (146)
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30030
Country
United States
Facility Name
Meridian Clinical Research, LLC (130)
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31406
Country
United States
Facility Name
Josephson Wallack Munshower Neurology P.C. (114)
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46256
Country
United States
Facility Name
Kosair Charities Pediatric Clinical Research Unit (120)
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Michigan Head-Pain and Neurological Institute (103)
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48104
Country
United States
Facility Name
Mercy Research (116)
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Clinical Research Center of NJ (123)
City
Voorhees
State/Province
New Jersey
ZIP/Postal Code
08043
Country
United States
Facility Name
Dent Neurosciences Research Center (129)
City
Amherst
State/Province
New York
ZIP/Postal Code
14226
Country
United States
Facility Name
OnSite Clinical Solutions, LLC (155)
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28277
Country
United States
Facility Name
Headache Wellness Center (Site 152)
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27405
Country
United States
Facility Name
Raleigh Neurology Associates, PA (113)
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
Akron Children's Hospital (site 139)
City
Akron
State/Province
Ohio
ZIP/Postal Code
44308
Country
United States
Facility Name
Cincinnati Children's Hospital (140)
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Facility Name
Preferred Primary Care Physicians, Inc. (115)
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15236
Country
United States
Facility Name
Access Clinical Trials, Inc. (151)
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Texas Neurology, P.A. (110)
City
Dallas
State/Province
Texas
ZIP/Postal Code
75214
Country
United States
Facility Name
Children's Medical Center Dallas (147)
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
J. Lewis Research Inc. Foothill Family Clinic (107)
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84109
Country
United States
Facility Name
Primary Children's Hospital Outpatient Services (117)
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84113
Country
United States
Facility Name
Granger Medical Holladay (111)
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84117
Country
United States
Facility Name
Pediatric Research of Charlottesville, LLC (104)
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22902
Country
United States
Facility Name
Northwest Clinical Research Center (132)
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98007
Country
United States
Facility Name
Multicare Health System- Mary Bridge Pediatrics- Tacoma (158)
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
Marshfield Clinic (145)
City
Marshfield
State/Province
Wisconsin
ZIP/Postal Code
54449
Country
United States

12. IPD Sharing Statement

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

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