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

January 8, 2021 updated by: Impax Laboratories, LLC

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
374

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pain-free status at 2 hours post treatment
Time Frame: 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).
2 hours post-dose

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Proportion of subjects who achieve pain-free status at 24 hours post-dose
Time Frame: 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
Time Frame: 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
Time Frame: 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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Impax Laboratories, LLC

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 27, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 2, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 28, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 6, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 6, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 8, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 11, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 8, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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