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

This study is not yet open for participant recruitment.
Verified November 2017 by IMPAX Laboratories, Inc.
Sponsor:
ClinicalTrials.gov Identifier:
NCT03275922
First Posted: September 8, 2017
Last Update Posted: November 8, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
IMPAX Laboratories, Inc.
  Purpose

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 Intervention Phase
Migraine Drug: Placebo ZNS Drug: ZNS Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:
A 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

Resource links provided by NLM:


Further study details as provided by IMPAX Laboratories, Inc.:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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).

  • 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.

  • 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.


Estimated Enrollment: 426
Anticipated Study Start Date: November 2017
Estimated Study Completion Date: May 2020
Estimated Primary Completion Date: April 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Placebo
Drug: ZNS
Zolmitriptan Nasal Spray
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 Name: Placebo
Drug: ZNS
Zolmitriptan Nasal Spray

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   6 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03275922


Contacts
Contact: Impax CT gov contact 510-240-6000 ImpaxSpecialtyPharma_RegAffairs@impaxlabs.com

Locations
United States, Florida
Premiere Research Institute @ Palm Beach Neurology, PA Not yet recruiting
West Palm Beach, Florida, United States, 33407
United States, Indiana
Josephson Wallack Munshower Neurology P.C. Not yet recruiting
Indianapolis, Indiana, United States, 46256
United States, Michigan
Michigan Head-Pain and Neurological Institute Not yet recruiting
Ann Arbor, Michigan, United States, 48104
United States, Utah
J. Lewis Research Inc. Foothill Family Clinic Not yet recruiting
Salt Lake City, Utah, United States, 84109
United States, Virginia
Pediatric Research of Charlottesville, LLC Not yet recruiting
Charlottesville, Virginia, United States, 22902
Sponsors and Collaborators
IMPAX Laboratories, Inc.
AstraZeneca
Investigators
Study Director: Impax Study Director IMPAX Laboratories, Inc.
  More Information

Responsible Party: IMPAX Laboratories, Inc.
ClinicalTrials.gov Identifier: NCT03275922     History of Changes
Other Study ID Numbers: IPX229-B16-01
First Submitted: September 6, 2017
First Posted: September 8, 2017
Last Update Posted: November 8, 2017
Last Verified: November 2017

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, Inc.:
Migraine
Headache
Pain
Efficacy
Pediatric

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Zolmitriptan
Oxazolidinones
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors