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Trial record 1 of 1 for:    impax | Migraine
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Efficacy & Safety Of Zomig Nasal Spray For Acute Migraine Treatment In Subjects 6 To 11 Years, With OLE

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.
 
ClinicalTrials.gov Identifier: NCT03275922
Recruitment Status : Recruiting
First Posted : September 8, 2017
Last Update Posted : October 29, 2019
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Impax Laboratories, LLC

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
Migraine Drug: Placebo ZNS Drug: ZNS Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 426 participants
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
Actual Study Start Date : December 4, 2017
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache Migraine

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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 :
  1. 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).

  2. 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.

  3. 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.



Information from the National Library of Medicine

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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.

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
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Contact: Impax Ct.gov contact 877-835-5472 clinicaltrials@amneal.com

Locations
Hide Hide 53 study locations
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United States, Arizona
Phoenix Children's Hospital (149) Recruiting
Phoenix, Arizona, United States, 85016
United States, Arkansas
Arkansas Children's Hospital (109) Recruiting
Little Rock, Arkansas, United States, 72202
United States, California
Advanced Research Center, Inc (134) Recruiting
Anaheim, California, United States, 92805
Sierra Medical Research (124) Recruiting
Fresno, California, United States, 17601
Newport Beach Clinical Research Assoicates, Inc. (108) Withdrawn
Newport Beach, California, United States, 92663
Shailesh M. Asaikar, MD. Inc. DBA Child and Adolescent Neurology Consultatns (119) Recruiting
Sacramento, California, United States, 95815
United States, Colorado
Children's Hospital Colorado (154) Recruiting
Aurora, Colorado, United States, 80045
Immunoe Research Centers (131) Withdrawn
Centennial, Colorado, United States, 80112
Blue Sky Neurology (106) Recruiting
Englewood, Colorado, United States, 80113
IMMUNOe Research Centers (150) Recruiting
Thornton, Colorado, United States, 80233
United States, Connecticut
Ki Health Partners, LLC dba New England INstitute for Clinical Research (128) Recruiting
Stamford, Connecticut, United States, 06905
United States, District of Columbia
Children's National Health System (141) Recruiting
Washington, District of Columbia, United States, 20010
United States, Florida
NW Florida Clinical Research Group, LLC (122) Recruiting
Gulf Breeze, Florida, United States, 32561
Clinical Neuroscience Solutions, Inc. (127) Recruiting
Jacksonville, Florida, United States, 32256
Precision Clinical Research, LLC. (135) Withdrawn
Lauderdale Lakes, Florida, United States, 33319
Axcess Medical Research (126) Recruiting
Loxahatchee Groves, Florida, United States, 33470
Biotech Pharmaceutical Group (138) Recruiting
Miami, Florida, United States, 33155
Sanitas Medical and Dental Institute/dba Sanitas Research, LLC (142) Recruiting
Miami, Florida, United States, 33155
Laszlo J. Mate, M.D., P.A. (153) Recruiting
North Palm Beach, Florida, United States, 33408
Clincial Neuroscience Solutions, Inc. (136) Recruiting
Orlando, Florida, United States, 32801
Pediatric Neurology, PA (125) Recruiting
Orlando, Florida, United States, 32819
East Florida Research (143) Recruiting
Port Saint Lucie, Florida, United States, 34983
Pedatric Epilepsy & Neurology Specialists (157) Not yet recruiting
Tampa, Florida, United States, 17601
Premiere Research Institute @ Palm Beach Neurology, PA (105) Terminated
West Palm Beach, Florida, United States, 33407
United States, Georgia
Clinical Integrative Research Center of Atlanta (121) Recruiting
Atlanta, Georgia, United States, 30328
NuDirections Clinical Research, LLC (159) Recruiting
Atlanta, Georgia, United States, 30350
iResearch Atlanta, LLC (146) Recruiting
Decatur, Georgia, United States, 30030
Meridian Clinical Research, LLC (130) Recruiting
Savannah, Georgia, United States, 31406
United States, Indiana
Josephson Wallack Munshower Neurology P.C. (114) Recruiting
Indianapolis, Indiana, United States, 46256
United States, Kentucky
Kosair Charities Pediatric Clinical Research Unit (120) Recruiting
Louisville, Kentucky, United States, 40202
United States, Michigan
Michigan Head-Pain and Neurological Institute (103) Recruiting
Ann Arbor, Michigan, United States, 48104
United States, Minnesota
Clinical Research Institute, Inc (102) Withdrawn
Minneapolis, Minnesota, United States, 55402
Clinical Research Institute (101) Withdrawn
Plymouth, Minnesota, United States, 55441
United States, Missouri
Mercy Research (116) Recruiting
Saint Louis, Missouri, United States, 63141
United States, New Hampshire
Dartmouth-Hitchock Medical Center (144) Withdrawn
Lebanon, New Hampshire, United States, 03756
United States, New Jersey
Clinical Research Center of NJ (123) Recruiting
Voorhees, New Jersey, United States, 08043
United States, New York
Dent Neurosciences Research Center (129) Recruiting
Amherst, New York, United States, 14226
United States, North Carolina
OnSite Clinical Solutions, LLC (155) Recruiting
Charlotte, North Carolina, United States, 28277
Headache Wellness Center (Site 152) Recruiting
Greensboro, North Carolina, United States, 27405
Raleigh Neurology Associates, PA (113) Recruiting
Raleigh, North Carolina, United States, 27607
United States, Ohio
Akron Children's Hospital (site 139) Recruiting
Akron, Ohio, United States, 44308
Cincinnati Children's Hospital (140) Recruiting
Cincinnati, Ohio, United States, 45229
United States, Pennsylvania
Preferred Primary Care Physicians, Inc. (115) Recruiting
Pittsburgh, Pennsylvania, United States, 15236
United States, Tennessee
Access Clinical Trials, Inc. (151) Recruiting
Nashville, Tennessee, United States, 37203
United States, Texas
Texas Neurology, P.A. (110) Recruiting
Dallas, Texas, United States, 75214
Children's Medical Center Dallas (147) Recruiting
Dallas, Texas, United States, 75235
United States, Utah
J. Lewis Research Inc. Foothill Family Clinic (107) Recruiting
Salt Lake City, Utah, United States, 84109
Primary Children's Hospital Outpatient Services (117) Recruiting
Salt Lake City, Utah, United States, 84113
Granger Medical Holladay (111) Terminated
Salt Lake City, Utah, United States, 84117
United States, Virginia
Pediatric Research of Charlottesville, LLC (104) Recruiting
Charlottesville, Virginia, United States, 22902
United States, Washington
Northwest Clinical Research Center (132) Recruiting
Bellevue, Washington, United States, 98007
Multicare Health System- Mary Bridge Pediatrics- Tacoma (158) Recruiting
Tacoma, Washington, United States, 98405
United States, Wisconsin
Marshfield Clinic (145) Recruiting
Marshfield, Wisconsin, United States, 54449
Sponsors and Collaborators
Impax Laboratories, LLC
AstraZeneca
Investigators
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Study Director: Impax Study Director Impax Laboratories, LLC

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Responsible Party: Impax Laboratories, LLC
ClinicalTrials.gov Identifier: NCT03275922    
Other Study ID Numbers: IPX229-B16-01
First Posted: September 8, 2017    Key Record Dates
Last Update Posted: October 29, 2019
Last Verified: February 2019

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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:
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Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases