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



Status:Recruiting
Conditions:Migraine Headaches
Therapuetic Areas:Neurology
Healthy:No
Age Range:6 - 11
Updated:2/17/2019
Start Date:December 4, 2017
End Date:May 2020
Contact:Impax CT gov contact
Email:ImpaxSpecialtyPharma_RegAffairs@impaxlabs.com
Phone:510-240-6000

Use our guide to learn which trials are right for you!

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.


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.
We found this trial at
44
sites
1111 Exposition Boulevard
Sacramento, California 95815
?
mi
from
Sacramento, CA
Click here to add this to my saved trials
1 Perkins Square
Akron, Ohio 44308
(330) 543-1000
Akron Children's Hospital From humble beginnings as a day nursery in 1890, Akron Children
?
mi
from
Akron, OH
Click here to add this to my saved trials
3980 Sheridan Drive
Amherst, New York 14226
?
mi
from
Amherst, NY
Click here to add this to my saved trials
1020 South Anaheim Boulevard
Anaheim, California 92805
?
mi
from
Anaheim, CA
Click here to add this to my saved trials
3120 Professional Drive
Ann Arbor, Michigan 48104
?
mi
from
Ann Arbor, MI
Click here to add this to my saved trials
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
1951 152nd Place Northeast
Bellevue, Washington 98007
?
mi
from
Bellevue, WA
Click here to add this to my saved trials
Charlotte, North Carolina 28277
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
1011 East Jefferson Street
Charlottesville, Virginia 22902
?
mi
from
Charlottesville, VA
Click here to add this to my saved trials
Cincinnati, Ohio 45229
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
6301 Gaston Avenue
Dallas, Texas 75214
?
mi
from
Dallas, TX
Click here to add this to my saved trials
?
mi
from
Dallas, TX
Click here to add this to my saved trials
125 Clairemont Avenue
Decatur, Georgia 30030
?
mi
from
Decatur, GA
Click here to add this to my saved trials
499 East Hampden Avenue
Englewood, Colorado 80113
?
mi
from
Englewood, CO
Click here to add this to my saved trials
200 West Bullard Avenue
Fresno, California 17601
?
mi
from
Fresno, CA
Click here to add this to my saved trials
Greensboro, North Carolina 27405
?
mi
from
Greensboro, NC
Click here to add this to my saved trials
?
mi
from
Gulf Breeze, FL
Click here to add this to my saved trials
7250 Clearvista Drive
Indianapolis, Indiana 46256
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
618 East South Street
Jacksonville, Florida 32256
?
mi
from
Jacksonville, FL
Click here to add this to my saved trials
4700 State Road 7
Lauderdale Lakes, Florida 33319
?
mi
from
Lauderdale Lakes, FL
Click here to add this to my saved trials
Lebanon, New Hampshire 03756
?
mi
from
Lebanon, NH
Click here to add this to my saved trials
Little Rock, Arkansas 72202
?
mi
from
Little Rock, AR
Click here to add this to my saved trials
13001 Southern Boulevard
Loxahatchee Groves, Florida 33470
?
mi
from
Loxahatchee Groves, FL
Click here to add this to my saved trials
Marshfield, Wisconsin 54449
?
mi
from
Marshfield, WI
Click here to add this to my saved trials
Miami, Florida 33155
?
mi
from
Miami, FL
Click here to add this to my saved trials
18610 Northwest 87th Avenue
Miami, Florida 33155
?
mi
from
Miami, FL
Click here to add this to my saved trials
Nashville, Tennessee 37203
?
mi
from
Nashville, TN
Click here to add this to my saved trials
3900 West Coast Highway
Newport Beach, California 92663
?
mi
from
Newport Beach, CA
Click here to add this to my saved trials
North Palm Beach, Florida 33408
?
mi
from
North Palm Beach, FL
Click here to add this to my saved trials
618 East South Street
Orlando, Florida 32801
?
mi
from
Orlando, FL
Click here to add this to my saved trials
7485 Sand Lake Commons Boulevard
Orlando, Florida 32819
?
mi
from
Orlando, FL
Click here to add this to my saved trials
140 Curry Hollow Road
Pittsburgh, Pennsylvania 15236
?
mi
from
Pittsburgh, PA
Click here to add this to my saved trials
320 Southeast Florida Street
Port Saint Lucie, Florida 34983
?
mi
from
Port Saint Lucie, FL
Click here to add this to my saved trials
1540 Sunday Drive
Raleigh, North Carolina 27607
?
mi
from
Raleigh, NC
Click here to add this to my saved trials
Saint Louis, Missouri 63141
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
2295 Foothill Drive
Salt Lake City, Utah 84109
?
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
999 East Murray Holladay Road
Salt Lake City, Utah 84117
?
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
?
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
6602 Waters Avenue
Savannah, Georgia 31406
?
mi
from
Savannah, GA
Click here to add this to my saved trials
?
mi
from
Stamford, CT
Click here to add this to my saved trials
?
mi
from
Tampa, FL
Click here to add this to my saved trials
2050 Voorhees Town Center
Voorhees, New Jersey 08043
?
mi
from
Voorhees, NJ
Click here to add this to my saved trials
Washington, District of Columbia 20010
?
mi
from
Washington,
Click here to add this to my saved trials
4631 North Congress Avenue
West Palm Beach, Florida 33407
?
mi
from
West Palm Beach, FL
Click here to add this to my saved trials