Clinical trial NCT03275922: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Migraine
Keywords: Migraine
Headache
Pain
Efficacy
Pediatric
Lead sponsor: Impax Laboratories, LLC
Sponsor class: INDUSTRY
Collaborators: name: AstraZeneca
First posted: 2017-09-08
Enrollment: 374
Sex: ALL
Minimum age (years): 6
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: A Multicenter, Randomized, Double-blind, Placebo-controlled, Crossover Study
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Pain-free status at 2 hours post treatment
timeFrame: 2 hours post-dose
Secondary outcomes:
measure: Proportion of subjects who achieve pain-free status at 24 hours post-dose
timeFrame: 24 hours post-dose
measure: Headache response at 24 hours post-dose
timeFrame: 24 hours post-dose
measure: Sustained headache response at 24 hours post-dose
timeFrame: 24 hours post-dose
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Phoenix Children's Hospital (149)
state: Arizona
city: Little Rock
country: United States
facility: Arkansas Children's Hospital (109)
state: Arkansas
city: Anaheim
country: United States
facility: Advanced Research Center, Inc (134)
state: California
city: Fresno
country: United States
facility: Sierra Medical Research (124)
state: California
city: Sacramento
country: United States
facility: Shailesh M. Asaikar, MD. Inc. DBA Child and Adolescent Neurology Consultatns (119)
state: California
city: Aurora
country: United States
facility: Children's Hospital Colorado (154)
state: Colorado
city: Englewood
country: United States
facility: Blue Sky Neurology (106)
state: Colorado
city: Thornton
country: United States
facility: IMMUNOe Research Centers (150)
state: Colorado
city: Stamford
country: United States
facility: Ki Health Partners, LLC dba New England INstitute for Clinical Research (128)
state: Connecticut
city: Washington
country: United States
facility: Children's National Health System (141)
state: District of Columbia
city: Gulf Breeze
country: United States
facility: NW Florida Clinical Research Group, LLC (122)
state: Florida
city: Jacksonville
country: United States
facility: Clinical Neuroscience Solutions, Inc. (127)
state: Florida
city: Loxahatchee Groves
country: United States
facility: Axcess Medical Research (126)
state: Florida
city: Miami
country: United States
facility: Biotech Pharmaceutical Group (138)
state: Florida
city: Miami
country: United States
facility: Sanitas Medical and Dental Institute/dba Sanitas Research, LLC (142)
state: Florida
city: North Palm Beach
country: United States
facility: Laszlo J. Mate, M.D., P.A. (153)
state: Florida
city: Orlando
country: United States
facility: Clincial Neuroscience Solutions, Inc. (136)
state: Florida
city: Orlando
country: United States
facility: Pediatric Neurology, PA (125)
state: Florida
city: Port Saint Lucie
country: United States
facility: East Florida Research (143)
state: Florida
city: Tampa
country: United States
facility: Pedatric Epilepsy & Neurology Specialists (157)
state: Florida
city: West Palm Beach
country: United States
facility: Premiere Research Institute @ Palm Beach Neurology, PA (105)
state: Florida
city: Atlanta
country: United States
facility: Clinical Integrative Research Center of Atlanta (121)
state: Georgia
city: Atlanta
country: United States
facility: NuDirections Clinical Research, LLC (159)
state: Georgia
city: Decatur
country: United States
facility: iResearch Atlanta, LLC (146)
state: Georgia
city: Savannah
country: United States
facility: Meridian Clinical Research, LLC (130)
state: Georgia
city: Indianapolis
country: United States
facility: Josephson Wallack Munshower Neurology P.C. (114)
state: Indiana
city: Louisville
country: United States
facility: Kosair Charities Pediatric Clinical Research Unit (120)
state: Kentucky
city: Ann Arbor
country: United States
facility: Michigan Head-Pain and Neurological Institute (103)
state: Michigan
city: Saint Louis
country: United States
facility: Mercy Research (116)
state: Missouri
city: Voorhees
country: United States
facility: Clinical Research Center of NJ (123)
state: New Jersey
city: Amherst
country: United States
facility: Dent Neurosciences Research Center (129)
state: New York
city: Charlotte
country: United States
facility: OnSite Clinical Solutions, LLC (155)
state: North Carolina
city: Greensboro
country: United States
facility: Headache Wellness Center (Site 152)
state: North Carolina
city: Raleigh
country: United States
facility: Raleigh Neurology Associates, PA (113)
state: North Carolina
city: Akron
country: United States
facility: Akron Children's Hospital (site 139)
state: Ohio
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital (140)
state: Ohio
city: Pittsburgh
country: United States
facility: Preferred Primary Care Physicians, Inc. (115)
state: Pennsylvania
city: Nashville
country: United States
facility: Access Clinical Trials, Inc. (151)
state: Tennessee
city: Dallas
country: United States
facility: Texas Neurology, P.A. (110)
state: Texas
city: Dallas
country: United States
facility: Children's Medical Center Dallas (147)
state: Texas
city: Salt Lake City
country: United States
facility: J. Lewis Research Inc. Foothill Family Clinic (107)
state: Utah
city: Salt Lake City
country: United States
facility: Primary Children's Hospital Outpatient Services (117)
state: Utah
city: Salt Lake City
country: United States
facility: Granger Medical Holladay (111)
state: Utah
city: Charlottesville
country: United States
facility: Pediatric Research of Charlottesville, LLC (104)
state: Virginia
city: Bellevue
country: United States
facility: Northwest Clinical Research Center (132)
state: Washington
city: Tacoma
country: United States
facility: Multicare Health System- Mary Bridge Pediatrics- Tacoma (158)
state: Washington
city: Marshfield
country: United States
facility: Marshfield Clinic (145)
state: Wisconsin
Study officials:
affiliation: Impax Laboratories, LLC
name: Impax Study Director
role: STUDY_DIRECTOR
References: