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

Migraine Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03275922
• Other study ID #: IPX229-B16-01
• Status: Completed
• Phase: Phase 3
• Start date: November 27, 2017
• Est. completion date: September 28, 2020

Study information

• Verified date: July 2020
• Source: Impax Laboratories, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 374
• Est. completion date: September 28, 2020
• Est. primary completion date: July 2, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 11 Years

Eligibility

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.

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

Drug:
• Placebo ZNS
Placebo Zolmitriptan Nasal Spray
• ZNS
Zolmitriptan Nasal Spray

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Impax Laboratories, LLC	AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain-free status at 2 hours post treatment	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	Proportion of subjects who achieve pain-free status at 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
Secondary	Headache response at 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
Secondary	Sustained headache response at 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