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

Completed · Phase 3 · Has a placebo group

Conditions studied: Migraine

In brief

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.

Key facts

Study ID

NCT03275922

Run by

Impax Laboratories, LLC

People needed

374

Starts

2017-11-27

Expected to finish

2020-09-28

Last updated by the study team

2021-01-11

Who can join

Age: 6 and older, up to 11. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Parent or legal guardian is able to provide written informed consent and subject is able to provide assent.
• Subjects ages 6 to 11 years throughout the double-blind portion of the studyAn established diagnosis of migraine
• By history, average migraine frequency of ≥ 2 attacks per month lasting on average ≥ 3 hours per attack
• By history, experiences at least 16 headache-free days per month on average

You may not qualify if…

• 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.
• 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.
• Had an unacceptable adverse experience following previous use of any 5HT1B/1D agonist drug (in the opinion of the investigator).
• Had not experienced satisfactory relief from migraine pain during prior treatment with 2 or more adequate courses of triptans.
• Prior use of any nasal spray (triptan or dihydroergotamine [DHE]) for the acute treatment of migraine
• Disease or anatomic abnormalities of the nasal cavity precluding or complicating the use of ZNS.

Where it is running

• Phoenix Children's Hospital (149) — Phoenix, Arizona, United States
• Arkansas Children's Hospital (109) — Little Rock, Arkansas, United States
• Advanced Research Center, Inc (134) — Anaheim, California, United States
• Sierra Medical Research (124) — Fresno, California, United States
• Shailesh M. Asaikar, MD. Inc. DBA Child and Adolescent Neurology Consultatns (119) — Sacramento, California, United States
• Children's Hospital Colorado (154) — Aurora, Colorado, United States
• Blue Sky Neurology (106) — Englewood, Colorado, United States
• IMMUNOe Research Centers (150) — Thornton, Colorado, United States
• Ki Health Partners, LLC dba New England INstitute for Clinical Research (128) — Stamford, Connecticut, United States
• Children's National Health System (141) — Washington D.C., District of Columbia, United States
• NW Florida Clinical Research Group, LLC (122) — Gulf Breeze, Florida, United States
• Clinical Neuroscience Solutions, Inc. (127) — Jacksonville, Florida, United States
• Axcess Medical Research (126) — Loxahatchee Groves, Florida, United States
• Biotech Pharmaceutical Group (138) — Miami, Florida, United States
• Sanitas Medical and Dental Institute/dba Sanitas Research, LLC (142) — Miami, Florida, 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
• East Florida Research (143) — Port Saint Lucie, Florida, United States
• Pedatric Epilepsy & Neurology Specialists (157) — Tampa, Florida, United States
• Premiere Research Institute @ Palm Beach Neurology, PA (105) — West Palm Beach, Florida, United States
• Clinical Integrative Research Center of Atlanta (121) — Atlanta, Georgia, United States
• NuDirections Clinical Research, LLC (159) — Atlanta, Georgia, United States
• iResearch Atlanta, LLC (146) — Decatur, Georgia, United States
• Meridian Clinical Research, LLC (130) — Savannah, Georgia, United States

Full record on ClinicalTrials.gov

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