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

NCT03275922 | Completed Phase 3 FDA Drug

• 1 other identifier: IPX229-B16-01
• Study Type: interventional
• Target: 374
• Locations: 1 country
• Sites: 47

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.

Conditions

Migraine

Keywords

Migraine; Headache; Pain; Efficacy; Pediatric

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Proportion of subjects who achieve pain-free status at 24 hours post-dose

  24 hours post-dose

• Headache response at 24 hours post-dose

  24 hours post-dose

• Sustained headache response at 24 hours post-dose

  24 hours post-dose

Study Arms (2)

Run-in - ZNS - Placebo - OLE

OTHER

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; Drug: ZNS

Run-in - Placebo - ZNS - OLE

OTHER

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; Drug: ZNS

Interventions

Placebo ZNS DRUG

Placebo Zolmitriptan Nasal Spray

Also known as: Placebo

Run-in - Placebo - ZNS - OLE; Run-in - ZNS - Placebo - OLE

ZNS DRUG

Zolmitriptan Nasal Spray

Run-in - Placebo - ZNS - OLE; Run-in - ZNS - Placebo - OLE

Eligibility Criteria

• Age: 6 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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.

Sponsors & Collaborators

• Impax Laboratories, LLC: lead
• AstraZeneca: collaborator

Study Sites (47)

Phoenix Children's Hospital (149)

Phoenix, Arizona, 85016, United States

Location

Arkansas Children's Hospital (109)

Little Rock, Arkansas, 72202, United States

Location

Advanced Research Center, Inc (134)

Anaheim, California, 92805, United States

Location

Sierra Medical Research (124)

Fresno, California, 17601, United States

Location

Shailesh M. Asaikar, MD. Inc. DBA Child and Adolescent Neurology Consultatns (119)

Sacramento, California, 95815, United States

Location

Children's Hospital Colorado (154)

Aurora, Colorado, 80045, United States

Location

Blue Sky Neurology (106)

Englewood, Colorado, 80113, United States

Location

IMMUNOe Research Centers (150)

Thornton, Colorado, 80233, United States

Location

Ki Health Partners, LLC dba New England INstitute for Clinical Research (128)

Stamford, Connecticut, 06905, United States

Location

Children's National Health System (141)

Washington D.C., District of Columbia, 20010, United States

Location

NW Florida Clinical Research Group, LLC (122)

Gulf Breeze, Florida, 32561, United States

Location

Clinical Neuroscience Solutions, Inc. (127)

Jacksonville, Florida, 32256, United States

Location

Axcess Medical Research (126)

Loxahatchee Groves, Florida, 33470, United States

Location

Biotech Pharmaceutical Group (138)

Miami, Florida, 33155, United States

Location

Sanitas Medical and Dental Institute/dba Sanitas Research, LLC (142)

Miami, Florida, 33155, United States

Location

Laszlo J. Mate, M.D., P.A. (153)

North Palm Beach, Florida, 33408, United States

Location

Clincial Neuroscience Solutions, Inc. (136)

Orlando, Florida, 32801, United States

Location

Pediatric Neurology, PA (125)

Orlando, Florida, 32819, United States

Location

East Florida Research (143)

Port Saint Lucie, Florida, 34983, United States

Location

Pedatric Epilepsy & Neurology Specialists (157)

Tampa, Florida, 17601, United States

Location

Premiere Research Institute @ Palm Beach Neurology, PA (105)

West Palm Beach, Florida, 33407, United States

Location

Clinical Integrative Research Center of Atlanta (121)

Atlanta, Georgia, 30328, United States

Location

NuDirections Clinical Research, LLC (159)

Atlanta, Georgia, 30350, United States

Location

iResearch Atlanta, LLC (146)

Decatur, Georgia, 30030, United States

Location

Meridian Clinical Research, LLC (130)

Savannah, Georgia, 31406, United States

Location

Josephson Wallack Munshower Neurology P.C. (114)

Indianapolis, Indiana, 46256, United States

Location

Kosair Charities Pediatric Clinical Research Unit (120)

Louisville, Kentucky, 40202, United States

Location

Michigan Head-Pain and Neurological Institute (103)

Ann Arbor, Michigan, 48104, United States

Location

Mercy Research (116)

St Louis, Missouri, 63141, United States

Location

Clinical Research Center of NJ (123)

Voorhees Township, New Jersey, 08043, United States

Location

Dent Neurosciences Research Center (129)

Amherst, New York, 14226, United States

Location

OnSite Clinical Solutions, LLC (155)

Charlotte, North Carolina, 28277, United States

Location

Headache Wellness Center (Site 152)

Greensboro, North Carolina, 27405, United States

Location

Raleigh Neurology Associates, PA (113)

Raleigh, North Carolina, 27607, United States

Location

Akron Children's Hospital (site 139)

Akron, Ohio, 44308, United States

Location

Cincinnati Children's Hospital (140)

Cincinnati, Ohio, 45229, United States

Location

Preferred Primary Care Physicians, Inc. (115)

Pittsburgh, Pennsylvania, 15236, United States

Location

Access Clinical Trials, Inc. (151)

Nashville, Tennessee, 37203, United States

Location

Texas Neurology, P.A. (110)

Dallas, Texas, 75214, United States

Location

Children's Medical Center Dallas (147)

Dallas, Texas, 75235, United States

Location

J. Lewis Research Inc. Foothill Family Clinic (107)

Salt Lake City, Utah, 84109, United States

Location

Primary Children's Hospital Outpatient Services (117)

Salt Lake City, Utah, 84113, United States

Location

Granger Medical Holladay (111)

Salt Lake City, Utah, 84117, United States

Location

Pediatric Research of Charlottesville, LLC (104)

Charlottesville, Virginia, 22902, United States

Location

Northwest Clinical Research Center (132)

Bellevue, Washington, 98007, United States

Location

Multicare Health System- Mary Bridge Pediatrics- Tacoma (158)

Tacoma, Washington, 98405, United States

Location

Marshfield Clinic (145)

Marshfield, Wisconsin, 54449, United States

Location

MeSH Terms

Conditions

Migraine Disorders; Headache; Pain

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Impax Study Director

  Impax Laboratories, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A Multicenter, Randomized, Double-blind, Placebo-controlled, Crossover Study

Study Record Dates

• First Submitted: September 6, 2017
• First Posted: September 8, 2017
• Study Start: November 27, 2017
• Primary Completion: July 2, 2020
• Study Completion: September 28, 2020
• Last Updated: January 11, 2021

Record last verified: 2020-07

Locations

US (47)