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

Phase 3

Completed

• Conditions: Migraine
• Interventions: Drug: Placebo ZNS; Drug: ZNS

• Registration Number: NCT03275922
• Lead Sponsor: Impax Laboratories, LLC

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-09-06
• Study First Submitted QC: 2017-09-06
• Study First Posted: 2017-09-08
• Study Start: 2017-11-27
• Status Verified: 2020-07
• Primary Completion: 2020-07-02
• Study Completion: 2020-09-28
• Last Update Submitted: 2021-01-08
• Last Update Posted: 2021-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 374

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Run-in - Placebo - ZNS - OLE	Placebo ZNS	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).
Run-in - ZNS - Placebo - OLE	Placebo ZNS	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).
Run-in - ZNS - Placebo - OLE	ZNS	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).
Run-in - Placebo - ZNS - OLE	ZNS	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).

Primary Outcome Measures

Name	Time	Method
Pain-free status at 2 hours post treatment	2 hours post-dose	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).

Secondary Outcome Measures

Name	Time	Method
Proportion of subjects who achieve pain-free status at 24 hours post-dose	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).
Sustained headache response at 24 hours post-dose	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.
Headache response at 24 hours post-dose	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.

Trial Locations

Locations (47)

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, District of Columbia, United States

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