Migraine
Conditions
Keywords
Migraine, Headache, Pain, Efficacy, Pediatric
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.
Interventions
DRUGPlacebo ZNS
Placebo Zolmitriptan Nasal Spray
DRUGZNS
Zolmitriptan Nasal Spray
Sponsors
AstraZeneca
Impax Laboratories, LLC
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
A Multicenter, Randomized, Double-blind, Placebo-controlled, Crossover Study
Eligibility
Sex/Gender
ALL
Age
6 Years to 11 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| 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. |
| 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. |
Countries
United States
Outcome results
None listed