A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 4 Study to Evaluate the Efficacy and Safety of Qudexy® XR in the Prevention of Migraine in Children 6 to 11 Years of Age

About this Study

To evaluate the efficacy and safety of Qudexy XR compared to placebo for the prevention of migraine in children 6 to 11 years of age.

Sponsor Protocol ID:P255-501
IRB Number:2020V0230
Pending Activation
Interventional
Phase 4
December 21, 2020
Eligibility Criteria
6 years old
11 years old
Both Male and Female
No
Yes
No

Inclusion Criteria1.  Subject is a female or male 6 to 11 years of age

2.  Subject weighs at least 17.0 kg and less than 50.0 kg at Visit 1

Exclusion Criteria1.  Subject has continuous migraines, defined as an unrelenting headache for a 28-day period.

2.  History of metabolic conditions (eg, diabetes), that may interfere with safety of subject and/or evaluation of migraines

3.  History of kidney stones.

4.  History over subject lifetime of any suicidal attempts.

5.  Subject has begun menses and any of the following: 

a) Subject has tested positive for pregnancy; OR

 b) Subject is pregnant, planning pregnancy, or lactating; OR 

c) Subject is taking an oral hormonal contraceptive (either combined [estrogen and progestogen containing] or progestogen-only) and is unable or unwilling to switch to an alternative highly effective contraceptive method