Clinical trial NCT04748601: Qudexy XR for the Prevention of Migraine in Children 6 to 11 Years Old
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 4 Study to Evaluate the Efficacy and Safety of Qudexy(R) XR in the Prevention of Migraine in Children 6 to 11 Years of Age
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Migraine Disorders
Lead sponsor: Upsher-Smith Laboratories
Sponsor class: INDUSTRY
First posted: 2021-02-10
Enrollment: 132
Sex: ALL
Minimum age (years): 6
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel Group Study
Primary purpose: TREATMENT

Brief summary: A Phase 4 study to evaluate Qudexy XR for the prevention of migraine in children 6 to 11 years of age.


Eligibility criteria: Inclusion Criteria:

1. Subject is a female or male 6 to 11 years of age, inclusive, at Visit 1 (Screening)
2. Subject weighs at least 17.0 kg and less than 50.0 kg at Visit 1 (Screening) based on 95 percentile weight for the age range.11
3. Subject has at least a 6-month history of headaches consistent with a diagnosis of migraine with or without aura (International Classification of Headache Disorders, 3rd Edition \[ICHD 3\]).
4. Subject had ≥8 self-reported headache days in the 28 days prior to Screening.
5. Subject has a PedMIDAS score \>10, indicating at least mild disruption in daily activities, and \<140, indicating extreme disability that may require more comprehensive, multi component therapy.

Exclusion Criteria:

1. Subject has continuous migraines, defined as an unrelenting headache for a 28-day period.
2. Subject is currently receiving treatment or has used Botulinum toxin (Botox®) within 3 months prior to Visit 1 (Screening).
3. Subject is currently receiving migraine prevention medication and has initiated or changed the dose within 28 days of Screening or is unwilling to avoid making a change during the duration of the study.
4. Subject has previously failed an adequate trial of topiramate (at least 3 months duration at a clinically appropriate dose) for prophylaxis of migraine headache due to lack of efficacy or AEs.
5. Subject has previously failed an adequate trial of \>3 migraine preventative medications.
6. Subject has a known history of allergic reaction to topiramate or any excipient in Qudexy XR.
7. Subject has a diagnosis or history of disease that may interfere with safety or evaluation of the study drug.
8. Subject is currently using an investigational drug or device or has used such within 30 days prior to Visit 1.
9. Subject has begun menses and any of the following:

   1. Subject has tested positive for pregnancy; OR
   2. Subject is pregnant, planning pregnancy, or lactating; OR
   3. 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.

Primary outcomes:
measure: Change from Baseline (last 28 days Run-In Period) in the monthly number of headache days during the 8-week Maintenance Period based on the diary.
timeFrame: 16 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Upsher-Smith Clinical Trial Site #5
state: Alabama
city: La Jolla
country: United States
facility: Upsher-Smith Clinical Trial Site #15
state: California
city: Aurora
country: United States
facility: Upsher-Smith Clinical Trials Site #3
state: Colorado
city: Stamford
country: United States
facility: Upsher-Smith Clinical Trial Site #1
state: Connecticut
city: Loxahatchee Groves
country: United States
facility: Upsher-Smith Clinical Trial Site #12
state: Florida
city: Orlando
country: United States
facility: Upsher-Smith Clinical Trial Site #8
state: Florida
city: Tampa
country: United States
facility: Upsher-Smith Clinical Trial Site #14
state: Florida
city: Ann Arbor
country: United States
facility: Upsher-Smith Clinical Trial Site #2
state: Michigan
city: Jackson
country: United States
facility: Upsher-Smith Clinical Trial Site #11
state: Mississippi
city: Bridgeton
country: United States
facility: Upsher-Smith Clinical Trial Site #10
state: Missouri
city: Cincinnati
country: United States
facility: Upsher-Smith Clinical Trial Site #4
state: Ohio
city: Portland
country: United States
facility: Upsher-Smith Clinical Trial Site #6
state: Oregon
city: Springfield
country: United States
facility: Upsher-Smith Clinical Trials Site #7
state: Oregon
city: McAllen
country: United States
facility: Upsher-Smith Clinical Trial Site #13
state: Texas
city: Huntington
country: United States
facility: Upsher-Smith Clinical Trial Site #9
state: West Virginia
Study officials:
References: