Ten percent of school age children have migraine, and it can be associated with significant functional disability, such as missing school, sports, social and family time. Girls and boys have about the same incidence of migraine until puberty, when it increases in girls and remains stable or decreases in boys. Non-pharmacologic tenants of good migraine management include adequate sleep, proper hydration, exercise, health foods, and learning how to manage stress. Non-pharmacologic interventions at our center include education in diet, sleep hygiene, exercise and stress management, biofeedback, cognitive-behavioral therapy, physical therapy and massage.
Some migraines, however, simply require medicines. While over-the-counter analgesics like Ibuprofen may help a low-level headache, true migraine often needs better, more specific therapy. While we have a number of good options for adults, there are not that many migraine-specific treatment choices for children and adolescents. Our pediatric migraine research program aims to change that, and bring safe, effective and well-tolerated pediatric migraine treatments to the market. Our current and upcoming studies include:
- AbbVie 305/306
This combined study aims to evaluate the efficacy, safety, and tolerability of oral ubrogepant for the acute treatment of migraine with or without aura in children and adolescents aged 6 to 17 years. Conducted by AbbVie Inc., the research includes two phases: a Phase 3, multicenter, randomized, double-blind, placebo-controlled, single-attack study (3110-305-002) and an open-label extension study (3110-306-002). The primary objective is to assess pain freedom at 2 hours post-dose, with secondary endpoints including pain relief, sustained pain freedom, and the absence of the most bothersome migraine-associated symptom. The study involves a screening period with a single-blind placebo lead-in, followed by randomization to either low or high doses of ubrogepant or placebo. Participants aged 12 to 17 receive 50 mg or 100 mg doses, while those aged 6 to 11 receive 25 mg or 50 mg doses. Safety assessments include adverse events, clinical laboratory tests, ECGs, vital signs, and the Columbia-Suicide Severity Rating Scale. An optional pharmacokinetic (PK) substudy collects blood samples to analyze drug absorption and metabolism. Additionally, an optional biomarker collection substudy gathers blood and urine samples for exploratory analysis. The study aims to provide new treatment options for pediatric migraine, focusing on both immediate and long-term safety and efficacy. An independent Data Safety and Monitoring Board (DSMB) oversees the study to ensure participant safety and data integrity. This comprehensive approach seeks to expand migraine treatment options for children and adolescents, addressing a significant unmet medical need.
Lundbeck 19356A/Lundbeck 19379A
This study is designed to evaluate the efficacy and safety of IV eptinezumab in adolescents
(12-17 years) for the preventive treatment of chronic migraine. Eptinezumab is an
intravenous infusion that is FDA approved for the treatment of chronic migraine in adults.
The aim of this study is for the medication to become FDA-approved for adolescent chronic
migraine as well. Eptinezumab works by inhibiting the release of a chemical in the brain
that is released during migraine attacks. This study includes a single 30-minute IV infusion
of either Eptinezumab or the placebo, comprised of a 4-week screening period, a 12-week
treatment period, and an 8-week wash-out period (no treatment). If eligible, participants
will be able to take part in the open-label extension study where they will receive a total of
three guaranteed eptinezumab infusions over the course of 44 weeks (about 10 months).
The study objective is to ultimately expand treatment options for chronic migraine in
pediatric patients.
Learn more (initial): https://classic.clinicaltrials.gov/ct2/show/NCT04965675
Learn more (extension):
https://clinicaltrials.gov/study/NCT05164172?locStr=Stamford,%20CT&country=United%2
0States&state=Connecticut&city=Stamford&aggFilters=ages:child&rank=6
Lundbeck 19357A/19379A
This study is designed to evaluate the efficacy and safety of intravenous (IV) eptinezumab
for preventive treatment of episodic migraine in pediatric patients aged 6 to 17 years. IV
eptinezumab is approved by the FDA for the preventative treatment of episodic migraine in
adults. The aim of this study is to get the medication approved for pediatric migrainesufferers as well. Eptinezumab works by inhibiting the release of a chemical in the brain that is released during migraine attacks. This study includes a single 30-minute IV infusion of either Eptinezumab or the placebo, comprised of a 4-week screening period, a 12-week treatment period, and an 8-week wash-out period (no treatment). If eligible, participants will be able to take part in the open-label extension study where they will receive a total of three guaranteed eptinezumab infusions over the course of 44 weeks (about 10 months).
The study objective is to ultimately expand treatment options for episodic migraine in
pediatric patients.
Learn more (initial): https://classic.clinicaltrials.gov/ct2/show/NCT05897320
Learn more (extension):
https://clinicaltrials.gov/study/NCT05164172?locStr=Stamford,%20CT&country=United%2
0States&state=Connecticut&city=Stamford&aggFilters=ages:child&rank=6
Amgen 20150125 + Open-Label Extension
The objective of this study is to evaluate the efficacy and safety of Erenumab, also
commonly known as Aimovig, in children aged 6 to 11 and adolescents aged 12 to 17 with
episodic migraine. Many treatments currently used are approved for adults, so the aim of
this study is to expand treatment options for children and adolescent episodic migrainesufferers as well. Erenumab works to block the receptor of a chemical that is released by the brain during migraine attacks. Participants will be administered either the medication or the placebo monthly as a subcutaneous (under the skin) injection for 24 weeks (6 injections). The participant has the option to roll over into the open-label extension study where they receive definite study medication for up to 40 weeks (10 injections).
Learn more: https://classic.clinicaltrials.gov/ct2/show/NCT03836040
All studies at NEICR are available at no cost to you, and there may be compensation for time and travel. Participation is completely voluntary, and you may withdraw at any time. To find out more about any of our studies, give us a call at 203-914-1903 or fill out the form below.