Episodic Migraine Clinical Trial
— PROSPECT-1Official title:
Interventional, Randomised, Double-blind, Parallel-group, Placebo-controlled Study to Evaluate the Efficacy and Safety of Intravenous (IV) Eptinezumab in Paediatric Patients (6 to 17 Years) for the Preventive Treatment of Episodic Migraine
The main goal of this trial is to learn whether eptinezumab helps reduce the number of days with episodic migraine in pediatric participants.
Status | Recruiting |
Enrollment | 315 |
Est. completion date | October 31, 2024 |
Est. primary completion date | October 31, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 6 Years to 17 Years |
Eligibility | Inclusion Criteria: - Diagnosis of migraine (with or without aura) according to the International Classification of Headache Disorders, 3rd edition (ICHD-3; in the opinion of the investigator) with history of migraine headaches of at least 6 months prior to the Screening Visit. - During the 28-day screening period, the participant (and their parent/caregiver, when applicable) must adequately complete the headache eDiary (=23 of the 28 days) following the day of the Screening Visit. - During the 28-day screening period, the participant must have =14 headache days, of which at least 4 are migraine days as documented in the eDiary. Exclusion Criteria: - History or diagnosis of chronic tension-type headache, hypnic headache, cluster headache, hemicrania continua, new daily persistent headache, or unusual migraine subtypes (previously referred to as complicated migraine), such as hemiplegic migraine (sporadic and familial), migraine with brainstem aura, recurrent painful ophthalmic neuropathy, or migraine with neurological accompaniments that are not typical of migraine aura (diplopia, altered consciousness, or long duration, e.g., >60 min). - History of moderate or severe head trauma or other neurological disorder or systemic medical disease that is, in the investigator's opinion, likely to affect the functions of the central nervous system. - Current psychiatric condition that is uncontrolled and/or untreated for a minimum of 6 months prior to the Screening Visit. Participants with a lifetime history of psychosis and/or mania are excluded. - Any other disorder for which the treatment takes priority over treatment of migraine or is likely to interfere with study treatment or impair treatment compliance. Other inclusion and exclusion criteria may apply. |
Country | Name | City | State |
---|---|---|---|
Argentina | Hospital Britanico de Buenos Aires | Barracas | Ciudad Autonoma De BuenosAires |
Argentina | Expertia S.A- Mautalen Salud e Investigacion | Ciudad Autonoma de Buenos Aires | Ciudad Autonoma De BuenosAires |
Argentina | Instituto Médico Río Cuarto | Río Cuarto | Cordoba |
Argentina | INECO Neurociencias Orono | Rosario | Santa Fe |
Argentina | Centro de Investigaciones Médicas Tucuman - PPDS | San Miguel de Tucuman | Tucuman |
Canada | The Kids Clinic | Ajax | Ontario |
Canada | Medical Arts Health Research Group - Penticton | Penticton | British Columbia |
Canada | Vancouver Island Health Authority | Victoria | British Columbia |
Italy | Azienda Ospedaliero Universitaria A Meyer - INCIPIT - PIN | Firenze | Toscana |
Italy | Istituto G Gaslini Ospedale Pediatrico IRCCS | Genova | Liguria |
Italy | Fondazione IRCCS Di Rilievo Nazionale Istituto Nazionale Neurologico Carlo Besta-VIA MANGIAGALLI 3 | Milano | Lombardia |
Italy | Ospedale San Raffaele S.r.l. - PPDS | Milano | Lombardia |
Italy | Fondazione Istituto Neurologico Nazionale Casimiro Mondino IRCCS | Pavia | Lombardia |
Italy | Azienda Ospedaliero Universitaria Pisana - Stabilimento Santa Chiara | Pisa | Toscana |
Italy | Ospedale Pediatrico Bambino Gesù IRCCS | Roma | Lazio |
Portugal | Centro Clínico Académico, Braga - Hospital de Braga | Braga | |
Portugal | ULS de Coimbra, EPE - Hospital Pediatrico de Coimbra | Coimbra | |
Portugal | Hospital CUF Descobertas | Lisboa | |
Portugal | ULS de Santo Antonio, EPE - Centro Materno Infantil Norte | Porto Covo | Setúbal |
Serbia | Childrens University Hospital | Belgrade | |
Serbia | University Clinical Center Kragujevac | Kragujevac | |
Serbia | University Clinical Center Nis | Nis | |
Serbia | Clinical Centre of Vojvodina | Novi Sad | |
Spain | Hospital Universitario Vall d'Hebron - PPDS | Barcelona | |
Spain | Hospital Clinico San Carlos | Madrid | |
Spain | Hospital Universitari i Politecnic La Fe de Valencia | Valencia | |
Spain | CHUVI - H.U. Alvaro Cunqueiro | Vigo | Pontevedra |
United Kingdom | Royal Hospital for Children (Glasgow) - PPDS - PIN | Glasgow | Glasgow City |
United Kingdom | James Paget University Hospitals NHS Foundation Trust | Great Yarmouth | Norfolk |
United States | Childrens Hospital Medical Center of Akron | Akron | Ohio |
United States | Michigan Head Pain and Neurological Institute | Ann Arbor | Michigan |
United States | University of Maryland School of Medicine | Baltimore | Maryland |
United States | OnSite Clinical Solutions, LLC - Randolph Rd - Charlotte - ClinEdge - PPDS | Charlotte | North Carolina |
United States | Cincinnati Children's Hospital Medical Center - PIN | Cincinnati | Ohio |
United States | North Suffolk Neurology-Commack | Commack | New York |
United States | Child Neurology of NW Florida | Gulf Breeze | Florida |
United States | A G A Clinical Trials - HyperCore - PPDS | Hialeah | Florida |
United States | Children's Specialty Group - 3 Commercial Place | Norfolk | Virginia |
United States | Road Runner Research Ltd | San Antonio | Texas |
United States | Ki Health Partners LLC DBA New England Institute for Clinical Research | Stamford | Connecticut |
United States | University of South Florida | Tampa | Florida |
Lead Sponsor | Collaborator |
---|---|
H. Lundbeck A/S |
United States, Argentina, Canada, Italy, Portugal, Serbia, Spain, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change From Baseline in the Number of Monthly Migraine Days (MMDs) Averaged Over Weeks 1-12 | Baseline, Weeks 1-12 | ||
Secondary | Response: =50% Reduction From Baseline in MMDs | Baseline, Weeks 1-4 and Weeks 1-12 | ||
Secondary | Percentage of Participants with Migraine on the Day After Dosing (Day 1) | On Day After Dosing | ||
Secondary | Change From Baseline in MMDs with Acute Medication Use | Baseline, Weeks 1-12 | ||
Secondary | Response: =75% reduction from baseline in MMDs | Baseline, Weeks 1-4 and Weeks 1-12 | ||
Secondary | Change From Baseline in the Number of Monthly Headache Days (MHDs) | Baseline, Weeks 1-12 | ||
Secondary | Change From Baseline in Monthly Hours with Headache | Baseline, Weeks 1-12 | ||
Secondary | Change From Baseline in Days with Acute Medication | Baseline, Weeks 1-12 | ||
Secondary | Change From Baseline in Rate of Migraines with Severe Pain Intensity | Baseline, Weeks 1-12 | ||
Secondary | Change From Baseline to Week 12 in Pediatric Migraine Disability Assessment (PedMIDAS) Score | Baseline, Week 12 | ||
Secondary | Free Eptinezumab Plasma Concentrations | Day 0 (pre-dose) and at Weeks 8, 12, and 20 | ||
Secondary | Number of Participants With Specific Anti-eptinezumab Antibodies (Anti-Drug Antibodies [ADA]) | Day 0 (pre-dose) and at Weeks 8, 12, and 20 | ||
Secondary | Number of Participants With Specific ADA-Positive Samples for Neutralizing Antibodies (NAb) | Day 0 (pre-dose) and at Weeks 8, 12, and 20 |
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