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| ID | Type | Description | Link |
|---|---|---|---|
| C4951009 | Other Identifier | Alias Study Number | |
| 2021-005246-15 | EudraCT Number | CTIS (EU) | |
| 2021-005246-15 | Registry Identifier | CTIS (EU) | |
| 2024-512382-13-00 | Registry Identifier | CTIS (EU) |
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The purpose of this study is to compare the efficacy and safety of rimegepant to placebo as a preventative treatment for migraine in children and adolescents ≥ 6 to <18 years with episodic migraine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rimegepant / BHV3000 | Active Comparator | Rimegepant 75mg or 50mg (2 X 25mg) ODT |
|
| Matching Placebo | Placebo Comparator | Matching placebo 75mg or 50mg (2 X 25mg) ODT |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rimegepant | Drug | Rimegepant 75mg or 50mg (2 X 25mg) ODT |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in the mean number of migraine days per month as measured over the 12-week double-blind phase of the study in adolescents with episodic migraine | Reduction from baseline in mean number of migraine days per month | 3 months (12 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Achievement of at least a 50% reduction from baseline in mean monthly migraine days over the course of the double-blind phase in adolescents with episodic migraine | 3 months (12 weeks) | |
| Change from baseline in the mean number of migraine days per month in the first 4 weeks (Weeks 1 through 4) of the double-blind treatment phase in adolescents with episodic migraine. |
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Inclusion Criteria:
Subject has at least a 6 month history of migraine (with or without aura) and including the following:
14 or less headache days per month during the 3 month period prior to the Screening Visit
6 or more migraine days during the Observation Period
14 or less headache days during the Observation Period
Pediatric Migraine Disability Assessment Scale (PedMIDAS) Disability Score of >10 to ≤50, indicating mild (score of 11 to 30) or moderate (score of 31 to 50) disruption in daily activities, as assessed at the Baseline (Randomization) Visit
Ability to verbally distinguish migraine attacks from tension/cluster or other types of headaches
Migraine attacks, on average, lasting 4 - 72 hours if untreated
Subjects on prophylactic migraine medication are permitted to remain on therapy if the dose has been stable for at least 3 months (12 weeks) prior to the Screening Phase, and the dose is not expected to change during the course of the study. 2) Male and female subjects ≥ 6 to <18 years; subjects must be less than 18 at the time of signing assent / consent.
3)Subjects must have a weight of ≥40 kg (child cohort requirement ≥15 kg) at the Screening Visit.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pfizer Pfizer CT.gov Call Center | Contact | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Belinga Clinic | Active, not recruiting | Fort Smith | Arkansas | 72901 | United States | |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41235617 | Derived | Shin L, Mentz O, Gelfand AA, de Prado BM, Shapiro H, Oh A, Onifade OO, Saunders J, Raj N, Szperka CL. Gepants for headache prevention in children and adolescents: A multicenter chart review study. Headache. 2026 Jan;66(1):239-248. doi: 10.1111/head.15087. Epub 2025 Nov 14. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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| Placebo | Drug | Matching placebo 75mg or 50mg (2 X 25mg) ODT |
|
|
| Weeks 1 through 4 of treatment |
| The mean change from baseline in the Pediatric Quality of Life (PedsQL™) total score at Week 12 of the double-blind treatment phase in adolescents with episodic migraine. | Total score at week 12 |
| Change from baseline in the mean number of migraine days per month over the entire course of the double-blind treatment phase in children and children and adolescents combined with episodic migraine. | 3 months (12 weeks) |
| Change from baseline on the proportion of subjects that have at least a 50% reduction in the mean number of moderate to severe migraine days per month. | Measured over the entire course of the double-blind treatment phase in children and children and adolescents combined with episodic migraine. | 3 months (12 weeks) |
| Compare the use of acute migraine-specific medications (triptans) based on the change from baseline in monthly acute migraine specific medication days. | Measured in each month and over the course of the entire double-blind treatment phase in adolescents, children and adolescents and children combined. | 3 months (12 weeks) |
| Evaluate the safety and tolerability of rimegepant as a preventative treatment for migraine in children and adolescents. | This will be evaluated by the number of subjects with treatment related adverse events by severity. | 72 Weeks |
| Evaluate the frequency of hepatic-related adverse events in subjects treated with rimegepant. | Measured by discontinuations in treated subjects due to elevated liver function tests. | 72 Weeks |
| Advanced Investigative Medicine, Inc. |
| Recruiting |
| Hawthorne |
| California |
| 90250 |
| United States |
| Velocity Clinical Research San Diego | Active, not recruiting | La Mesa | California | 91942 | United States |
| Colorado Springs Neurological Associates | Active, not recruiting | Colorado Springs | Colorado | 80907 | United States |
| Advanced Neurosciences Research, LLC | Terminated | Fort Collins | Colorado | 80528 | United States |
| Velocity Clinical Research, Washington DC | Recruiting | Washington D.C. | District of Columbia | 20016 | United States |
| Accel Research Sites Network - Edgewater Clinical Research Unit | Active, not recruiting | Edgewater | Florida | 32132 | United States |
| Direct Helpers Research Center | Recruiting | Hialeah | Florida | 33012 | United States |
| New Med Research, Inc | Terminated | Hollywood | Florida | 33020 | United States |
| Complete Health Research | Active, not recruiting | Ormond Beach | Florida | 32174 | United States |
| D&H Tamarac Research Center LLC | Recruiting | Tamarac | Florida | 33321 | United States |
| Santos Research Center, CORP | Recruiting | Tampa | Florida | 33615 | United States |
| Augusta University | Recruiting | Augusta | Georgia | 30912 | United States |
| WR-Mount Vernon Clinical Research, LLC | Active, not recruiting | Sandy Springs | Georgia | 30328 | United States |
| Meridian Clinical Research, LLC | Active, not recruiting | Savannah | Georgia | 31406 | United States |
| Extraordinary Family Healthcare | Active, not recruiting | Snellville | Georgia | 30078 | United States |
| Renew Health Clinical Research LLC | Active, not recruiting | Snellville | Georgia | 30078 | United States |
| Northwest Clinical Trials, Inc. | Recruiting | Boise | Idaho | 83704 | United States |
| Diamond Headache Clinic | Terminated | Chicago | Illinois | 60642 | United States |
| Nola Research Works, LLC | Recruiting | New Orleans | Louisiana | 70125 | United States |
| Safe Haven Clinical Research | Recruiting | Clinton | Mississippi | 39056 | United States |
| Roy Blunt NextGen Precision Health Building | Recruiting | Columbia | Missouri | 65211 | United States |
| University of Missouri Health Care - Investigation Pharmacy | Recruiting | Columbia | Missouri | 65212 | United States |
| University of Missouri-Clinical and Translational Sciences Unit | Recruiting | Columbia | Missouri | 65212 | United States |
| University of Missouri | Recruiting | Columbia | Missouri | 65212 | United States |
| Velocity Clinical Research, Grand Island | Recruiting | Grand Island | Nebraska | 68803 | United States |
| Papillion Research Center/CCT Research | Recruiting | Papillion | Nebraska | 68046 | United States |
| Renown Regional Medical Center | Active, not recruiting | Reno | Nevada | 89502 | United States |
| Dent Neurosciences Research Center, Inc. | Active, not recruiting | Amherst | New York | 14226 | United States |
| Montefiore Medical Center | Recruiting | The Bronx | New York | 10461 | United States |
| Carolina Institute for Clinical Research, LLC | Active, not recruiting | Fayetteville | North Carolina | 28303 | United States |
| Cincinnati Children's Hospital Medical Center | Recruiting | Cincinnati | Ohio | 45229 | United States |
| Velocity Clinical Research | Active, not recruiting | Cincinnati | Ohio | 45242 | United States |
| Lynn Health Science Institute | Active, not recruiting | Oklahoma City | Oklahoma | 73112 | United States |
| Coastal Pediatric Research | Active, not recruiting | Charleston | South Carolina | 29414 | United States |
| Tribe Clinical Research LLC | Terminated | Greenville | South Carolina | 29607 | United States |
| Avera McKennan Hospital & University Health Center | Recruiting | Sioux Falls | South Dakota | 57105 | United States |
| Avera Research Institute | Recruiting | Sioux Falls | South Dakota | 57108 | United States |
| Avera Medical Group Pediatrics - Dawley Farm | Recruiting | Sioux Falls | South Dakota | 57110 | United States |
| Monroe Carell Jr Children's Hospital at Vanderbilt | Terminated | Nashville | Tennessee | 37232 | United States |
| Alina Clinical Trials, LLC. | Recruiting | Dallas | Texas | 75209 | United States |
| North Texas Center for Clinical Research | Recruiting | Frisco | Texas | 75034 | United States |
| DM Clinical Research - Cy Fair | Recruiting | Houston | Texas | 77065 | United States |
| SCLA Management - Drop Box | Recruiting | Houston | Texas | 77077 | United States |
| SCLA Management Office | Recruiting | Houston | Texas | 77077 | United States |
| NeuroCare Plus | Recruiting | Houston | Texas | 77094 | United States |
| Red Star Research, LLC | Active, not recruiting | Lake Jackson | Texas | 77566 | United States |
| DCT-McAllen Primary Care Research, LLC dba Discovery Clinical Trials | Recruiting | McAllen | Texas | 78503 | United States |
| DCT-Stone Oak, LLC dba Discovery Clinical Trials | Recruiting | San Antonio | Texas | 78258 | United States |
| Texas Institute for Neurological Disorders | Active, not recruiting | Sherman | Texas | 75092 | United States |
| DM Clinical Research (Administrative Office Only) | Recruiting | Tomball | Texas | 77375 | United States |
| Victoria Clinical Research Group | Terminated | Victoria | Texas | 77901 | United States |
| Meridian Clinical Research, LLC | Active, not recruiting | Portsmouth | Virginia | 23703 | United States |
| Children's and Women's Health Centre of British Columbia | Terminated | Vancouver | British Columbia | V6H 3V4 | Canada |
| Centre Hospitalier Intercommunal de Creteil | Recruiting | Créteil | 94000 | France |
| Centre Hospitalier Universitaire de Montpellier | Active, not recruiting | Montpellier | 34295 | France |
| Hopital des Enfants | Recruiting | Toulouse | 31059 | France |
| UOSVD Centro Epilessia ed EEG dellEta Evolutiva | Recruiting | Bari | BARI / Puglia | 70132 | Italy |
| Sapienza Universita di Roma Polo Pontino - ICOT, Headache clinic | Recruiting | Latina | Latina/lazio | 04100 | Italy |
| IRCCS San Raffaele | Recruiting | Rome | Lazio | 00166 | Italy |
| Istituto Neurologico "Carlo Besta" Fondazione IRCCS | Recruiting | Milan | Lombardy | 20133 | Italy |
| Divisione di Neurologia, Ospedale Pediatrico Bambino Gesu | Recruiting | Rome | Rome/lazio | 00165 | Italy |
| ASST Spedali Civili di Brescia | Recruiting | Brescia | 25069 | Italy |
| Jinnouchi Neurosurgical Clinic | Recruiting | Kasuga-shi | Fukuoka | 816-0802 | Japan |
| Hikita Pediatric Clinic | Recruiting | Kiryu-shi | Gunma | 376-0035 | Japan |
| Konan Medical Center | Recruiting | Higashinada-ku Kobe-shi | Hyōgo | 658-0064 | Japan |
| Yamaguchi Clinic | Recruiting | Nishinomiya-shi | Hyōgo | 663-8204 | Japan |
| Mito Kyodo General Hospital | Not yet recruiting | Mito | Ibaraki | 310-0015 | Japan |
| Tanaka Neurosurgery & Headache Clinic | Recruiting | Kagoshima | Kagoshima-ken | 890-0052 | Japan |
| Atago Hospital | Recruiting | Kochi | Kochi | 780-0051 | Japan |
| Sendai Headache and Neurology Clinic | Recruiting | Taihaku-ku Sendai-shi | Miyagi | 982-0014 | Japan |
| Tennouji Dai Brain Clinic | Recruiting | Abeno-ku Osaka-shi | Osaka | 545-0053 | Japan |
| Tominaga Clinic | Recruiting | Naniwa-ku | Osaka | 556-0015 | Japan |
| Saitama Neuropsychiatric Institute | Recruiting | Chuo-ku Saitama-shi | Saitama | 338-8577 | Japan |
| Tokyo Headache Clinic | Recruiting | Shibuya-ku | Tokyo | 151-0051 | Japan |
| Tokyo Medical University Hospital | Recruiting | Shinjuku-ku | Tokyo | 160-0023 | Japan |
| Clinical Research Center Sp. z o.o. MEDIC-R Sp. k. | Recruiting | Poznan | Greater Poland Voivodeship | 61-731 | Poland |
| Wojewodzki Specjalistyczny Szpital Dzieciecy | Recruiting | Krakow | Lesser Poland Voivodeship | 31-503 | Poland |
| MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak | Recruiting | Wroclaw | Lower Silesian Voivodeship | 52-210 | Poland |
| NZOZ Neuromed M. i M. Nastaj Sp. P. | Recruiting | Lublin | Lublin Voivodeship | 20-064 | Poland |
| MTZ Clinical Research Powered by Pratia | Terminated | Warsaw | Masovian Voivodeship | 02-172 | Poland |
| NZOZ Wielospecjalistyczna Poradnia Lekarska SYNAPSIS | Active, not recruiting | Katowice | Silesian Voivodeship | 40-123 | Poland |
| Neurologia Slaska Centrum Medyczne | Recruiting | Katowice | Silesian Voivodeship | 40-689 | Poland |
| Next Stage Sp. Z o.o. | Recruiting | Warsaw | WOJ. Mazowieckie | 02-121 | Poland |
| Hospital Universitari Parc Tauli | Recruiting | Sabadell | Barcelona | 08208 | Spain |
| Hospital Clinico Universitario de Valladolid (HCUV) | Recruiting | Valladolid | Castille and León | 47003 | Spain |
| Hospital Alvaro Cunqueiro | Recruiting | Vigo | Galicia | 36312 | Spain |
| Instituto de Investigaciones del Sueno | Recruiting | Madrid | 28036 | Spain |
| Virgen del Rocio Hospital | Recruiting | Seville | 41013 | Spain |
| Hospital Universitario y Politecnico La Fe | Recruiting | Valencia | 46026 | Spain |
| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| D012001 | Hyperacusis |
| D020795 | Photophobia |
| D009325 | Nausea |
| ID | Term |
|---|---|
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014786 | Vision Disorders |
| D005128 | Eye Diseases |
| D012817 | Signs and Symptoms, Digestive |
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| ID | Term |
|---|---|
| C578443 | rimegepant sulfate |
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