Rimegepant for Pediatric Migraine
Recruiting in Palo Alto (17 mi)
+389 other locations
Age: < 18
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: Pfizer
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?The purpose of this study is to test the safety and efficacy of BHV-3000 versus placebo in the acute treatment of moderate or severe migraine in children and adolescents.
Do I need to stop my current medications to join the trial?The trial allows you to stay on one stable prophylactic migraine medication, as long as it's not a CGRP antagonist. If you were taking a prophylactic migraine medication that you stopped, it must have been discontinued at least 90 days before the screening. The protocol does not specify about other medications, so it's best to discuss with the trial team.
Is the drug Rimegepant/BHV3000 a promising treatment for pediatric migraine?The information provided does not specifically mention Rimegepant/BHV3000, so we cannot determine if it is a promising treatment for pediatric migraine based on the given articles.12345
What safety data is available for Rimegepant in treating migraines?Rimegepant has been evaluated in several studies for its safety in treating migraines. It was well tolerated in phase II and III trials, with adverse events being mild or moderate and not leading to trial discontinuation. It received FDA approval for acute migraine treatment in 2020. Ongoing trials are assessing its long-term safety and efficacy for other conditions. Additionally, a study on subjects with hepatic impairment showed that Rimegepant was safe across different levels of liver function.6781011
What data supports the idea that Rimegepant for Pediatric Migraine is an effective drug?The available research shows that Rimegepant is effective in treating migraines. It has been shown to provide pain relief and help with migraine symptoms, with effects lasting up to 48 hours. It was well tolerated, meaning most people didn't have serious side effects. Compared to other treatments like erenumab and galcanezumab, Rimegepant also showed positive results in reducing the number of migraine days each month and improving quality of life.678911
Eligibility Criteria
This trial is for children and teens aged 6 to under 18 with a history of migraines, weighing over 40 kg. They must be able to tell the difference between migraine and other headaches, may use stable doses of certain migraine prevention meds but not CGRP antagonists, and should have had 1-8 significant migraine attacks per month in the past two months.Inclusion Criteria
I am between 6 and 17 years old and will not turn 18 during the study.
I've had 1-8 severe attacks a month in the last 2 months, lasting over 3 hours.
I am not using any CGRP antagonist medications like erenumab.
I weigh more than 40 kg.
Exclusion Criteria
I have a history of cluster or hemiplegic migraine headaches.
I have had a stable mental health condition for at least 6 months.
I have a history of serious head injury or a neurological condition that could affect my brain function.
I have had surgery on my stomach or intestines that affects how my body processes food.
I have or had liver disease or viral hepatitis.
Participant Groups
The study is testing BHV-3000 (Rimegepant) against a placebo for quickly treating moderate or severe migraines in young people. Participants will randomly receive either the actual medication or a dummy pill without knowing which one they are taking.
2Treatment groups
Active Control
Placebo Group
Group I: BHV3000 (active drug)Active Control1 Intervention
BHV3000 (rimegepant) 75 mg or 50 mg ODT
Group II: PlaceboPlacebo Group1 Intervention
Matching 75 mg or 50 mg ODT placebo
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
Seattle Children's Hospital Investigational Drug ServicesSeattle, WA
University of Kentucky HospitalLexington, KY
Future Search Trials of Dallas, LPDallas, TX
Children's Medical Center, DallasDallas, TX
More Trial Locations
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Who is running the clinical trial?
PfizerLead Sponsor
Biohaven Pharmaceutical Holding Company Ltd.Lead Sponsor
References
Rizatriptan 5 mg for the acute treatment of migraine in adolescents: results from a double-blind, single-attack study and two open-label, multiple-attack studies. [2012]To examine the short- and long-term efficacy and tolerability of rizatriptan 5 mg in adolescents with migraine.
Pediatric migraine: recognition and treatment. [2022]The diagnosis of migraine headache in childhood rests on criteria similar to those used in migraine in adults. It is important, however, to appreciate several fundamental differences. These differences include the duration of attack, which is often far shorter than in an adult, and the location of the attack, which may be bilateral in many children. The treatment of children and adolescents with migraines includes treatment modalities for acute attacks, preventive medications when the attacks are frequent, and biobehavioral modes of therapy to address long-term management of the disorder. The controlled clinical trials of medications in pediatric migraine have suffered from high placebo response rates that may be related to the sites conducting the study (ie, headache specialist vs clinical research organizations). The medications have proved to be safe in the pediatric age group. Treatment modalities for acute migraine include over-the-counter nonsteroidal anti-inflammatory drugs (NSAIDs), as well as the oral triptans such as sumatriptan succinate, rizatriptan benzoate, and zolmitriptan and the nasal spray formulations of sumatriptan and zolmitriptan. Subcutaneous sumatriptan and parenteral dihydroergotamine have also been used limitedly. Preventive treatment for patients with frequent or disabling migraines (or both) includes the antidepressants amitriptyline hydrochloride and nortriptyline hydrochloride, the anticonvulsants divalproex sodium and topiramate, and the antihistaminic agent cyprohepatine hydrochloride. Biobehavioral approaches aimed at addressing the fundamental lifestyle issues and nonpharmacologic approaches to management are fundamental to long-term success.
Efficacy and tolerability of rizatriptan in pediatric migraineurs: results from a randomized, double-blind, placebo-controlled trial using a novel adaptive enrichment design. [2012]Treatment options for children and adolescents with migraine are limited. This study evaluated rizatriptan for the acute treatment of migraine in children and adolescents.
Long-term open-label safety study of rizatriptan acute treatment in pediatric migraineurs. [2017]To evaluate the safety/tolerability of rizatriptan in the long-term acute treatment of migraine in pediatric patients.
Newly Approved Agents for the Treatment and Prevention of Pediatric Migraine. [2022]Treatment of pediatric migraine remains an unmet medical need. There continues to be a paucity of pediatric randomized controlled trials for the treatment of migraine, both in the acute and preventive settings. Pediatric studies are often complicated by high placebo-response rates and much of our current practice is based on adult trials. This lack of significant pediatric studies results in a wide variation in migraine management both amongst clinicians and between institutions, and evidence-based treatments are not always administered. In this article, we aim to briefly review newly approved abortive and preventive agents for migraine in the pediatric age group. Over-the-counter anti-inflammatory medications, including ibuprofen, naproxen sodium, aspirin, and acetaminophen are reasonable first-line options for abortive therapy. In addition, studies have shown triptans, or migraine-specific agents, to be safe and effective in children and adolescents and several formulations have been approved for the pediatric population, including rizatriptan, almotriptan, zolmitriptan nasal spray, and naproxen sodium/sumatriptan in combination.
Safety of Rimegepant, an Oral CGRP Receptor Antagonist, Plus CGRP Monoclonal Antibodies for Migraine. [2021]Evaluate the safety and tolerability of oral rimegepant when used for acute treatment concomitantly with a monoclonal antibody (mAb) targeting the calcitonin gene-related peptide (CGRP) ligand or receptor (CGRP mAb) for the preventive treatment of migraine.
Rimegepant Orally Disintegrating Tablet for Acute Migraine Treatment: A Review. [2021]To review the pharmacology, pharmacokinetics, efficacy, safety, and place in therapy of rimegepant for treatment of migraine.
Rimegepant for the treatment of migraine. [2021]Rimegepant is an oral calcitonin gene-related peptide (CGRP) receptor antagonist developed with a novel quick-dissolve oral tablet formulation for the acute treatment of migraine by Biohaven Pharmaceuticals, under license from Bristol Myers Squibb. The completed phase II and III trials showed its efficacy in terms of pain freedom, pain relief, release of migraine symptoms and lifestyle recovery, with an effect sustained up to 48 h. Significant clinical efficacy has been reported with a rimegepant single dose. Rimegepant was well tolerated and the few adverse events were mild or moderate and did not cause trial discontinuation. It received Food and Drug Administration (FDA) approval on February 27, 2020, for the acute treatment of migraine headache. Three clinical trials are currently ongoing to evaluate: i) the long-term safety as migraine acute treatment; ii) the efficacy and safety as a preventive treatment for migraine; and iii) the efficacy and safety for refractory trigeminal neuralgia. Future studies should be designed also to evaluate potential drug-drug interactions.
Matching-adjusted indirect comparisons of oral rimegepant versus placebo, erenumab, and galcanezumab examining monthly migraine days and health-related quality of life in the treatment of migraine. [2021]Rimegepant is an orally administered small-molecule calcitonin gene-related peptide (CGRP) receptor antagonist, with demonstrated efficacy in the acute treatment of migraine. Recent estimates from a single-arm trial (BHV3000-201) have also shown evidence of long-term preventive effects in monthly migraine days (MMDs) and health-related quality of life (HRQoL). This study aimed to compare MMDs and HRQoL data for oral rimegepant to those obtained in placebo-controlled trials for injectable anti-CGRP monoclonal antibodies (mAbs) galcanezumab and erenumab.
Rimegepant 75 mg in Subjects With Hepatic Impairment: Results of a Phase 1, Open-Label, Single-Dose, Parallel-Group Study. [2023]Rimegepant is a small-molecule calcitonin gene-related peptide receptor antagonist (gepant) with demonstrated efficacy and safety in the acute and preventive treatment of migraine. Here, we report the pharmacokinetics and safety of a single 75-mg oral dose of rimegepant in subjects with severe, moderate, or mild hepatic impairment and matched healthy subjects from an open-label, single-dose, 4-group phase 1 study. Thirty-six subjects aged 41-71 years were enrolled, including 6 each with severe, moderate, or mild hepatic impairment and 18 healthy subjects. All subjects completed the study. A
Efficacy and Safety of Rimegepant for Migraine Patients: A Meta-analysis of Randomized Controlled Studies. [2023]Rimegepant may have some potential in treating migraine, and this meta-analysis aims to study the efficacy and safety of rimegepant for migraine patients.