Prestige 2

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Konvent Der Barmherzigen Brueder

Participant type

Patients

Age range

18-64 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nervous System Diseases [C10]

Decision date (initial)

2026-03-13

Transition trial

No

Low-intervention

Yes

Rare-disease indication

No

Vulnerable population

No

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy

- To assess the influence of body weight, body fat and obesity on the efficacy of rimegepant

Secondary objectives 1

1. To assess the influence of body weight, body fat and obesity on secondary efficacy endpoints. - Identify parameters with influence on response to rimegepant like body weight, BMI, sex steroid levels, CGRP and rimegepant levels; genetic polymorphisms in CYP3A4, CYP2C9, BCRP and TRPV1 genes

Conditions and MedDRA coding

Migraine

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. - Signed Written Informed Consent Written informed consent must be obtained from the patient in accordance with requirements of the ethics committee, prior to the initiation of any protocol-required procedures.
2. Target Population o Patients with a body mass index: ≥30 kg/m2 ; o Patient has at least 1 year history of migraine (with or without aura) consistent with a diagnosis according to the International Classification of Headache Disorders, 3rd Edition, including the following:  Migraine attacks present for more than 1 year with the age of onset prior to 50 years of age  Migraine attacks, on average, lasting about 4 - 72 hours if untreated. Not more than 8 attacks of moderate or severe intensity per month within last 3 months  Patients must be able to distinguish migraine attacks from tension/cluster headaches.  Consistent migraine headaches of at least 2 migraine headache attacks of moderate or severe intensity in each of the 3 months prior to the Screening Visit, which is maintained during the Screening Period.  Less than 15 days with headache (migraine or non-migraine) per month in each of the 3 months prior to the Screening Visit, which is maintained during the Screening Period.  Patients on prophylactic migraine medication are permitted to remain on therapy provided they have been on a stable dose for at least 3 months prior to study entry.
3. Age and Reproductive Status o Male and Female patients ≥ 18 years and older Women of childbearing potential (WOCBP) and non-sterile men must be using two acceptable methods of contraception to avoid pregnancy throughout the study in such a manner that the risk of pregnancy is minimized. Males with vasectomy are considered surgically sterile provided the procedure occurred more than 6 months prior to study participation o No clinically significant abnormality identified on the medical or laboratory evaluation. A subject with a clinical abnormality or laboratory parameters outside the reference range may be included only if the investigator considers that the finding is not clinically significant and will not introduce additional risk factors and will not interfere with the study procedures o At the Baseline Visit prior to dispensing Investigational Study Medication, WOCBP must have a negative urine pregnancy test o Women must not be breastfeeding

Exclusion criteria 5

1. - Disease Target Exclusion Patient has a history of basilar migraine or hemiplegic migraine
2. Medical History and Concurrent Diseases o Patient history of HIV disease o Patient history with current evidence of uncontrolled, unstable or recently diagnosed cardiovascular disease, such as ischemic heart disease, coronary artery vasospasm, and cerebral ischemia. Patients with Myocardial Infarction (MI), Acute Coronary Syndrome (ACS),Percutaneous Coronary Intervention (PCI), cardiac surgery, stroke or transient ischemic attack (TIA) during the 6 months prior to screening. o Uncontrolled hypertension (high blood pressure), or uncontrolled diabetes (however patients can be included who have stable hypertension and/or diabetes for 3 months prior to being enrolled) o Patient has a current diagnosis of major depression, other pain syndromes, psychiatric conditions (e.g., schizophrenia), dementia, or significant neurological disorders (other than migraine) that, in the Investigator’s opinion, might interfere with study assessments o Patient has a history of gastric, or small intestinal surgery, or has a disease thatcauses malabsorption o The patient has a history or current evidence of any significant and/or unstable medical conditions (e.g., history of congenital heart disease or arrhythmia, known suspected infection, hepatitis B or C, or cancer) that, in the investigator’s opinion, would expose them to undue risk of a significant adverse event (AE) or interfere with assessments of safety or efficacy during the course of the trial o History of, treatment for, or evidence of, alcohol or drug abuse within the past 12 months or patients who have met DSM-V criteria for any significant substance use disorder within the past 12 months from the date of the screening o Patients should be excluded if they have a positive drug screen for drugs of abuse that in the investigator’s judgment is medically significant, in that it would impact the safety of the patient or the interpretation of the study results.
3. Allergies and Adverse Drug Reactions History of drug or other allergy which, in the opinion of the principal investigator, makes the subject unsuitable for participation in the study
4. Sex and Reproductive Status o Females of child-bearing potential who are unwilling or unable to use an acceptable contraceptive method or abstinence to avoid pregnancy for the entire study period and for 56 days after the study. o Women who are pregnant or breastfeeding. Women with a positive pregnancy test on enrollment or prior to study drug administration
5. ECG and Laboratory Test Findings o Estimated glomerular filtration rate (eGFR) ≤ 40 ml/min/1.73m2 o Corrected QT interval > 470 msec (QTc by method of Frederica), during theScreening/Baseline Phase o Left Bundle Branch block o Right Bundle Branch Block with a QRS duration ≥ 150 msec. o Intraventricular Conduction Defect with a QRS duration ≥ 150 msec. o Serum bilirubin (Total, Direct or Indirect) > 1,0 mg/dl o Neutrophil count ≤ 40 % o AST (SGOT) or ALT (SGPT) > 45 U/l

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. - Response or non-response to rimegepant 75 mg or 2x75 mg expressed as percentage in pain freedom or freedom from the most bothersome migraine-associated symptom apart from headache after 2 hours (reported in questionnaire)

Secondary endpoints 1

1. - Freedom from photophobia, phonophobia, nausea and pain relief 2 hours after administration of rimegepant in either 75 mg or 2x75 mg during a moderate to severe migraine episode; probability of using rescue medication within 24 hours after the dose; sustained freedom from pain, sustained pain relief, pain relapse 2 hours to 48 hours after the dose - Blood: sex steroid levels, rimegepant concentration, CGRP. parameters: Total body weight, total body water (TBW), free mass (FFM), fat mass (FM), s

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Konvent Der Barmherzigen Brueder

Sponsor organisation

Konvent Der Barmherzigen Brueder

Address

Seilerstaette 2

City

Linz

Postcode

4020

Country

Austria

Scientific contact point

Organisation

Konvent Der Barmherzigen Brueder

Contact name

Bocksrucker Angelika

Public contact point

Organisation

Konvent Der Barmherzigen Brueder

Contact name

Bocksrucker Angelika

Locations

1 EU/EEA country · 1 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 13 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications