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Also known as Standard of Care (SOC) Migraine Preventive Medication
Standard of Care Migraine Preventive Medication · 1 trial · 1 indication
An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. A TEAE is an AE that occurs or worsens after receiving investigational study drug.
| Arm | Type | Description |
|---|---|---|
| Oral SOC Migraine Preventive Medication | ACTIVE_COMPARATOR | Oral standard of care (SOC) medication recognized as safe and effective for the prevention of migraine, based on investigator's judgement in consultation with the participant. |
| Atogepant 60 mg | EXPERIMENTAL | Atogepant 60 mg tablet taken orally, once daily for 52 weeks. |
| Name | Type | Description |
|---|---|---|
| Standard of Care (SOC) Migraine Preventive Medication | DRUG | Standard of care medication selected based on investigator's judgement, recognized as safe and effective for the prevention of migraine. |
| Atogepant | DRUG | Atogepant tablets taken orally, once daily for 52 weeks. |
Inclusion Criteria: * Written informed consent and participant privacy information (e.g., written authorization for use and release of health and research study information) obtained from the participant prior to initiation of any study-specific procedures. * Participant is a candidate to be prescr...
Standard of Care Migraine Preventive Medication is the term used in a Phase 3 study of atogepant 60 mg daily for preventing migraine in adults with episodic migraine. The trial, NCT03700320, was an active-controlled study that enrolled 744 participants and has been completed.
It is used for the prevention of episodic migraine in adults. The Phase 3 trial evaluated atogepant 60 mg taken daily in participants 18 years and older with episodic migraine, comparing it against an active control treatment over the course of the study.
AbbVie Inc. (ticker ABBV) is the developer associated with this migraine preventive treatment. The company sponsored the Phase 3 study of atogepant 60 mg daily for episodic migraine prevention that was conducted in the United States.
It is in Phase 3 development. One Phase 3 trial, NCT03700320, has been completed, and no trials are currently listed as active. The study evaluated atogepant 60 mg daily for migraine prevention in adults with episodic migraine.
The relevant trial is NCT03700320, a Phase 3 study titled Study to Evaluate the Safety and Tolerability of Treatment With Atogepant 60 mg Daily for the Prevention of Migraine in Participants With Episodic Migraine. It enrolled 744 participants, was active-controlled, and has been completed.
Yes. Standard of Care Migraine Preventive Medication and Standard of Care (SOC) Migraine Preventive Medication refer to the same treatment. SOC is simply the abbreviated form of the name used in the Phase 3 atogepant 60 mg episodic migraine prevention study.