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Standard of Care Migraine Preventive Medication

Phase 3

Episodic Migraine | Small molecule | Neurology |AbbVie Inc.|Last Updated: Jun 15, 2021

Target and mechanism

ModalitySmall molecule

Also known as Standard of Care (SOC) Migraine Preventive Medication

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLEDDMC
Total Trials1
Total Enrollment744

FDA Designations

No designations recorded

Clinical trial landscape

Standard of Care Migraine Preventive Medication · 1 trial · 1 indication

Phase 3 1
NCT03700320Study to Evaluate the Safety and Tolerability of Treatment With Atogepant 60 mg Daily for the Prevention of Migraine in Participants With Episodic MigraineEpisodic Migraine
COMPLETED744 Analytics
PHASE3COMPLETED
Study to Evaluate the Safety and Tolerability of Treatment With Atogepant 60 mg Daily for the Prevention of Migraine in Participants With Episodic Migraine
Episodic MigraineUnlock trial analytics

Study Endpoints

Primary Endpoints

Percentage of Participants With at Least 1 Treatment Emergent Adverse Event (TEAE)
From first dose up to the end of study (median treatment of 52 weeks) + 4 weeks follow-up

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.

Secondary Endpoints

Percentage of Participants With Clinically Significant Laboratory Values as Assessed by the Investigator
From first dose up to the end of study (median treatment of 52 weeks) + 4 weeks follow-up
Percentage of Participants With Clinically Significant Electrocardiogram (ECG) Findings as Assessed by the Investigator
Up to Week 52
Percentage of Participants With Clinically Significant Vital Sign Measurements as Assessed by the Investigator
From first dose up to the end of study (median treatment of 52 weeks + 4 weeks follow-up)
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Oral SOC Migraine Preventive MedicationACTIVE_COMPARATOROral 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 mgEXPERIMENTALAtogepant 60 mg tablet taken orally, once daily for 52 weeks.

Interventions

NameTypeDescription
Standard of Care (SOC) Migraine Preventive MedicationDRUGStandard of care medication selected based on investigator's judgement, recognized as safe and effective for the prevention of migraine.
AtogepantDRUGAtogepant tablets taken orally, once daily for 52 weeks.
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Eligibility Criteria

Age Range18 Years to 80 Years
SexALL
Healthy VolunteersNo
Study Sites112

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...

Countries:United States
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