Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03939312
Other study ID # 3101-309-002
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date May 6, 2019
Est. completion date March 31, 2021

Study information

Verified date April 2022
Source Allergan
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the safety and tolerability of atogepant 60 mg once a day for the prevention of migraine in participants with episodic migraine.


Read more »

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Atogepant
Atogepant Tablets

See more »

Sponsors (1)

Lead Sponsor Collaborator
Allergan

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of Participants With at Least 1 Treatment-Emergent Adverse Event and Treatment-Emergent Serious Adverse Event (TEAEs/TESAEs) An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first dose of study drug. From dose of study drug until 30 days following last dose of study drug (up to approximately Week 44)
Secondary Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values as Assessed by the Investigator Clinical laboratory test values are considered PCS if they meet either the lower-limit or higher-limit PCS criteria defined in the categories below. Percentage of participants with PCS laboratory values are summarized for chemistry, hematology, and urinalysis. Only those categories where at least 1 person had a non-PCS value at Baseline and met the PCS criterion at least once during post-baseline are reported. Up to Week 44
Secondary Percentage of Participants With Potentially Clinically Significant (PCS) Electrocardiograms (ECGs) Findings as Assessed by the Investigator 12-lead ECGs were performed at select study visits. Only those categories where at least 1 person had a non-PCS value at Baseline and met the PCS criterion at least once during postbaseline are reported. Up to Week 40
Secondary Percentage of Participants With Potentially Clinically Significant (PCS) Vital Sign Measurements as Assessed by the Investigator PCS postbaseline vital sign values are summarized for categories: systolic and diastolic blood pressures [sitting and standing], pulse rate [sitting and standing], respiratory rate, temperature, weight. Only those categories where at least 1 person had a non-PCS value at Baseline and met the PCS criterion at least once during postbaseline are reported. Up to Week 44
Secondary Number of Participants With Suicidal Ideation and Behaviour Using 5-Point Scale of Columbia-Suicide Severity Rating Scale (C-SSRS) C-SSRS is a clinician-rated instrument that reports the severity of both suicidal ideation and behavior. Suicidal ideation is classified on a 5-item scale: 1 (wish to be dead), 2 (nonspecific active suicidal thoughts), 3 (active suicidal ideation with any methods [not plan] without intent to act), 4 (active suicidal ideation with some intent to act, without specific plan), and 5 (active suicidal ideation with specific plan and intent). Suicidal behavior is classified on a 5-item scale: 0 (no suicidal behavior), 1 (preparatory acts or behavior), 2 (aborted attempt), 3 (interrupted attempt), and 4 (actual attempt). More than 1 classification can be selected provided they represent separate episodes. Suicidal ideation: Minimum total score 1, maximum total score 5; higher total scores indicate more suicidal ideation. Suicidal behavior: Minimum total score 0, maximum total score 4; higher total scores indicate more suicidal behavior. OL Treatment Period: Up to Week 40; Safety Follow-up Period: Week 44
See also
  Status Clinical Trial Phase
Recruiting NCT06047457 - A Study to Evaluate the Effectiveness and Safety of Dysport® for the Prevention of Episodic Migraine in Adults Phase 3
Completed NCT02569853 - DFN-11 Injection in Episodic Migraine With or Without Aura Phase 3
Completed NCT00719134 - The Effects of Expectation and Knowledge on Rizatriptan and Placebo Treatment of Acute Migraine Headache Phase 4
Completed NCT03700320 - Study to Evaluate the Safety and Tolerability of Treatment With Atogepant 60 mg Daily for the Prevention of Migraine in Participants With Episodic Migraine Phase 3
Terminated NCT04936061 - Transnasal Cooling for Migraine N/A
Recruiting NCT05281770 - Monoclonal CGRP Antibodies for Migraine Prevention - a Nationwide Real Life Study
Recruiting NCT05042037 - Probiotics as Adjunctive Migraine Prophylaxis N/A
Recruiting NCT04628429 - CGRP Inhibition, Autonomic Function, and Migraine
Active, not recruiting NCT05028569 - Study of BOTOX Injections in Prevention of Migraine in Adult Participants With Episodic Migraine Phase 3
Withdrawn NCT01257893 - Aspirin Resistance in Women With Migraine N/A
Recruiting NCT06051604 - Mi-Helper Transnasal Cooling for Acute Treatment of Migraine N/A
Completed NCT03132233 - Energy for the Brain N/A
Completed NCT03927144 - Study of Sustained Benefit of AMG334 in Adult Episodic Migraine Patients Phase 4
Recruiting NCT06248671 - Prophylactic Treatment With Atorvastatin for Episodic Migraine. Phase 2
Recruiting NCT05711394 - A Study to Assess the Adverse Events and Change in Disease Activity of Oral Atogepant Tablets in Pediatric Participants (6-17 Years of Age) With Episodic Migraine Phase 3
Recruiting NCT05449145 - The Effects of Vitamin D Plus Omega-3 Polyunsaturated Fatty Acids in Patients With Episodic Migraine N/A
Completed NCT04031781 - The Role of Left Prefrontal Transcranial Magnetic Stimulation in Episodic Migraine Prophylaxis N/A
Completed NCT05264129 - Study to Assess Adverse Events When Ubrogepant Tablets in Combination With Atogepant Tablets Are Used to Treat Adult Participants With Migraine Phase 4
Completed NCT04740827 - Atogepant for Prophylaxis of Migraine in Participants Who Failed Previous Oral Prophylactic Treatments. Phase 3
Completed NCT05853900 - Study of Two Digital Therapeutics for the Prevention of Episodic Migraine Phase 3

External Links