Effectiveness, Safety, and Tolerability of Analgesics in the Prevention of Chronic Migraine

Chronic Migraine Clinical Trial

Official title:

A Phase III, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallelist Study Evaluating the Efficacy, Safety, and Tolerability of Atogepant for the Prevention of Chronic Migraine (Progress)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04961671
• Other study ID #: D2019119
• Status: Completed
• Phase: Phase 3
• Start date: December 1, 2019
• Est. completion date: May 1, 2021

Study information

• Verified date: June 2021
• Source: Peking University Third Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Study Objectives:

To evaluate the safety and tolerability of atogepant 30 mg twice per day (BID) and 60 mg once daily for the prevention of chronic migraine (CM). To prospectively test for superiority of atogepant 30 mg BID and 60 mg once daily versus placebo for the prevention of CM.

Description:

Study Objectives:

To evaluate the safety and tolerability of atogepant 30 mg twice per day (BID) and 60 mg once daily for the prevention of chronic migraine (CM). To prospectively test for superiority of atogepant 30 mg BID and 60 mg once daily versus placebo for the prevention of CM. Clinical Hypotheses: In participants with CM, at least one of the following atogepant doses (30 mg BID and 60 mg once daily) is superior to placebo as measured by the change from baseline in mean monthly migraine days across the 12-week treatment period. Atogepant has an acceptable safety and tolerability profile in participants with CM.

Study Design Structure: Multicenter, randomized, double-blind, placebo-controlled, parallel-group study Duration: The study will consist of a 4-week screening and baseline period, a 12-week double-blind treatment period, and a follow-up period of 4 additional weeks, for a total duration of20 weeks Study Intervention: Atogepant 30 mg BID and 60 mg once daily tablets Control: Atogepant-matching placebo Dosage/Dose Regimen: Atogepant 30 mg BID, atogepant 60 mg once daily, and placebo will be administered for 12 weeks duration.

Randomization/Stratification:

Approximately 750 participants will be randomized to I of 3 treatment arms in a I: I: I ratio as follows:

• Placebo (n = 250)

• Atogepant 30 mg BID (n = 250) C • Atogepant 60 mg once daily (n = 250)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 750
• Est. completion date: May 1, 2021
• Est. primary completion date: November 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• AIM-D is a PRO assessment scale with nine items that is used to assess the impact of migraine on the ability to perform daily activities And a decline in bodily function. Subjects were asked to use a six-point rating scale ranging from "not difficult at all", "somewhat difficult", "slightly difficult", "very difficult", "very difficult" to "not complete at all" to rate daily activities (such as household chores, business trips, family leisure activities, leisure or social activities outside the home, drama, etc.) completed within the last 24 hours Difficulty with vigorous physical activity) and reduced physical function (e.g. difficulty walking, moving the body, bending forward, shaking head) Rate the difficulty you encounter. Some items included the answer "I don't have..." ", for example: "I have no plan On a business trip.

Exclusion Criteria:

• Difficulty distinguishing migraine headaches from tension-type or other headaches

• Has a history of migraine, accompanied by diplopia or decreased level of consciousness, or retinal migraine as defined by ICHD-3, 2018 3. Has a current diagnosis of new persistent daily headache, trigeminal autonomic cephalgia (eg, cluster headache), or painful cranial neuropathy as defined by ICHD- - History of an inadequate response to> 4 medications (2 of which have different mechanisms of action) prescribed for the prevention of migraine (see to Section 12.3)

• Currently taking more than I medication with demonstrated efficacy for the prevention of migraine OR participants who are taking 1 migraine prevention medication, but in the opinion of the investigator: the dose has not been stable and/or the medication has not been well-tolerated for at least 12 weeks prior to Visit I the participant is not willing or able to maintain taking this medication at a stable dose and dosage regimen throughout the study

Related Conditions & MeSH terms

• Chronic Migraine
• Migraine Disorders

Intervention

Drug:
• atogepant
atogepant30 mg BID
• atogepant
atogepant60 mg
• placebo
placebo

Locations

Country	Name	City	State
China	Allergan Limited I" Floor Marlow International, The Parkway Marlow, Buckinghamshire SL7 IYL United Kingdom	Beijing
China	Peking Yniversity Third Hospital	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Peking University Third Hospital	Allergan Limited 1st Floor Marlow International, The Parkway Marlow, Buckinghamshire SL7 lYL

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduced mobility due to migraine - diary	Reduced mobility due to migraine - diary is a assessment scale with nine items that is used to assess the impact of migraine on the ability to perform daily activities And a decline in bodily function. Subjects were asked to use a six-point rating scale ranging from "not difficult at all", "somewhat difficult", "slightly difficult", "very difficult", "very difficult" to "not complete at all" to rate daily activities (such as household chores, business trips, family leisure activities, leisure or social activities outside the home, drama, etc.) completed within the last 24 hours Difficulty with vigorous physical activity) and reduced physical function (e.g. difficulty walking, moving the body, bending forward, shaking head) Rate the difficulty you encounter. Some items included the answer "I don't have..."	24 hours after recruitment