A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO EVALUATE THE EFFICACY, SAFETY, AND TOLERABILITY OF ATOGEPANT FOR THE PREVENTION OF CHRONIC MIGRAINE (PROGRESS)

Phase 1

• Conditions: Chronic migraine; MedDRA version: 21.1Level: LLTClassification code 10066636Term: Chronic migraineSystem Organ Class: 100000004852; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2018-004337-32-GB
• Lead Sponsor: Allergan Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-08-05
• Last Update Posted: 10 August 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 750

Inclusion Criteria

1. Written informed consent and participant privacy information (eg, Written Authorization for Use and Release of Health and Research Study Information) obtained from the participant prior to initiation of any study-specific procedures
2. Male or female participants ages 18 to 80 years, inclusive, at Visit 1
3. At least a 1-year history of CM consistent with a diagnosis according to the ICHD 3, 2018
4. Age of the participant at the time of migraine onset < 50 years
5. Confirmation of headache/migraine headache day frequency as follows:
a. History of, on average, = 15 headache days per month in the 3 months prior to Visit 1 in the opinion of the investigator AND
b. = 15 headache days during the 4-week screening/baseline period per the electronic diary (eDiary) AND
c. = 8 days during the 4-week screening/baseline period that qualify as being a migraine day per the eDiary
6. Completed at least 20 out of 28 days in the eDiary during baseline period and is able to read, understand, and complete the study questionnaires and eDiary per investigator’s judgment
7. Participants must be using a medically acceptable and effective method of birth control during the course of the entire study, as defined in Section 4.4.3 of the study protocol
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 728
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 22

Exclusion Criteria

1.Difficulty distinguishing migraine headaches from tension-type or other headaches
2.Has a history of migraine, accompanied by diplopia or decreased level of consciousness or retinal migraine
3.Has a current diagnosis of new persistent daily headache, trigeminal autonomic cephalgia (eg, cluster headache), or painful cranial neuropathy
4.History of an inadequate response to > 4 medications (2 of which have different mechanisms of action) prescribed for the prevention of migraine
5.Currently taking more than 1 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 1
•the participant is not willing or able to maintain taking this medication at a stable dose and dosage regimen throughout the study
6.Requirement for any medication, diet, or non-pharmacological treatment that is on the list of prohibited concomitant medications or treatments that cannot be discontinued or switched to an allowable alternative medication or treatment
7.Usage of opioids and/or barbiturates > 4 days/month in the 3 months prior to Visit 1 per investigator’s judgment or during the baseline period
8.Woman is pregnant, planning to become pregnant during the course of the study, or currently lactating
9.An ECG with clinically significant abnormalities at screening
10.QTcF > 450 msec for males and QTcF > 470 msec for females at Visit 1 on the final central vendor ECG report
11.Clinically significant cardiovascular or cerebrovascular disease per the investigator’s opinion
12.Hypertension as defined by sitting systolic BP > 160 mm Hg or sitting diastolic BP > 100 mm Hg at Visits 1 or Visit 2
13.Clinically significant laboratory values OR any of the following laboratory values at Visit 1
•ALT or AST > 1 x ULN OR
•total bilirubin > 1 x ULN (except diagnosis of Gilbert’s disease) OR
•serum albumin < 2.8 g/dL
14.Any clinically significant hematologic, endocrine, pulmonary, renal, hepatic, gastrointestinal, or neurologic disease
•If there is a history of such a disease, but the condition has been stable for more than 1 year prior to Visit 1, and is judged by the investigator as not likely to interfere with study participation
•Participants on dialysis for renal failure are excluded
15.History of acute hepatitis within 6 months of screening; or chronic hepatitis, or a positive result on anti hepatitis A IgM antibody, hepatitis B surface antigen, anti–hepatitis C antibody, or anti-hepatitis E IgM antibody testing
16.In the opinion of the investigator, confounding psychiatric conditions, dementia, epilepsy or significant neurological disorders other than migraine
17.Any other concurrent pain condition that, in the opinion of the investigator, may significantly impact the current headache disorder
18.Significant risk of self-harm based on clinical interview and responses on the C-SSRS, or of harm to others; participants must be excluded if they report suicidal ideation with intent in the past 6 months or report suicidal behavior in the 6 months prior to Visit 1 or Visit 2 assessments
19.History of malignancy in the 5 years prior to Visit 1, except for adequately treated basal cell or squamous cell skin cancer, or in situ cervical cancer
20.History of any gastrointestinal prior procedures or gastrointestinal conditions that may affect the absorp

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the safety and tolerability of atogepant 30 mg twice per day (BID) and atogepant 60 mg once daily for the prevention of chronic migraine (CM).<br>To prospectively test for superiority of atogepant 30 mg twice per day (BID) and atogepant 60 mg once daily versus placebo for the prevention of CM.;Secondary Objective: Not applicable;Primary end point(s): The primary efficacy endpoint is the change from baseline in mean monthly migraine days across the 12-week treatment period. <br>;Timepoint(s) of evaluation of this end point: From baseline to Week 12. Baseline is defined as the number of migraine days during the last 28 days of the baseline phase (ie, Day -28 to -1).