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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04686136




Registration number
NCT04686136
Ethics application status
Date submitted
21/12/2020
Date registered
28/12/2020
Date last updated
23/03/2023

Titles & IDs
Public title
A Long-Term Safety and Tolerability Extension Study Evaluating Atogepant for the Prevention of Chronic or Episodic Migraine
Scientific title
A Phase 3, Multicenter, Open-Label 156-Week Extension Study To Evaluate The Long-Term Safety And Tolerability Of Oral Atogepant For The Prevention Of Migraine In Participants With Chronic Or Episodic Migraine
Secondary ID [1] 0 0
2020-002470-27
Secondary ID [2] 0 0
3101-312-002
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Episodic Migraine 0 0
Chronic Migraine 0 0
Condition category
Condition code
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Atogepant 60 mg

Experimental: Atogepant 60 mg - Taken once daily


Treatment: Drugs: Atogepant 60 mg
Tablets containing 60 mg of Atogepant
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants with at Least 1 Treatment Emergent Adverse Event
Timepoint [1] 0 0
156 weeks
Secondary outcome [1] 0 0
Percentage of Participants with Clinically Significant Laboratory Values (Chemistry, Hematology, Urinalysis) as assessed by the Investigator
Timepoint [1] 0 0
156 weeks
Secondary outcome [2] 0 0
Percentage of Participants with Clinically Significant Electrocardiograms (ECGs) Findings as assessed by the Investigator
Timepoint [2] 0 0
156 weeks
Secondary outcome [3] 0 0
Percentage of Participants with Clinically Significant Vital Sign Measurements as assessed by the Investigator
Timepoint [3] 0 0
156 weeks
Secondary outcome [4] 0 0
Columbia-Suicide Severity Rating Scale (C-SSRS) Assessing Suicidal Ideation and Behaviour using 5-Point Scales
Timepoint [4] 0 0
156 weeks

Eligibility
Key inclusion criteria
- Eligible participants who completed Visit 7, and Visit 8 if applicable, of Study
3101-303-002 or Study 3101-304-002 without significant protocol deviations and who did not
experience an Adverse Event that may indicate an unacceptable safety risk.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Participants requiring any medication, diet, or nonpharmacological treatment on the
list of prohibited concomitant medications or treatments that cannot be discontinued
or switched to an allowable alternative.

- Participants with an ECG indicating clinically significant abnormalities at Visit 1.

- Participants with hypertension at Visit 1.

- Participants with a significant risk of self-harm, or of harm to others; participants
who report suicidal ideation with intent, with or without a plan, since the last
visit, must be excluded.

- Participants with clinically significant hematologic, endocrine, cardiovascular,
pulmonary, renal, hepatic, gastrointestinal, or neurologic disease.

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
19/02/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
13/09/2024
Actual
Sample size
Target
Accrual to date
Final
596
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
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Arizona
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Kladno
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Plzen
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Prague 10
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Czechia
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Prague 4
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Prague
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Praha
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Taipei City
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United Kingdom
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London

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Allergan
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This study will evaluate the Long-Term Safety and Tolerability of Atogepant 60 mg daily for
the Prevention of Migraine in Participants with Chronic or Episodic Migraine
Trial website
https://clinicaltrials.gov/ct2/show/NCT04686136
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

Contacts
Principal investigator
Name 0 0
ALLERGAN INC.
Address 0 0
Allergan
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries