CTIS2022-501100-94-00
Recruiting
Phase 1
A Phase 3, Multicenter, 12-Week, Double Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Atogepant for the Preventive Treatment of Episodic Migraine in Pediatric Subjects 6 to 17 years of age - M21-201
ConditionsEpisodic MigraineMedDRA version: 20.0Level: PTClassification code: 10052787Term: Migraine without aura Class: 100000004852MedDRA version: 22.0Level: LLTClassification code: 10082019Term: Episodic migraine Class: 10029205MedDRA version: 20.0Level: PTClassification code: 10027607Term: Migraine with aura Class: 100000004852Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Episodic Migraine
- Sponsor
- Abbvie Deutschland GmbH & Co. KG
- Enrollment
- 450
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Weight is \>\= 20 kg (44 lbs) and \< 135 kg (298 lbs)., History of episodic migraine with or without aura consistent with a diagnosis according to the International Classification of Headache Disorders (ICHD) \-3 (2018\) for at least 6 months., Participant has to have 4 to 14 migraine days and \< 15 headache days in the 28\-day baseline period per eDiary., To be eligible for the PK substudy, participants must be 6 to 11 years of age (inclusive), with a history of migraine and per investigator judgment is appropriate to receive preventive treatment for migraine.
Exclusion Criteria
- •History of migraine aura with diplopia or impairment of level of consciousness, hemiplegic migraine, or retinal migraine as defined by ICHD\-3 (2018\)., Have a current diagnosis of chronic migraine as defined by ICHD\-3 (2018\)., Have a current diagnosis of new persistent daily headache, trigeminal autonomic cephalgia (e.g., cluster headache), or painful cranial neuropathy as defined by ICHD\-3 (2018\)., Have required in\-hospital (excluding emergency department visits) treatment for migraine 3 or more times in the 6 months prior to Visit 1\.
Outcomes
Primary Outcomes
Not specified
Similar Trials
Active, not recruiting
Not Applicable
A Phase III, 12-Week, Multicentre, Double-Blind, Randomised, Placebo- and Active Comparator-Controlled, Parallel Group Study to Investigate the Efficacy and Safety of GW406381, 5mg, 10mg, 25mg, and 50mg administered orally once daily, in Adults with Rheumatoid ArthritisRheumatoid ArthritisMedDRA version: 7.1Level: LLTClassification code 10039073EUCTR2005-000158-61-EEGlaxoSmithKline Research & Development Limited2,210
Active, not recruiting
Not Applicable
A Phase III, 12-Week, Multicentre, Double-Blind, Randomised, Placebo- and Active Comparator-Controlled, Parallel Group Study to Investigate the Efficacy and Safety of GW406381, 5mg, 10mg, 25mg, and 50mg administered orally once daily, in Adults with Rheumatoid ArthritisRheumatoid ArthritisMedDRA version: 7.1Level: LLTClassification code 10039073EUCTR2005-000158-61-HUGlaxoSmithKline Research & Development Limited2,210
Active, not recruiting
Not Applicable
A Phase III, 12-Week, Multicentre, Double-Blind, Randomised, Placebo- and Active Comparator-Controlled, Parallel Group Study to Investigate the Efficacy and Safety of GW406381, 5mg, 10mg, 25mg, and 50mg administered orally once daily, in Adults with Rheumatoid ArthritisEUCTR2005-000158-61-IEGlaxoSmithKline Research & Development Limited2,210
Active, not recruiting
Not Applicable
A Phase III, 12-Week, Multicentre, Double-Blind, Randomised, Placebo- and Active Comparator-Controlled, Parallel Group Study to Investigate the Efficacy and Safety of GW406381, 5mg, 10mg, 25mg, and 50mg administered orally once daily, in Adults with Rheumatoid ArthritisRheumatoid ArthritisMedDRA version: 7.1Level: LLTClassification code 10039073EUCTR2005-000158-61-DEGlaxoSmithKline Research & Development Limited2,210
Active, not recruiting
Not Applicable
A Phase III, 12-Week, Multicentre, Double-Blind, Randomised, Placebo- and Active Comparator-Controlled, Parallel Group Study to Investigate the Efficacy and Safety of GW406381, 5mg, 10mg, 25mg, and 50mg administered orally once daily, in Adults with Rheumatoid ArthritisRheumatoid ArthritisMedDRA version: 7.1Level: LLTClassification code 10039073EUCTR2005-000158-61-LVGlaxoSmithKline Research & Development Limited2,210