Migraine Clinical Trial
Official title:
Randomized, Double-blind, Placebo-Controlled, Multiple-Attack Study With an Open-Label Extension to Evaluate the Efficacy, Safety, Tolerability, and the Consistency of Effect of Atogepant for the Acute Treatment of Migraine (ECLIPSE)
A migraine attack is a moderate or severe headache that usually occurs on one side of the head and is often accompanied by throbbing, sensitivity to light, sensitivity to sound, nausea, or other symptoms. The main goal of the study is to see if atogepant is effective, safe, and well-tolerated in treating migraine attacks quickly. Atogepant is a medicine currently approved for the preventive treatment of migraine in adults and has been shown to be effective and well tolerated when taken daily to prevent migraine attacks. This study includes double-blind phase means that neither the participants nor the study doctors know who is given which study treatment (atogepant or placebo) followed by an open-label phase meaning that both participants and study doctors know which study treatment is given. All participants will receive atogepant during the open-label part of the study. This study will include 1300 participants aged 18-75 years with a history of migraine at approximately 160 sites across the world. All participants will receive both atogepant and placebo to treat qualifying migraines. At the start of the study, participants will be randomized to 1 of 4 dosing sequences to determine when they will receive atogepant and when they will receive placebo during the study. After treating 4 qualifying migraine attacks, participants will receive open-label atogepant for any additional migraine attacks they have until the end of the study (Week 24). There may be a bigger responsibility for participants in this study than there would be in participants receiving standard of care treatment. participants will attend regular visits during the study at a hospital or clinic, as well as telephone visits, and the effects of treatment will be checked by completion of questionnaires in an electronic diary, medical assessments, blood tests, and checking for side effects.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT05525611 -
Cabergoline as a Preventive Treatment for Chronic Migraine
|
N/A | |
| Completed |
NCT06192173 -
Patent Foramen Ovale Closure in Migraine
|
||
| Recruiting |
NCT03832998 -
Efficacy and Safety of Erenumab in Pediatric Subjects With Chronic Migraine
|
Phase 3 | |
| Enrolling by invitation |
NCT04196933 -
Analysis of Vestibular Compensation Following Clinical Intervention for Vestibular Schwannoma
|
N/A | |
| Not yet recruiting |
NCT06428838 -
Eptinezumab as an Adjunct to Standard of Care for Migraine in an Acute Emergency Context
|
Phase 3 | |
| Completed |
NCT06304675 -
Manageable Environmental Factors in Migraine
|
||
| Completed |
NCT04084314 -
Assessment of Prolonged Safety and tOLerability of in Migraine Patients in a Long-term OpeN-label Study
|
Phase 4 | |
| Recruiting |
NCT05517200 -
Pilot Study for a Machine Learning Test for Migraine
|
||
| Completed |
NCT04179474 -
Safety, Tolerability and Drug- Drug Interaction Study of Ubrogepant With Erenumab or Galcanezumab in Participants With Migraine
|
Phase 1 | |
| Recruiting |
NCT04603976 -
Registry for Migraine - Clinical Core
|
Phase 4 | |
| Completed |
NCT03597529 -
CHOCOlate MeLatonin for AdolescenT MigrainE
|
Phase 2 | |
| Completed |
NCT04197349 -
Safety, Tolerability and Pharmacokinetics of ALD1910 in Healthy Men and Woman
|
Phase 1 | |
| Recruiting |
NCT05891808 -
miR-155 Expression in Episodic and Chronic Migraine
|
||
| Active, not recruiting |
NCT05064371 -
Long-Term Extension Study With Eptinezumab as Preventive Treatment in Participants With Migraine in Japan
|
Phase 3 | |
| Suspended |
NCT04069572 -
Vibratory Stimulation for the Treatment of Chronic Pain
|
N/A | |
| Not yet recruiting |
NCT04859374 -
Chronic Pain and Conditioned Pain Modulation After on Line-behavioral Approach
|
N/A | |
| Not yet recruiting |
NCT03083860 -
Evaluation of Migraine Management Mobile App Combined With Electrophysiological Measurements for Identification of Migraine Attack Risk and Beneficial Preventive Actions.
|
N/A | |
| Completed |
NCT02905227 -
A Study of the Pulmonary Safety and Pharmacokinetics of Zolmitriptan Inhalation Powder
|
Phase 1 | |
| Enrolling by invitation |
NCT02532023 -
The Combined Effects of omega3 Fatty Acids and Curcumin Supplementation on Inflammatory and Endothelial Factors in Migraine Patients
|
Phase 4 | |
| Completed |
NCT02108678 -
One-Day Intervention for Depression and Impairment in Migraine Patients
|
N/A |