Ignite Creation Date:
2024-05-19 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06417775
Status:
RECRUITING
Last Update Posted:
2024-07-15
First Post:
2024-05-13
Brief Title:
Study of Oral Ubrogepant to Assess Adverse Events and Change in Disease Activity in Adult Participants With Menstrual Migraine
Sponsor:
AbbVie
Organization:
AbbVie
Study Overview
Official Title:
A Phase 3 Multicenter Randomized Double-Blind Placebo-Controlled Study to Evaluate the Efficacy Safety and Tolerability of Ubrogepant for the Preventive Treatment of Menstrual Migraine With an Open-Label Extension
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A migraine is a moderate to severe headache typically on one side of the head A migraine attack is a headache that may be accompanied by throbbing nausea vomiting sensitivity to light and sound or other symptoms Menstrual migraine MM is defined as migraine attacks that occur within the perimenstrual period PMP in at least 2 out of 3 menstrual cycles The PMP is from 2 days before the onset of menstrual bleeding to 2 days after This study will assess how safe and effective ubrogepant is in treating menstrual migraine Adverse Events and change in disease activity will be assessed
Ubrogepant is an investigational drug being developed for short-term prevention of menstrual migraine Participants will be randomly assigned to one of the 2 groups to receive either ubrogepant or placebo Around 450 adult female participants with menstrual migraine will be enrolled in approximately 85 sites in the United States and Puerto Rico
Participants will receive oral ubrogepant tablets once daily for 7 consecutive days starting 3 days prior to estimated onset of menses per cycle for 3 PMPs during double-blind period 16 weeks Eligible participants may continue to receive oral ubrogepant tablets once daily for 7 consecutive days per cycle starting 3 days prior to estimated onset of menses during open-label extension period 52 weeks
There may be higher treatment burden for participants in this trial compared to their standard of care Participants will collect data daily in electronic diaries and attend regular visits during the study at a hospital or clinic The effect of the treatment will be checked by medical assessments blood tests checking for side effects and completing questionnaires
Ubrogepant is an investigational drug being developed for short-term prevention of menstrual migraine Participants will be randomly assigned to one of the 2 groups to receive either ubrogepant or placebo Around 450 adult female participants with menstrual migraine will be enrolled in approximately 85 sites in the United States and Puerto Rico
Participants will receive oral ubrogepant tablets once daily for 7 consecutive days starting 3 days prior to estimated onset of menses per cycle for 3 PMPs during double-blind period 16 weeks Eligible participants may continue to receive oral ubrogepant tablets once daily for 7 consecutive days per cycle starting 3 days prior to estimated onset of menses during open-label extension period 52 weeks
There may be higher treatment burden for participants in this trial compared to their standard of care Participants will collect data daily in electronic diaries and attend regular visits during the study at a hospital or clinic The effect of the treatment will be checked by medical assessments blood tests checking for side effects and completing questionnaires
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None