Ignite Creation Date:
2024-05-06 @ 7:50 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06151561
Status:
COMPLETED
Last Update Posted:
2024-04-04
First Post:
2023-11-22
Brief Title:
Study of AGN-151586 in Japanese Participants With Moderate to Severe Glabellar Lines
Sponsor:
AbbVie
Organization:
AbbVie
Study Overview
Official Title:
A Phase 12 Randomized Double-Blinded Placebo-Controlled Study of AGN-151586 in the Treatment of Japanese Subjects With Moderate to Severe Glabellar Lines
Status:
COMPLETED
Status Verified Date:
2024-04
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:
Facial lines that develop from repeated facial expression such as glabellar lines GL are typically treated by selectively weakening specific muscles with small quantities of botulinum toxin The purpose of this study is to evaluate the safety and efficacy of AGN-151586 over a range of doses for the treatment of moderate to severe GL in Japanese participants
AGN-151586 is an investigational product being developed for the treatment of GL Participants are randomly assigned to receive AGN-151586 or placebo There is 1 in a 4 chance that participants will receive placebo Around 24 adult participants with moderate to severe GL will be enrolled in the study in approximately 2 sites in Japan
Participants will receive either AGN-151586 or Placebo administered as 5 intramuscular injections to the glabellar complex on Day 1 The duration of the study will be approximately 6 weeks
There may be higher treatment burden for participants in this trial compared to their standard of care Participants will 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
AGN-151586 is an investigational product being developed for the treatment of GL Participants are randomly assigned to receive AGN-151586 or placebo There is 1 in a 4 chance that participants will receive placebo Around 24 adult participants with moderate to severe GL will be enrolled in the study in approximately 2 sites in Japan
Participants will receive either AGN-151586 or Placebo administered as 5 intramuscular injections to the glabellar complex on Day 1 The duration of the study will be approximately 6 weeks
There may be higher treatment burden for participants in this trial compared to their standard of care Participants will 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?:
False
Is an FDA AA801 Violation?:
None