Ignite Creation Date:
2024-05-05 @ 6:38 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00512135
Status:
COMPLETED
Last Update Posted:
2021-04-02
First Post:
2007-08-06
Brief Title:
Safety and Efficacy of NT 201 IncobotulinumtoxinA Xeomin in the Treatment of Glabellar Frown Lines
Sponsor:
Merz Pharmaceuticals GmbH
Organization:
Merz Pharmaceuticals GmbH
Study Overview
Official Title:
A Prospective Open-label Multicenter Repeat-dose Trial to Investigate the Safety and Efficacy of NT 201 Free of Complexing Proteins in the Treatment of Glabellar Frown Lines
Status:
COMPLETED
Status Verified Date:
2021-03
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:
The study objective was to investigate the safety and efficacy of incobotulinumtoxinA Xeomin during repeat dose treatment of glabellar frown lines 801 participants with moderate to severe glabellar frown lines at maximum frown who completed participation in one of the studies in this program ie MRZ 60201-05201 MRZ 60201-05271 MRZ 60201-07241 or MRZ 60201-07411 were eligible to participate in this repeat-dose study
Detailed Description:
This was a prospective multicenter open-label non-control group design Phase 3 clinical study Approximately 880 participants who were to complete former studies in this program 370 participants from studies MRZ 60201-05201 8 and MRZ 60201-05271 8 as well as approximately 510 participants from studies MRZ 60201-07241 10 and MRZ 60201-07411 11 were expected to enroll in this study in 26 centers in the United States Canada and Germany Participants with moderate to severe glabellar frown lines at maximum frown who completed participation in one of these four feeder studies in the frown line program were eligible to participate in this repeated dose study Each participant received a dose of 20 units incobotulinumtoxinA Xeomin intramuscular injection on Visit 1 Day 0 of Cycle 1 Re-injections with 20 U NT 201 could be performed on Day 0 of a subsequent cycle for up to 8 cycles one cycle 85 days Intervals between treatments were at least three months or 12 weeks ie 85 days For a new treatment cycle to start the participant had to request a re-injection The investigator then had to assess if the glabellar frown lines had relapsed to moderate or severe In this case a new injection could be administered The treatment duration per participant was 24 months and up to eight cycles for participants enrolled from studies MRZ 60201-05201 and MRZ 60201-05271 and 6 months and up to two cycles for participants enrolled from studies MRZ 60201-07241 and MRZ 60201-07411 respectively Participants enrolled from studies MRZ 60201-05201 and MRZ 60201-05271 participated at least one year in the study whereas participants enrolled from studies MRZ 60201-07241 and MRZ 60201-07411 participated for six months and up to two cycles
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2006-005342-36 | EUDRACT_NUMBER | None | None |