Ignite Creation Date:
2024-05-06 @ 1:53 AM
Last Modification Date:
2024-10-26 @ 11:11 AM
Study NCT ID:
NCT01920087
Status:
WITHDRAWN
Last Update Posted:
2014-03-13
First Post:
2013-08-08
Brief Title:
Efficacy and Safety of ATNC05 in Treatment of Atypical Facial Pain
Sponsor:
Allodynic Therapeutics Inc
Organization:
Allodynic Therapeutics Inc
Study Overview
Official Title:
Phase II Double Blind Randomized Placebo Controlled Safety and Efficacy Study of ATNC05 in Patients With Atypical Facial Pain With an Open-Label Extension Phase for Nonresponders
Status:
WITHDRAWN
Status Verified Date:
2014-03
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:
AFP
Brief Summary:
The purpose of the study is to test the efficacy of ATNC05 in the treatment of Atypical Facial Pain AFP also known as Persistent Idiopathic Facial Pain PIFP This research project targets patients with chronic constant facial pain and excludes patients with primarily paroxysmal pain
Detailed Description:
ATNC05 is a rational combination of two well-characterized drugs with decades of clinical use The investigators hypothesize that the combination acts synergistically to reduce AFP
The trial consists of a double-blind treatment period of twelve weeks with either Placebo or ATNC05 Subjects who do not respond to the study medication will continue on to a twelve week Open-Label extension phase during which they will receive ATNC05
The subjects will have six office visits during the Double-Blind phase Subjects continuing to the Open-Label phase will have four additional visits
Data gathering procedures include daily pain questionnaire forms as well as questionnaires and physical examination during office visits
The trial consists of a double-blind treatment period of twelve weeks with either Placebo or ATNC05 Subjects who do not respond to the study medication will continue on to a twelve week Open-Label extension phase during which they will receive ATNC05
The subjects will have six office visits during the Double-Blind phase Subjects continuing to the Open-Label phase will have four additional visits
Data gathering procedures include daily pain questionnaire forms as well as questionnaires and physical examination during office visits
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