NCT01920087

Efficacy and Safety of ATNC05 in Treatment of Atypical Facial Pain

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• Status: Withdrawn
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Allodynic Therapeutics, Inc · Industry
• Sex: All
• Age: 18 Years – 89 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Atypical Facial Pain
• Persistent Idiopathic Facial Pain
• Atypical Trigeminal Neuralgia
• Neuropathic Orofacial Pain
• Neuropathic Facial Pain

Interventions

Type	Name	Description
DRUG	ATNC05	Subject will take between two and four capsules of study medication per day, according to the dose titration schedule in the protocol.
DRUG	Placebo	Subject will take between two and four capsules of study medication per day, according to the dose titration schedule in the protocol.

Timeline

• Start date: 2014-03-01
• Primary completion: 2016-03-01
• Completion: 2016-07-01
• First posted: 2013-08-09
• Last updated: 2014-03-13

Locations

1 site across 1 country: United States