NCT03797521

A Study in Patients With Trichotillomania

A Phase 2, Double Blind, Placebo-Controlled Study to Explore the Safety, Tolerability, and Activity of SXC-2023 in Adults With Moderate to Severe Trichotillomania (TTM) When Dosed for 6 Weeks

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 128 (actual)
• Sponsor: Promentis Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to explore the safety, tolerability and activity of SXC-2023 when dosed for 6 weeks versus placebo in adult patients with moderate to severe Trichotillomania.

Detailed description

This is a Phase 2, multicenter, double-blind, placebo-controlled, parallel-group study consisting of a screening period of up to 40 days, a 6 week randomized double-blind treatment period, followed by an up to 2 week safety follow-up period after the last dose of study medication. Patients will be randomized to one of four treatment groups. Patients will participate for a total of up to 10 weeks, including screening, the 6-week treatment period and follow-up.

Conditions

• Trichotillomania

Interventions

Type	Name	Description
DRUG	SXC-2023	SXC-2023 oral capsules
DRUG	Placebo	Matching Placebo oral capsules

Timeline

• Start date: 2018-12-19
• Primary completion: 2019-12-02
• Completion: 2019-12-16
• First posted: 2019-01-09
• Last updated: 2021-10-28

Locations

13 sites across 1 country: United States

Regulatory

• FDA-regulated drug study