NCT04524975

А Dose-finding Study to Assess the Efficacy and Safety of CD-008-0045 in Patients With Generalized Anxiety Disorder

A Multicenter, Randomized, Double-blind, Placebo-controlled, Dose-finding, Pilot Study to Assess the Efficacy and Safety of CD-008-0045 in Patients With Generalized Anxiety Disorder

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 129 (actual)
• Sponsor: ChemRar Research and Development Institute, LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, randomized, double-blind, placebo-controlled, dose-finding pilot study to assess the efficacy and safety of CD-008-0045 in patients with Generalized Anxiety Disorder (GAD). Each patient will participate in the study for the period of approximately 10 weeks: Screening and Run-in period: 1 week; Study Treatment period: 8 weeks; Follow-up period: 1 week.

Detailed description

The study drug CD-008-0045 has a multi-targeted activity, i.e., able to inhibit adrenergic, dopamine, serotonin, and histamine receptors, thus allowing to assume its wide therapeutic potential. At Screening, the patients who meet the inclusion/exclusion criteria will be included into one-week single-blind Placebo Run-in period. At Week 0 the patients will be randomized to receive CD-008-0045 60 mg daily, CD-008-0045 40 mg daily or Placebo for 8 weeks. The potential withdrawal syndrome will be assessed during one-week Follow-up Period.

Conditions

• Anxiety Disorder Generalized

Interventions

Type	Name	Description
DRUG	CD-008-0045	CD-008-0045 20 mg capsules
DRUG	Placebo	Placebo capsules

Timeline

• Start date: 2018-10-02
• Primary completion: 2019-08-20
• Completion: 2019-11-01
• First posted: 2020-08-24
• Last updated: 2020-08-24

Locations

15 sites across 1 country: Russia