NCT04598867

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

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 200 (estimated)
• 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- and active-controlled 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 37 weeks: Screening and Run-in period: 1 week; Study Treatment period: 32 weeks; Follow-up period: 4 weeks.

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 start double-blind Placebo and active comparator treatment period. The patients will be randomized to receive CD-008-0045 40 mg daily or Placebo or Afobazol (fabomotizole) for 8 weeks. After that, there will be an open-label treatment period for 26 weeks. The potential withdrawal syndrome will be assessed during four-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
DRUG	Afobazol	Afobazol 10 mg tabletes

Timeline

• Start date: 2020-12-01
• Primary completion: 2023-05-01
• Completion: 2023-06-01
• First posted: 2020-10-22
• Last updated: 2020-10-22