EDG004 Treatment of Adult Patients With Generalized Anxiety Disorder (GAD)

NCT02305797 | Completed Phase 3 Results

• 1 other identifier: EDG004-003
• Study Type: interventional
• Target: 495
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the efficacy of EDG004 compared to placebo for the treatment of adult patients with GAD, diagnosed by Diagnostic and Statistical Manual of Mental Disorders, 5th Ed. (DSM-5) and confirmed by the Mini International Neuropsychiatric Interview (MINI 7.0). Efficacy will be measured by a statistically significant greater mean reduction from baseline compared to endpoint in anxiety symptoms as measured by the total score of the clinician-rated Hamilton Rating Scale for Anxiety (HAM-A) for the EDG004 treatment group compared to placebo.

Conditions

Generalized Anxiety Disorder (GAD)

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Hamilton Anxiety Rating Scale (HAM-A) Total Score at Visit 7 (Day 42)

  HAM-A Total Score was rated by the clinician. Scores range from 0 to 56. A lower score is favorable. Baseline was defined as the last non-missing value prior to receiving double-blind study drug.

  Day 42 (Visit 7)

Secondary Outcomes (1)

• Change From Baseline in the Clinical Global Impression-Severity (CGI-S) Score at Visit 7 (Day 42)

  Day 42 (Visit 7)

Study Arms (2)

EDG004

EXPERIMENTAL

EDG004 - Extended release lorazepam capsules

Drug: Extended-release lorazepam

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Extended-release lorazepam DRUG

Extended-release lorazepam capsules

Also known as: EDG004

EDG004

Placebo DRUG

Placebo capsules

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women between the ages of 18-65 years and
• Diagnosed with GAD and
• No other psychiatric conditions, and are otherwise medically healthy.

You may not qualify if:

• Women who are pregnant or lactating.

Sponsors & Collaborators

• Edgemont Pharmaceuticals, LLC: lead

Study Sites (1)

Multiple Investigational Sites

Multiple Locations, California, United States

Location

MeSH Terms

Conditions

Generalized Anxiety Disorder

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Results Point of Contact

• Title: Director of Regulatory Affairs and Product Development
• Organization: Cardinal Health Regulatory Sciences

david.rhein@cardinalhealth.com

913.451.3955

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2014
• First Posted: December 3, 2014
• Study Start: January 1, 2015
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: September 26, 2018
• Results First Posted: September 26, 2018

Record last verified: 2016-07

Locations

US (1)