Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

COMPLETED Phase 3

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

NCT02305797 · View on ClinicalTrials.gov ↗

Study 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.

Interventions

  • DRUG Placebo
  • DRUG Extended-release lorazepam

Study Locations (1)

California

  • Multiple Investigational Sites — Multiple Locations

Trial Details

FieldValue
Enrollment Target 495 participants
Start Date 2015-01
Est. Completion 2016-05
Phase Phase 3

Sponsor

Edgemont Pharmaceuticals

1 total trials

Interested in This Trial?

Always speak with your doctor before enrolling in a clinical trial.

Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02305797

The ClinicalTrials.gov registry entry for NCT02305797 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 495 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Edgemont Pharmaceuticals, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Generalized Anxiety Disorder (GAD) appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT02305797 reports 1 study location spanning 1 distinct geographic area — top geographies include California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT02305797 about?

NCT02305797 is a clinical study titled "EDG004 Treatment of Adult Patients With Generalized Anxiety Disorder (GAD)". 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 stati...

What is the current status of trial NCT02305797?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 495 participants. The study started on 2015-01. Estimated completion is 2016-05.

What conditions does trial NCT02305797 study?

This clinical trial studies the following conditions: Generalized Anxiety Disorder (GAD). These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT02305797?

The interventions under investigation include: Placebo (DRUG), Extended-release lorazepam (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02305797?

This trial is sponsored by Edgemont Pharmaceuticals, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT02305797 being conducted?

This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial