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Study of AD128 Versus Placebo in Obstructive Sleep Apnea

NCT04449133 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2021-09-27

No results posted yet for this study

Summary

Obstructive Sleep Apnea (OSA) is the most common and serious of the sleep disorders. Long-term, OSA is associated with increased morbidity and mortality, with a number of adverse cardiovascular, neurocognitive, metabolic, and daytime functioning consequences. No drugs are currently approved for OSA treatment.

This is a randomized, double blind, placebo controlled, cross-over, inpatient phase 2 clinical trial to examine the efficacy and the safety of a fixed dose level of AD128 in patients with OSA.

Conditions

Interventions

DRUG

AD128

Oral administration of two capsules before sleep for 7 days.

DRUG

Placebo

Oral administration of two capsules before sleep for 7 days.

Sponsors & Collaborators

  • YGHEA, CRO Division of Ecol Studio spa

    collaborator INDUSTRY

  • STM Pharma PRO srl

    collaborator UNKNOWN

  • Apnimed Inc.

    collaborator UNKNOWN

  • Istituto Auxologico Italiano

    lead OTHER

Principal Investigators

  • Elisa Perger, MD · Istituto Auxologico Italiano

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-03
Primary Completion
2020-10-30
Completion
2020-10-31

Countries

  • Italy

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04449133 on ClinicalTrials.gov