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Study for Efficacy and Dose Escalation of AD313 + Atomoxetine (SEED)

NCT05101122 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2023-04-07

Study results available
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Summary

The SEED study is designed to assess the safety and efficacy for Obstructive Sleep Apnea (OSA) of 3 escalating dose combinations of atomoxetine with AD313 compared to baseline and to atomoxetine alone.

Conditions

Interventions

DRUG

Dosing 1: Atomoxetine

Oral administration at bedtime

DRUG

AD313

Escalating dose of AD313; Oral administration at bedtime

Sponsors & Collaborators

  • Apnimed

    lead INDUSTRY

Principal Investigators

  • Ron Farkas, MD, PhD · Apnimed Inc.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
25 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-19
Primary Completion
2022-04-18
Completion
2022-04-18
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

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 NCT05101122 on ClinicalTrials.gov