High Dose Oxytocin Nasal Spray for Treatment of Tinnitus

NCT04210310 | Terminated Phase 3 Results DMC FDA Drug

• 1 other identifier: 19-01381
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the effects of high-dose intranasal oxytocin for treating tinnitus. The hypothesis is that high dose intranasal oxytocin can significantly reduce tinnitus severity and disability.

Conditions

Tinnitus

Outcome Measures

Primary Outcomes (1)

• Change in Visual Analogue Scale (VAS)-Rated Tinnitus Loudness

  Participants use a VAS to rate the loudness of tinnitus on an 11-point Likert scale. Total scores range from 0 (minimum) to 10 (maximum); higher scores indicate greater tinnitus loudness. No response to nasal spray is defined as a decrease in VAS Score of less than 2, while a patient-reported improvement is defined as a decrease in VAS Score of more than 3.

  Baseline, Week 9

Study Arms (2)

high-dose intranasal oxytocin

EXPERIMENTAL

Subjects will be asked to use one spray in one nostril 4 times daily (9AM, 1PM, 5PM and 9 PM). Subjects will take 4 sprays daily of oxytocin for the entire study.

Drug: Oxytocin

Nasal spray

PLACEBO COMPARATOR

Subjects swill be asked to use one spray in one nostril 4 times daily (9AM, 1PM, 5PM and 9 PM). The spray can be taken with or without food. Subjects will take 4 sprays daily of the placebo for the entire study.

Other: Placebo nasal spray

Interventions

Oxytocin DRUG

The investigational product, oxytocin nasal spray (45 units/0.1mL for 38mL) is composed of: oxytocin powder (0.3080g), magnesium chloride crystals (2.3100g), citric acid anhydrous gran. (0.1080g), sodium citrate powder (2.1500g), sterile water for irrigation (38.000mL), and Pcca Mucolox liquid base (3.8000mL). Subjects will be asked to self-administer the study medication with 1 puff in one nostril 4 times per day

Also known as: Pitocin

high-dose intranasal oxytocin

Placebo nasal spray OTHER

A placebo nasal spray, consisting of magnesium, chloride crystals, citric acid anhydrous gran., sodium citrate powder, sterile water for irrigation, and Pcca Mucolox liquid base. Both active drug and the placebo will appear identical in the glass bottles. The placebo will be administered in the same manner as the active study drug, with 1 puff in one nostril four times per day.

Nasal spray

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects with continuous perception of subjective tinnitus for ≥ 6 months duration.
• Subjects must have had a normal otolaryngologic evaluation within the past year with no evidence of otitis media or externa, a Tinnitus Handicap Inventory (THI) of \> 16.
• Subjects must have tinnitus loudness rating of \>4/10.

You may not qualify if:

• Subjects who are being treated for tinnitus \< 6 months due to the acute nature of their condition
• Subjects who have a slight handicap according to the Tinnitus Handicap Inventory Severity Scale.
• Those with tinnitus of a muscular or vascular etiology
• Subjects with conductive hearing loss, history of migraine, or prior use of oxytocin nasal spray.
• Women of childbearing age will not be approached for participation due to the risk of oxytocin-induced uterine contractions.
• Subjects who suffer from migraines.
• Subjects who have history of pulmonary edema, Congestive Heart Failure, and severe renal disease.

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

222 East 41st Street Ambulatory Care Center, Preston Robert Tisch Center for Men's Health

New York, New York, 10017, United States

Location

MeSH Terms

Conditions

Tinnitus

Interventions

Oxytocin

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Limitations and Caveats

Study was prematurely terminated due to PI/Study Team departure from institution. No outcome measure data collected or analyzed. All participants lost to follow-up.

Results Point of Contact

• Title: Lawrence Newman, MD
• Organization: NYU Langone Health - Preston Robert Tisch Center for Men's Health

Lawrence.Newman@nyulangone.org

646-754-2000

Study Officials

• Lawrence Newman, MD

  NYU Langone

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2019
• First Posted: December 24, 2019
• Study Start: January 15, 2020
• Primary Completion: May 10, 2022
• Study Completion: May 10, 2022
• Last Updated: October 5, 2022
• Results First Posted: October 5, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• Access Criteria: The investigator who proposed to use the data.Upon reasonable request. Requests should be directed to Lawrence.newman@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

Locations

US (1)