NAC for Head Trauma-induced Anosmia

Early N-Acetyl Cysteine Treatment for Head Trauma-induced Anosmia

This study will compare administration of N-Acetyl Cysteine (NAC) versus placebo for the treatment of olfactory loss due to head injury. The hypothesis is that treatment with NAC acutely after head injury will result in improved olfactory function

Study Overview

• Status: Terminated
• Conditions: Anosmia; Head Trauma
• Intervention / Treatment: Drug: N Acetyl Cysteine; Drug: Placebo oral capsule

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Florida
    • Miami, Florida, United States, 33136
      • University Of Miami, Otolaryngology Department

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Admitted to Ryder Trauma Center for observation acutely following head injury (i.e. concussion), with documented hyposmia or anosmia by University of Pennsylvania Smell Identification Test (SIT).
• Male or female, aged 18 years or older
• Provision of signed and dated informed consent form
• Stated willingness to comply with all study procedures and availability for the duration of the study
• Ability to take oral medication and be willing to adhere to the NAC regimen
• For females of reproductive potential: use of highly effective contraception for at least 1 month prior to screening and agreement to use such a method during study participation and for an additional 4 weeks after the end of NAC administration

Exclusion Criteria:

• Severe trauma requiring ongoing inpatient treatment beyond 48 hours
• Pregnancy (based on urine screening) or lactation
• Known allergic reactions to components of NAC, such as Mucomyst
• Currently taking nitrates such as nitroglycerine and/or isosorbide regularly
• Currently taking azathioprine (Imuran) or cyclophosphamide (Cytoxan)
• Known diagnosis of cystinuria (renal condition in which cysteine supplement should be avoided)
• Febrile illness within 1 week
• Treatment with another investigational drug or other intervention within 3 months
• Active sinonasal disease by imaging and/or nasal exam, i.e. rhinosinusitis, nasal polyps
• Adults unable to consent
• Prisoners, employees or subordinates
• Individuals who are not yet adults (infants, children, teenagers). This population is excluded because efficacy has not yet been established in adults.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NAC Group; NAC group will be administered orally as a 4 gram loading dose, followed by 2 g PO BID for 4 days, then 1.5 g PO BID for 2 days	Drug: N Acetyl Cysteine; 2 g PO BID for 4 days, then 1.5 g PO BID for 2 days
Placebo Comparator: Placebo Group; Placebo group will be administered orally as a 4 gram loading dose, followed by 2 g PO BID for 4 days, then 1.5 g PO BID for 2 days	Drug: Placebo oral capsule; 2 g PO BID for 4 days, then 1.5 g PO BID for 2 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Olfactory Function	Olfactory function will be measured using the University of Pennsylvania Smell Identification Test (UPSIT). The UPSIT is a self-administered 40-item test involving microencapsulated (scratch-and-sniff) odors with a forced-choice design. The total score ranges from 0-40 with the higher score indicating better olfactory function.	4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life Questionnaire	Quality of life will be measured using the questionnaire for Olfactory Disorders (QOD). QOD has a total score from 0-75 with the higher score indicating a better quality of life.	4 months

Collaborators and Investigators

• Sponsor: University of Miami
• Investigators: Principal Investigator: Roy Casiano, MD, University of Miami

Study record dates

Study Major Dates

• Study Start (Actual): October 12, 2018
• Primary Completion (Actual): January 7, 2020
• Study Completion (Actual): January 7, 2020

Study Registration Dates

• First Submitted: August 29, 2018
• First Submitted That Met QC Criteria: September 19, 2018
• First Posted (Actual): September 21, 2018

Study Record Updates

• Last Update Posted (Actual): February 4, 2021
• Last Update Submitted That Met QC Criteria: February 3, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Trauma, Nervous System; Sensation Disorders; Olfaction Disorders; Wounds and Injuries; Craniocerebral Trauma; Anosmia; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antiviral Agents; Protective Agents; Respiratory System Agents; Antioxidants; Antidotes; Free Radical Scavengers; Expectorants; Acetylcysteine; N-monoacetylcystine
• Other Study ID Numbers: 20170856

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No