NAC for Head Trauma-induced Anosmia

NCT03680911 | Terminated Phase 3 Results FDA Drug

• 1 other identifier: 20170856
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Anosmia; Head Trauma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Quality of Life Questionnaire

  4 months

Study Arms (2)

NAC Group

EXPERIMENTAL

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

Placebo Group

PLACEBO COMPARATOR

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

Interventions

N Acetyl Cysteine DRUG

2 g PO BID for 4 days, then 1.5 g PO BID for 2 days

NAC Group

Placebo oral capsule DRUG

2 g PO BID for 4 days, then 1.5 g PO BID for 2 days

Placebo Group

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

University Of Miami, Otolaryngology Department

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Anosmia; Craniocerebral Trauma

Interventions

Acetylcysteine

Condition Hierarchy (Ancestors)

Olfaction Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Roy R. Casiano, MD
• Organization: University of Miami

rcasiano@med.miami.edu

305-243-5290

Study Officials

• Roy Casiano, MD

  University of Miami

  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: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 29, 2018
• First Posted: September 21, 2018
• Study Start: October 12, 2018
• Primary Completion: January 7, 2020
• Study Completion: January 7, 2020
• Last Updated: February 4, 2021
• Results First Posted: February 4, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)