NAC for Head Trauma-induced Anosmia

NCT ID: NCT03680911

Last Updated: 2021-02-04

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-12
• Study Completion Date: 2020-01-07

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: EXPERIMENTAL

N Acetyl Cysteine

Intervention Type: DRUG

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

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

Group Type: PLACEBO_COMPARATOR

Placebo oral capsule

Intervention Type: DRUG

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

Interventions

N Acetyl Cysteine

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

Intervention Type: DRUG

Placebo oral capsule

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

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Miami

OTHER

Sponsor Role: lead

Responsible Party

Roy R. Casiano

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Roy Casiano, MD

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

University Of Miami, Otolaryngology Department

Miami, Florida, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

20170856

Identifier Type: -

Identifier Source: org_study_id