NAC for Head Trauma-induced Anosmia

University of Miami

Status and phase

Terminated

Phase 3

Conditions

Head Trauma

Anosmia

Treatments

Drug: N Acetyl Cysteine

Drug: Placebo oral capsule

Study type

Interventional

Funder types

Other

Identifiers

NCT03680911

20170856

Details and patient eligibility

About

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

Enrollment

7 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.