NAC for Head Trauma-induced Anosmia

• Status: Terminated
• Trial end date: 2020-01-07
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bradley Goldstein; University of Miami
• Treatments: Acetylcysteine; N-monoacetylcystine

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.