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NAC for Head Trauma-induced Anosmia

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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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

7 participants in 2 patient groups, including a placebo group

NAC Group
Experimental group
Description:
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
Treatment:
Drug: N Acetyl Cysteine
Placebo Group
Placebo Comparator group
Description:
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
Treatment:
Drug: Placebo oral capsule

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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