NAC for Head Trauma-induced Anosmia

Anosmia Clinical Trial

Official title:

Early N-Acetyl Cysteine Treatment for Head Trauma-induced Anosmia

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03680911
• Other study ID #: 20170856
• Status: Terminated
• Phase: Phase 3
• Start date: October 12, 2018
• Est. completion date: January 7, 2020

Study information

• Verified date: February 2021
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: January 7, 2020
• Est. primary completion date: January 7, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anosmia
• Craniocerebral Trauma
• Head Trauma
• Olfaction Disorders
• Wounds and Injuries

Intervention

Drug:
• N Acetyl Cysteine
2 g PO BID for 4 days, then 1.5 g PO BID for 2 days
• Placebo oral capsule
2 g PO BID for 4 days, then 1.5 g PO BID for 2 days

Locations

Country	Name	City	State
United States	University Of Miami, Otolaryngology Department	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Quality of Life Questionnaire	Quality of life will be measured using the questionnaire for Olfactory Disorders (QOD). QOD has a total score from 0-75 with the higher score indicating a better quality of life.	4 months