NAC for Head Trauma-induced Anosmia

Phase 3

Terminated

• Conditions: Anosmia; Head Trauma
• Interventions: Drug: Placebo oral capsule; Drug: N Acetyl Cysteine

• Registration Number: NCT03680911
• Lead Sponsor: University of Miami

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

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-08-29
• Study First Submitted QC: 2018-09-19
• Study First Posted: 2018-09-21
• Study Start: 2018-10-12
• Primary Completion: 2020-01-07
• Study Completion: 2020-01-07
• Results First Submitted: 2020-12-21
• Status Verified: 2021-02
• Results First Submitted QC: 2021-02-03
• Last Update Submitted: 2021-02-03
• Results First Posted: 2021-02-04
• Last Update Posted: 2021-02-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 7

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Group	Placebo oral capsule	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
NAC Group	N Acetyl Cysteine	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

Primary Outcome Measures

Name	Time	Method
Olfactory Function	4 months	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.

Secondary Outcome Measures

Name	Time	Method
Quality of Life Questionnaire	4 months	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.

Trial Locations

Locations (1)

University Of Miami, Otolaryngology Department; 🇺🇸 Miami, Florida, United States