Back to resultsNAC for Head Trauma-induced Anosmia
Primary Purpose
Anosmia, Head Trauma
Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
N Acetyl Cysteine
Placebo oral capsule
Sponsored by
About this trial
This is an interventional treatment trial for Anosmia
Eligibility 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.
Sites / Locations
- University Of Miami, Otolaryngology Department
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
NAC Group
Placebo Group
Arm 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
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
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03680911
Brief Title
NAC for Head Trauma-induced Anosmia
Official Title
Early N-Acetyl Cysteine Treatment for Head Trauma-induced Anosmia
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Terminated
Why Stopped
Poor participant compliance
Study Start Date
October 12, 2018 (Actual)
Primary Completion Date
January 7, 2020 (Actual)
Study Completion Date
January 7, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anosmia, Head Trauma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
NAC Group
Arm Type
Experimental
Arm 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
Arm Title
Placebo Group
Arm Type
Placebo Comparator
Arm 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
Intervention Type
Drug
Intervention Name(s)
N Acetyl Cysteine
Intervention Description
2 g PO BID for 4 days, then 1.5 g PO BID for 2 days
Intervention Type
Drug
Intervention Name(s)
Placebo oral capsule
Intervention Description
2 g PO BID for 4 days, then 1.5 g PO BID for 2 days
Primary Outcome Measure Information:
Title
Olfactory Function
Description
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.
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Quality of Life Questionnaire
Description
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.
Time Frame
4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roy Casiano, MD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Of Miami, Otolaryngology Department
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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NAC for Head Trauma-induced Anosmia
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