AnosmiaPhase 3NCT03680911
NAC for Head Trauma-induced Anosmia
A Phase 3 study testing N Acetyl Cysteine in people with Anosmia and Head Trauma, run by University of Miami at 1 site in United States.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anosmia, Head Trauma
- What is being tested?
- N Acetyl Cysteine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Oct 2018to 7 Jan 2020
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 12Show fewer
- 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 locations and contacts
1 site in 1 country.
United States1 site
University Of Miami, Otolaryngology Department
Miami, Florida, 33136
About this study
Official title: Early N-Acetyl Cysteine Treatment for Head Trauma-induced Anosmia
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
- Conditions
- Anosmia, Head Trauma
- Being tested
- N Acetyl Cysteine, Placebo oral capsule
- Medical subject headings
- Anosmia, Craniocerebral Trauma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N Acetyl CysteineDrug
2 g PO BID for 4 days, then 1.5 g PO BID for 2 days
Placebo oral capsuleDrug
2 g PO BID for 4 days, then 1.5 g PO BID for 2 days
| Study group | Role | What they receive |
|---|---|---|
| NAC Group | Experimental | 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 Receives: Drug: N Acetyl Cysteine |
| Placebo Group | Placebo comparator | 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 Receives: Drug: Placebo oral capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 months
Secondary outcomes (1)
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.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2018
- Study start12 Oct 2018
- Primary completion7 Jan 2020
- Study completion7 Jan 2020
Why it stopped: Poor participant compliance
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AnosmiaStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roy R. Casiano, University of Miami
- Investigators
- Roy Casiano, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03680911
- Sponsor's protocol ID
- 20170856
- Status last verified
- Feb 2021
- First submitted
- 29 Aug 2018
- Last updated
- 4 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early N-Acetyl Cysteine Treatment for Head Trauma-induced Anosmia
- ClinicalTrials.gov ID
- NCT03680911
- Acronym / sponsor ID
- 20170856
- Conditions
- Anosmia, Head Trauma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Poor participant compliance
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 12 Oct 2018 (actual)
- Primary completion
- 7 Jan 2020 (actual)
- Study completion
- 7 Jan 2020 (actual)
- First posted
- 21 Sep 2018 (actual)
- Results
- Posted 4 Feb 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NAC Group | Experimental | Drug: N Acetyl CysteineNAC 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 | Placebo comparator | Drug: Placebo oral capsulePlacebo 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| N Acetyl Cysteine2 g PO BID for 4 days, then 1.5 g PO BID for 2 days | Drug | NAC Group |
| Placebo oral capsule2 g PO BID for 4 days, then 1.5 g PO BID for 2 days | Drug | Placebo Group |
Primary outcome
Olfactory Function
Time frame: 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.
1 secondary outcome
Quality of Life Questionnaire
Time frame: 4 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roy Casiano, MD principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing N Acetyl Cysteine in people with Anosmia and Head Trauma, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Olfactory Function (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2021.