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Poor participant compliance
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| N Acetyl Cysteine | Drug | 2 g PO BID for 4 days, then 1.5 g PO BID for 2 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Roy Casiano, MD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Of Miami, Otolaryngology Department | Miami | Florida | 33136 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | NAC Group | 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 N Acetyl Cysteine: 2 g PO BID for 4 days, then 1.5 g PO BID for 2 days |
| FG001 | Placebo Group | 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 Placebo oral capsule: 2 g PO BID for 4 days, then 1.5 g PO BID for 2 days |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Visit 1 (Baseline) |
| |||||||||||||
| At Home Treatment |
| |||||||||||||
| Visit 2 (1 Month Follow up) |
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| Visit 3 (4 Month Follow up) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | NAC Group | 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 N Acetyl Cysteine: 2 g PO BID for 4 days, then 1.5 g PO BID for 2 days |
| BG001 | Placebo Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Data will not be reported due to confidentiality, there was only one participant to complete the 1 month follow up visit. Study was terminated prior to the remaining participants completing any follow up visits as per protocol. | Posted | 4 months |
|
19 weeks
Only treatment-related adverse events are collected and reported. Non-treatment related Adverse Events were not monitored/assessed.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | NAC Group | 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 N Acetyl Cysteine: 2 g PO BID for 4 days, then 1.5 g PO BID for 2 days |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Roy R. Casiano, MD | University of Miami | 305-243-5290 | rcasiano@med.miami.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 19, 2019 | Dec 21, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000086582 | Anosmia |
| D006259 | Craniocerebral Trauma |
| ID | Term |
|---|---|
| D000857 | Olfaction Disorders |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000111 | Acetylcysteine |
| ID | Term |
|---|---|
| D003545 | Cysteine |
| D000603 | Amino Acids, Sulfur |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| Placebo oral capsule |
| Drug |
2 g PO BID for 4 days, then 1.5 g PO BID for 2 days |
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| NOT COMPLETED |
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| NOT COMPLETED |
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| NOT COMPLETED |
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|
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
Placebo oral capsule: 2 g PO BID for 4 days, then 1.5 g PO BID for 2 days
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 |
| Placebo Group |
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 Placebo oral capsule: 2 g PO BID for 4 days, then 1.5 g PO BID for 2 days |
|
| 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. | Data will not be reported due to confidentiality, there was only one participant to complete the 1 month follow up visit. Study was terminated prior to the remaining participants completing any follow up visits as per protocol. | Posted | 4 months |
|
|
| 0 |
| 3 |
| 0 |
| 3 |
| 0 |
| 3 |
| EG001 | Placebo Group | 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 Placebo oral capsule: 2 g PO BID for 4 days, then 1.5 g PO BID for 2 days | 0 | 4 | 0 | 4 | 0 | 4 |
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| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D000596 |
| Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |