Trial Outcomes & Findings for NAC for Head Trauma-induced Anosmia (NCT NCT03680911)
NCT ID: NCT03680911
Last Updated: 2021-02-04
Results Overview
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.
TERMINATED
PHASE3
7 participants
4 months
2021-02-04
Participant Flow
Participant milestones
| Measure |
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
|
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
|
|---|---|---|
|
Visit 1 (Baseline)
STARTED
|
3
|
4
|
|
Visit 1 (Baseline)
COMPLETED
|
3
|
4
|
|
Visit 1 (Baseline)
NOT COMPLETED
|
0
|
0
|
|
At Home Treatment
STARTED
|
3
|
4
|
|
At Home Treatment
COMPLETED
|
0
|
1
|
|
At Home Treatment
NOT COMPLETED
|
3
|
3
|
|
Visit 2 (1 Month Follow up)
STARTED
|
0
|
1
|
|
Visit 2 (1 Month Follow up)
COMPLETED
|
0
|
1
|
|
Visit 2 (1 Month Follow up)
NOT COMPLETED
|
0
|
0
|
|
Visit 3 (4 Month Follow up)
STARTED
|
0
|
1
|
|
Visit 3 (4 Month Follow up)
COMPLETED
|
0
|
0
|
|
Visit 3 (4 Month Follow up)
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
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
|
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
|
|---|---|---|
|
At Home Treatment
Study Termination
|
3
|
0
|
|
At Home Treatment
Lost to Follow-up
|
0
|
1
|
|
At Home Treatment
Withdrawal by Subject
|
0
|
2
|
|
Visit 3 (4 Month Follow up)
Study Termination
|
0
|
1
|
Baseline Characteristics
NAC for Head Trauma-induced Anosmia
Baseline characteristics by cohort
| Measure |
NAC Group
n=3 Participants
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
|
Placebo Group
n=4 Participants
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
|
Total
n=7 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
48.3 years
STANDARD_DEVIATION 11.9 • n=99 Participants
|
36.8 years
STANDARD_DEVIATION 15.8 • n=107 Participants
|
41.7 years
STANDARD_DEVIATION 14.5 • n=206 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 4 monthsPopulation: 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.
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.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4 monthsPopulation: 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.
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.
Outcome measures
Outcome data not reported
Adverse Events
NAC Group
Placebo Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place