Trial Outcomes & Findings for NAC for Head Trauma-induced Anosmia (NCT 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.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

7 participants

Primary outcome timeframe

4 months

Results posted on

2021-02-04

Participant Flow

Participant milestones

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

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

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=93 Participants	36.8 years STANDARD_DEVIATION 15.8 • n=4 Participants	41.7 years STANDARD_DEVIATION 14.5 • n=27 Participants
Sex: Female, Male Female	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Sex: Female, Male Male	3 Participants n=93 Participants	4 Participants n=4 Participants	7 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=93 Participants	4 Participants n=4 Participants	6 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Black or African American	2 Participants n=93 Participants	3 Participants n=4 Participants	5 Participants n=27 Participants
Race (NIH/OMB) White	1 Participants n=93 Participants	1 Participants n=4 Participants	2 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants

PRIMARY outcome

Timeframe: 4 months

Population: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

Adverse Events

NAC Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Roy R. Casiano, MD

University of Miami

Phone: 305-243-5290

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place