Trial Outcomes & Findings for Neuroendocrine Dysfunction in Traumatic Brain Injury: Effects of Testosterone Therapy (NCT NCT01201863)

Results Overview

The FIM is the most widely accepted functional assessment measure in use in the rehabilitation community in the US. It is an 18-item ordinal clinician rating scale that is useful for assessment of functional skills progress during inpatient rehabilitation. It measures levels of independent/dependent performance of 13 motor functions and 5 cognitive functions. By adding the points for each item, the possible total score ranges from 18 to 126, with higher numbers indicating better performance. A restricted FIM total score that eliminated the toileting, bladder management and bowel management items was computed and used in the final analysis with scores ranging from 14-105). The restricted FIM total score was used as the primary outcome measure.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

46 participants

Primary outcome timeframe

Administered at baseline and every other week for up to 12 weeks with 7 total possible administrations.

Results posted on

2021-07-27

Participant Flow

Male in-patients with TBI at Craig Hospital meeting study criteria were screened from November 1, 2010 through July 24, 2014:

A total of 46 participants meeting all criteria were enrolled and randomized of which 22 had low testosterone levels, and 24 who had normal T were followed as controls. The total number who started and were followed was 46.

Participant milestones

Participant milestones
Measure	Intervention - Treatment Men with TBI meeting study criteria with Low Testosterone levels will be randomly assigned to either a treatment or placebo group. They will participate in blood assays at baseline and every other week for 12 weeks during inpatient rehabilitation hospitalization. They will also be scored on the FIM (primary outcome measure) and the NIH Toolbox (Secondary Outcome Measure. Androgel (Testosterone Gel): 2.5 gram stickpacks administered with starting dosage of 5g increasing to a max of 10g.	Intervention Placebo Men with TBI meeting study criteria with Low Testosterone levels will be randomly assigned to either a treatment or placebo group. They will participate in blood assays at baseline and every other week for 12 weeks during inpatient rehabilitation hospitalization. They will also be scored on the FIM (primary outcome measure) and the NIH Toolbox (Secondary Outcome Measure. Androgel Placebo: 2.5 gram stickpacks with starting dose of 5g increasing to max of 10g.	Normal - No Intervention Enrolled participants with normal T
Overall Study STARTED	12	10	24
Overall Study COMPLETED	11	6	18
Overall Study NOT COMPLETED	1	4	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Neuroendocrine Dysfunction in Traumatic Brain Injury: Effects of Testosterone Therapy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Low T Intervention - Treatment n=12 Participants Men with TBI meeting study criteria with Low Testosterone levels were randomly assigned to either a treatment or placebo group. They will participate in blood assays at baseline and every other week for 12 weeks during inpatient rehabilitation hospitalization. They will also be scored on the FIM (primary outcome measure) and the NIH Toolbox (Secondary Outcome Measure. Androgel (Testosterone Gel): 2.5 gram stickpacks administered with starting dosage of 5g increasing to a max of 10g.	Low T Intervention - Placebo n=10 Participants Men with TBI meeting study criteria with Low Testosterone levels were randomly assigned to either a treatment or placebo group. They will participate in blood assays at baseline and every other week for 12 weeks during inpatient rehabilitation hospitalization. They will also be scored on the FIM (primary outcome measure) and the NIH Toolbox (Secondary Outcome Measure. Androgel Placebo: 2.5 gram stickpacks with starting dose of 5g increasing to max of 10g.	Normal T No Intervention - Followed n=24 Participants A subset of men with TBI meeting study criteria with Normal Testosterone levels were assessed at all data collection time points. They will participate in blood assays at baseline and every other week for 12 weeks during inpatient rehabilitation hospitalization. They will also be scored on the FIM (primary outcome measure) and the NIH Toolbox (Secondary Outcome Measure.	Total n=46 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=5 Participants	10 Participants n=7 Participants	24 Participants n=5 Participants	46 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	10 Participants n=7 Participants	24 Participants n=5 Participants	46 Participants n=4 Participants

PRIMARY outcome

Timeframe: Administered at baseline and every other week for up to 12 weeks with 7 total possible administrations.

The FIM is the most widely accepted functional assessment measure in use in the rehabilitation community in the US. It is an 18-item ordinal clinician rating scale that is useful for assessment of functional skills progress during inpatient rehabilitation. It measures levels of independent/dependent performance of 13 motor functions and 5 cognitive functions. By adding the points for each item, the possible total score ranges from 18 to 126, with higher numbers indicating better performance. A restricted FIM total score that eliminated the toileting, bladder management and bowel management items was computed and used in the final analysis with scores ranging from 14-105). The restricted FIM total score was used as the primary outcome measure.

Outcome measures

Outcome measures
Measure	Intervention Placebo n=6 Participants Men with TBI meeting study criteria with Low Testosterone levels were randomly assigned to either a treatment or placebo group. They participated in blood assays at baseline and every other week for up to 12 weeks during inpatient rehabilitation hospitalization. At the same assessment points, they were also scored on the FIM (primary outcome measure) and were administered the NIH Toolbox (Secondary Outcome Measure). Androgel Placebo: 2.5 gram stickpacks with starting dose of 5g increasing to max of 10g.	No Intervention n=18 Participants Men with TBI and normal T were followed for assessments only. They participated in blood assays at baseline and every other week for up to 12 weeks during inpatient rehabilitation hospitalization. At the same assessment points, they were also scored on the FIM (primary outcome measure) and were administered the NIH Toolbox (Secondary Outcome Measure).	Intervention - Treatment n=11 Participants Men with TBI meeting study criteria with Low Testosterone levels were randomly assigned to either a treatment or placebo group. They participated in blood assays at baseline and every other week for up to 12 weeks during inpatient rehabilitation hospitalization. At the same assessment points, they were also scored on the FIM (primary outcome measure) and were administered the NIH Toolbox (Secondary Outcome Measure). Androgel (Testosterone Gel): 2.5 gram stickpacks administered with starting dosage of 5g increasing to a max of 10g.
Restricted Functional Independence Measure (FIM) Baseline	16 units on a scale Interval 14.0 to 29.0	21 units on a scale Interval 14.0 to 59.0	34 units on a scale Interval 14.0 to 61.0
Restricted Functional Independence Measure (FIM) Six Week	31 units on a scale Interval 20.0 to 73.0	36 units on a scale Interval 14.0 to 94.0	52 units on a scale Interval 22.0 to 98.0

Adverse Events

Low T Intervention - Treatment

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Low T Intervention - Placebo

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Normal T - No Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Low T Intervention - Treatment n=13 participants at risk Men with TBI meeting study criteria with Low Testosterone levels will be randomly assigned to either a treatment or placebo group. They will participate in blood assays at baseline and every other week for 12 weeks during inpatient rehabilitation hospitalization. They will also be scored on the FIM (primary outcome measure) and the NIH Toolbox (Secondary Outcome Measure). Androgel (Testosterone Gel): 2.5 gram stickpacks administered with starting dosage of 5g increasing to a max of 10g.	Low T Intervention - Placebo n=10 participants at risk Men with TBI meeting study criteria with Low Testosterone levels will be randomly assigned to either a treatment or placebo group. They will participate in blood assays at baseline and every other week for 12 weeks during inpatient rehabilitation hospitalization. They will also be scored on the FIM (primary outcome measure) and the NIH Toolbox (Secondary Outcome Measure). Androgel Placebo: 2.5 gram stickpacks with starting dose of 5g increasing to max of 10g.	Normal T - No Intervention n=24 participants at risk A subset of men with TBI meeting study criteria with Normal Testosterone levels will participate in blood assays at baseline and every other week for 12 weeks during inpatient rehabilitation hospitalization. They will also be scored on the FIM (primary outcome measure) and the NIH Toolbox (Secondary Outcome Measure).
Hepatobiliary disorders Elevated ALT	7.7% 1/13 • Number of events 1	0.00% 0/10	0.00% 0/24
Endocrine disorders greater than 100 ng/dl total testosterone change from screen to baseline	7.7% 1/13 • Number of events 1	20.0% 2/10 • Number of events 2	0.00% 0/24
Renal and urinary disorders Elevated PSA	0.00% 0/13	10.0% 1/10 • Number of events 1	0.00% 0/24

Additional Information

Don Gerber, PsyD

Craig Hospital

Phone: 303-789-8478

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place