Trial Outcomes & Findings for Recombinant Human Growth Hormone During Rehabilitation From Traumatic Brain Injury. (NCT NCT00766038)

Last Updated: 2019-11-18

Results Overview

Processing Speed Index ages standardized score. In this scale, higher scores represent better functioning, lower scores represent poorer function. 100 = mean of a normative population. 110 = 1 standard deviation above normal; 90 = 1 standard deviation below normal 120 = 2 standard deviations above normal; 80 = 2 standard deviations below normal

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

63 participants

Primary outcome timeframe

6 months

Results posted on

2019-11-18

Participant Flow

Participant milestones

Participant milestones
Measure	Active Treatment With Recombinant Human Growth Hormone The GH treatment arm will receive a starting dose of 400 microgramsg/day, with increases (or decreases) in dose by 100-200 micrograms/day each month, monitoring for side effects, until goal IGF-1 (in the upper quartile of the range for age and body weight) is reached up to maximum dose of 1,000 microgramsg/day. Dose adjustments may be modified by the investigators for participants receiving oral estrogens or other circumstances know to influence GH dosing or atypical responses to treatment. Recombinant human Growth Hormone: 400 micrograms/day SC for 6 months. Dose adjusted based on serum IGF-1 measurements	Placebo Treatment Doses for participants receiving placebo will also be adjusted monthly to maintain the blinding. Placebo: SC injection daily
Overall Study STARTED	31	32
Overall Study COMPLETED	16	18
Overall Study NOT COMPLETED	15	14

Reasons for withdrawal

Reasons for withdrawal
Measure	Active Treatment With Recombinant Human Growth Hormone The GH treatment arm will receive a starting dose of 400 microgramsg/day, with increases (or decreases) in dose by 100-200 micrograms/day each month, monitoring for side effects, until goal IGF-1 (in the upper quartile of the range for age and body weight) is reached up to maximum dose of 1,000 microgramsg/day. Dose adjustments may be modified by the investigators for participants receiving oral estrogens or other circumstances know to influence GH dosing or atypical responses to treatment. Recombinant human Growth Hormone: 400 micrograms/day SC for 6 months. Dose adjusted based on serum IGF-1 measurements	Placebo Treatment Doses for participants receiving placebo will also be adjusted monthly to maintain the blinding. Placebo: SC injection daily
Overall Study Lost to Follow-up	15	14

Baseline Characteristics

Recombinant Human Growth Hormone During Rehabilitation From Traumatic Brain Injury.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment With Recombinant Human Growth Hormone n=31 Participants The GH treatment arm will receive a starting dose of 400 microgramsg/day, with increases (or decreases) in dose by 100-200 micrograms/day each month, monitoring for side effects, until goal IGF-1 (in the upper quartile of the range for age and body weight) is reached up to maximum dose of 1,000 microgramsg/day. Dose adjustments may be modified by the investigators for participants receiving oral estrogens or other circumstances know to influence GH dosing or atypical responses to treatment. Recombinant human Growth Hormone: 400 micrograms/day SC for 6 months. Dose adjusted based on serum IGF-1 measurements	Placebo Treatment n=32 Participants Doses for participants receiving placebo will also be adjusted monthly to maintain the blinding. Placebo: SC injection daily	Total n=63 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	31 Participants n=93 Participants	32 Participants n=4 Participants	63 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Continuous	32.2 years STANDARD_DEVIATION 15.2 • n=93 Participants	30.1 years STANDARD_DEVIATION 13.7 • n=4 Participants	31.1 years STANDARD_DEVIATION 14.3 • n=27 Participants
Sex: Female, Male Female	14 Participants n=93 Participants	15 Participants n=4 Participants	29 Participants n=27 Participants
Sex: Female, Male Male	17 Participants n=93 Participants	17 Participants n=4 Participants	34 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=93 Participants	4 Participants n=4 Participants	8 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	27 Participants n=93 Participants	28 Participants n=4 Participants	55 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	3 Participants n=93 Participants	2 Participants n=4 Participants	5 Participants n=27 Participants
Race (NIH/OMB) White	28 Participants n=93 Participants	30 Participants n=4 Participants	58 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
Region of Enrollment United States	31 Participants n=93 Participants	32 Participants n=4 Participants	63 Participants n=27 Participants
Baseline IGF-1 level < 1 SD below expected mean	3 Participants n=93 Participants	3 Participants n=4 Participants	6 Participants n=27 Participants
Baseline L-Arginine stimulation test	2.2 ng/mL n=93 Participants	1.2 ng/mL n=4 Participants	1.3 ng/mL n=27 Participants

PRIMARY outcome

Timeframe: 6 months

Outcome measures

Outcome measures
Measure	rhGH Treatment n=31 Participants The GH treatment arm will receive a starting dose of 400 microgramsg/day, with increases (or decreases) in dose by 100-200 micrograms/day each month, monitoring for side effects, until goal IGF-1 (in the upper quartile of the range for age and body weight) is reached up to maximum dose of 1,000 microgramsg/day. Dose adjustments may be modified by the investigators for participants receiving oral estrogens or other circumstances know to influence GH dosing or atypical responses to treatment. Recombinant human Growth Hormone: 400 micrograms/day SC for 6 months. Dose adjusted based on serum IGF-1 measurements	Placebo Treament n=32 Participants Doses for participants receiving placebo will also be adjusted monthly to maintain the blinding. Placebo: SC injection daily
Functional Outcome 6 Months After Injury, as Measured by the Processing Speed Index	82.5 Processing speed index standardized scor Interval 73.0 to 96.0	82.5 Processing speed index standardized scor Interval 79.0 to 99.0

SECONDARY outcome

Timeframe: 4 years

Serum levels of Insulin-Like Growth Factor-1.

Outcome measures

Outcome measures
Measure	rhGH Treatment n=31 Participants The GH treatment arm will receive a starting dose of 400 microgramsg/day, with increases (or decreases) in dose by 100-200 micrograms/day each month, monitoring for side effects, until goal IGF-1 (in the upper quartile of the range for age and body weight) is reached up to maximum dose of 1,000 microgramsg/day. Dose adjustments may be modified by the investigators for participants receiving oral estrogens or other circumstances know to influence GH dosing or atypical responses to treatment. Recombinant human Growth Hormone: 400 micrograms/day SC for 6 months. Dose adjusted based on serum IGF-1 measurements	Placebo Treament n=32 Participants Doses for participants receiving placebo will also be adjusted monthly to maintain the blinding. Placebo: SC injection daily
IGF-1 Levels.	245.5 ng/mL Interval 203.5 to 321.5	173.0 ng/mL Interval 145.0 to 237.0

SECONDARY outcome

Timeframe: 1 year

Outcome measures

Outcome measures
Measure	rhGH Treatment n=31 Participants The GH treatment arm will receive a starting dose of 400 microgramsg/day, with increases (or decreases) in dose by 100-200 micrograms/day each month, monitoring for side effects, until goal IGF-1 (in the upper quartile of the range for age and body weight) is reached up to maximum dose of 1,000 microgramsg/day. Dose adjustments may be modified by the investigators for participants receiving oral estrogens or other circumstances know to influence GH dosing or atypical responses to treatment. Recombinant human Growth Hormone: 400 micrograms/day SC for 6 months. Dose adjusted based on serum IGF-1 measurements	Placebo Treament n=32 Participants Doses for participants receiving placebo will also be adjusted monthly to maintain the blinding. Placebo: SC injection daily
Processing Speed Index 1 Year After Injury	86.0 Processing speed index standardized scor Interval 76.0 to 111.0	89.5 Processing speed index standardized scor Interval 81.0 to 99.0

SECONDARY outcome

Timeframe: 1 day

Measurement of serum GH levels over 90 minutes after administration of L-arginine

Outcome measures

Outcome measures
Measure	rhGH Treatment n=31 Participants The GH treatment arm will receive a starting dose of 400 microgramsg/day, with increases (or decreases) in dose by 100-200 micrograms/day each month, monitoring for side effects, until goal IGF-1 (in the upper quartile of the range for age and body weight) is reached up to maximum dose of 1,000 microgramsg/day. Dose adjustments may be modified by the investigators for participants receiving oral estrogens or other circumstances know to influence GH dosing or atypical responses to treatment. Recombinant human Growth Hormone: 400 micrograms/day SC for 6 months. Dose adjusted based on serum IGF-1 measurements	Placebo Treament n=32 Participants Doses for participants receiving placebo will also be adjusted monthly to maintain the blinding. Placebo: SC injection daily
GH Response to L-arginine Stimulation at Baseline	2.2 ng/mL Interval 0.6 to 5.9	1.2 ng/mL Interval 0.5 to 5.7

SECONDARY outcome

Timeframe: Baseline

Serum IGF-1 levels at baseline for both treatment groups was correlated with the Processing Speed Index recorded at baseline, using Pearson's correlation coefficient. Perason's correlation coefficient is a measure of the linear correlation between two variables X and Y. It has a value between +1 and -1, where 1 is total positive linear correlation, 0 is no linear correlation, and -1 is total negative linear correlation.

Outcome measures

Outcome measures
Measure	rhGH Treatment n=31 Participants The GH treatment arm will receive a starting dose of 400 microgramsg/day, with increases (or decreases) in dose by 100-200 micrograms/day each month, monitoring for side effects, until goal IGF-1 (in the upper quartile of the range for age and body weight) is reached up to maximum dose of 1,000 microgramsg/day. Dose adjustments may be modified by the investigators for participants receiving oral estrogens or other circumstances know to influence GH dosing or atypical responses to treatment. Recombinant human Growth Hormone: 400 micrograms/day SC for 6 months. Dose adjusted based on serum IGF-1 measurements	Placebo Treament n=32 Participants Doses for participants receiving placebo will also be adjusted monthly to maintain the blinding. Placebo: SC injection daily
IGF-1 Levels	0.1 Pearson's correlation coefficient	0.1 Pearson's correlation coefficient

SECONDARY outcome

Timeframe: 4 years

Rates of diabetes mellitus, arthralgias, or peripheral edema between rhGH treatment and placebo.

Outcome measures

Outcome measures
Measure	rhGH Treatment n=31 Participants The GH treatment arm will receive a starting dose of 400 microgramsg/day, with increases (or decreases) in dose by 100-200 micrograms/day each month, monitoring for side effects, until goal IGF-1 (in the upper quartile of the range for age and body weight) is reached up to maximum dose of 1,000 microgramsg/day. Dose adjustments may be modified by the investigators for participants receiving oral estrogens or other circumstances know to influence GH dosing or atypical responses to treatment. Recombinant human Growth Hormone: 400 micrograms/day SC for 6 months. Dose adjusted based on serum IGF-1 measurements	Placebo Treament n=32 Participants Doses for participants receiving placebo will also be adjusted monthly to maintain the blinding. Placebo: SC injection daily
Rates of Diabetes Mellitus, Arthralgias, or Peripheral Edema. Diabetes mellitus	0 Participants	0 Participants
Rates of Diabetes Mellitus, Arthralgias, or Peripheral Edema. Arthralgia	2 Participants	6 Participants
Rates of Diabetes Mellitus, Arthralgias, or Peripheral Edema. Peripheral edema	0 Participants	1 Participants
Rates of Diabetes Mellitus, Arthralgias, or Peripheral Edema. None	29 Participants	25 Participants

Adverse Events

Recombinant Human Growth Hormone

Serious events: 2 serious events

Other events: 12 other events

Deaths: 0 deaths

Placebo Treatment

Serious events: 2 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Recombinant Human Growth Hormone n=31 participants at risk The GH treatment arm will receive a starting dose of 400 microgramsg/day, with increases (or decreases) in dose by 100-200 micrograms/day each month, monitoring for side effects, until goal IGF-1 (in the upper quartile of the range for age and body weight) is reached up to maximum dose of 1,000 microgramsg/day. Dose adjustments may be modified by the investigators for participants receiving oral estrogens or other circumstances know to influence GH dosing or atypical responses to treatment. Recombinant human Growth Hormone: 400 micrograms/day SC for 6 months. Dose adjusted based on serum IGF-1 measurements	Placebo Treatment n=32 participants at risk Doses for participants receiving placebo will also be adjusted monthly to maintain the blinding. Placebo: SC injection daily
Nervous system disorders seizure	6.5% 2/31	6.2% 2/32

Other adverse events

Other adverse events
Measure	Recombinant Human Growth Hormone n=31 participants at risk The GH treatment arm will receive a starting dose of 400 microgramsg/day, with increases (or decreases) in dose by 100-200 micrograms/day each month, monitoring for side effects, until goal IGF-1 (in the upper quartile of the range for age and body weight) is reached up to maximum dose of 1,000 microgramsg/day. Dose adjustments may be modified by the investigators for participants receiving oral estrogens or other circumstances know to influence GH dosing or atypical responses to treatment. Recombinant human Growth Hormone: 400 micrograms/day SC for 6 months. Dose adjusted based on serum IGF-1 measurements	Placebo Treatment n=32 participants at risk Doses for participants receiving placebo will also be adjusted monthly to maintain the blinding. Placebo: SC injection daily
Musculoskeletal and connective tissue disorders Arthralgia	6.5% 2/31 • Number of events 2	18.8% 6/32 • Number of events 6
Nervous system disorders Headache	3.2% 1/31 • Number of events 31	9.4% 3/32 • Number of events 32
General disorders Elective Surgery	19.4% 6/31 • Number of events 31	12.5% 4/32 • Number of events 32
Musculoskeletal and connective tissue disorders Myalgia	3.2% 1/31 • Number of events 31	18.8% 6/32 • Number of events 32
Nervous system disorders Drowsiness	3.2% 1/31 • Number of events 31	3.1% 1/32 • Number of events 32
General disorders Dry mouth	3.2% 1/31 • Number of events 31	9.4% 3/32 • Number of events 32

Additional Information

Ramon Diaz-Arrastia

University of Pennsylvania

Phone: 215-662-9732

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place