Trial Outcomes & Findings for Effects of Growth Hormone on Cognition and Cerebral Metabolism in Adults With Growth Hormone Deficiency (NCT NCT01007071)

Last Updated: 2017-11-17

Results Overview

Functional MRI scans were to be performed at baseline and at 16 weeks. Changes in functional connectivity before and after 16 weeks of treatment were analyzed. The analysis involved approximately 40,000 paired sample t-tests. The dependent variable here for each subject is the correlation between the BOLD timeseries in the seed region (posterior cingulate cortex) and the BOLD timeseries in a given, standard space, brain voxel. This paired-sample t-test is run, separately, for every voxel in the brain. The pre-specified Outcome Measure intended to report the number of voxels that showed significant changes with active treatment. A preliminary analysis was conducted using a paired-sample t-test at each of the 40,000+ voxels, however, none of the voxels reached the level of significance. Since no significant voxels were detected, subsequent planned analyses were not performed, and summary level data cannot be reported for this Outcome Measure.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

11 participants

Primary outcome timeframe

Baseline and 16 weeks

Results posted on

2017-11-17

Participant Flow

Subjects were recruited from the neuroendocrine center at Stanford Hospital

All patients were naïve to study drug, per protocol and eligibility criteria. Therefore, no washouts or other required delays were part of the study.

Participant milestones

Participant milestones
Measure	Growth Hormone Subjects were randomized to receive growth Human Growth Hormone (1-134) (Nutropin) for 16 weeks	Placebo Subjects were randomized to receive placebo for 16 weeks, and then were immediately crossed over to receive active study drug for 16 weeks
Overall Study STARTED	6	5
Overall Study COMPLETED	6	5
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effects of Growth Hormone on Cognition and Cerebral Metabolism in Adults With Growth Hormone Deficiency

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Growth Hormone n=6 Participants Subjects were randomized to receive growth Human Growth Hormone (1-134) (Nutropin) for 16 weeks All subjects were diagnosed with growth hormone deficiency using standard testing.	Placebo n=5 Participants Subjects were randomized to receive placebo for 16 weeks, and then were immediately crossed over to receive active study drug for 16 weeks All subjects were diagnosed with growth hormone deficiency using standard testing.	Total n=11 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
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants	3 Participants n=7 Participants	9 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Region of Enrollment United States	6 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 16 weeks

Population: Preliminary analysis did not work as intended and subsequent data were not collected from any participants (please see the detailed explanation in the Measure Description).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 16 weeks

Executive function was assessed in part B of the 2-part Trail Making Test. In Part A, 25 circles are distributed over a sheet of paper, numbered 1 - 25, and the patient draws lines to connect the numbers in ascending order. In Part B, the circles include both numbers (1-13) and letters (A-L); as in Part A, the patient draws lines to connect the circles in an ascending pattern, but with the added task of alternating between the numbers and letters (i.e., 1-A-2-B-3-C, etc.). The patient is instructed to connect the circles as quickly as possible. The amount of time the patient takes to connect the circles is recorded as their score. If patients make an error, they are corrected then continue from the last correct circle. The number of seconds for completion of part B is reported, therefore higher scores reveal greater impairment.

Outcome measures

Outcome measures
Measure	Growth Hormone n=5 Participants Subjects randomized to growth hormone for 16 weeks Human Growth Hormone (1-134): Subjects to receive growth hormone	Placebo n=5 Participants Subjects randomized to placebo for 16 weeks Placebo: Subjects randomized to placebo
Neuropsychological Testing of Executive Function	69.4 seconds Standard Deviation 4.5	77.6 seconds Standard Deviation 25.5

Adverse Events

Human Growth Hormone (1-134)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Human Growth Hormone (1-134) n=6 participants at risk This arm received study drug for 16 weeks. There were no serious adverse events.	Placebo n=5 participants at risk This arm received placebo for 16 weeks. There were no serious adverse evens in this group.
Cardiac disorders chest pain	0.00% 0/6 • Data were collected during study (16 weeks) and for subsequent 4 months. No difference in definition.	20.0% 1/5 • Number of events 1 • Data were collected during study (16 weeks) and for subsequent 4 months. No difference in definition.

Additional Information

Dr. Laurence Katznelson

Stanford University

Phone: 650-736-9551

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place