The present study will investigate the benefits of Genotropin® in patients suffering from severe GH deficiency after TBI and will focus on the potential effects on cognitive functionThe primary objective of this study is to establish the effects of…
ID
Source
Brief title
Condition
- Hypothalamus and pituitary gland disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is the change from baseline in the CogState* composite
score at Week 36.
Secondary outcome
• Change from baseline in CogState* composite score at Week 12 and 24.
• Change from baseline in lean body mass and fat mass (kg) as measured by Dual
Energy X-ray Absorptiometry (DXA) at Week 36.
• Change from baseline in neurological outcome as assessed by the Extended
Glasgow-Outcome-Scale (GOS-E) at Week 36.
• Change from baseline in quality of life using SF-36 Health Survey at Week 36.
• Change from baseline in Assessment of Growth Hormone Deficiency in Adults
(AGHDA) questionnaires at Week 36.
Background summary
Genotropin® is somatropin (in injectible form) and is able to replace the human
growth hormone because it is a copy of the natural growth hormone made by the
body*s pituitary gland. The only difference is Genotropin® is a man-made
product. Genotropin® is approved for the treatment in adults for growth
hormone deficiency and it has been used in over 53,000 patients worldwide and
this drug has been studied for over 10 years.
Study objective
The present study will investigate the benefits of Genotropin® in patients
suffering from severe GH deficiency after TBI and will focus on the potential
effects on cognitive function
The primary objective of this study is to establish the effects of Growth
Hormone (GH) replacement in patients with severe GH deficiency after Traumatic
Brain Injury (TBI) on cognitive function.
Study design
This study will enroll approximately 120 patients and will comprise of 2
phases, a screening phase and a 36-week multicenter, double-blind,
placebo-controlled phase:
1. The screening phase will be up to 1 month on subjects who have suffered a
TBI and have proven or suspected GH deficiency (after testing).
2. The double-blind treatment phase will be 36 weeks during which eligible
subjects will receive placebo or recombinant growth hormone in a 1:1
randomization ratio.
Intervention
Subjects randomized to receive treatment with Genotropin® (somatropin) will be
initiated at a dosage of 0.2 mg/day s.c. in men and 0.3 mg/day s.c. in women.
Dose adaptation will take place monthly until the subject has stabilized in the
upper half of the normal range.
Study burden and risks
Besides the treatment patients will undergo:
-pulse and blood pressure (5x)
-Waist Circumference (2x)
-pregnancy test (1x)
-blood draw (4x)
-body composition DXA machine (2x)
-cognitive function test (5x)
-2 questionnaires (2x), 1 questionnaire (3x)
Some of the side effects are:
• Fluid retention - causing swelling.
• Stiffness of the extremities
• Myalgia (muscle pain/aches)
• Arthralgia (Severe Joint pain)
• Paraesthesia (skin sensation, burning, prickling, itching, tingling with no
apparent physical cause.)
These side effects are common and can occur in 1 to 10% of patients, and:
• Diabetes type II
• Headache (due to benign intracranial hypertension)
These side effects are rare and occur only in 0.01% of patients.
Redness, swelling and bruising might develop on the location of injection.
Rivium Westlaan 142
2909 LD Capelle a/d IJssel
Nederland
Rivium Westlaan 142
2909 LD Capelle a/d IJssel
Nederland
Listed location countries
Age
Inclusion criteria
1) Be at least 18 years of age and at the age of legal consent, and no older than 55 years of age (men and women).;2)Have had a previous TBI (more than 1 year and less than 10 years) prior to the screening visit.;3) Have proven severe GH deficiency as diagnosed by dynamic testing within the last 6 months.
Exclusion criteria
1) Has any current malignancy except:
a. Those >5 years ago without recurrence.
b. Excised basal cell carcinoma or squamous cell cancer.
2) History of cranial irradiation.
3) Growth hormone replacement therapy in the last 12 months.
4) History of hypothalamic / pituitary disease which was diagnosed prior to TBI.
5) History of dementia unrelated to TBI.
6) History of benign intracranial hypertension.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2007-003586-41-NL |
| CCMO | NL19113.078.07 |