Treatment Of Adult Growth Hormone Deficiency After Traumatic Brain Injury

Brain Injuries Clinical Trial

Official title:

Placebo Controlled Trial on the Efficacy of Growth Hormone Replacement Therapy in Patients With Growth Hormone Deficiency After Traumatic Brain Injury.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00555009
• Other study ID #: A6281289
• Status: Terminated
• Phase: Phase 4
• First received: October 24, 2007
• Last updated: June 1, 2010
• Start date: March 2008
• Est. completion date: January 2009

Study information

• Verified date: March 2009
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Agenzia Italiana del Farmaco (AIFA)
• Study type: Interventional

Clinical Trial Summary

To establish the effects of genotropin replacement on cognitive function in patients with severe growth hormone deficiency after traumatic brain injury.

Description:

The study was terminated on 15-Dec-2008 due to an inability to recruit the protocol specified patient population. The study has not been terminated due to any safety concerns.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Have had a previous traumatic brain injury (more than 1 year and less than 20 years) prior to the screening visit.

• Have an Extended Glasgow Outcome Scale (GOS-E) more than or equal to 5.

• Have proven GHD deficiency

Exclusion Criteria:

• Active systemic malignancy or active intracranial tumor. A successfully treated tumor or malignancy is not an exclusion criterion if the patient has not had active disease for 5 years and is not currently receiving maintenance chemotherapy, (except for basal cell skin cancers.

• Receiving treatment with prednisolone in doses above 10 mg/day or treatment with other oral glucocorticosteroids above replacement doses is not permitted throughout the study. Topical and inhaled corticosteroids are permitted.

• History of dementia unrelated to TBI

• History of benign intracranial hypertension

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Brain Injuries
• Dwarfism, Pituitary
• Endocrine System Diseases
• Growth Hormone Deficiency

Intervention

Drug:
• Genotropin
Subcutaneous injection, starting dose 0.2mg/day for males and 0.3mg/day for female with dose titration at 0.1mg to 0.2 mg increments in accordance to IGF-1 results for a total duration of 36 weeks.
• Placebo
Subcutaneous injection, with dummy dose titration for a total duration of 36 weeks.

Locations

Country	Name	City	State
France	Pfizer Investigational Site	Creteil Cedex
France	Pfizer Investigational Site	Paris Cedex 13
Italy	Pfizer Investigational Site	Ferrara
Italy	Pfizer Investigational Site	Roma
Netherlands	Pfizer Investigational Site	Rotterdam
Spain	Pfizer Investigational Site	Sevilla
Sweden	Pfizer Investigational Site	Göteborg
Sweden	Pfizer Investigational Site	Stockholm
United Kingdom	Pfizer Investigational Site	Salford	Manchester

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

France,  Italy,  Netherlands,  Spain,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in the Cognitive Function (CogState™) Composite Score at Week 36	CogState™: 7 tasks: Detection (Part A); Identification; One back working memory; Monitoring; One card learning; Prediction; Detection (Part B). Detection, Identification, Monitoring score range: 2 (worse) to 5 (best); One back working memory/one card learning score range: 0 (worse) to 1.57 (best); Prediction score range: 0 (worse) to 100 (best). Composite change score=average of cognitive change scores for each task at each postdrug assessment; total possible score: -300 to 300. Change=change from baseline (average of 2 postdose assessments). Positive composite score=improved performance.	Baseline, Week 36	No
Secondary	Change From Baseline in CogState™ at Week 12 and 24.	CogState™: 7 tasks: Detection (Part A); Identification; One back working memory; Monitoring; One card learning; Prediction; Detection (Part B). Detection, Identification, Monitoring score range: 2 (worse) to 5 (best); One back working memory/one card learning score range: 0 (worse) to 1.57 (best); Prediction score range: 0 (worse) to 100 (best). Composite change score=average of cognitive change scores for each task at each postdrug assessment; total possible score: -300 to 300. Change=change from baseline (average of 2 postdose assessments). Positive composite score=improved performance.	Baseline, Week 12 and 24	No
Secondary	Change From Baseline in Lean Body Mass and Fat Mass at Week 36	The change from Baseline values for lean body mass and fat mass is calculated as the difference between the parameter values at Visit 36, and the parameter values at Baseline.	Baseline, Week 36	No
Secondary	Change From Baseline in Neurological Outcome as Assessed by Extended Glasgow Outcome Scale (GOS-E) at Week 36	The GOS is widely used for assessing outcome after head injury and non-traumatic acute brain insults and is performed by a physician. The GOS-E uses eight points to assess disability and handicap. The GOS-E focuses on how the injury has affected functioning in major areas of life rather than on the particular deficits and symptoms caused by injury. The overall score ranges from 1-8; 1=Death and 8=Upper Good Recovery	Baseline, Week 36	No
Secondary	Change From Baseline in Quality of Life Using Short Form (SF)-36 Health Survey at Week 36	A subject administered scale assessing general quality of life. A subject administered score, scale, direction of scale. The SF-36 consists of 36 questions covering the following eight health domains (subscales): Physical Functioning, Bodily Pain, Role Limitations Due to Physical Problems, Role Limitations Due to Emotional Problems, General Health Perceptions, Mental Health, Social Function, Vitality.	Baseline, Week 36	No
Secondary	Change From Baseline In Assessment of Growth Hormone Deficiency in Adults (AGHDA) Questionnaires at Week 36	The AGHDA is a quality of life subject-administered questionnaire that is condition-specific and comprises of 25 'Yes' or 'No' statements covering 6 dimensions - mobility, pain, energy, sleep, emotional reactions and social isolation. The AGHDA total score change from Baseline values is calculated as the difference between the total score at Visit 6 (Week 36), and the total score at Baseline.	Baseline, Week 36	No
Secondary	Change From Baseline in Cardiovascular Risk	The cardiovascular risk parameters (low-density lipoprotein-cholesterol, high-density lipoprotein cholesterol, total cholesterol and fasting triglycerides) was measured at all visits (Weeks 2, 4, 12, 24, and 36).	Baseline, Weeks 2, 4, 12, 24, and 36	No
Secondary	Change From Baseline in Weight		Baseline, Weeks 2, 4, 12, 24, and 36	No
Secondary	Change From Baseline in Waist Circumference		Baseline, Weeks 2, 4, 12, 24, and 36	No

External Links

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