Efficacy and Safety of Growth Hormone Treatment in Spinal Cord Injury (GHSCI)
|ClinicalTrials.gov Identifier: NCT01329757|
Recruitment Status : Unknown
Verified January 2015 by Antonio Oliviero, Hospital Nacional de Parapléjicos de Toledo.
Recruitment status was: Active, not recruiting
First Posted : April 6, 2011
Last Update Posted : January 12, 2015
Objectives: To evaluate the efficacy and safety of one year treatment based on daily doses of exogenous growth hormone (GH) in patients with traumatic spinal cord injury. The first six months the pharmacological treatment will be associated to rehabilitation treatment.
The main hypothesis is that GH can improve motor function of patients with traumatic spinal cord injury below the lesion level. The hypothesis is based on possible effects of GH at muscle and synaptic level. GH can also promote axonal growth and regeneration.
Design: Clinical trial placebo-controlled, double-blind intervention with blind evaluation by third parties and blinding in the analysis of data (triple-blind design).
Duration of intervention and monitoring: 364 days.
Primary outcome measures. Changes of the American Spinal Injury Association (ASIA) scale (motor score)
|Condition or disease||Intervention/treatment||Phase|
|Spinal Cord Injury||Drug: GH Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||76 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Efficacy and Safety of Growth Hormone (GH) Treatment in Spinal Cord Injury(SCI): A Triple-blinded, Randomised, Placebo-controlled Trial|
|Study Start Date :||April 2011|
|Estimated Primary Completion Date :||November 2015|
|Estimated Study Completion Date :||November 2015|
Active Comparator: GH
Administration of a daily dose of GH (0.4mg)for 1 year
Administration of a subcutaneously injected daily dose of GH (0.4mg)for 1 year
Other Name: Genotonorm
Placebo Comparator: Placebo
Administration of a daily dose of placebo for 1 year
Administration of a subcutaneously injected daily dose of placebo for 1 year
Other Name: Provided by the Genotonorm producer (Pfizer)
- Motor Score of the American Spinal Injury Association (ASIA) scale [ Time Frame: 12 months ]Motor score of the ASIA scale reports the strenght of 10 key muscles in each body side (5 key muscles in upper limb and 5 key muscles in lower limb). The strenght is rated between 0 and 5 (Medical Research Council-MRC scale). The ASIA motor score range is between 0 and 100 (normal).
- ASIA [ Time Frame: 12 months ]ASIA grades
- ASIA sensory score [ Time Frame: 12 months ]ASIA sensory score
- Spasticity [ Time Frame: Baseline, 15 days, 6 months, 12 months ]Penn scale and Ashworth scale
- Pain [ Time Frame: Baseline, 15 days, 6 months, 12 months ]Visual analogic scale (VAS)
- Independence Measures and Quality of life [ Time Frame: 12 months ]Spinal Cord Indipendence Measures (SCIM) and the Quality of Life Questionnaire (EQ 5D)
- Neurophysiological Measures [ Time Frame: 6 months and 12 months ]Motor Evoked Potentials, Somatosensory Evoked Potentials, Motor Neurography
- Safety [ Time Frame: 15, 30, 60, 90, 120, 150, 180, 360 days ]Recording of any adverse event, full blood and urine examination
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01329757
|Hospital Nacional de Paraplejicos|
|Toledo, Spain, 45004|
|Principal Investigator:||Antonio Oliviero, MD, PhD||Hospital Nacional de Paraplejicos|