Clinical trial NCT01329757: Efficacy and Safety of Growth Hormone Treatment in Spinal Cord Injury
Official title: Efficacy and Safety of Growth Hormone (GH) Treatment in Spinal Cord Injury(SCI): A Triple-blinded, Randomised, Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Spinal Cord Injury
Keywords: Spinal Cord Injury
Growth Hormone
Trauma
Incomplete
ASIA
Lead sponsor: Hospital Nacional de Parapléjicos de Toledo
Sponsor class: OTHER
Collaborators: name: Ministerio de Salud y Politicas Sociales (Ministry of Health)
First posted: 2011-04-06
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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)


Eligibility criteria: Inclusion Criteria:

* Traumatic Spinal cord injury
* Incomplete (ASIA scale B or C)
* Level of injury: Between C4 and D12
* More than 18 months from the SCI injury.

Exclusion Criteria:

* Non traumatic Spinal cord injury
* Complete SCI (ASIA A)
* Incomplete (ASIA D or E)
* Less than 18 months from the SCI
* Intensive Care Unit (ICU) staying for a period of 2 months or more
* More than 3 urological infections in the last year
* Pneumonia in the 6 months prior to the study
* Severe respiratory failure
* History of head trauma
* Severe psychiatric disorder
* A history of heart disease, diabetes or hypertension
* Concomitant Neurological Diseases
* Regular use of substances of abuse
* Patients with severe kidney and / or liver failure.
* Patients who can not be included in an intensive rehabilitation program
* Patients who are pregnant or breast-feeding
* History of malignancy
* Impossibility to obtain informed consent

Primary outcomes:
measure: Motor Score of the American Spinal Injury Association (ASIA) scale
timeFrame: 12 months
Secondary outcomes:
measure: ASIA
timeFrame: 12 months
measure: ASIA sensory score
timeFrame: 12 months
measure: Spasticity
timeFrame: Baseline, 15 days, 6 months, 12 months
measure: Pain
timeFrame: Baseline, 15 days, 6 months, 12 months
measure: Independence Measures and Quality of life
timeFrame: 12 months
measure: Neurophysiological Measures
timeFrame: 6 months and 12 months
measure: Safety
timeFrame: 15, 30, 60, 90, 120, 150, 180, 360 days
Other outcomes:
Locations:
city: Toledo
country: Spain
facility: Hospital Nacional de Paraplejicos
Study officials:
affiliation: Hospital Nacional de Paraplejicos
name: Antonio Oliviero, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: