Overview

This trial is active, not recruiting.

Condition spinal cord injury
Treatments gh, placebo
Phase phase 3
Sponsor Hospital Nacional de Parapléjicos de Toledo
Collaborator Ministerio de Salud y Politicas Sociales (Ministry of Health)
Start date April 2011
End date November 2015
Trial size 76 participants
Trial identifier NCT01329757, FHNP-CT001

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)

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
Administration of a daily dose of GH (0.4mg)for 1 year
gh Genotonorm
Administration of a subcutaneously injected daily dose of GH (0.4mg)for 1 year
(Placebo Comparator)
Administration of a daily dose of placebo for 1 year
placebo Provided by the Genotonorm producer (Pfizer)
Administration of a subcutaneously injected daily dose of placebo for 1 year

Primary Outcomes

Measure
Motor Score of the American Spinal Injury Association (ASIA) scale
time frame: 12 months

Secondary Outcomes

Measure
ASIA
time frame: 12 months
ASIA sensory score
time frame: 12 months
Spasticity
time frame: Baseline, 15 days, 6 months, 12 months
Pain
time frame: Baseline, 15 days, 6 months, 12 months
Independence Measures and Quality of life
time frame: 12 months
Neurophysiological Measures
time frame: 6 months and 12 months
Safety
time frame: 15, 30, 60, 90, 120, 150, 180, 360 days

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

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

Additional Information

Official title Efficacy and Safety of Growth Hormone (GH) Treatment in Spinal Cord Injury(SCI): A Triple-blinded, Randomised, Placebo-controlled Trial
Principal investigator Antonio Oliviero, MD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in January 2015.
Information provided to ClinicalTrials.gov by Hospital Nacional de Parapléjicos de Toledo.