Study for the assesment of the efficacy and safey of NUTROPIN® in patients with spinal cord injury (SCI) and growth hormone deficiency (GHD).

Phase 1

• Conditions: Spinal Cord Injury and Growth Hormone Deficiency; MedDRA version: 14.1Level: PTClassification code 10041558Term: Spinal cord injury thoracicSystem Organ Class: 10022117 - Injury, poisoning and procedural complications; MedDRA version: 14.1Level: PTClassification code 10041554Term: Spinal cord injury cervicalSystem Organ Class: 10022117 - Injury, poisoning and procedural complications; Therapeutic area: Body processes [G] - Bones and nerves physological processes [G11]

• Registration Number: EUCTR2011-005377-23-ES
• Lead Sponsor: Guillem Cuatrecasas Cambra

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-05-21
• Last Update Posted: 29 May 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

-Men or women aged 18 to 50 years (inclusive)
-Cervical or thoracic (dorsal) spine injuries (C5-T12)
-Complete lesions (ASIA A) with SSEP and EMG evaluation
-Stability of the recovery (at least 12 months since injury)
-Maintenance of muscular structure (no more than 24 months since injury)
-Partial (<10 ng/ml) or total (<5 ng/ml) GH deficiency (assessed by GH stimulation tests)
-Signed informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-Spinal cord injury of non-traumatic origin
-Adverse effects or hypersensitivity to GH or its excipients
-Lack of neurophysiological assessment/confirmation of SCI
-Previous very intensive rehabilitation
-Previous growth hormone therapy
-Evidence of any active malignancy or cancer in the last 5 years
-Acute illnesses at time of randomization
- Pregnancy
-Participation in another interventional study
-Inability to comply with the requirements of the study or who in the opinion of the investigator should not participate in the study

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Evaluate the efficacy and safety of Nutropin® in combination with intensive rehabilitation compared to placebo with intensive rehabilitation in patients with Spinal Cord Injury;Secondary Objective: - to assess QoL and spasticity changes<br>- to assess neurological motor and sensibility changes<br>- to assess safety;Primary end point(s): Changes in Spinal Cord Independence Measure (SCIM) III score;Timepoint(s) of evaluation of this end point: SCIM III will be assesed 4 times in 6 months: at visit 1 (day1), visit 2(month 1), visit 3(month 3) and visit 4 (month 6)

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): - Changes in quality of life: Nottingham Health Profile (NHP) score<br>- Neurological motor changes: percentage of patients with selective muscle activity >1 spinal metamere below lesion. <br>- Neurological profound and superficial sensory changes: percentage of patients with > 1 spinal metamere below lesion: Metamere neurological activity mapping (ASIA) at physical examination (Neurophysiology) confirmed by:<br> a.Electromyogram with measurement of individualized motor units to measure efferent motoneurons activity (A? and C fibers).<br> b.Somatosensory evoked potencials (SSEP) to measure direct posterior A? and A? fibers activity (Goll and Burdach posterior Fasciculae).<br>-Changes in spasticity assessment: Modified Ashworth Score (MAS) (Rehabilitation);Timepoint(s) of evaluation of this end point: Secondary endpoint will be assesed during the study visits (Visit 0, 1, 2, 3 and 4)