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

A phase II, single-center, prospective, randomized, double-blind, parallel and placebo-controlled pilot clinical study to assess the efficacy and safety of NUTROPIN® in combination with intensive rehabilitation in adults with spinal cord injury (SCI) and growth hormone deficiency (GHD).

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-005377-23-ES

Enrollment

Registered

2012-05-21

Start date

2012-07-18

Completion date

Unknown

Last updated

2017-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spinal Cord Injury and Growth Hormone Deficiency MedDRA version: 14.1 Level: PT Classification code 10041558 Term: Spinal cord injury thoracic System Organ Class: 10022117 - Injury, poisoning and procedural complications MedDRA version: 14.1 Level: PT Classification code 10041554 Term: Spinal cord injury cervical System Organ Class: 10022117 - Injury, poisoning and procedural complications

Interventions

Trade Name: NUTROPIN Product Name: NutropinAq 10 mg/2 ml (30 UI) Pharmaceutical Form: Solution for injection INN or Proposed INN: SOMATROPIN CAS Number: 12629-01-5 Concentration unit: mg/kg milligram(

Eligibility

Sex/Gender

All

Inclusion criteria

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 (=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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 - to assess neurological motor and sensibility changes - 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)	—

Measure

Time frame

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 - to assess neurological motor and sensibility changes - 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

Measure	Time frame
Secondary end point(s): - Changes in quality of life: Nottingham Health Profile (NHP) score - Neurological motor changes: percentage of patients with selective muscle activity >1 spinal metamere below lesion. - 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: a.Electromyogram with measurement of individualized motor units to measure efferent motoneurons activity (A? and C fibers). b.Somatosensory evoked potencials (SSEP) to measure direct posterior A? and A? fibers activity (Goll and Burdach posterior Fasciculae). -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)	—

Measure

Time frame

Secondary end point(s): - Changes in quality of life: Nottingham Health Profile (NHP) score - Neurological motor changes: percentage of patients with selective muscle activity >1 spinal metamere below lesion. - 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: a.Electromyogram with measurement of individualized motor units to measure efferent motoneurons activity (A? and C fibers). b.Somatosensory evoked potencials (SSEP) to measure direct posterior A? and A? fibers activity (Goll and Burdach posterior Fasciculae). -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)

—

Countries

Spain

Contacts

Public ContactJoan Romero Càlix

Fundación Step by Step

jromero@fundacionsbs.org34932231663

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026