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

• Register: EUCTR
• Last refreshed on: 29 May 2017
• Main ID: EUCTR2011-005377-23-ES
• Date of registration: 21/05/2012
• Prospective Registration: Yes
• Primary sponsor: Guillem Cuatrecasas Cambra
• Public title: Study for the assesment of the efficacy and safey of NUTROPIN® in patients with spinal cord injury (SCI) and growth hormone deficiency (GHD).
• Scientific title: 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).
• Date of first enrolment: 18/07/2012
• Target sample size: 20
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2011-005377-23
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Spain

Contacts

• Name: Joan Romero Càlix
• Affiliation: Fundación Step by Step

• Name: Joan Romero Càlix
• Affiliation: Fundación Step by Step

Key inclusion & exclusion 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 (<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


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

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

Therapeutic area: Body processes [G] - Bones and nerves physological processes [G11]

Intervention(s)

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(s)/kilogram
Concentration type: up to
Concentration number: 0.0125-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Subcutaneous use

Primary Outcome(s)

Primary end point(s): Changes in Spinal Cord Independence Measure (SCIM) III score

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

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(s)

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)

Secondary ID(s)

SCI-GHD-201

Source(s) of Monetary Support

Ipsen Pharma, S.A.