Multiple Sclerosis MedDRA version: 9.1 Level: LLT Classification code 10063399 Term: Relapsing-remitting multiple sclerosis MedDRA version: 9.1 Level: LLT Classification code 10063400 Term: Secondary progressive multiple sclerosis
Conditions
Interventions
Trade Name: Genotropin
Product Name: Genotropin
Pharmaceutical Form: Solution for injection
INN or Proposed INN: human recombinant growth hormone
CAS Number: 12629-01-5
Concentration unit: mg/ml milli
Sponsors
University of Leipzig
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Age 18-55 years (included), female or male MS according to McDonald criteria, 2005 revision (Polman et al., 2005) Relapsing-remitting (RRMS) or secondary progressive (SPMS) course EDSS 0 – 5.5 (included) Time since resolution of the last relapse or dose of corticosteroid treatment at least six weeks Time since onset of a clinically manifest episode of optic neuritis at least one year Pathological prolongation of visual evoked potentials on at least one eye, documented to be stable for at least three months On screening MRI, at least three supratentorial lesions in T2/FLAIR All patients must give written consent for participation in the study prior to the screening 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 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Primary progressive course of MS (PPMS) More than four Gd contrast enhancing lesions on screening MRI Ophthalmologic condition associated with impaired visual acuity, visual field cuts or other impairment of visual function, other than related to MS; glaucoma stable under regular treatment is acceptable Treatment with an immunosuppressive agent (azathioprine, mitoxanthrone, methotrexate), natalizumab or any monoclonal antibody within six months before start of rhGH treatment History of chronic disease of the immune system other than MS or of a known immunodeficiency syndrome Diabetes mellitus, pathological percentage of HbA1c at screening Patients with a history of malignancy or lymphoproliferative disorder, or current malignant tumor of any type or location Patients unable to undergo MRI scans, including claustrophobia or history of severe hypersensitivity to gadolinium Dementia/severe cognitive deficits Patients with thyroid diseases (unless an individual consultion with an endocrinologist justifies participation) Contraindication to the planned therapy (e. g. hypersensitivity to trial medication or one of its components) Ongoing drug abuse HIV positive Pregnant or nursing women Women with child bearing potential without effective contraception (a highly effective method of birth control is defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner. For subjects using a hormonal contraceptive method, information regarding the product under evaluation and its potential effect on the contraceptive should be addressed). Expected low compliance Concomitant participation in other clinical trials Contraindication to the planned therapy as per Summary of Prescribing Information (Fachinformation): Suspected progression or reappearance of intra-cranial mass lesions; patients suffering from acute major disease, which resulted from experiencing complications after heart or abdominal surgery, after multiple accidental trauma or respiratory failure; Prader-Willi-Syndrome
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To rule out a major increase in inflammatory disease activity by s.c. hGH using high-frequency contrast-enhanced brain MRI;Secondary Objective: To demonstrate clinical safety of s.c. hGH in MS To provide initial data on therapeutic efficacy of hGH in MS (surrogate marker);Primary end point(s): Cumulative number of active (new or gadolinium-enhancing) lesions on brain MRI performed every four weeks during the 12-week baseline period and the first 12 weeks of the treatment period. That is, numbers of active lesions from week –8, week –4 and baseline will be compared to numbers of active lesions from week 4, week 8 and week 12. | — |
Countries
Germany
Outcome results
None listed