Pilot trial of recombinant human growth hormone for remyelination in multiple sclerosis - rhGH in MS

Phase 1

• Conditions: Multiple Sclerosis; MedDRA version: 9.1Level: LLTClassification code 10063399Term: Relapsing-remitting multiple sclerosis; MedDRA version: 9.1Level: LLTClassification code 10063400Term: Secondary progressive multiple sclerosis

• Registration Number: EUCTR2006-006465-16-DE
• Lead Sponsor: niversity of Leipzig

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-05-03
• Last Update Posted: 9 May 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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

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

Study & Design

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

Primary Outcome Measures

Name	Time	Method
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<br><br>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.