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

• Register: EUCTR
• Last refreshed on: 9 May 2016
• Main ID: EUCTR2006-006465-16-DE
• Date of registration: 03/05/2007
• Prospective Registration: Yes
• Primary sponsor: University of Leipzig
• Public title: Pilot trial of recombinant human growth hormone for remyelination in multiple sclerosis - rhGH in MS
• Scientific title: Pilot trial of recombinant human growth hormone for remyelination in multiple sclerosis - rhGH in MS
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2006-006465-16
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: yes Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: yes Other specify the comparator: single cross-over, i.e. patients serve as their own control (baseline vs. treatment period)
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Germany

Key inclusion & exclusion 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:
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


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

Health Condition(s) or Problem(s) studied

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

Intervention(s)

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 milligram(s)/millilitre
Concentration type: equal
Concentration number: 5-12

Primary Outcome(s)

Main Objective: To rule out a major increase in inflammatory disease activity by s.c. hGH using high-frequency contrast-enhanced brain MRI

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.

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)

Secondary ID(s)

rhGH in MS