A clinical trial to test if NU100 is safe and can treat patient with relapsing types of multiple sclerosis

• Conditions: relapsing forms of multiple sclerosis; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2011-002683-24-HU
• Lead Sponsor: uron Biotech, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-12-15
• Last Update Posted: 23 December 2013

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

Patients will be eligible to participate in the study if all of the following criteria are met at both screening (V-1) and baseline (V0):
1.Female or male patients, aged between 18 and 60 years, inclusive
2.Signed and dated statement of informed consent
3.Diagnosis of RRMS according to McDonald’s Criteria – revision 2010
4.Interferon (IFN) beta-1b naïve
5.Expanded Disability Status Scale (EDSS) score of < 5.5
6.At least 1 documented relapse in the past year (defined as the appearance of a new clinical sign/symptom [one that had been stable for at least 30 days] that persisted for a minimum of 24 hours in the absence of fever)
---or---
a subclinical sign/symptom (defined as a Gd enhancing lesion or a new T2 lesion demonstrated on MRI examination on a prior MRI that has been completed within 1 year of the screening MRI). The Screening (V-1) MRI should not be used for this determination.
7.No relapse in the 4 weeks prior to the screening visit (V-1).
8.Must be in a clinically stable or improving neurological state 4 weeks preceding the screening visit (V-1).

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 500
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients meeting any of the following exclusion criteria at screening (V-1) and baseline (V0) will not be enrolled in the study:
1.Relapse at the baseline visit (V0) or occurring within 4 weeks prior to the screening visit (V-1)
2.Intake of glatiramer acetate within 3 months prior to the screening (V-1) visit
3.Intake of previous immunotherapy or immunosuppressant treatment, within 4 months prior to the screening (V-1) visit
4.Intake of or previously received therapy with cladribine or alemtuzumab or any monoclonal antibody therapy administration for treatment of MS
5.An active viral,, bacterial, or systemic fungal infection within 1 week of baseline (V0)
6.Use of systemic steroids within 3 weeks prior to the screening (V-1) MRI
7.Progressive disease
8.Level of liver enzymes 2.5 x the upper limit of normal
9.Abnormal renal function (estimated Glomerular Filtration Rate [eGFR] < 60 ml/min/1.73 m2 )
10.Positive serology or history for Hepatitis B, C, or human immunodeficiency virus (HIV)
11.Serious or acute coronary diseases, defined by at least 1 of the following conditions:
a.Clinical symptoms of ischemic heart disease
b.ST elevation or depression > 2 mm on the electrocardiogram (ECG)
c.Clinical symptoms of cardiac failure and/or current medical treatment for cardiac failure
d.Severe ventricular arrhythmia (frequent premature ventricular beats)
e.Atrioventricular block at third level
12.Chronic use of non-steroidal anti-inflammatory drugs (NSAIDs)
13.History of any of the following:
a.Severe depression or suicide attempt
b.Uncontrolled seizure disorder
c.Cancer, excluding adequately treated basal cell carcinoma of the skin or adequately treated in situ carcinoma of the cervix
d.Previous contrast reaction to gadolinium or any other contraindications to MRI (e.g., metal in the eye, pacemakers, aneurysm clip)
14.Allergy to human albumin or to mannitol
15.Excessive alcohol use or illicit drug use
16.Women who are breast feeding, pregnant, or planning to become pregnant, or are unwilling to use an effective birth control method while on study
17.Medical, psychiatric, or other conditions that compromise the patient's ability to understand the patient information, to give informed consent, to comply with the trial protocol, or to complete the study
18.Participation in any other study involving investigational or marketed products, concomitantly or within 30 days prior to entry in the study
Current participation in other clinical trials

Study & Design

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