Phase 3 Study to Evaluate Efficacy and Safety of NU100 in Patients With Relapsing Remitting Multiple Sclerosis (RRMS)

Launched by NURON BIOTECH INC. · Nov 2, 2011

Keywords

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Gender

ALL

Eligibility criteria

• 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 (Polman et al., 2011)
• • 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).
• 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
• • 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:
• • Clinical symptoms of ischemic heart disease
• • ST elevation or depression \> 2 mm on the electrocardiogram (ECG)
• • Clinical symptoms of cardiac failure and/or current medical treatment for cardiac failure
• • Severe ventricular arrhythmia (frequent premature ventricular beats)
• • Atrioventricular block at third level
• • 12. Chronic use of non-steroidal anti-inflammatory drugs
• 13. History of any of the following:
• • Severe depression or suicide attempt
• • Uncontrolled seizure disorder
• • Cancer, excluding adequately treated basal cell carcinoma of the skin or adequately treated in situ carcinoma of the cervix
• • 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