Multiple Sclerosis
Conditions
Keywords
MS, SPMS, RRMS, Relapsing Forms of Secondary Progressive Multiple Sclerosis (SPMS), or Relapsing-Remitting Multiple Sclerosis (RRMS)
Brief summary
The purpose of this study is to determine the safety and tolerability of ELND002 in patients with relapsing forms of secondary progressive multiple sclerosis (SPMS) or relapsing-remitting multiple sclerosis (RRMS).
Interventions
DRUGELND002
DRUGPlacebo
Sponsors
Elan Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Has either clinically definite or laboratory-supported definite relapsing forms of MS for at least 2 years * Patients with SPMS or RRMS have documented medical history of relapse in the past year or MRI-documented evidence of MS activity in the past year * Has had an inadequate response or intolerability to interferon and/or glatiramer acetate * Is able and willing to undergo Gd administration and repeat MRI testing
Exclusion criteria
* Has primary progressive MS (PPMS) * Any history of treatment with recombinant humanized monoclonal antibodies * Has received treatment with immunosuppressant medications or experimental agents within 3 months prior to the Baseline * A history of opportunistic infection or the presence of any active infection within 3 months prior to Baseline * Any history of congestive heart failure or currently has a pacemaker * Has a known or suspected hypersensitivity to sulfonamides or any of the components of the investigational drug * Has any medical history or psychiatric condition that would impact outcome or study participation * Has other clinically significant abnormality on physical, neurological, laboratory, or ECG examination as listed in the protocol during the Screening Phase
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the safety and tolerability of ELND002 including the identification of dose-limiting toxicity(ies) (DLT) and determination of the maximum tolerated dose (MTD) in patients with multiple sclerosis (MS). | 12 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of PK and PD measures of ELND002 (including but not limited to Cmax, Tmax, T1/2, AUC) | 12 weeks | Measurement of drug concentration, alpha 4 receptor saturation, soluble VCAM and MADCAM. |
| Assessment of the cumulative number and volume of Gd-enhancing T1-weighed MRI brain lesions | 12 weeks | — |
| Reduction in rate of clinical relapses. | 12 weeks | — |
Countries
Canada, United States
Outcome results
None listed