A Safety and Efficacy Study of ELND002 in Patients With Relapsing Form
A Phase 1b, Dose-Escalating, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Safety and Efficacy of Subcutaneous ELND002 in Patients With Relapsing Forms of Multiple Sclerosis
What it found
The trial ended early for another reason (see below).
This trial finished 13 years ago. We found no results in the registry or in any paper that cites it.
What was tested
Treatment tested
- ELND002
Placebo
- Placebo
What it measured
Main measures
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
Safety
Other measures (3)
Assessment of PK and PD measures of ELND002 (including but not limited to Cmax, Tmax, T1/2, AUC)
12 weeks
MRI lesionsHow the body handles the medicineAssessment of the cumulative number and volume of Gd-enhancing T1-weighed MRI brain lesions
12 weeks
MRI lesionsReduction in rate of clinical relapses.
12 weeks
Relapses
Who could take part
Relapsing and progressive · 18 to 65
Show the full criteria
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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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).
Papers
Loading reviews and guidelines…
History
Started
Mar 2010
Main results due
Dec 2012