A Safety and Efficacy Study of ELND002 in Patients With Relapsing Forms of Multiple Sclerosis
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01144351 |
Recruitment Status :
Terminated
First Posted : June 15, 2010
Last Update Posted : December 14, 2015
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Multiple Sclerosis | Drug: ELND002 Drug: Placebo | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 32 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | 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 |
Study Start Date : | March 2010 |
Actual Primary Completion Date : | December 2012 |

Arm | Intervention/treatment |
---|---|
Experimental: ELND002
ELND002 sc injection
|
Drug: ELND002 |
Placebo Comparator: Placebo
placebo injection
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Drug: Placebo |
- 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). [ Time Frame: 12 weeks ]
- Assessment of PK and PD measures of ELND002 (including but not limited to Cmax, Tmax, T1/2, AUC) [ Time Frame: 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 [ Time Frame: 12 weeks ]
- Reduction in rate of clinical relapses. [ Time Frame: 12 weeks ]

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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01144351
United States, California | |
Research Site | |
Berkeley, California, United States, 94705 | |
Research Site | |
Fresno, California, United States, 93710 | |
Research Site | |
Newport Beach, California, United States, 92663 | |
United States, Colorado | |
Research Site | |
Aurora, Colorado, United States, 80045 | |
United States, Florida | |
Research Site | |
Tampa, Florida, United States, 33609 | |
Research Site | |
Vero Beach, Florida, United States, 32960 | |
United States, Illinois | |
Research Site | |
Northbrook, Illinois, United States, 60062 | |
United States, Michigan | |
Research Site | |
Farmington Hills, Michigan, United States, 48334 | |
United States, Minnesota | |
Research Site | |
Minneapolis, Minnesota, United States, 55404 | |
United States, New Mexico | |
Research Site | |
Albuquerque, New Mexico, United States, 87106 | |
United States, North Carolina | |
Research Site | |
Raleigh, North Carolina, United States, 27607 | |
United States, Ohio | |
Research Site | |
Cincinnati, Ohio, United States, 45219 | |
Research Site | |
Uniontown, Ohio, United States, 44685 | |
United States, Tennessee | |
Research Site | |
Cordova, Tennessee, United States, 78258 | |
Research Site | |
Knoxville, Tennessee, United States, 37920 | |
United States, Texas | |
Research Site | |
San Antonio, Texas, United States, 78258 | |
United States, Utah | |
Research Site | |
Salt Lake City, Utah, United States, 84106 | |
Canada, Alberta | |
Research Site | |
Calgary, Alberta, Canada, T2N 2T9 | |
Canada, Quebec | |
Research Site | |
Greenfield Park, Quebec, Canada, J4V 2J2 | |
Research Site | |
Montreal, Quebec, Canada, H3A 2B4 |
Responsible Party: | Elan Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT01144351 |
Other Study ID Numbers: |
ELND002-MS103 |
First Posted: | June 15, 2010 Key Record Dates |
Last Update Posted: | December 14, 2015 |
Last Verified: | December 2015 |
MS SPMS RRMS Relapsing Forms of Secondary Progressive Multiple Sclerosis (SPMS) or Relapsing-Remitting Multiple Sclerosis (RRMS) |
Multiple Sclerosis Sclerosis Pathologic Processes Demyelinating Autoimmune Diseases, CNS Autoimmune Diseases of the Nervous System |
Nervous System Diseases Demyelinating Diseases Autoimmune Diseases Immune System Diseases |