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A Safety and Efficacy Study of ELND002 in Patients With Relapsing Forms of Multiple Sclerosis

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
Sponsor:
Information provided by (Responsible Party):
Elan Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE June 9, 2010
First Posted Date  ICMJE June 15, 2010
Last Update Posted Date December 14, 2015
Study Start Date  ICMJE March 2010
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 11, 2010)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 16, 2011)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 11, 2010)
  • Assessment of PK and PD measures of ELND002 (including but not limited to Cmax, Tmax, T1/2, AUC) [ Time Frame: 12 weeks ]
  • Assessment of the cumulative number and volume of Gd-enhancing T1-weighed MRI brain lesions [ Time Frame: 12 weeks ]
  • Rate of clinical relapses over the 12-week treatment period [ Time Frame: 12 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Safety and Efficacy Study of ELND002 in Patients With Relapsing Forms of Multiple Sclerosis
Official Title  ICMJE 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
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Multiple Sclerosis
Intervention  ICMJE
  • Drug: ELND002
  • Drug: Placebo
Study Arms  ICMJE
  • Experimental: ELND002
    ELND002 sc injection
    Intervention: Drug: ELND002
  • Placebo Comparator: Placebo
    placebo injection
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: April 12, 2013)
32
Original Estimated Enrollment  ICMJE
 (submitted: June 11, 2010)
125
Study Completion Date  ICMJE Not Provided
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01144351
Other Study ID Numbers  ICMJE ELND002-MS103
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Elan Pharmaceuticals
Study Sponsor  ICMJE Elan Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Elan Pharmaceuticals
Verification Date December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP