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

• ClinicalTrials.gov Identifier: NCT01144351
• Recruitment Status: Terminated
• First Posted: June 15, 2010
• Last Update Posted: December 14, 2015
• Sponsor: Elan Pharmaceuticals
• Information provided by (Responsible Party): Elan Pharmaceuticals

Tracking Information

• First Submitted Date: June 9, 2010
• First Posted Date: June 15, 2010
• Last Update Posted Date: December 14, 2015
• Study Start Date: March 2010
• Actual Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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 (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: A Safety and Efficacy Study of ELND002 in Patients With Relapsing Forms of Multiple Sclerosis
• 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
• 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: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Multiple Sclerosis

Intervention

• Drug: ELND002
• Drug: Placebo

Study Arms

• Experimental: ELND002
  ELND002 sc injection
  Intervention: Drug: ELND002
• Placebo Comparator: Placebo
  placebo injection
  Intervention: Drug: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: April 12, 2013): 32
• Original Estimated Enrollment (submitted: June 11, 2010): 125
• Study Completion Date: Not Provided
• Actual Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Canada, United States

Administrative Information

• NCT Number: NCT01144351
• Other Study ID Numbers: ELND002-MS103
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Elan Pharmaceuticals
• Study Sponsor: Elan Pharmaceuticals
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Elan Pharmaceuticals
• Verification Date: December 2015