NCT01144351

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).

Trial Health

40
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P50-P75 for phase_1 multiple-sclerosis

Geographic Reach
2 countries

20 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2010

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 9, 2010

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 15, 2010

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Last Updated

December 14, 2015

Status Verified

December 1, 2015

Enrollment Period

2.8 years

First QC Date

June 9, 2010

Last Update Submit

December 10, 2015

Conditions

Multiple Sclerosis

Keywords

MSSPMSRRMSRelapsing Forms of Secondary Progressive Multiple Sclerosis (SPMS)or Relapsing-Remitting Multiple Sclerosis (RRMS)

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Assessment of PK and PD measures of ELND002 (including but not limited to Cmax, Tmax, T1/2, AUC)

    12 weeks

  • 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

Study Arms (2)

ELND002

EXPERIMENTAL

ELND002 sc injection

Drug: ELND002

Placebo

PLACEBO COMPARATOR

placebo injection

Drug: Placebo

Interventions

ELND002DRUG
ELND002
PlaceboDRUG
Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

Research Site

Berkeley, California, 94705, United States

Location

Research Site

Fresno, California, 93710, United States

Location

Research Site

Newport Beach, California, 92663, United States

Location

Research Site

Aurora, Colorado, 80045, United States

Location

Research Site

Tampa, Florida, 33609, United States

Location

Research Site

Vero Beach, Florida, 32960, United States

Location

Research Site

Northbrook, Illinois, 60062, United States

Location

Research Site

Farmington Hills, Michigan, 48334, United States

Location

Research Site

Minneapolis, Minnesota, 55404, United States

Location

Research Site

Albuquerque, New Mexico, 87106, United States

Location

Research Site

Raleigh, North Carolina, 27607, United States

Location

Research Site

Cincinnati, Ohio, 45219, United States

Location

Research Site

Uniontown, Ohio, 44685, United States

Location

Research Site

Cordova, Tennessee, 78258, United States

Location

Research Site

Knoxville, Tennessee, 37920, United States

Location

Research Site

San Antonio, Texas, 78258, United States

Location

Research Site

Salt Lake City, Utah, 84106, United States

Location

Research Site

Calgary, Alberta, T2N 2T9, Canada

Location

Research Site

Greenfield Park, Quebec, J4V 2J2, Canada

Location

Research Site

Montreal, Quebec, H3A 2B4, Canada

Location

MeSH Terms

Conditions

Multiple SclerosisMultiple Sclerosis, Relapsing-Remitting

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 9, 2010

First Posted

June 15, 2010

Study Start

March 1, 2010

Primary Completion

December 1, 2012

Last Updated

December 14, 2015

Record last verified: 2015-12

Locations

US(17)CA(3)