Trial record 13 of 46 for:    acorda

An Intravenous Infusion Study of rHIgM22 in Patients With Multiple Sclerosis Immediately Following a Relapse

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2016 by Acorda Therapeutics
Sponsor:
Collaborator:
PRA Health Sciences
Information provided by (Responsible Party):
Acorda Therapeutics
ClinicalTrials.gov Identifier:
NCT02398461
First received: March 13, 2015
Last updated: January 19, 2016
Last verified: January 2016
  Purpose
This is a Phase 1, multi-center, double-blind, randomized, placebo-controlled, dose-escalation study in subjects with relapsing Multiple Sclerosis (MS). The primary outcome will be the safety and tolerability of a single dose of rHIgM22 in relapsing MS subjects.

Condition Intervention Phase
Multiple Sclerosis, Acute Relapsing
Drug: rHIgM22
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-Blind, Placebo-Controlled, Single Ascending Dose Intravenous Infusion Study of rHIgM22 in Patients With Multiple Sclerosis Immediately Following a Relapse

Resource links provided by NLM:


Further study details as provided by Acorda Therapeutics:

Primary Outcome Measures:
  • Safety and tolerability of single ascending doses of rHIgM22 in patients with MS immediately following a relapse as measured by the number of patients with Adverse Events (AEs) [ Time Frame: Up to 180 days ] [ Designated as safety issue: Yes ]
    Assessed by review of the AEs, including Serious Adverse Events (SAEs), clinical symptoms and signs, clinical laboratory tests and Electrocardiogram (ECGs).


Secondary Outcome Measures:
  • Maximum measured plasma concentration (Cmax) of single ascending doses of rHIgM22 [ Time Frame: Pre-dose (day 1), specified time points up to 48 hours post treatment ] [ Designated as safety issue: No ]
  • Time to maximum plasma concentration (Tmax) of single ascending doses of rHIgM22 [ Time Frame: Pre-dose (day 1), specified time points up to 48 hours post treatment ] [ Designated as safety issue: No ]
  • Half-life (T1/2) of single ascending doses of rHIgM22 [ Time Frame: Pre-dose (day 1), specified time points up to 48 hours post treatment ] [ Designated as safety issue: No ]
  • Area under the concentration curve from time 0 to the concentration at last time point (AUC0-last) of single ascending doses of rHIgM22 [ Time Frame: Pre-dose (day 1), specified time points up to 48 hours post treatment ] [ Designated as safety issue: No ]
  • Immunogenicity profile of single ascending doses of rHIgM22 [ Time Frame: Specified time points up to 180 days post treatment ] [ Designated as safety issue: No ]
    Blood samples will be collected from subjects post treatment for assessment to detect the presence of anti-drug antibodies and neutralizing antibodies.

  • The Expanded Disability Status Scale (EDSS) [ Time Frame: Screening, specified time points up to 180 days post treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: April 2015
Estimated Study Completion Date: November 2016
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: rHIgM22
Patients will be enrolled sequentially in 2 separate cohorts, representing escalating dose levels. Each dose cohort will comprise 15 subjects, randomly assigned to receive either rHIgM22 (n=10) or placebo (n=5).
Drug: rHIgM22
Administered via IV infusion
Other Name: M22
Placebo Comparator: Placebo
Patients will be enrolled sequentially in 2 separate cohorts, representing escalating dose levels. Each dose cohort will comprise 15 subjects, randomly assigned to receive either rHIgM22 (n=10) or placebo (n=5).
Drug: Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males or females (18-70 years of age; < 104 kg)
  • Capable of giving informed consent
  • Meet diagnostic criteria for MS, as defined by revised (2010) McDonald criteria
  • Present with a clinical acute relapse defined as a new or worsening neurological symptoms attributable to MS preceded by a stable or improving neurological state of at least 30 days, not associated with fever or infection, lasting at least 24 hours and accompanied by an objective physical (neurological) exam finding as confirmed by the Investigator
  • Has at least one new, identifiable, measurable and active lesion on MRI (Gd+) meeting the criteria of the imaging charter.

Exclusion Criteria:

  • Certain specified co-morbidities (including pregnancy)
  • Taking certain proscribed medications
  • A medical regimen that has changed in the month prior to screening
  • Inability to undergo requisite MRI evaluations
  • Drug or alcohol abuse
  • Any other reason for which, in the opinion of the Investigator, the subject should not participate in the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02398461

Locations
United States, California
Acorda Site #12 Recruiting
Long Beach, California, United States, 90806
Contact: Mercado Minie    866-787-4257      
Acorda Site #3 Recruiting
Sacramento, California, United States, 95817
Contact: Butters Janelle    916-734-6276      
Acorda Site #7 Recruiting
San Francisco, California, United States, 94158
Contact: Shum Nancy    415-502-7219      
Acorda Site #15 Recruiting
Stanford, California, United States, 94305
Contact: Bernadette Gabriel    650-721-6188      
United States, Colorado
Acorda Site #11 Recruiting
Aurora, Colorado, United States, 80045
Contact: Mary M Cook    303-724-7968      
Acorda Site #16 Recruiting
Centennial, Colorado, United States, 80112
Contact: Getchell Leah    303-224-4672      
United States, Indiana
Acorda Site #5 Withdrawn
Indianapolis, Indiana, United States, 46202
United States, Missouri
Acorda Site #14 Recruiting
Saint Louis, Missouri, United States, 63131
Contact: Payne-Gates Delea    314-996-7775      
United States, New Jersey
Acorda Site #19 Recruiting
Teaneck, New Jersey, United States, 07666
Contact: Melvin Stacy    201-833-3000 ext 3762      
United States, New York
Acorda Site #10 Recruiting
Rochester, New York, United States, 14642
Contact: Scheid Eileen    585-275-6673      
United States, Rhode Island
Acorda Site #17 Withdrawn
Providence, Rhode Island, United States, 02905
United States, Texas
Acorda Site #18 Recruiting
Dallas, Texas, United States, 75390-8508
Contact: Lawrence Holly    214-648-9312      
United States, Washington
Acorda Site #2 Recruiting
Seattle, Washington, United States, 98101
Contact: Chan Christine    206-342-6976      
Acorda Site #6 Recruiting
Seattle, Washington, United States, 98122
Contact: Courtney Yuriko    206-320-2200      
Sponsors and Collaborators
Acorda Therapeutics
PRA Health Sciences
  More Information

Responsible Party: Acorda Therapeutics
ClinicalTrials.gov Identifier: NCT02398461     History of Changes
Other Study ID Numbers: IM22-MS-1033 
Study First Received: March 13, 2015
Last Updated: January 19, 2016
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Sclerosis
Autoimmune Diseases
Autoimmune Diseases of the Nervous System
Demyelinating Autoimmune Diseases, CNS
Demyelinating Diseases
Immune System Diseases
Nervous System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 25, 2016