Efficacy and Safety of BIIB019 (Daclizumab High Yield Process) Versus Interferon β 1a in Participants With Relapsing-Remitting Multiple Sclerosis ((DECIDE))

May 31, 2016 updated by: Biogen

Multicenter, Double-blind, Randomized, Parallel-group, Monotherapy, Active-control Study to Determine the Efficacy and Safety of Daclizumab High Yield Process (DAC HYP) Versus Avonex® (Interferon β 1a) in Patients With Relapsing-Remitting Multiple Sclerosis

The primary study objective is to test the superiority of Daclizumab High Yield Process (DAC HYP) compared to interferon β 1a (IFN β-1a) in preventing multiple sclerosis (MS) relapse in participants with relapsing remitting multiple sclerosis.

The secondary study objectives are to test the superiority of DAC HYP compared to IFN β-1a in slowing functional decline and disability progression and maintaining quality of life in this participant population.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1841

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
    • Buenos Aires
      • Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
        • Research Site
    • Mendoza
      • Godoy Cruz, Mendoza, Argentina
        • Research Site
    • Santa Fe
      • Rosario, Santa Fe, Argentina
        • Research Site
  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia
        • Research Site
      • New Lambton Heights, New South Wales, Australia
        • Research Site
    • Queensland
      • Auchenflower, Queensland, Australia
        • Research Site
    • South Australia
      • Woodville, South Australia, Australia
        • Research Site
    • Victoria
      • Fitzroy, Victoria, Australia
        • Research Site
      • Heidelberg West, Victoria, Australia
        • Research Site
  • Brazil
      • Rio de Janeiro, Brazil
        • Research Site
    • Bahia
      • Belo Horizonte, Bahia, Brazil
        • Research Site
    • Distrito Federal
      • Brasilia, Distrito Federal, Brazil
        • Research Site
    • Pernambuco
      • Recife, Pernambuco, Brazil
        • Research Site
    • Rio Grande
      • Porto Alegre, Rio Grande, Brazil
        • Research Site
      • Sao Paulo, Rio Grande, Brazil
        • Research Site
    • Sao Paulo
      • Campinas, Sao Paulo, Brazil
        • Research Site
      • Ribeirão Preto, Sao Paulo, Brazil
        • Research Site
  • Canada
    • Alberta
      • Calgary, Alberta, Canada
        • Research Site
      • Edmonton, Alberta, Canada
        • Research Site
    • British Columbia
      • Vancouver, British Columbia, Canada
        • Research Site
    • Newfoundland and Labrador
      • Saint John, Newfoundland and Labrador, Canada
        • Research Site
    • Ontario
      • London, Ontario, Canada
        • Research Site
      • Ottawa, Ontario, Canada
        • Research Site
    • Quebec
      • Gatineau, Quebec, Canada
        • Research Site
      • Greenfield Park, Quebec, Canada
        • Research Site
      • Montréal, Quebec, Canada
        • Research Site
    • Saskatchewan
      • Regina, Saskatchewan, Canada
        • Research Site
  • Czech Republic
      • Brno, Czech Republic
        • Research Site
      • Hradec Kralove, Czech Republic
        • Research Site
      • Jihlava, Czech Republic
        • Research Site
      • Ostrava, Czech Republic
        • Research Site
      • Pardubice, Czech Republic
        • Research Site
    • Jihocesky Kraj
      • Brno, Jihocesky Kraj, Czech Republic
        • Research Site
    • Kraj Vysocina
      • Jihlava, Kraj Vysocina, Czech Republic
        • Research Site
    • Olomoucký kraj
      • Olomouc, Olomoucký kraj, Czech Republic
        • Research Site
    • Praha
      • Praha 10, Praha, Czech Republic
        • Research Site
      • Praha 2, Praha, Czech Republic
        • Research Site
    • Severomoravksy Krav
      • Havirov, Severomoravksy Krav, Czech Republic
        • Research Site
  • Denmark
      • Copenhagen, Denmark
        • Research Site
      • Glostrup, Denmark
        • Research Site
      • Odense C, Denmark
        • Research Site
      • Århus, Denmark
        • Research Site
  • Finland
      • Helsinki, Finland
        • Research Site
      • Oulu, Finland
        • Research Site
      • Seinäjoki, Finland
        • Research Site
      • Turku, Finland
        • Research Site
    • Western Finalnd
      • Tampere, Western Finalnd, Finland
        • Research Site
  • France
      • Bourdeaux, France
        • Research Site
      • Dijon, France
        • Research Site
      • Lille, France
        • Research Site
      • Lomme, France
        • Research Site
      • Marseille Cedex 9, France
        • Research Site
      • Nancy, France
        • Research Site
      • Toulouse Cedex 3, France
        • Research Site
    • Alsace
      • Strasbourg, Alsace, France
        • Research Site
    • Basse-normandie
      • Caen Cedex 5, Basse-normandie, France
        • Research Site
    • Ile-de-france
      • Bobigny, Ile-de-france, France
        • Research Site
      • Paris, Ile-de-france, France
        • Research Site
      • Paris Cedex 5, Ile-de-france, France
        • Research Site
    • Picardie
      • Amiens, Picardie, France
        • Research Site
    • Provence Alpes Cote D'azur
      • Nice, Provence Alpes Cote D'azur, France
        • Research Site
    • Rhone-alpes
      • Lyon, Rhone-alpes, France
        • Research Site
  • Georgia
      • Tbilisi, Georgia
        • Research Site
  • Germany
      • Berlin, Germany
        • Research Site
      • Hamburg, Germany
        • Research Site
      • Tübingen, Germany
        • Research Site
    • Baden-Wurttemberg
      • Bad Mergentheim, Baden-Wurttemberg, Germany
        • Research Site
    • Baden-wuerttemberg
      • Freiburg, Baden-wuerttemberg, Germany
        • Research Site
    • Bayern
      • Bamberg, Bayern, Germany
        • Research Site
      • Bayreuth, Bayern, Germany
        • Research Site
      • München, Bayern, Germany
        • Research Site
      • Neuburg an der Donau, Bayern, Germany
        • Research Site
    • Hessen
      • Marburg, Hessen, Germany
        • Research Site
    • Nordrhein Westfalen
      • Essen, Nordrhein Westfalen, Germany
        • Research Site
      • Koln, Nordrhein Westfalen, Germany
        • Research Site
    • Nordrhein-Westfalen
      • Munster, Nordrhein-Westfalen, Germany
        • Research Site
    • Rheinland-Pfalz
      • Trier, Rheinland-Pfalz, Germany
        • Research Site
    • Sachsen
      • Dresden, Sachsen, Germany
        • Research Site
  • Greece
    • Attica
      • Athens, Attica, Greece
        • Research Site
    • Crete
      • Heraklion, Crete, Greece
        • Research Site
    • Macedoni
      • Thessaloniki, Macedoni, Greece
        • Research Site
  • Hungary
      • Budapest, Hungary
        • Research Site
      • Esztergom, Hungary
        • Research Site
      • Miskolc, Hungary
        • Research Site
      • Nyíregyháza, Hungary
        • Research Site
      • Veszprém, Hungary
        • Research Site
    • Fejer
      • Székesfehérvár, Fejer, Hungary
        • Research Site
    • Gyor-moson-sopron
      • Gyor, Gyor-moson-sopron, Hungary
        • Research Site
  • India
      • New Delhi, India
        • Research Site
    • Andhra Pradesh
      • Hyderabad, Andhra Pradesh, India
        • Research Site
    • Dwivdee
      • Delhi, Dwivdee, India
        • Research Site
    • Karnataka
      • Bangalore, Karnataka, India
        • Research Site
    • Kerala
      • Trivandrum, Kerala, India
        • Research Site
    • Maharashtra
      • Mumbai, Maharashtra, India
        • Research Site
      • Nagpur, Maharashtra, India
        • Research Site
  • Ireland
      • Dublin, Ireland
        • Research Site
  • Israel
      • Beer-Sheva, Israel
        • Research Site
      • Haifa, Israel
        • Research Site
      • Kfar Saba, Israel
        • Research Site
      • Tzfat, Israel
        • Research Site
    • Ashqelon
      • Ashkelon, Ashqelon, Israel
        • Research Site
    • Beer Yaakov
      • Tzrifin, Beer Yaakov, Israel
        • Research Site
    • Petah Tiqwa
      • Petach Tikva, Petah Tiqwa, Israel
        • Research Site
  • Italy
      • Bari, Italy
        • Research Site
      • Cagliari, Italy
        • Research Site
      • Catania, Italy
        • Research Site
      • Firenze, Italy
        • Research Site
      • Genova, Italy
        • Research Site
      • Milano, Italy
        • Research Site
      • Padova, Italy
        • Research Site
      • Roma, Italy
        • Research Site
    • PA
      • Cefalù, PA, Italy
        • Research Site
    • Torino
      • Orbassano, Torino, Italy
        • Research Site
  • Mexico
    • Distrito Federal
      • Mexico, Distrito Federal, Mexico
        • Research Site
    • Jalisco
      • Guadalajara, Jalisco, Mexico
        • Research Site
  • Moldova, Republic of
      • Chisinau, Moldova, Republic of
        • Research Site
  • Poland
      • Bydgoszczas, Poland
        • Research Site
      • Plewiska, Poland
        • Research Site
    • Dolnoslaskie
      • Lublin, Dolnoslaskie, Poland
        • Research Site
    • Kujawsko-pomorskie
      • Bydgoszcz, Kujawsko-pomorskie, Poland
        • Research Site
      • Grudziadz, Kujawsko-pomorskie, Poland
        • Research Site
    • Lodzkie
      • Lódz, Lodzkie, Poland
        • Research Site
    • Malopolskie
      • Kraków, Malopolskie, Poland
        • Research Site
    • Mazowieckie
      • Warszawa, Mazowieckie, Poland
        • Research Site
    • Podlaskie
      • Bialystok, Podlaskie, Poland
        • Research Site
    • Pomorskie
      • Gdansk, Pomorskie, Poland
        • Research Site
    • Slaskie
      • Katowice, Slaskie, Poland
        • Research Site
    • Swietokrzycie
      • Kielce, Swietokrzycie, Poland
        • Research Site
    • Warminsko-mazurskie
      • Olsztyn, Warminsko-mazurskie, Poland
        • Research Site
    • Wielkopolskie
      • Poznan, Wielkopolskie, Poland
        • Research Site
    • Zachodniopomorskie
      • Szczecin, Zachodniopomorskie, Poland
        • Research Site
  • Romania
      • Iasi, Romania
        • Research Site
      • Târgu Mures, Romania
        • Research Site
    • Bucuresti
      • Bucurest, Bucuresti, Romania
        • Research Site
    • Cluj
      • Cluj-Napoca, Cluj, Romania
        • Research Site
    • Timis
      • Timisoara, Timis, Romania
        • Research Site
  • Russian Federation
      • Chelyabinsk, Russian Federation
        • Research Site
      • Kaluga, Russian Federation
        • Research Site
      • Kemerovo, Russian Federation
        • Research Site
      • Krasnoyarsk, Russian Federation
        • Research Site
      • Moscow, Russian Federation
        • Research Site
      • Nizhny Novgorod, Russian Federation
        • Research Site
      • Novosibirsk, Russian Federation
        • Research Site
      • Perm, Russian Federation
        • Research Site
      • Saint Petersburg, Russian Federation
        • Research Site
      • Smolensk, Russian Federation
        • Research Site
      • Tomsk, Russian Federation
        • Research Site
      • Tumen, Russian Federation
        • Research Site
      • Ufa, Russian Federation
        • Research Site
    • Povolje-Tatarstan
      • Kazan, Povolje-Tatarstan, Russian Federation
        • Research Site
    • Ural
      • Ekaterinburg, Ural, Russian Federation
        • Research Site
    • Yaroslavlr
      • Yaroslavl, Yaroslavlr, Russian Federation
        • Research Site
  • Serbia
      • Belgrade, Serbia
        • Research Site
      • Kragujevac, Serbia
        • Research Site
      • Nis, Serbia
        • Research Site
      • Novi Sad, Serbia
        • Research Site
  • Spain
      • Barcelona, Spain
        • Research Site
      • Cordoba, Spain
        • Research Site
      • Girona, Spain
        • Research Site
      • Madrid, Spain
        • Research Site
      • Sevilla, Spain
        • Research Site
    • Barcelona
      • L´Hospitalet de Llobregat, Barcelona, Spain
        • Research Site
  • Sweden
      • Göteborg, Sweden
        • Research Site
      • Linköping, Sweden
        • Research Site
      • Malmö, Sweden
        • Research Site
      • Stockholm, Sweden
        • Research Site
  • Switzerland
      • Basel, Switzerland
        • Research Site
      • Lugano, Switzerland
        • Research Site
  • Ukraine
      • Dnepropetrovsk, Ukraine
        • Research Site
      • Kharkiv, Ukraine
        • Research Site
      • Kyviv, Ukraine
        • Research Site
      • Odessa, Ukraine
        • Research Site
      • Poltava, Ukraine
        • Research Site
      • Vinnitsa, Ukraine
        • Research Site
      • Zaporozhye, Ukraine
        • Research Site
  • United Kingdom
      • Brighton, United Kingdom
        • Research Site
      • Bristol, United Kingdom
        • Research Site
      • Edinburgh, United Kingdom
        • Research Site
      • London, United Kingdom
        • Research Site
      • New Castle Upon Tyne, United Kingdom
        • Research Site
      • Nottingham, United Kingdom
        • Research Site
      • Romford, United Kingdom
        • Research Site
      • Salford, United Kingdom
        • Research Site
      • Sheffield, United Kingdom
        • Research Site
  • United States
    • Arizona
      • Gilbert, Arizona, United States
        • Research Site
      • Phoenix, Arizona, United States
        • Research Site
      • Tucson, Arizona, United States
        • Research Site
    • Arkansas
      • Little Rock, Arkansas, United States
        • Research Site
    • California
      • La Jolla, California, United States
        • Research Site
    • Colorado
      • Aurora, Colorado, United States
        • Research Site
    • Florida
      • Naples, Florida, United States
        • Research Site
      • Pompano Beach, Florida, United States
        • Research Site
      • St. Petersburg, Florida, United States
        • Research Site
      • Sunrise, Florida, United States
        • Research Site
    • Georgia
      • Atlanta, Georgia, United States
        • Research Site
    • Illinois
      • Evanston, Illinois, United States
        • Research Site
    • Indiana
      • Fort Wayne, Indiana, United States
        • Research Site
      • Indianapolis, Indiana, United States
        • Research Site
    • Iowa
      • Des Moines, Iowa, United States
        • Research Site
    • Kansas
      • Kansas City, Kansas, United States
        • Research Site
    • Kentucky
      • Lexington, Kentucky, United States
        • Research Site
    • Maryland
      • Baltimore, Maryland, United States
        • Research Site
    • Massachusetts
      • Springfield, Massachusetts, United States
        • Research Site
      • Worchester, Massachusetts, United States
        • Research Site
    • Michigan
      • Clinton Township, Michigan, United States
        • Research Site
    • Missouri
      • Saint Louis, Missouri, United States
        • Research Site
    • New Hampshire
      • Lebanon, New Hampshire, United States
        • Research Site
    • New Jersey
      • New Brunswick, New Jersey, United States
        • Research Site
    • New Mexico
      • Albuquerque, New Mexico, United States
        • Research Site
    • New York
      • Buffalo, New York, United States
        • Research Site
      • Latham, New York, United States
        • Research Site
      • New York, New York, United States
        • Research Site
      • Rochester, New York, United States
        • Research Site
    • North Carolina
      • Charlotte, North Carolina, United States
        • Research Site
      • Raleigh, North Carolina, United States
        • Research Site
      • Winston Salem, North Carolina, United States
        • Research Site
    • Oregon
      • Medford, Oregon, United States
        • Research Site
      • Portland, Oregon, United States
        • Research Site
    • Pennsylvania
      • Allentown, Pennsylvania, United States
        • Research Site
      • Philadelphia, Pennsylvania, United States
        • Research Site
      • Pittsburg, Pennsylvania, United States
        • Research Site
    • Rhode Island
      • Providence, Rhode Island, United States
        • Research Site
    • Tennessee
      • Franklin, Tennessee, United States
        • Research Site
      • Knoxville, Tennessee, United States
        • Research Site
    • Utah
      • Salt Lake City, Utah, United States
        • Research Site
    • Vermont
      • Burlington, Vermont, United States
        • Research Site
    • Washington
      • Kirkland, Washington, United States
        • Research Site
      • Seattle, Washington, United States
        • Research Site
      • Tacoma, Washington, United States
        • Research Site
    • Wisconsin
      • Milwaukee, Wisconsin, United States
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Key Inclusion Criteria:

  • Must have a confirmed diagnosis of Relapsing Remitting Multiple Sclerosis (RRMS), and a cranial magnetic resonance imaging (MRI) demonstrating lesion(s) consistent with MS
  • Must have a baseline Expanded Disability Status Scale (EDSS) between 0.0 and 5.0, inclusive
  • Male subjects and female subjects of childbearing potential must be willing to practice effective contraception during the study and be willing and able to continue contraception for 4 months after their last dose of study treatment

Key Exclusion Criteria:

  • Known intolerance, contraindication to, or history of non-compliance with Avonex® 30 µg
  • History of treatment with Daclizumab High Yield Process (Dac HYP)
  • History of malignancy
  • History of severe allergic or anaphylactic reactions
  • Known hypersensitivity to study drugs or their excipients
  • History of abnormal laboratory results indicative of any significant disease
  • History of human immunodeficiency virus (HIV) or other immunodeficient conditions
  • History of drug or alcohol abuse (as defined by the Investigator) within the 2 years prior to randomization
  • History of seizure disorder or unexplained blackouts OR history of a seizure within 6 months prior to Baseline
  • History of suicidal ideation or an episode of clinically severe depression (as determined by the Investigator) within 3 months prior to Day 1
  • An MS relapse that has occurred within the 50 days prior to randomization AND/OR the subject has not stabilized from a previous relapse prior to randomization
  • Known history of, or positive screening test result for hepatitis C virus or hepatitis B virus
  • Varicella or herpes zoster virus infection or any severe viral infection within 6 weeks before screening
  • Exposure to varicella zoster virus within 21 days before screening

NOTE: Other protocol-defined Inclusion/Exclusion criteria may apply.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Daclizumab High Yield Process 150 mg SC
Daclizumab High Yield Process (DAC HYP) 150mg subcutaneous (SC) injection once every 4 weeks plus placebo to IFN β-1a intramuscular (IM) injection once weekly for 96 to 144 weeks
Biological: BIIB019 (Daclizumab High Yield Process)
Daclizumab High Yield Process for subcutaneous injection
Other Names:
  • DAC HYP
Drug: Interferon beta-1a Placebo
Placebo to interferon beta-1a intramuscular injection
Active Comparator: IFN β-1a 30 µg IM
Interferon beta-1a (IFN β-1a) 30 µg IM once weekly plus placebo to DAC HYP SC once every 4 weeks for 96 to 144 weeks
Biological: Interferon beta-1a
Interferon beta-1a for intramuscular injection
Other Names:
  • Avonex
  • IFN β-1a
Drug: Daclizumab High Yield Process Placebo
Placebo to Daclizumab High Yield Process subcutaneous injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adjusted Annualized Relapse Rate (ARR)
Time Frame: Up to 144 weeks
Relapses are defined as new or recurrent neurological symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurological findings upon examination by the examining neurologist. Only relapses confirmed by Independent Neurology Evaluation Committee (INEC) are included in this analysis. Adjusted ARR was estimated from a negative binomial regression model adjusted for the baseline relapse rate, history of prior IFN beta use, baseline Expanded Disability Status Scale score (EDSS; ≤ 2.5 vs > 2.5) and baseline age (≤ 35 vs > 35 years). Data after participants switched to alternative MS medications are excluded.
Up to 144 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adjusted Mean Number of New or Newly Enlarging T2 Hyperintense Lesions up to Week 96
Time Frame: up to 96 weeks
The quantity of lesions is assessed by brain magnetic resonance imaging (MRI). The adjusted mean number is estimated from a negative binomial regression model, adjusted for baseline volume of T2 from a negative binomial regression model, adjusted for baseline volume of T2 hyperintense lesions, history of prior IFN beta use and baseline age (≤ 35 vs > 35 years). To account for the timing of the MRI measurement, the logarithmic transformation of the scan number of the MRI assessment is included in the model as the 'offset' parameter. Observed data after participants switched to alternative MS medications are excluded. Missing data are not imputed. Only observed new or newly enlarging T2 lesions at the last visit of the participant up to Week 96 visit are used in this analysis.
up to 96 weeks
Proportion of Participants With Sustained Disability Progression at 144 Weeks
Time Frame: Baseline through 144 weeks
Sustained disability progression is defined as: at least a 1.0-point increase on the EDSS from Baseline EDSS ≥ 1.0 that is sustained for 12 weeks, or at least a 1.5-point increase on the EDSS from baseline EDSS = 0 that is sustained for 12 weeks. The EDSS measures the disability status of people with MS on a scale that ranges from 0 to 10, with higher scores indicating more disability. Estimated proportion of participants with progression is based on the Kaplan-Meier product limit method. Participants were censored at the time of withdrawal/switch if they withdrew from study or switched to alternative MS medication without a progression. Participants with a tentative progression at the End of Treatment Period Visit (or the last EDSS assessment prior to alternative MS start date) and no confirmation assessment were censored at their last EDSS assessment.
Baseline through 144 weeks
Proportion of Participants Relapse-free at Week 144
Time Frame: 144 weeks
Relapses are defined as new or recurrent neurological symptoms not associated with fever or infection, lasting at least 24 hours, and accompanied by new objective neurological findings upon examination by the examining neurologist. Only relapses confirmed by INEC are included in this analysis. Data after participants switched to alternative MS medications are excluded. The estimated proportion of subjects relapse-free at Week 144 is based on the Kaplan-Meier product limit method.
144 weeks
Percentage of Participants With a ≥ 7.5 Point Worsening From Baseline in the Multiple Sclerosis Impact Scale (MSIS-29) Physical Impact Score at 96 Weeks
Time Frame: Baseline and 96 weeks
The MSIS-29 is a 29-item disease-specific patient-reported outcome measure that has been developed and validated to examine the physical and psychological impact of MS from a patient's perspective; it measures physical and psychological items. Worsening in the MSIS-29 physical score is defined as an increase of ≥ 7.5 points in the MSIS-29 physical score at 96 weeks compared to baseline. If a participant was missing data for less than 10 of the 20 items that make up the physical score, then the mean of the non-missing items were used for the missing items. If a participant was missing 10 or more of the 20 items that make up the physical score, or missing the questionnaire entirely, or if the questionnaire was completed after the participant switched to alternative MS medication, a random effects model was used to estimate the MSIS-29 physical score.
Baseline and 96 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biogen

Collaborators

AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2010

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

July 1, 2014

Study Registration Dates

First Submitted

January 26, 2010

First Submitted That Met QC Criteria

February 5, 2010

First Posted (Estimate)

February 8, 2010

Study Record Updates

Last Update Posted (Estimate)

July 11, 2016

Last Update Submitted That Met QC Criteria

May 31, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 205MS301
  • 2009-012500-11

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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