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Trial record 1 of 1 for:    Randomized Treatment Interruption of Natalizumab
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Treatment Interruption of Natalizumab (RESTORE)

This study has been completed.
Elan Pharmaceuticals
Information provided by (Responsible Party):
Biogen Identifier:
First received: February 17, 2010
Last updated: September 12, 2013
Last verified: November 2012

This is a randomized, rater blinded trial in patients who interrupt treatment with natalizumab with or without being treated with other immunomodulatory drugs, or continue treatment with natalizumab.

The main purpose of this study is to find out the following, when participants stop taking natalizumab for 24 weeks:

  • when MS symptoms return, and
  • if other drugs for MS may help control MS symptoms during the natalizumab-interruption period.

This study will also explore how quickly the effects of natalizumab return after resuming natalizumab dosing.

Condition Intervention Phase
Relapsing Remitting Multiple Sclerosis Drug: natalizumab Drug: interferon beta 1-a Drug: methylprednisolone Other: IV placebo Drug: glatiramer acetate Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Treatment Interruption of Natalizumab

Resource links provided by NLM:

Further study details as provided by Biogen:

Primary Outcome Measures:
  • Time Course to Return of Radiological and/or Clinical Evidence of Multiple Sclerosis Activity, as Measured by the Percentage of Subjects Who Met Magnetic Resonance Imaging (MRI) and/or Clinical Relapse Rescue Criteria. [ Time Frame: 28 Weeks ]
    Rescue criteria were: 1) central reader MRI finding of 1 new gadolinium-enhancing (Gd+) lesion of >0.8 cubic centimeters in volume or 2 or more Gd+ lesions of any size 2) clinical relapse. Clinical relapse was new or recurrent neurological symptoms not associated with fever or infection, lasting at least 24 hours, as defined by: an increase of ≥1 grade in ≥2 functional scales of the Expanded Disability Status Scale (EDSS); an increase of ≥2 grades in 1 functional scale of the EDSS; or an increase of >0.5 in EDSS if the previous EDSS was ≤5.5, or ≥0.5 if the previous EDSS was >5.5

Secondary Outcome Measures:
  • Time Course to Return of Radiological Activity, as Measured by the Percentage of Subjects Who Met Magnetic Resonance Imaging (MRI) Rescue Criteria. [ Time Frame: 28 Weeks ]
    MRI rescue criteria were the presence of 1 new gadolinium-enhancing (Gd+) lesion of >0.8 cubic centimeters in volume or 2 or more Gd+ lesions of any size, according to the central MRI reader.

Enrollment: 175
Study Start Date: March 2010
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: natalizumab Drug: natalizumab
300 mg intravenous every 4 weeks
Placebo Comparator: IV placebo Other: IV placebo
placebo intravenous every 4 weeks
Active Comparator: interferon β-1a, glatiramer acetate, or methylprednisolone Drug: interferon beta 1-a
30 ug intramuscular once per week
Drug: methylprednisolone
1000 mg intravenous every 4 weeks
Drug: glatiramer acetate
20 mg subcutaneous once daily


Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Major criteria include:

  • A diagnosis of a relapsing form of MS
  • Treatment with natalizumab according to locally approved prescribing information
  • Other protocol defined inclusion/exclusion criteria may apply
  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 identifier: NCT01071083

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United States, Alabama
Research Site
Cullman, Alabama, United States, 35058
United States, California
Research Site
San Francisco, California, United States, 94117
United States, Colorado
Research Site
Fort Collins, Colorado, United States
United States, Florida
Research Site
Pompano Beach, Florida, United States, 33060
United States, Georgia
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Atlanta, Georgia, United States, 30309
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Atlanta, Georgia, United States, 30327
United States, Illinois
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Chicago, Illinois, United States, 60612
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Lake Barrington, Illinois, United States, 60010
United States, Iowa
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Des Moines, Iowa, United States, 50314
United States, Massachusetts
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Boston, Massachusetts, United States, 2135
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Boston, Massachusetts, United States, 2215
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Buffalo, New York, United States, 14203
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Latham, New York, United States, 12110
Research Site
Patchogue, New York, United States, 11772
United States, North Carolina
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Charlotte, North Carolina, United States, 28207
Research Site
Raleigh, North Carolina, United States, 27607
United States, Ohio
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Cleveland, Ohio, United States, 44195
Research Site
Uniontown, Ohio, United States
United States, Utah
Research Site
Salt Lake City, Utah, United States, 84103
United States, Washington
Research Site
Seattle, Washington, United States, 98111
Research Site
Freiburg, Baden-Wuerttemberg, Germany, 79106
Research Site
Munchen, Bayern, Germany, 81675
Research Site
Hennigsdorf, Brandenburg, Germany, 16761
Research Site
Marburg, Hessen, Germany, 35039
Research Site
Bochum, Nordrhein-Westfalen, Germany, 44791
Research Site
Dresden, Sachsen, Germany, 1307
Research Site
Hamburg, Germany, 20246
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L´Hospitalet de Llobregat, Barcelona, Spain, 8907
Research Site
Málaga, Malaga, Spain, 29010
Research Site
El Palmar, Murcia, Spain, 30120
Research Site
Barcelona, Spain, 8035
Research Site
Valencia, Spain, 46009
Research Site
Valencia, Spain, 46010
Sponsors and Collaborators
Elan Pharmaceuticals
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Biogen Identifier: NCT01071083     History of Changes
Other Study ID Numbers: 101MS205
Study First Received: February 17, 2010
Results First Received: October 25, 2012
Last Updated: September 12, 2013

Keywords provided by Biogen:

Additional relevant MeSH terms:
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Interferon beta-1a
Methylprednisolone Hemisuccinate
Glatiramer Acetate
Prednisolone acetate
Methylprednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic
Immunosuppressive Agents
Antirheumatic Agents
Anti-Inflammatory Agents
Antiemetics processed this record on June 21, 2017