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Long-Term Assessment of Remyelinating Therapy (RENEWed)

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ClinicalTrials.gov Identifier: NCT02657915
Recruitment Status : Completed
First Posted : January 18, 2016
Last Update Posted : March 2, 2018
Sponsor:
Information provided by (Responsible Party):
Biogen

Brief Summary:
The primary objective of the study is to assess full-field visual evoked potential (FF-VEP) latency in subjects who were enrolled in Study 215ON201 (NCT01721161) 2 years (+ 4 months) after the last study visit. The secondary objective is to assess clinical progression and severity of central nervous system (CNS) demyelinating disease in subjects who were enrolled in Study 215ON201 2 years (+ 4 months) after the last study visit. No study drug dosing is planned for this study.

Condition or disease Intervention/treatment Phase
Acute Optic Neuritis Drug: Placebo Drug: BIIB033 100mg/Kg Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: This was a follow-up study with no investigational product; however, the allocation method in RENEW was randomised-controlled and to maintain the blind from RENEW, the treatment disclosure for RENEW was not shared with study sites or participants until the end of this study.
Official Title: A Multicenter, Follow-Up Study to Assess Long-Term Electrophysiologic and Clinical Outcomes in Subjects Previously Enrolled in Study 215ON201
Actual Study Start Date : March 31, 2016
Actual Primary Completion Date : January 23, 2017
Actual Study Completion Date : January 23, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo
This was a follow-up study with no investigational product administered. Subjects in the placebo arm had received at least 1 dose of placebo in RENEW.
Drug: Placebo
Administered as specified in the treatment arm.
Other Name: Sterile normal saline (0.9% sodium chloride for IV administration)

Experimental: BIIB033 100mg/Kg
This was a follow-up study with no investigational product administered. Subjects in the BIIB033 arm had received at least 1 dose of 100 mg/kg BIIB033 in RENEW.
Drug: BIIB033 100mg/Kg
Administered as specified in the treatment arm.




Primary Outcome Measures :
  1. Change in FF-VEP latency of the affected eye as compared to the baseline of the fellow eye at 2 years (+ 4 months) after the last study visit assessment (Week 32) in Study 215ON201. [ Time Frame: Day 1 ]
    A full field visual evoked potential is an evoked potential caused by a visual stimulus, such as an alternating checkerboard pattern on a computer screen. Responses are recorded from electrodes that are placed on the back of the head and are observed as a reading on an electroencephalogram (EEG). These responses usually originate from the occipital cortex, the area of the brain involved in receiving and interpreting visual signals.


Secondary Outcome Measures :
  1. Incidence of clinically definite multiple sclerosis (CDMS) [ Time Frame: Day 1 ]
  2. Time to diagnosis of CDMS [ Time Frame: Day1 ]
  3. Severity of CNS demyelinating disease with Expanded Disability Status Scale (EDSS) [ Time Frame: Day 1 ]
    The EDSS measures disability status on a scale ranging from 0 to 10, with higher scores indicating more disability. Scoring is based on measures of impairment in eight functional systems on examination by a neurologist.

  4. Severity of CNS demyelinating disease with Symbol-Digit Modalities Test (SDMT) [ Time Frame: Day 1 ]
    The SDMT involves a simple substitution task. Using a reference key, the examinee has 90 seconds to pair specific numbers with given geometric figures. Because examinees can give either written or spoken responses, the test is well suited for use with individuals who have motor disabilities or speech disorders. Because it involves only geometric figures and numbers, the SDMT is relatively culture free as well and can be administered to individuals who do not speak English.

  5. Severity of CNS demyelinating disease with multiple sclerosis functional composite (MSFC) [ Time Frame: Day 1 ]
    The MSFC is a three-part, standardized, quantitative, assessment instrument for use in clinical studies, particularly clinical trials, of MS. The three components of the MSFC are: (1) measure leg function/ambulation, (2) measure arm/hand function, and (3) measure cognitive function.

  6. Number of gadolinium (Gd)-enhanced lesions [ Time Frame: Day 1 ]
  7. Volume of T2 lesions [ Time Frame: Day 1 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Must have participated in Study 215ON201 and received at least 1 dose of BIIB033 or placebo, as per protocol, within 2 years (+ 4 months) from Day 1 of this study (2 years from Week 32 or projected Week 32 visit, if the subject did not complete all visits in Study 215ON201).

Key Exclusion Criteria:

  • Not previously enrolled in Study 215ON201
  • Subjects with recent kidney function, such as serum creatinine above upper limit of normal range, will not be allowed to receive administration of Gd but will otherwise be allowed to participate in the study, including magnetic resonance imaging (MRI) assessments not requiring the use of Gd.
  • Female subjects must have had a recent pregnancy test and must not be breastfeeding prior to MRI assessments with Gd.

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02657915


Locations
Australia, New South Wales
Research Site
Sydney, New South Wales, Australia
Australia, Victoria
Research Site
Parkville, Victoria, Australia
Belgium
Research Site
Brugge, Belgium
Canada, Ontario
Research Site
Ottawa, Ontario, Canada
Czechia
Research Site
Olomouc, Czechia
Research Site
Praha, Czechia
Denmark
Research Site
Glostrup, Denmark
Germany
Research Site
Bamberg, Germany
Research Site
Berlin, Germany
Research Site
Dresden, Germany
Research Site
Düsseldorf, Germany
Research Site
Tübingen, Germany
Hungary
Research Site
Budapest, Hungary
Italy
Research Site
Milan, Italy
Spain
Research Site
Barcelona, Spain
Research Site
Córdoba, Spain
Research Site
Murcia, Spain
Research Site
Sevilla, Spain
Research Site
Valendia, Spain
Sweden
Research Site
Solna, Sweden
United Kingdom
Research Site
Birmingham, United Kingdom
Research Site
Glasgow, United Kingdom
Research Site
London, United Kingdom
Sponsors and Collaborators
Biogen
Investigators
Study Director: Medical Director Biogen

Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT02657915     History of Changes
Other Study ID Numbers: 215ON203
2015-003618-26 ( EudraCT Number )
First Posted: January 18, 2016    Key Record Dates
Last Update Posted: March 2, 2018
Last Verified: February 2018

Keywords provided by Biogen:
FF-VEP
mfVEP
Human anti-LINGO-1
BIIB033
AON

Additional relevant MeSH terms:
Neuritis
Optic Neuritis
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Optic Nerve Diseases
Cranial Nerve Diseases
Eye Diseases