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Long-Term Assessment of Remyelinating Therapy (RENEWED)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02657915
Recruitment Status : Completed
First Posted : January 18, 2016
Results First Posted : September 23, 2019
Last Update Posted : September 23, 2019
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 NCT01721161 2 years (+ up to 12 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 NCT01721161 2 years (+ up to 12 months) after the last study visit. Intervention was administered in the previous study. The participants, investigator and outcome assessors remain blinded in this follow-up study.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: This was a follow-up study with no investigational product; however, the allocation method in RENEW Study (NCT01721161) 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.
Primary Purpose: Other
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 10, 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, investigational product was administered in the previous study. Participants in the placebo arm have received at least 1 dose of placebo.
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, investigational product was administered in the previous study. Participants in the BIIB033 arm have received at least 1 dose of 100 mg/kg BIIB033.
Drug: BIIB033 100mg/Kg
Administered as specified in the treatment arm.




Primary Outcome Measures :
  1. FF-VEP Latency of the Affected Eye as Compared to the Baseline of the Fellow Eye at 2 Years (+ up to 12 Months) After the Last Study Visit Assessment (Week 32) in RENEW Study (NCT01721161) [ Time Frame: Baseline (RENEW Study [NCT01721161]), Day 1 (NCT02657915) ]
    A full field visual evoked potential (FF-VEP) 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. Number of Participants That Developed Clinically Definite Multiple Sclerosis (CDMS) After Enrollment in RENEW Study (NCT01721161) [ Time Frame: RENEW Study (NCT01721161) to Day 1 (NCT02657915) ]
    The diagnosis of clinically definite multiple sclerosis (CDMS) was made on the basis of clinical criteria and requires that a patient experience at least 2 neurologic events consistent with demyelination, separated both in time and in location in the central nervous system.

  2. Time to Diagnosis of CDMS [ Time Frame: RENEW Study (NCT01721161) to Day 1 (NCT02657915) ]
    The diagnosis of CDMS was made on the basis of clinical criteria and requires that a patient experience at least 2 neurologic events consistent with demyelination, separated both in time and in location in the central nervous system. Time to diagnosis of CDMS in Study NCT02657915 was the time from the diagnosis of acute optic neuritis (AON) to the date of confirmed MS. Measured in Days using the Median (50th percentile) for each arm.

  3. Severity of Central Nervous System (CNS) Demyelinating Disease as Assessed Using the Expanded Disability Status Scale (EDSS) [ Time Frame: Day 1 (NCT02657915) ]
    The EDSS score is based on neurological testing and an examination of functional systems (FS), which are areas of the central nervous system which control bodily functions. These functional systems are: pyramidal (ability to walk), Cerebellar (coordination), brain stem (speech and swallowing), sensory (touch and pain), bowel and bladder functions, visual, mental and Other (includes any other neurological findings due to MS). An overall score ranging from 0 (normal) to 10 (disability) was calculated. Higher scores indicate greater disability.

  4. Severity of CNS Demyelinating Disease as Assessed Using the Symbol- Digit Modalities Test (SDMT) [ Time Frame: Day 1 (NCT02657915) ]
    SDMT is a screening test for cognitive impairment. Participants were given 90 seconds in which to pair specific numbers with given geometric figures using a key. Scores range from 0 to 110 (best). Originate from the occipital cortex, the area of the brain involved in receiving and interpreting visual signals.

  5. Severity of CNS Demyelinating Disease as Assessed Using the Multiple Sclerosis Functional Composite (MSFC) Assessment [ Time Frame: Day 1 (NCT02657915) ]
    MSFC has 3 component- timed 25-foot walk (T25FW), 9-hole peg test (9HPT) [dominant and nondominant hands] and (3-second) paced auditory serial addition Test (PASAT). The MSFC Z-score is calculated by creating Z-scores for each component of the MSFC and averaging them to create an overall composite score. MSFC Z-score = (Z25-foot-walk + Z9HPT + ZPASAT-3)/3, where Zj refers to Z-scores of component j. A Z-score represented the number of standard deviations participant's test result was higher (Z >0) or lower (Z <0) than the average test result (Z = 0) from the reference population. Higher scores indicate better outcomes.

  6. Change in Number of Gadolinium (Gd)-Enhanced Lesions From Baseline in RENEW Study (NCT01721161) to Day 1 (NCT02657915) [ Time Frame: Baseline (RENEW Study [NCT01721161]), Day 1 (NCT02657915) ]
    Change in disease activity from baseline with brain magnetic resonance imaging (MRI) was calculated and reported. MRI analysis included number of consensus GD-enhanced lesions as a measure of disease activity.

  7. Change in Volume of T2 Lesions From Baseline in RENEW Study (NCT01721161) to Day 1 (NCT02657915) [ Time Frame: Baseline (RENEW Study [NCT01721161]), Day 1 (NCT02657915) ]
    Change in disease activity from baseline with brain magnetic MRI was calculated and reported. MRI analysis included volume of T2 lesions as disease activity.



Information from the National Library of Medicine

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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 NCT01721161 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 NCT01721161).

Key Exclusion Criteria:

  • Not previously enrolled in Study NCT01721161
  • 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
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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
Valencia, 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
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Study Director: Medical Director Biogen
  Study Documents (Full-Text)

Documents provided by Biogen:
Statistical Analysis Plan  [PDF] March 2, 2017
Study Protocol  [PDF] June 8, 2016

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Responsible Party: Biogen
ClinicalTrials.gov Identifier: NCT02657915    
Other Study ID Numbers: 215ON203
2015-003618-26 ( EudraCT Number )
First Posted: January 18, 2016    Key Record Dates
Results First Posted: September 23, 2019
Last Update Posted: September 23, 2019
Last Verified: August 2019
Keywords provided by Biogen:
FF-VEP
mfVEP
Human anti-LINGO-1
BIIB033
AON
Additional relevant MeSH terms:
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Neuritis
Optic Neuritis
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Optic Nerve Diseases
Cranial Nerve Diseases
Eye Diseases