Clinical trial NCT02657915: Long-Term Assessment of Remyelinating Therapy
Official title: A Multicenter, Follow-Up Study to Assess Long-Term Electrophysiologic and Clinical Outcomes in Subjects Previously Enrolled in Study 215ON201
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Optic Neuritis
Keywords: FF-VEP
mfVEP
Human anti-LINGO-1
BIIB033
AON
Lead sponsor: Biogen
Sponsor class: INDUSTRY
First posted: 2016-01-18
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility 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.

Primary outcomes:
measure: 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)
timeFrame: Baseline (RENEW Study [NCT01721161]), Day 1 (NCT02657915)
Secondary outcomes:
measure: Number of Participants That Developed Clinically Definite Multiple Sclerosis (CDMS) After Enrollment in RENEW Study (NCT01721161)
timeFrame: RENEW Study (NCT01721161) to Day 1 (NCT02657915)
measure: Time to Diagnosis of CDMS
timeFrame: RENEW Study (NCT01721161) to Day 1 (NCT02657915)
measure: Severity of Central Nervous System (CNS) Demyelinating Disease as Assessed Using the Expanded Disability Status Scale (EDSS)
timeFrame: Day 1 (NCT02657915)
measure: Severity of CNS Demyelinating Disease as Assessed Using the Symbol- Digit Modalities Test (SDMT)
timeFrame: Day 1 (NCT02657915)
measure: Severity of CNS Demyelinating Disease as Assessed Using the Multiple Sclerosis Functional Composite (MSFC) Assessment
timeFrame: Day 1 (NCT02657915)
measure: Change in Number of Gadolinium (Gd)-Enhanced Lesions From Baseline in RENEW Study (NCT01721161) to Day 1 (NCT02657915)
timeFrame: Baseline (RENEW Study [NCT01721161]), Day 1 (NCT02657915)
measure: Change in Volume of T2 Lesions From Baseline in RENEW Study (NCT01721161) to Day 1 (NCT02657915)
timeFrame: Baseline (RENEW Study [NCT01721161]), Day 1 (NCT02657915)
Other outcomes:
Locations:
city: Sydney
country: Australia
facility: Research Site
state: New South Wales
city: Parkville
country: Australia
facility: Research Site
state: Victoria
city: Brugge
country: Belgium
facility: Research Site
city: Ottawa
country: Canada
facility: Research Site
state: Ontario
city: Olomouc
country: Czechia
facility: Research Site
city: Praha
country: Czechia
facility: Research Site
city: Glostrup
country: Denmark
facility: Research Site
city: Bamberg
country: Germany
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Dresden
country: Germany
facility: Research Site
city: Düsseldorf
country: Germany
facility: Research Site
city: Tübingen
country: Germany
facility: Research Site
city: Budapest
country: Hungary
facility: Research Site
city: Milan
country: Italy
facility: Research Site
city: Barcelona
country: Spain
facility: Research Site
city: Córdoba
country: Spain
facility: Research Site
city: Murcia
country: Spain
facility: Research Site
city: Sevilla
country: Spain
facility: Research Site
city: Valencia
country: Spain
facility: Research Site
city: Solna
country: Sweden
facility: Research Site
city: Birmingham
country: United Kingdom
facility: Research Site
city: Glasgow
country: United Kingdom
facility: Research Site
city: London
country: United Kingdom
facility: Research Site
Study officials:
affiliation: Biogen
name: Medical Director
role: STUDY_DIRECTOR
References: