Phase 2
N=52
Long-Term Assessment of Remyelinating Therapy
Acute Optic Neuritis
Bottom Line
View on ClinicalTrials.gov: NCT02657915 ↗Enrolled (actual)
52
Serious AEs
0.0%
Results posted
Sep 2019
Primary outcome: Primary: 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) — 100.68; 102.29; 119.52; 114.20 milliseconds (msec) — p==0.165
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Placebo (Drug); BIIB033 100mg/Kg (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Biogen
- Primary completion
- Jan 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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) |
100.68; 102.29; 119.52; 114.20 | =0.165 |
| SECONDARY Number of Participants That Developed Clinically Definite Multiple Sclerosis (CDMS) After Enrollment in RENEW Study (NCT01721161) |
12; 12 | — |
| SECONDARY Time to Diagnosis of CDMS |
386.0; 909.5 | — |
| SECONDARY Severity of Central Nervous System (CNS) Demyelinating Disease as Assessed Using the Expanded Disability Status Scale (EDSS) |
1.22; 1.26 | — |
| SECONDARY Severity of CNS Demyelinating Disease as Assessed Using the Symbol- Digit Modalities Test (SDMT) |
56.7; 58.7 | — |
| SECONDARY Severity of CNS Demyelinating Disease as Assessed Using the Multiple Sclerosis Functional Composite (MSFC) Assessment |
-0.82; -0.06 | — |
| SECONDARY Change in Number of Gadolinium (Gd)-Enhanced Lesions From Baseline in RENEW Study (NCT01721161) to Day 1 (NCT02657915) |
0.2; 0.1; 0.2; -0.1 | — |
| SECONDARY Change in Volume of T2 Lesions From Baseline in RENEW Study (NCT01721161) to Day 1 (NCT02657915) |
0.9710; 0.7341; 0.5090; 0.6244 | — |
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.
Data sourced from ClinicalTrials.gov (NCT02657915). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.