EUCTR2015-003618-26-DE
Active, not recruiting
Phase 1
A Multicenter, Follow-Up Study to Assess Long-Term Electrophysiologic and Clinical Outcomes in Subjects Previously Enrolled in Study 215ON201 - RENEWed
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Acute Optic Neuritis
- Sponsor
- Biogen Idec Research Limited
- Enrollment
- 80
- Status
- Active, not recruiting
- Last Updated
- 8 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Must have participated in Study 215ON201 and received at least 1 dose of BIIB033 or placebo, as per protocol, within 2 years (\+ up to 12 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\).
- •2\. Ability of the subject to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use confidential health information in accordance with national and local subject privacy regulations.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 80
- •F.1\.3 Elderly (\>\=65 years) no
- •F.1\.3\.1 Number of subjects for this age range
Exclusion Criteria
- •1\. Not previously enrolled in Study 215ON201\.
- •2\. Inability to comply with study requirements.
- •3\. Other unspecified reasons that, in the opinion of the Investigator or Biogen, make the subject unsuitable for enrolment.
- •4\. Subjects with recent kidney function, such as serum creatinine above upper limit of normal range, will not be allowed to receive administration of gadolinium (Gd) but will otherwise be allowed to participate in the study, including MRI assessments not requiring the use of Gd.
- •5\. Female subjects must have had a recent pregnancy test and must not be breastfeeding prior to MRI assessments with Gd.
Outcomes
Primary Outcomes
Not specified
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