Trial record 6 of 275 for:
biogen | biogen
215ON201 BIIB033 In Acute Optic Neuritis (AON) (RENEW)
This study is currently recruiting participants.
Verified May 2013 by Biogen Idec
Sponsor:
Biogen Idec
Collaborators:
Biogen Idec Australia Pty Ltd
Biogen Idec Research Ltd.
Biogen Idec MA Inc.
Information provided by (Responsible Party):
Biogen Idec
ClinicalTrials.gov Identifier:
NCT01721161
First received: October 25, 2012
Last updated: May 15, 2013
Last verified: May 2013
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Purpose
The primary objective of the study is to evaluate the efficacy of BIIB033 in subjects with their first episode of unilateral Acute Optic Neuritis (AON). The secondary objective of this study in this study population is to assess the safety, tolerability, and pharmacokinetics (PK) of BIIB033.
| Condition | Intervention | Phase |
|---|---|---|
|
Acute Optic Neuritis |
Biological: BIIB033 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A Randomized, Double-Blind, Parallel-Group, Placebo Controlled Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of BIIB033 in Subjects With First Episode of Acute Optic Neuritis |
Further study details as provided by Biogen Idec:
Primary Outcome Measures:
- Change in optic nerve conduction velocity (NCV) at Week 24 for the affected eye from the baseline of unaffected fellow eye as determined by full-field visual evoked potential (FF-VEP). [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Change in thickness of the retinal nerve fiber layer (RNFL) at Week 24 for the affected eye from the baseline of unaffected fellow eye as determined by spectral-domain optical coherence tomography (SD-OCT). [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
- Change in thicknesses of the retinal ganglion cell layer/inner plexiform retinal layer (RGCL/IPL) at Week 24 for the affected eye from the baseline of unaffected fellow eye as determined by segmentation of SD-OCT. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
- Change in low-contrast letter acuity (LCLA) at Week 24 from baseline as determined by 1.25% and 2.5% low contrast Sloan letter charts. [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
- Number of participants with Adverse events (AEs) and serious adverse events (SAEs) [ Time Frame: 32 weeks ] [ Designated as safety issue: Yes ]
- Population PK assessment as measured by Serum BIIB033 concentrations [ Time Frame: 32 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 80 |
| Study Start Date: | December 2012 |
| Estimated Study Completion Date: | October 2014 |
| Estimated Primary Completion Date: | September 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: BIIB033
Subjects will receive BIIB033 100 mg/kg via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses).
|
Biological: BIIB033 |
|
Placebo Comparator: Placebo
Subjects will receive Placebo via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses).
|
Biological: BIIB033 |
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Ability to provide written consent and any authorization required by law.
- Aged 18 to 55 years old, inclusive, at the time of informed consent.
- Confirmed diagnosis of Acute Optic Neuritis (AON)
- All male or female subjects of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for at least 6 months after their last dose of study treatment.
Exclusion Criteria:
- Prior episode(s) of optic neuritis or loss of vision not due to AON.
- Subjects with an established diagnosis of Multiple Sclerosis are excluded except if newly diagnosed based on the current episode of AON and positive brain MRI results consistent with the 2010 revisions to the McDonald's criteria.
- Previous history of a clinically significant disease.
- Females who have a positive pregnancy test result, or who are pregnant, breastfeeding, or planning to conceive during the study.
- History of human immunodeficiency virus (HIV), hepatitis C virus antibody, or hepatitis B virus.
- History or evidence of drug or alcohol abuse within 2 years prior to Screening.
- Current enrollment in any other study treatment or disease study within 3 months prior to Day 1/Baseline.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01721161
Contacts
| Contact: Biogen Idec | neurologyclinicaltrials@biogenidec.com |
Locations
| Australia, Victoria | |
| Research Site | Recruiting |
| Parkville, Victoria, Australia | |
| Australia | |
| Research Site | Recruiting |
| Camperdown, Australia | |
| Research Site | Recruiting |
| Westmead, Australia | |
| Belgium | |
| Research Site | Recruiting |
| Brugge, Belgium | |
| Research Site | Recruiting |
| Brussels, Belgium | |
| Research Site | Recruiting |
| Ghent, Belgium | |
| Canada | |
| Research Site | Recruiting |
| Calgary, Canada | |
| Research Site | Recruiting |
| Halifax, Canada | |
| Research Site | Recruiting |
| Montreal, Canada | |
| Czech Republic | |
| Research Site | Recruiting |
| Olomouc, Czech Republic | |
| Germany | |
| Research Site | Recruiting |
| Bamberg, Germany | |
| Research Site | Recruiting |
| Dusseldorf, Germany | |
| Research Site | Recruiting |
| Tubingen, Germany | |
| Hungary | |
| Research Site | Recruiting |
| Budapest, Hungary | |
| Italy | |
| Research Site | Recruiting |
| Firenze, Italy | |
| Research Site | Recruiting |
| Milano, Italy | |
| Research site | Recruiting |
| Roma, Italy | |
| Spain | |
| Research Site | Recruiting |
| Barcelona, Spain | |
| Research Site | Recruiting |
| Malaga, Spain | |
| Research Site | Recruiting |
| Sevilla, Spain | |
| Research Site | Recruiting |
| Valencia, Spain | |
| Sweden | |
| Research Site | Recruiting |
| Lund, Sweden | |
| Research Site | Recruiting |
| Stockholm, Sweden | |
| United Kingdom | |
| Research Site | Recruiting |
| Birmingham, United Kingdom | |
| Research Site | Recruiting |
| Glasgow, United Kingdom | |
Sponsors and Collaborators
Biogen Idec
Biogen Idec Australia Pty Ltd
Biogen Idec Research Ltd.
Biogen Idec MA Inc.
More Information
No publications provided
| Responsible Party: | Biogen Idec |
| ClinicalTrials.gov Identifier: | NCT01721161 History of Changes |
| Other Study ID Numbers: | 215ON201 |
| Study First Received: | October 25, 2012 |
| Last Updated: | May 15, 2013 |
| Health Authority: | Belgium: Federal Agency for Medicinal Products and Health Products Italy: Ethics Committee Australia: Therapeutic Goods Administration (TGA) United Kingdom: Medicines and Healthcare Products Regulatory Agency Germany: Federal Institute for Drugs and Medical Devices Spain: Spanish Agency of Medicines Czech Republic: State Institute for Drug Control Sweden: Medical Products Agency Italy: Ministry of Health Canada: Health Canada Hungary: National Institute of Pharmacy |
Keywords provided by Biogen Idec:
|
Optic Neuritis |
Additional relevant MeSH terms:
|
Neuritis Optic Neuritis Peripheral Nervous System Diseases Neuromuscular Diseases |
Nervous System Diseases Optic Nerve Diseases Cranial Nerve Diseases Eye Diseases |
ClinicalTrials.gov processed this record on May 19, 2013