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| Sponsor: | Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH |
|---|---|
| Information provided by: | Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH |
| ClinicalTrials.gov Identifier: | NCT00355095 |
Purpose
The purpose of this study is to determine the safety and efficacy of erythropoietin as an add-on therapy to methylprednisolone in subjects with acute autoimmune optic neuritis.
| Condition | Intervention | Phase |
|---|---|---|
|
Optic Neuritis |
Drug: Erythropoietin |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention |
| Official Title: | Double Blind, Placebo-controlled Study to Determine the Safety and Efficacy of Erythropoietin as an add-on Therapy of Methylprednisolone in Subjects With Acute Optic Neuritis (VISION PROTECT) |
| Estimated Enrollment: | 40 |
| Study Start Date: | August 2006 |
| Estimated Study Completion Date: | June 2011 |
| Estimated Primary Completion Date: | February 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
erythropoietin
|
Drug: Erythropoietin
intravenous daily 3.3 *10^4 Units, duration 3 days
Other Name: Erypo®
|
|
No Intervention: 2
Placebo
|
SUMMARY This study is a multicenter, double-blind, placebo-controlled, parallel-group study to determine the safety and efficacy of erythropoietin (Epo) as an add-on therapy to methylprednisolone (Mpred) in subjects with acute autoimmune optic neuritis.
The primary study endpoint is nerve fiber loss in the optical nerve head determined by optical coherence tomography at weeks 4, 8, and 16 compared to baseline.
Further study objectives include visual acuity, visual field perception, optic nerve atrophy determined by magnetic resonance imaging (MRI), and recovery of visual evoked potentials (VEPs).
A number of 40 subjects will be randomized in equal numbers into one of the two treatment groups.
Treatment groups:
Epo or placebo will be administered i.v. at three consecutive days. Epo or placebo is to be given once daily following application of Mpred preferably between 8 and 10 a.m..
Subjects will be randomized to one of the following two treatment groups and dosed as follows:
Men and women between the ages of 18 and 50, inclusive, diagnosed with acute unilateral optic neuritis with or without prior diagnosis of multiple sclerosis (according to McDonald criteria; Polman et al., 2005) will be considered for inclusion into the study. Those subjects must have a decreased visual acuity on the affected eye to 0.5 or less and must have signed written informed consent. While safety will be monitored during the study, an efficacy evaluation will be done after all subjects have completed week 16.
Each subject included in the study will be seen by a treating neurologist and an examining neurologist as well as by an examining ophthalmologist. The treating neurologist will function as the primary treating physician and conduct all subject safety assessments. The examining ophthalmologist and the examining neurologist will conduct all evaluations of vision/optical nerve head atrophy and neurological symptoms, respectively, but will not be involved in any other aspect of patient care. A neurophysiologist will perform measurements of VEPs. MRIs will be performed by a neuroradiologist.
Eligibility| Ages Eligible for Study: | 18 Years to 50 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
To be eligible to participate in this study, candidates must meet the following eligibility criteria at the time of randomization:
Exclusion Criteria:
Candidates will be excluded from study if any of the following exclusion criteria exist at the time of randomization:
Medical history:
Treatment history
Contacts and Locations| Germany | |
| Department of Neurology University Hospital Goettingen | |
| Goettingen, Niedersachsen, Germany, 37075 | |
| Department of Neurology University Homborg Hospital of the Saarland, Germany | |
| Homburg, Saarland, Germany, 66421 | |
| University Hospital of Hamburg-Eppendorf (Institut of Neuroimmunology and Clinical MS Research (INIMS)) | |
| Hamburg, Germany, 20246 | |
| Study Director: | Ricarda Diem, MD Prof. | Department of Neurology University Homborg Hospital of the Saarland, Germany |
More Information
| Responsible Party: | Dirk Simon, Institut fuer anwendungsorientierte Forschung und klinische Studien gGmbH |
| ClinicalTrials.gov Identifier: | NCT00355095 History of Changes |
| Other Study ID Numbers: | 0026 |
| Study First Received: | July 20, 2006 |
| Last Updated: | September 17, 2010 |
| Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
|
multiple sclerosis add-on Therapy erythropoietin methylprednisolone autoimmune optic neuritis |
|
Neuritis Optic Neuritis Peripheral Nervous System Diseases Neuromuscular Diseases Nervous System Diseases Optic Nerve Diseases Cranial Nerve Diseases Eye Diseases Epoetin Alfa Methylprednisolone acetate Prednisolone acetate Methylprednisolone Methylprednisolone Hemisuccinate Prednisolone Prednisolone phosphate |
Hematinics Hematologic Agents Therapeutic Uses Pharmacologic Actions Anti-Inflammatory Agents Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Central Nervous System Agents Gastrointestinal Agents Neuroprotective Agents Protective Agents Glucocorticoids Hormones |