Safety and Efficacy Study of Erythropoietin as add-on Therapy of Methylprednisolone to Treat Acute Optic Neuritis

NCT00355095 | Completed Phase 2

• 1 other identifier: 0026
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Optic Neuritis

Keywords

multiple sclerosis; add-on Therapy; erythropoietin; methylprednisolone; autoimmune optic neuritis

Outcome Measures

Primary Outcomes (1)

• nerve fiber loss in the optical nerve head determined by optical coherence tomography at weeks 4,8 and 16 compared to baseline. Measurements at baseline and week 16 are used to calculate estimates for changes and differences between the groups.

  4 months

Secondary Outcomes (1)

• Visual acuity and visual field perception determined at weeks 1, 4, 8, 16 compared to baseline (week 0). MRI measurements of optic nerve atrophy performed at weeks 4, 8 and 16 compared to baseline (week 0)

  4 months

Study Arms (2)

1

ACTIVE COMPARATOR

erythropoietin

Drug: Erythropoietin

2

NO INTERVENTION

Placebo

Interventions

Erythropoietin DRUG

intravenous daily 3.3 \*10\^4 Units, duration 3 days

Also known as: Erypo®

1

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• To be eligible to participate in this study, candidates must meet the following eligibility criteria at the time of randomization:
• Must give written informed consent and authorize the release and use of protected health information (PHI).
• Must be 18 to 50 years old, inclusive, at the time of informed consent.
• Must have acute unilateral optic neuritis with or without prior diagnosis of MS (according to McDonald criteria).
• Must have had normal visual acuity on both eyes before and no history of optic neuritis.
• Must have a decreased visual acuity on the affected eye to 0.5 or less at screening.

You may not qualify if:

• Medical history:
• Abnormal laboratory results or clinical signs indicative of any significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, gastrointestinal, dermatologic, psychiatric, renal, neurological (other than MS), and/or other major disease.
• History of prior optic neuritis on the affected or non-affected eye.
• History of squint or amblyopia on either side.
• Hyperopia \> 3dptr on either side.
• Myopia \< -5dptr on either side.
• Astigmatism \> 2dptr on either side.
• Horizontal cup disc ratio \> 0.5 on either side.
• Retinal nerve fiber layer thickness outside normal values (with respect to the OCT data base).
• Ocular diseases effecting visual acuity or visual fields (cataract, glaucoma, maculadegeneration, diabetic retinopathy, retinal heredodegeneration or others).
• History of elevated blood pressure.
• Systolic blood pressure of \> 159 mmHg, diastolic blood pressure \> 99 mmHg at screening examination.
• History of thromboembolic events.
• Frequent thromboembolic events in 1st grade family members.
• Significant surgery within the 4 weeks prior to randomization.

Sponsors & Collaborators

• Institut fuer anwendungsorientierte Forschung und klinische Studien GmbH: lead

Study Sites (3)

University Hospital of Hamburg-Eppendorf (Institut of Neuroimmunology and Clinical MS Research (INIMS))

Hamburg, Hamburg, 20246, Germany

Location

Department of Neurology University Hospital Goettingen

Göttingen, Lower Saxony, 37075, Germany

Location

Department of Neurology University Homborg Hospital of the Saarland, Germany

Homburg, Saarland, 66421, Germany

Location

Related Publications (3)

• Maier K, Rau CR, Storch MK, Sattler MB, Demmer I, Weissert R, Taheri N, Kuhnert AV, Bahr M, Diem R. Ciliary neurotrophic factor protects retinal ganglion cells from secondary cell death during acute autoimmune optic neuritis in rats. Brain Pathol. 2004 Oct;14(4):378-87. doi: 10.1111/j.1750-3639.2004.tb00081.x.

  PMID: 15605985 BACKGROUND

• Suhs KW, Papanagiotou P, Hein K, Pul R, Scholz K, Heesen C, Diem R. Disease Activity and Conversion into Multiple Sclerosis after Optic Neuritis Is Treated with Erythropoietin. Int J Mol Sci. 2016 Sep 30;17(10):1666. doi: 10.3390/ijms17101666.

  PMID: 27706045 DERIVED

• Suhs KW, Hein K, Sattler MB, Gorlitz A, Ciupka C, Scholz K, Kasmann-Kellner B, Papanagiotou P, Schaffler N, Restemeyer C, Bittersohl D, Hassenstein A, Seitz B, Reith W, Fassbender K, Hilgers R, Heesen C, Bahr M, Diem R. A randomized, double-blind, phase 2 study of erythropoietin in optic neuritis. Ann Neurol. 2012 Aug;72(2):199-210. doi: 10.1002/ana.23573.

  PMID: 22926853 DERIVED

MeSH Terms

Conditions

Optic Neuritis; Multiple Sclerosis

Interventions

Erythropoietin

Condition Hierarchy (Ancestors)

Optic Nerve Diseases; Cranial Nerve Diseases; Nervous System Diseases; Eye Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Ricarda Diem, MD Prof.

  Department of Neurology University Homborg Hospital of the Saarland, Germany

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 20, 2006
• First Posted: July 21, 2006
• Study Start: August 1, 2006
• Primary Completion: February 1, 2011
• Study Completion: July 1, 2011
• Last Updated: September 13, 2012

Record last verified: 2012-09

Locations

DE (3)