MOdification of VIsual Outcomes After Optic Neuritis in CIS or MS by Gilenya (MOVING Study)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Charite University, Berlin, Germany
Sponsor:
Collaborator:
Charité Neurocure AG Flöel
Information provided by (Responsible Party):
Friedemann Paul, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT01647880
First received: July 23, 2012
Last updated: September 17, 2014
Last verified: September 2014
  Purpose

In the MOVING study should be examined, whether early therapeutic intervention with fingolimod (Gilenya ®) after optic neuritis(ON) has a favorable visual outcome as a comparative therapie with Interferon beta-1b (Extavia®), as measured by multifocal visual evoked potentials (mVEP) after 6 month compared to baseline.


Condition Intervention Phase
Multiple Sclerosis
Drug: Verum arm receiving Gilenya®
Drug: Active Comparator receiving Extavia®
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Phase II/III Study to Investigate the Effects of Fingolimod Versus Interferon Beta-1b on Visual Recovery After Optic Neuritis

Resource links provided by NLM:


Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • Efficacy parameters [ Designated as safety issue: Yes ]
    Decrease of latency of mVEP of the affected eye after 6 months treatment with Gilenya® vs. Extavia® compared to baseline


Secondary Outcome Measures:
  • Efficacy parameters [ Designated as safety issue: Yes ]
    Decrease in the latency of the mVEP from the affected eye at the time points 1, 3 and 12 months in comparison to baseline. Retinal nerve fiber layer thickness and macular volume in OCT, visual contrast sensitivity, visual field, Color vision, visual quality of life, in CMRT lesion load in cMRT , neurotrophic factors and axonal damage markers (neurofilament) and neurotrophins (for example, BDNF) in the serum


Estimated Enrollment: 88
Study Start Date: July 2013
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fingolimod (Gilenya®)
0,5 mg once a day in the morning, oral
Drug: Verum arm receiving Gilenya®
Active Comparator: Interferon beta-1b (Extavia®)
every second day, s.c.
Drug: Active Comparator receiving Extavia®

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of relapsing-remitting multiple sclerosis (RRMS)
  • ability to consent and a written approval
  • First acute ON attack to the fit eye within 30 days before screening
  • Age 18 - 55 years at screening
  • EDSS ≤ 6.0
  • No MS Attack except for ON in the last 30 days before screening
  • No immunomodulatory therapy for at least three Months (before randomization), or
  • strong immunomodulatory therapy with interferon beta or glatiramer acetate for at least 6 months
  • visus in the affected eye at least 0.1
  • latency of Conventional VEP in the affected eye

    • = 115 ms or difference> = 15 ms to the opposite side at a Study at least 4 but no more than 6 weeks after Onset of clinical symptoms
  • At least 2 T2 lesions typical of MS in a previous MRI

Exclusion Criteria:

  • other MS course than RRMS
  • any condition which could interfere or prevent the MRI study or other investigations
  • known allergy or intolerance, or other contraindication against Gd-DTPA
  • Patients with known contraindications to treatment with fingolimod (Gilenya ®) or interferon beta-1b Extavia ®
  • Competing diseases which could affect visual functions such as diabetic, retinopathy, glaucoma, retinal detachment
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01647880

Contacts
Contact: Olaf Hoffmann, PD Dr. med. 030-450 539040 olaf.hoffmann@charite.de

Locations
Germany
Charité-Universitätsmedizin Berlin Recruiting
Berlin, Germany
Contact: Olaf Hoffmann, PD Dr. med.    030-450 539040    olaf.hoffmann@charite.de   
Sankt Josefs Krankenhaus Potsdam Neurologie Recruiting
Potsdam, Germany
Contact: Christian Albert, MD         
Sponsors and Collaborators
Charite University, Berlin, Germany
Charité Neurocure AG Flöel
Investigators
Study Director: Olaf Hoffmann, PD Dr. med. Charite- NeuroCure
  More Information

No publications provided

Responsible Party: Friedemann Paul, Sponsor Deputy, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT01647880     History of Changes
Other Study ID Numbers: MOVING
Study First Received: July 23, 2012
Last Updated: September 17, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Multiple Sclerosis
Optic Neuritis
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Optic Nerve Diseases
Cranial Nerve Diseases
Eye Diseases
Interferon-beta
Interferon beta-1b
Fingolimod
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic
Immunosuppressive Agents

ClinicalTrials.gov processed this record on September 18, 2014