Multiple SclerosisPhase 2/3MOVINGNCT01647880
MOdification of VIsual Outcomes After Optic Neuritis in CIS or MS by Gilenya (MOVING Study)
A Phase 2/3 study testing Verum arm receiving Gilenya® and Active Comparator receiving Extavia® in people with Multiple Sclerosis, run by Charite University, Berlin, Germany at 2 sites in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Verum arm receiving Gilenya® and Active Comparator receiving Extavia®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 2 sitesGermany
- Study dates
- Jul 2013to Apr 2016
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Charité-Universitätsmedizin Berlin
Berlin
Sankt Josefs Krankenhaus Potsdam Neurologie
Potsdam
About this study
Official title: Phase II/III Study to Investigate the Effects of Fingolimod Versus Interferon Beta-1b on Visual Recovery After Optic Neuritis
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.
- Conditions
- Multiple Sclerosis
- Being tested
- Verum arm receiving Gilenya®, Active Comparator receiving Extavia®
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Verum arm receiving Gilenya®Drug
Active Comparator receiving Extavia®Drug
| Study group | Role | What they receive |
|---|---|---|
| Fingolimod (Gilenya®) | Experimental | 0,5 mg once a day in the morning, oral Receives: Drug: Verum arm receiving Gilenya® |
| Interferon beta-1b (Extavia®) | Active comparator | every second day, s.c. Receives: Drug: Active Comparator receiving Extavia® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy parameters
Decrease of latency of mVEP of the affected eye after 6 months treatment with Gilenya® vs. Extavia® compared to baseline
Secondary outcomes (1)
Efficacy parameters
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2012 (estimated)
- Study startJul 2013
- Primary completionApr 2016
- Study completionApr 2016
Why it stopped: delayed recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- NeuroCure Clinical Research Center, Charite, Berlin
- Responsible party
- Principal investigator, Friedemann Paul, Charite University, Berlin, Germany
- Investigators
- Olaf Hoffmann, PD Dr. med., Study director, Charite- NeuroCure
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01647880
- Sponsor's protocol ID
- MOVING
- Acronym
- MOVING
- Status last verified
- Jul 2021
- First submitted
- 23 Jul 2012
- Last updated
- 29 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Albert C, Mikolajczak J, Liekfeld A, Piper SK, Scheel M, Zimmermann HG, Nowak C, Dorr J, Bellmann-Strobl J, Chien C, Brandt AU, Paul F, Hoffmann O. Fingolimod after a first unilateral episode of acute optic neuritis (MOVING) - preliminary results from a randomized, rater-blind, active-controlled, phase 2 trial. BMC Neurol. 2020 Mar 3;20(1):75. doi: 10.1186/s12883-020-01645-z.
PubMed 32126977
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II/III Study to Investigate the Effects of Fingolimod Versus Interferon Beta-1b on Visual Recovery After Optic Neuritis
- ClinicalTrials.gov ID
- NCT01647880
- Acronym / sponsor ID
- MOVING / MOVING
- Conditions
- Multiple Sclerosis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: delayed recruitment
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- NeuroCure Clinical Research Center, Charite, Berlin
- Study start
- Jul 2013
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 24 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fingolimod (Gilenya®) | Experimental | Drug: Verum arm receiving Gilenya®0,5 mg once a day in the morning, oral |
| Interferon beta-1b (Extavia®) | Active comparator | Drug: Active Comparator receiving Extavia®every second day, s.c. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Verum arm receiving Gilenya® | Drug | Fingolimod (Gilenya®) |
| Active Comparator receiving Extavia® | Drug | Interferon beta-1b (Extavia®) |
Primary outcome
Efficacy parameters
Decrease of latency of mVEP of the affected eye after 6 months treatment with Gilenya® vs. Extavia® compared to baseline
1 secondary outcome
Efficacy parameters
Results and safety
The study was stopped early (reason given: delayed recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2021.
- Derived from this study: PubMed 32126977Albert C, Mikolajczak J, Liekfeld A, Piper SK, Scheel M, Zimmermann HG, Nowak C, Dorr J, Bellmann-Strobl J, Chien C, Brandt AU, Paul F, Hoffmann O. Fingolimod after a first unilateral episode of acute optic neuritis (MOVING) - preliminary results from a randomized, rater-blind, active-controlled, phase 2 trial. BMC Neurol. 2020 Mar 3;20(1):75. doi: 10.1186/s12883-020-01645-z.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olaf Hoffmann, PD Dr. med. study director
Charite- NeuroCure
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Verum arm receiving Gilenya® and Active Comparator receiving Extavia® in people with Multiple Sclerosis, run by Charite University, Berlin, Germany at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 29 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: delayed recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy parameters. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01647880, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2021.