CLINICAL TRIALS PROFILE FOR EXTAVIA

All Clinical Trials for EXTAVIA

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01466114 ↗	Estriol Treatment in Multiple Sclerosis (MS): Effect on Cognition	Recruiting	Synthetic Biologics (formerly Adeona Pharmaceuticals)	Phase 2	2011-10-01	Approximately 50% of people diagnosed with Multiple Sclerosis (MS) will develop problems with cognition. Currently, there are no FDA-approved treatments targeting cognitive function in Multiple Sclerosis. This trial will ascertain whether treatment with an estrogen pill, used in combination with standard MS anti-inflammatory drugs, can improve cognitive testing as compared to treatment with a placebo pill in combination with standard anti-inflammatory drugs in women with MS.
NCT01466114 ↗	Estriol Treatment in Multiple Sclerosis (MS): Effect on Cognition	Recruiting	University of California, Los Angeles	Phase 2	2011-10-01	Approximately 50% of people diagnosed with Multiple Sclerosis (MS) will develop problems with cognition. Currently, there are no FDA-approved treatments targeting cognitive function in Multiple Sclerosis. This trial will ascertain whether treatment with an estrogen pill, used in combination with standard MS anti-inflammatory drugs, can improve cognitive testing as compared to treatment with a placebo pill in combination with standard anti-inflammatory drugs in women with MS.
NCT01647880 ↗	MOdification of VIsual Outcomes After Optic Neuritis in CIS or MS by Gilenya (MOVING Study)	Terminated	NeuroCure Clinical Research Center	Phase 2/Phase 3	2013-07-01	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.
NCT01647880 ↗	MOdification of VIsual Outcomes After Optic Neuritis in CIS or MS by Gilenya (MOVING Study)	Terminated	NeuroCure Clinical Research Center, Charite, Berlin	Phase 2/Phase 3	2013-07-01	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.
NCT01647880 ↗	MOdification of VIsual Outcomes After Optic Neuritis in CIS or MS by Gilenya (MOVING Study)	Terminated	Charite University, Berlin, Germany	Phase 2/Phase 3	2013-07-01	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.
NCT01982942 ↗	Safety, Tolerability and Activity Study of Ibudilast in Subjects With Progressive Multiple Sclerosis	Completed	National Institute of Neurological Disorders and Stroke (NINDS)	Phase 2	2013-11-01	This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study designed to evaluate the safety, tolerability and activity of ibudilast administered twice daily over a 96 week period in subjects with primary or secondary progressive multiple sclerosis who are currently untreated with long-term MS disease modifying therapy (DMT) or who are receiving either glatiramer acetate (GA) or interferon beta-1, any formulation (IFNβ-1A [Avonex, Rebif] or IFNβ-1B [Betaseron, Extavia]). Study drug or placebo will be administered to a total of 250 male and female subjects from 21 to 65 years old, inclusive, in two treatment groups. Randomization of subjects will be stratified by disease status (primary progressive multiple sclerosis or secondary progressive multiple sclerosis) and immunomodulating therapy status: current use of immunomodulating therapy or no current use of immunomodulating therapy. The study will consist of a screening phase (up to 30 days) followed by a treatment phase (96 weeks) and a follow-up visit (1 month post Week 96 visit). Following the screening phase, subjects who continue to meet entry criteria will be randomly assigned to 1 of 2 treatment groups: doses up to ibudilast 100 mg/day or matching-placebo in a 1:1 ratio. Study drug will be administered twice daily (BID), e.g., ibudilast 50 mg or placebo taken in the morning and evening).
NCT01982942 ↗	Safety, Tolerability and Activity Study of Ibudilast in Subjects With Progressive Multiple Sclerosis	Completed	National Institutes of Health (NIH)	Phase 2	2013-11-01	This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study designed to evaluate the safety, tolerability and activity of ibudilast administered twice daily over a 96 week period in subjects with primary or secondary progressive multiple sclerosis who are currently untreated with long-term MS disease modifying therapy (DMT) or who are receiving either glatiramer acetate (GA) or interferon beta-1, any formulation (IFNβ-1A [Avonex, Rebif] or IFNβ-1B [Betaseron, Extavia]). Study drug or placebo will be administered to a total of 250 male and female subjects from 21 to 65 years old, inclusive, in two treatment groups. Randomization of subjects will be stratified by disease status (primary progressive multiple sclerosis or secondary progressive multiple sclerosis) and immunomodulating therapy status: current use of immunomodulating therapy or no current use of immunomodulating therapy. The study will consist of a screening phase (up to 30 days) followed by a treatment phase (96 weeks) and a follow-up visit (1 month post Week 96 visit). Following the screening phase, subjects who continue to meet entry criteria will be randomly assigned to 1 of 2 treatment groups: doses up to ibudilast 100 mg/day or matching-placebo in a 1:1 ratio. Study drug will be administered twice daily (BID), e.g., ibudilast 50 mg or placebo taken in the morning and evening).

Clinical Trial Conditions for EXTAVIA

Condition Name

Condition Name for EXTAVIA
Intervention	Trials
Multiple Sclerosis, Secondary Progressive	1
Primary-progressive Multiple Sclerosis	1
Relapsing Multiple Sclerosis	1
Relapsing-remitting Multiple Sclerosis	1

Condition MeSH

Condition MeSH for EXTAVIA
Intervention	Trials
Multiple Sclerosis	4
Sclerosis	3
Multiple Sclerosis, Chronic Progressive	2
Optic Neuritis	1

Clinical Trial Locations for EXTAVIA

Trials by Country

Trials by Country for EXTAVIA
Location	Trials
United States	32
Germany	1

Trials by US State

Trials by US State for EXTAVIA
Location	Trials
Colorado	3
California	3
Pennsylvania	2
Washington	2
Texas	2

Clinical Trial Progress for EXTAVIA

Clinical Trial Phase

Clinical Trial Phase for EXTAVIA
Clinical Trial Phase	Trials
Phase 4	1
Phase 2/Phase 3	1
Phase 2	2

Clinical Trial Status

Clinical Trial Status for EXTAVIA
Clinical Trial Phase	Trials
Terminated	2
Recruiting	1
Completed	1

Clinical Trial Sponsors for EXTAVIA

Sponsor Name

Sponsor Name for EXTAVIA
Sponsor	Trials
MediciNova	1
Biogen	1
Synthetic Biologics (formerly Adeona Pharmaceuticals)	1

Sponsor Type

Sponsor Type for EXTAVIA
Sponsor	Trials
Other	6
NIH	2
Industry	2