Theriva Biologics Inc (TOVX)

[BioChica]

Primary Outcome Measures: 2013 2 years before final results

* Relapse Rate [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]


Secondary Outcome Measures:

* severity of "Relapse" as assessed by degree of worsening of Expanded Disability Status Scale (EDSS) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
* severity of "Relapse" as assessed by degree of worsening of Multiple Sclerosis Functional Composite (MSFC) [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
* Proportion of subjects with confirmed progression in Expanded Disability Status Scale (EDSS) (at least 1.0 point for at least 6 months on two exams) between baseline and conclusion [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
* Expanded Disability Status Scale (EDSS) progression from baseline at conclusion [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
* Multiple Sclerosis Functional Composite (MSFC) progression from baseline at conclusion [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
* Improvement in Paced Serial Addition Test (PASAT) scores between baseline and conclusion [ Time Frame: 2 years ] [ Designated as safety issue: No ]
* Improvement in 7-24 Spatial Recall test scores between baseline and conclusion [ Time Frame: 2 years ] [ Designated as safety issue: No ]
* Improvement in Selective Reminding Test scores between baseline and conclusion [ Time Frame: 2 years ] [ Designated as safety issue: No ]
* Brain MRI enhancing lesions [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
* Brain atrophy on MRI [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]


Estimated Enrollment: 150
Study Start Date: March 2007
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)