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IVIG

Phase 2

Spinocerebellar Ataxia | Monoclonal antibody | Neurology |Baxter International Inc.|Last Updated: Jul 23, 2013

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment5
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01350440Safety and Efficacy of Intravenous Immune Globulin in Treating Spinocerebellar AtaxiaPHASE2 COMPLETED 5Aug 1, 2011Jul 1, 2013Jul 23, 20131 United States
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Study Endpoints
Primary Endpoints
Scale for the Assessment and Rating of Ataxia
participants will be followed for approximately 4 months
Secondary Endpoints
Timed 25 foot walk
participants will be followed for approximately 4 months
Clinical Global impression
participants will be followed for approximately 4 months
Biodex Balance SD
participants will be followed for approximately 4 months
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
IVIGEXPERIMENTALIntravenous Immune Globulin
Interventions
NameTypeDescription
IVIGBIOLOGICALIntravenous Immune Globulin
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Eligibility Criteria
Age Range10 Years — 50 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Outpatients with SCA diagnosed by a movement disorder specialist. 2. Age 10 years to 80 years. 3. Able to ambulate with or without assistance for 30 feet. 4. Women of child-bearing potential must use a reliable method of contraception and must provide a negative pregnancy tes...

Countries:United States
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