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IVIG

Phase 2

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

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment5

FDA Designations

No designations recorded

Clinical trial landscape

IVIG · 1 trial · 1 indication

Phase 2 1
NCT01350440Safety and Efficacy of Intravenous Immune Globulin in Treating Spinocerebellar AtaxiaSpinocerebellar Ataxia
COMPLETED5 Analytics
PHASE2COMPLETED
Safety and Efficacy of Intravenous Immune Globulin in Treating Spinocerebellar Ataxia
Spinocerebellar AtaxiaUnlock trial analytics

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 to 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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Frequently asked questions about IVIG

What is IVIG used for in spinocerebellar ataxia?

IVIG is being studied as a treatment for spinocerebellar ataxia, a neurological condition. It is an investigational therapy in clinical development, and it has not been approved for this use. A Phase 2 clinical trial has been completed to evaluate its safety and efficacy in patients with this condition.

Who makes IVIG?

IVIG is being developed by Baxter International Inc., a company traded on the New York Stock Exchange under the ticker symbol BAX. The company is conducting clinical research to evaluate the drug's potential in treating spinocerebellar ataxia.

What phase is IVIG in for spinocerebellar ataxia?

IVIG is in Phase 2 clinical development for spinocerebellar ataxia. A Phase 2 trial has been completed, and the drug remains investigational. It is not approved by regulatory authorities for this indication.

What clinical trials has IVIG been in?

IVIG has been studied in one clinical trial, identified as NCT01350440, titled 'Safety and Efficacy of Intravenous Immune Globulin in Treating Spinocerebellar Ataxia.' This Phase 2 trial was completed in the United States and enrolled 5 participants.

Is IVIG a monoclonal antibody?

Yes, IVIG is a monoclonal antibody. It is being evaluated as a therapeutic option for spinocerebellar ataxia, a neurological disorder. The drug is in clinical development and has undergone a Phase 2 trial to assess its safety and efficacy.