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Generated: February 19, 2019

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CLINICAL TRIALS PROFILE FOR GLYCEROL PHENYLBUTYRATE

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Clinical Trials for Glycerol Phenylbutyrate

Trial ID Title Status Sponsor Phase Summary
NCT01881984 Use of Ravicti™ in Patients With MCAD Deficiency With the 985A>G (K304E) Mutation Completed Horizon Pharma Ireland, Ltd., Dublin Ireland Phase 1 This is a medical research study to test a medication in adult patients with a disease called medium-chain acyl-CoA dehydrogenase (MCAD) deficiency caused by at least one copy of the 985A>G mutation. The medication is glycerol phenylbutyrate, called Ravicti, which is currently FDA approved for the treatment of urea cycle disorders. Previous research suggests that Ravicti may also be effective in the treatment MCAD deficiency. This study will investigate the safety and efficacy (how well it works) of Ravicti in patients with MCAD deficiency caused by having at least one copy of the 985A>G mutation.
NCT01881984 Use of Ravicti™ in Patients With MCAD Deficiency With the 985A>G (K304E) Mutation Completed University of Pittsburgh Phase 1 This is a medical research study to test a medication in adult patients with a disease called medium-chain acyl-CoA dehydrogenase (MCAD) deficiency caused by at least one copy of the 985A>G mutation. The medication is glycerol phenylbutyrate, called Ravicti, which is currently FDA approved for the treatment of urea cycle disorders. Previous research suggests that Ravicti may also be effective in the treatment MCAD deficiency. This study will investigate the safety and efficacy (how well it works) of Ravicti in patients with MCAD deficiency caused by having at least one copy of the 985A>G mutation.
NCT01949766 Transition From Buphenyl to RAVICTI for the Therapy of Byler Disease No longer available University of Pittsburgh N/A This is a single patient compassionate use protocol to determine whether RAVICTI will improve bile flow in a subject who previously tolerated therapy with Buphenyl.
NCT02046434 Phenylbutyrate Response as a Biomarker for Alpha-synuclein Clearance From the Brain Active, not recruiting University of Colorado, Denver Phase 1 This is a Phase I clinical trial of the FDA approved drug Glycerol Phenylbutyrate to see if phenylbutyrate can increase the removal of alpha-synuclein from the brain into the bloodstream. Alpha-synuclein forms abnormal protein deposits in dopamine neurons and is believed to cause the death of brain cells, leading to Parkinson's Disease.
NCT02246218 A Study of the Safety, Efficacy and Pharmacokinetics of Glycerol Phenylbutyrate in Pediatric Subjects Under 2 Years of Age With Urea Cycle Disorders (UCDs) Recruiting Horizon Therapeutics, LLC Phase 4 This is an open-label study consisting of a transition period to RAVICTI, followed by a safety extension period for at least 6 months and up to 24 months of treatment with RAVICTI, depending on age at enrollment. It is designed to capture information important for evaluating safety, pharmacokinetics and efficacy in young children. Subjects who are followed by or referred to the Investigator for management of their UCD or assessment of high blood ammonia may be eligible for this study. Subjects eligible for this study will include patients ranging from newborn to < 2 years of age with either a diagnosed or clinically suspected UCD.
Trial ID Title Status Sponsor Phase Summary

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Clinical Trial Conditions for Glycerol Phenylbutyrate

Condition Name

Condition Name for Glycerol Phenylbutyrate
Intervention Trials
Urea Cycle Disorder 2
Cystic Fibrosis 1
Byler Disease 1
Parkinson's Disease 1
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Condition MeSH

Condition MeSH for Glycerol Phenylbutyrate
Intervention Trials
Urea Cycle Disorders, Inborn 2
Disease 2
Parkinson Disease 1
Cholestasis, Intrahepatic 1
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Clinical Trial Locations for Glycerol Phenylbutyrate

Trials by Country

Trials by Country for Glycerol Phenylbutyrate
Location Trials
United States 19
Switzerland 1
Canada 1
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Trials by US State

Trials by US State for Glycerol Phenylbutyrate
Location Trials
Pennsylvania 3
Alabama 1
Minnesota 1
New York 1
Ohio 1
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Clinical Trial Progress for Glycerol Phenylbutyrate

Clinical Trial Phase

Clinical Trial Phase for Glycerol Phenylbutyrate
Clinical Trial Phase Trials
Phase 4 2
Phase 1/Phase 2 1
Phase 1 2
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Clinical Trial Status

Clinical Trial Status for Glycerol Phenylbutyrate
Clinical Trial Phase Trials
Not yet recruiting 2
Active, not recruiting 1
Recruiting 1
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Clinical Trial Sponsors for Glycerol Phenylbutyrate

Sponsor Name

Sponsor Name for Glycerol Phenylbutyrate
Sponsor Trials
University of Pittsburgh 2
Horizon Therapeutics, LLC 2
Horizon Pharma Ireland, Ltd., Dublin Ireland 1
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Sponsor Type

Sponsor Type for Glycerol Phenylbutyrate
Sponsor Trials
Other 6
Industry 3
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