A Pilot Study of Oxaloacetate in Subjects With Treated PD

University of Kansas

Status and phase: Completed; Phase 3; Phase 2

Conditions: Parkinson's Disease

Treatments: Drug: Placebo; Drug: Oxaloacetate (OAA)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01741701

13397

Details and patient eligibility

About

The purpose of this study is to determine if Oxaloacetate (OAA) is a safe and effective treatment for Parkinson's disease. Each subject will be asked to make 3 study visits and complete two safety follow-up phone calls over a 4 month period.

Enrollment: 33 patients

Sex: All

Ages: 30+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Able to give informed consent and follow instructions per the protocol
• Diagnosis of idiopathic PD within 7 years of diagnosis
• Taking stable doses of levodopa and would not predictably need adjustment in PD medications for 4 months
• Unified Parkinson's Disease Rating Scale (UPDRS) II + III at least 30 points at baseline

Exclusion criteria

• Previously taken Oxaloacetate
• Participation in other drug studies or use of other investigational products within 30 days prior to baseline
• In the Investigator's opinion, any unstable or clinically significant condition that would impair the subjects' ability to comply with study follow-up
• Other known or suspected cause of parkinsonism

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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33 participants in 2 patient groups, including a placebo group

Oxaloacetate (OAA)

Experimental group

Description:

active capsule containing 100 mg OAA and 100 mg ascorbate, taken daily

Treatment:

Drug: Oxaloacetate (OAA)

Placebo

Placebo Comparator group

Description:

placebo capsules that contain only 100 mg ascorbate, taken daily

Treatment:

Drug: Placebo