Skip to main content
MedPathMedPath Home
Clinical Trials/NCT06772220
NCT06772220
Recruiting
Not Applicable

Pilot Study of Open Label Homocysteine Management Therapy in Levodopa-treated Parkinson's Disease

Oregon Health and Science University1 site in 1 country150 target enrollmentStarted: March 5, 2024Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
ConditionsParkinson&Amp;#39;s Disease

Overview

Phase
Not Applicable
Status
Recruiting
Enrollment
150
Locations
1
Primary Endpoint
Hyperhomocysteinemia and B vitamin deficiency
OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

Brief Summary

This is a research study investigating elevated homocysteine in the blood of patients with Parkinson's disease who are currently receiving treatment with levodopa. We are evaluating if elevated homocysteine can be corrected using open label B vitamin therapy, as well as the impact of homocysteine levels on cognitive function.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
40 Years to 90 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Diagnosis of probable Parkinson's Disease according to Movement Disorders Society criteria.
  • •Currently treated with levodopa at a minimum dose of 300 mg/day
  • •Montreal Cognitive Assessment (MOCA) ≥15
  • •Demonstrated capacity to provide informed consent.
  • •40-90 years of age
  • •Estimated glomerular filtration rate ≥60
  • •Absence of uncontrolled hypertension in medical history
  • •Absence of insulin use

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Hyperhomocysteinemia and B vitamin deficiency

Time Frame: baseline measurement

Plasma pyridoxine in subjects with vs without hyperhomocysteinemia

Secondary Outcomes

  • Hyperhomocysteinemia and cognitive assessments(From enrollment to the end of treatment at 3 months)
  • Hyperhomocysteinemia and measurement of neurofilament light in plasma(From enrollment to the end of treatment at 3 months)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Joseph Quinn

OHSU Parkinson Center Director

Oregon Health and Science University

Study Sites (1)

Loading locations...

Similar Trials

Approved For Marketing
Not Applicable
Expanded Access Program for Asfotase Alfa Treatment for Patients With Infantile- or Juvenile-onset Hypophosphatasia (HPP)Hypophosphatasia
NCT02496689Alexion Pharmaceuticals, Inc.
Completed
Phase 3
A Study of an Investigational Drug to See How it Affects the People With Parkinson's Disease Complicated by Motor Fluctuations ("OFF" Episodes) Compared to an Approved Drug Used to Treat People With Parkinson's Disease Complicated by Motor Fluctuations ("OFF" Episodes)Motor OFF Episodes Associated With Parkinson's Disease
NCT03391882Sumitomo Pharma America, Inc.113
Completed
Phase 1
Minocycline in Primary Sclerosing Cholangitis (PSC)Primary Sclerosing Cholangitis
NCT00630942Mayo Clinic16
Completed
Phase 2
Copenhagen Head Injury Ciclosporin (CHIC) StudyTraumatic Brain Injury
NCT01825044NeuroVive Pharmaceutical AB16
Completed
Phase 2
Safety and Efficacy Study of Asfotase Alfa in Adolescents and Adults With Hypophosphatasia (HPP)Hypophosphatasia
NCT01163149Alexion Pharmaceuticals, Inc.19