Gastrointestinal Dopamine Decarboxylase and Levodopa Pharmacokinetics

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Beth Israel Deaconess Medical Center
Study ID
NCT07793461
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Levodopa (L-dopa) — DRUG
    levodopa will be administered to all participants in this single arm study

Study Details

The main treatment for Parkinson's disease is a medication called levodopa. Levodopa has to be absorbed from the gut and travel to the brain to work, but a naturally occurring enzyme in the lining of the stomach, called dopamine decarboxylase (AADC), can break some of it down before it ever reaches the brain. We do not yet know whether people whose stomachs have more of this enzyme absorb less of their levodopa dose, have worsened gastrointestinal (GI) symptoms associated with levodopa intake, and whether that affects how well the medication controls their movement symptoms. This research may help doctors understand why levodopa works better in some people with Parkinson's disease than others, which could help improve treatment in future.

Key Dates

First listed
Aug 28, 2026
Start date
Jul 31, 2027
Status verified
Aug 2026
Primary completion
Jul 31, 2030
Completion
Dec 31, 2030

Study Design

Enrollment
40 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Elevated AADC
    Participants will be administered a single dose of levodopa at the start of the study period
  • Experimental: Non-elevated AADC
    Participants will be administered a single dose of levodopa at the start of the study period

Primary Outcome Measure

levodopa pharmacodynamics [ Time Frame: 0-4 hours after oral levodopa ingestion. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Beth Israel Deaconess Medical CenterBostonMassachusetts02215
Louise Halbert, BA
[email protected]
6176670698
Trisha Pasricha, MD, MPH
[email protected]
6176670161
Trisha S Pasricha, MD, MPH (PRINCIPAL_INVESTIGATOR)

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By research site
Beth Israel Deaconess Medical Center· Boston, MA

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