Gastrointestinal Dopamine Decarboxylase and Levodopa Pharmacokinetics

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorBeth Israel Deaconess Medical Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Parkinson's disease

Gastric biopsies previously obtained during clinically-indicated EGD procedure

Taking dopamine replacement therapy currently

Disqualifiers

No history of Parkinson's disease

Trial design

Design model

Parallel

Treatments tested in this trial

  • Levodopa (L-dopa)

    Drug

    levodopa will be administered to all participants in this single arm study

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Elevated AADCExperimental treatment 1 intervention
Group B: Non-elevated AADCExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

levodopa pharmacodynamics

Peripheral levodopa levels will be assessed via blood draw to determine time (in minutes) to reach maximum concentration in the blood. Lower Tmax indicates quicker bioavailability.

Time frame
0-4 hours after oral levodopa ingestion.

Secondary outcomes

1

The Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part III score

Neurological symptoms will be assessed during study period. A lower score indicates less severe symptoms.

Time frame
0-4 hours after oral levodopa ingestion

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Beth Israel Deaconess Medical Center

Lead sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

This trial is not recruiting at the moment. You can still explore other options: