A Phase 4 interventional study of Levodopa (L-dopa) in Parkinson's Disease, sponsored by Beth Israel Deaconess Medical Center. Not yet recruiting at 1 site in United States. Per ClinicalTrials.gov, last updated 2026-08-28.
Sponsored by Beth Israel Deaconess Medical Center · Phase 4, Interventional, and Basic science
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Among 51 studies testing levodopa in Parkinson Disease — 3 open to participants now, 3 under way, none of them phase 3. Levodopa · Parkinson Disease.
Among the 51 studies testing levodopa in Parkinson Disease, this one is the 28th largest by planned enrollment of the 50 interventional ones that give a count, is the only one that started in 2027, is one of 17 in phase 4, and was the 51st registered.
4,576 studies on the registry are indexed under Parkinson Disease; 1,087 are open to participants now.
Browse Parkinson Disease studies →3 of the 51 studies testing levodopa in Parkinson Disease are open now, in 2 countries. Recruiting first, the newest first:
Second Affiliated Hospital of Soochow University · Sites in China
Ages 30–80
Emory University · Sites in United States
Ages 45–75 · Healthy volunteers
By country, each count listing its studies:
Levodopa: first FDA approval 1970 (LARODOPA), first EMA approval 2003. What it is approved for, and how studies give it, is on its page →
Of the 750 Parkinson Disease studies recruiting now, 312 (42%) set no upper age limit and 127 (17%) stop at 75 or younger; 64 take children under 18; 190 take healthy volunteers.
This study: all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
51 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 10 · Phase 2 11 · Phase 3 12 · Phase 4 17
First in 1998; this study’s year is marked. 1 started in 2027.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 40 is close to the median of 40 across 3,355 interventional studies indexed under Parkinson Disease.
Median enrollment 56 across the 50 interventional studies. Of the 45 that completed or were terminated, 18 (40%) have results posted.
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33 of 51 have an industry lead sponsor. The 10 most frequent:
Beth Israel Deaconess Medical Center is the lead sponsor of 568 studies on the registry; 79 are open to participants now.
Of its 76 completed or terminated interventional studies of FDA-regulated products, 62 (82%) have results posted.
10 studies in Parkinson Disease by Beth Israel Deaconess Medical Center: 1 open now, 2 under way, none of them phase 3. Of 7 finished, 2 (29%) have results posted.
Among the 10 studies in Parkinson Disease by Beth Israel Deaconess Medical Center, this one is the only one that started in 2027, is the only one in phase 4, and was the 10th registered.
Beth Israel Deaconess Medical Center’s Parkinson Disease studies by the year they started, since 2006.
1 of the studies testing levodopa in Parkinson Disease that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06234995Emory UniversityCortical Electrophysiology of Response Inhibition in Parkinson's Disease | 2027-09 |
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Among the 51 studies testing levodopa in Parkinson Disease, from their registry updates:
Nothing recorded among them since 2026-09-25.
Among Beth Israel Deaconess Medical Center’s 10 in Parkinson Disease:
Nothing recorded among them since 2026-09-25.
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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.
Patients will be asked to fast overnight prior to the study visit, including holding any doses of dopamine replacement therapy that they may be prescribed, including levodopa or equivalents, and any promotility agents, including cholinesterase inhibitors or peripherally-restricted dopamine antagonists (ie. Domperidone), that may impact gastric transit.
At the start of the study visit, patients will undergo a neurological exam by a study investigator blinded to which study group the patient belongs. Exams will be performed according to the Movement Disorder Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III, a validated clinical score of motor impairment in Parkinson's disease (PD). They will also undergo a baseline blood draw (5.5 mLs) through an indwelling venous cannula in the antecubital vein. Immediately afterwards, a single oral dose of levodopa (100 mg) obtained through the BIDMC research pharmacy with a standard volume of water (100 mL). Repeat blood samples will be collected immediately after oral levodopa ingestion (T=0) and then repeated every ½ hour until T=4 hours for a total of 10 draws, including the baseline. The initial placement of indwelling venous cannula will mitigate the necessity for repeated venipuncture during the study visit. At each ½ hour interval, additionally, patients will undergo repeat MDS-UPDRS-III assessments. After the 4-hour study concludes, the patient will be allowed to consume any food they would like and can resume home medications as previously prescribed clinically. Blood samples will be centrifuged to separate plasma and immediately frozen at -80oC until analysis by an investigator blinded to which study group the patient belongs.
Separately, patients' prior clinically-obtained gastric biopsy blocks will be requested from BIDMC pathology (as otherwise discarded specimen) and stained for presence of AADC. This will not require any further time or visits from the patient themselves.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will be administered a single dose of levodopa at the start of the study period
Drug: Levodopa (L-dopa)
Participants will be administered a single dose of levodopa at the start of the study period
Drug: Levodopa (L-dopa)
levodopa will be administered to all participants in this single arm study
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.
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
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Jul 2027; primary completion for Jul 2030, 36 months later.
Of 41 non-industry phase 4 interventional studies under Parkinson Disease, half reached primary completion within 41 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 75. This study's planned 36 months is below that.
Counting every sponsor, half of 56 studies reached it within 28 months; a quarter within 19 and three quarters within 65.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Levodopa
Beth Israel Deaconess Medical Center →