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Levodopa

Generic Name
Levodopa
Brand Names
Dhivy, Duodopa, Duopa, Inbrija, Parcopa, Prolopa, Rytary, Sinemet, Stalevo
Drug Type
Small Molecule
Chemical Formula
C9H11NO4
CAS Number
59-92-7
Unique Ingredient Identifier
46627O600J
Background

Levodopa is a prodrug of dopamine that is administered to patients with Parkinson's due to its ability to cross the blood-brain barrier. Levodopa can be metabolised to dopamine on either side of the blood-brain barrier and so it is generally administered with a dopa decarboxylase inhibitor like carbidopa to prevent metabolism until after it has crossed the blood-brain barrier. Once past the blood-brain barrier, levodopa is metabolized to dopamine and supplements the low endogenous levels of dopamine to treat symptoms of Parkinson's. The first developed drug product that was approved by the FDA was a levodopa and carbidopa combined product called Sinemet that was approved on May 2, 1975.

Indication

Levodopa on its own is formulated as an oral inhalation powder indicated for intermittent treatment of off episodes in Parkinson's patients who are already being treated with carbidopa and levodopa. Levodopa is most commonly formulated as an oral tablet with a peripheral dopa decarboxylase inhibitor indicated for treatment of Parkinson's disease, post-encephalitic parkinsonism, and symptomatic parkinsonism following carbon monoxide intoxication or manganese intoxication.

Associated Conditions
Paralysis agitans, Parkinson's Disease (PD), Parkinsonism, Parkinsonism post encephalitic, Restless Legs Syndrome (RLS), Advanced Motor fluctuations

A Study to Evaluate SAGE-217 in Participants With Parkinson's Disease

Phase 2
Completed
Conditions
Parkinson Disease
Interventions
Drug: Antiparkinsonian Agent(s)
First Posted Date
2016-12-22
Last Posted Date
2023-11-29
Lead Sponsor
Biogen
Target Recruit Count
29
Registration Number
NCT03000569
Locations
🇺🇸

Sage Investigational Site, Orem, Utah, United States

Pilot Study to Evaluate ActiMyo Measured Activity in Parkinson Disease Patients & Healthy Volunteers

Not Applicable
Completed
Conditions
Parkinson Disease
Healthy Volunteers
Interventions
Other: Controlled environment tests (series of tasks of everyday life)
Device: ActiMyo recording
Other: Diary completion
First Posted Date
2016-05-30
Last Posted Date
2017-10-10
Lead Sponsor
Institut de Myologie, France
Target Recruit Count
30
Registration Number
NCT02785978
Locations
🇫🇷

Association Institut de Myologie, Paris, France

🇫🇷

Département des Maladies du Système Nerveux, GH Pitie Salpatriere, Paris, France

🇫🇷

Service de Neurochirurgie, Hopital Henri Mondor, Creteil, France

Pharmacokinetic-pharmacodynamic Interaction Between BIA 3-202 and Levodopa/Benserazide

Phase 1
Completed
Conditions
Parkinson's Disease (PD)
Interventions
First Posted Date
2016-05-20
Last Posted Date
2016-06-14
Lead Sponsor
Bial - Portela C S.A.
Target Recruit Count
17
Registration Number
NCT02778594
Locations
🇵🇹

Human Pharmacology Unit, S. Mamede do Coronado, Portugal

Efficacy of Levodopa/Benserazide Dispersible Tablet on Response Fluctuations in PD Patients With Delayed ON

Phase 4
Completed
Conditions
Parkinson Disease
Interventions
First Posted Date
2016-05-12
Last Posted Date
2021-05-07
Lead Sponsor
Seoul National University Hospital
Target Recruit Count
40
Registration Number
NCT02769793
Locations
🇰🇷

SMG-SNU Boramae Medical Center, Seoul, Korea, Republic of

🇰🇷

Samsung Medical Center, Seoul, Korea, Republic of

Efficacy and Safety Proof of Concept Study in Patients With Parkinson's Disease and End-of-dose Wearing-off (COMPOC)

Phase 2
Completed
Conditions
Parkinson's Disease
Interventions
First Posted Date
2016-05-06
Last Posted Date
2018-04-05
Lead Sponsor
Orion Corporation, Orion Pharma
Target Recruit Count
84
Registration Number
NCT02764125
Locations
🇱🇻

Investigator, Riga, Latvia

🇫🇮

Clinical Research Services Turku CRST, Turku, Finland

🇩🇪

Study Coordinating Investigator, Harleshausen, Kassel, Germany

and more 1 locations

A Study of L-DOPA for Depression and Slowing in Older Adults

Phase 4
Completed
Conditions
Major Depressive Disorder
Dysthymia
Depression Not Otherwise Specified
Decreased Gait Speed
Decreased Processing Speed
Interventions
First Posted Date
2016-04-20
Last Posted Date
2023-06-13
Lead Sponsor
New York State Psychiatric Institute
Target Recruit Count
47
Registration Number
NCT02744391
Locations
🇺🇸

New York State Psychiatric Institute, New York, New York, United States

Levodopa Benserazide Generic Formulation Versus the Originator

Phase 4
Completed
Conditions
Parkinson Disease
Interventions
First Posted Date
2016-04-18
Last Posted Date
2024-04-10
Lead Sponsor
IRCCS San Raffaele Roma
Target Recruit Count
44
Registration Number
NCT02741947
Locations
🇮🇹

Irccs San Raffaele Pisana, Rome, Italy

Efficacy Phase IIa Study of CVXL-0107 in Advanced Parkinson's Disease

Phase 2
Completed
Conditions
Idiopathic Parkinson Disease
Interventions
First Posted Date
2015-12-29
Last Posted Date
2017-07-24
Lead Sponsor
CleveXel Pharma
Target Recruit Count
21
Registration Number
NCT02641054
Locations
🇫🇷

Clevexel Pharma, Maisons-Alfort, France

A Study of the Safety and Levodopa Pharmacokinetics Following Single Dose Administration of CVT 301 (Levodopa Inhalation Powder) in Smoking and Non-Smoking Adults

Phase 1
Completed
Conditions
Smoking
Interventions
First Posted Date
2015-12-17
Last Posted Date
2016-07-14
Lead Sponsor
Acorda Therapeutics
Target Recruit Count
60
Registration Number
NCT02633839
Locations
🇺🇸

Site 001, Daytona Beach, Florida, United States

🇺🇸

Site 002, Dallas, Texas, United States

Effects of PR Oxycodone and of Levodopa, vs Placebo, on Central Neuropathic Pain in Parkinson's Disease

Phase 2
Completed
Conditions
Parkinson Disease
Interventions
First Posted Date
2015-11-10
Last Posted Date
2022-03-02
Lead Sponsor
University Hospital, Toulouse
Target Recruit Count
67
Registration Number
NCT02601586
Locations
🇫🇷

University Hospital of Bordeaux, Bordeaux, France

🇫🇷

CHU Amiens, Amiens, France

🇫🇷

Henri Mondor Hospital, Créteil, France

and more 15 locations
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