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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

Efficacy and Safety Study of Inhaled CVT 301 in Parkinson's Disease Patients for Treatment of OFF Episodes

Phase 2
Completed
Conditions
Idiopathic Parkinson's Disease
Interventions
Drug: Placebo
First Posted Date
2013-01-29
Last Posted Date
2018-08-08
Lead Sponsor
Acorda Therapeutics
Target Recruit Count
89
Registration Number
NCT01777555
Locations
🇺🇸

Civitas Investigational Site 1014, Cleveland, Ohio, United States

🇺🇸

Civitas Investigational Site 1004, Boca Raton, Florida, United States

🇺🇸

Civitas Investigational Site 1002, Port Charlotte, Florida, United States

and more 19 locations

Apokyn for Motor IMProvement of Morning AKinesia Trial (AM IMPAKT)

Phase 4
Completed
Conditions
Motor Symptoms
Parkinson's Disease
Hypomobility
Akinesia
Delayed Levodopa Onset
Interventions
First Posted Date
2013-01-17
Last Posted Date
2023-08-14
Lead Sponsor
MDD US Operations, LLC a subsidiary of Supernus Pharmaceuticals
Target Recruit Count
127
Registration Number
NCT01770145
Locations
🇺🇸

Henry Ford West Bloomfield Hospital, Bloomfield Hills, Michigan, United States

🇺🇸

University of Texas Health Science Center, Houston, Department of Neurology, Houston, Texas, United States

🇺🇸

Center for Neurological Care and Research, San Antonio, Texas, United States

and more 9 locations

Rotigotine Versus Placebo, A Study To Evaluate The Efficacy In Advanced Stage Idiopathic Parkinson's Disease Patients

Phase 3
Completed
Conditions
Idiopathic Parkinson's Disease
Interventions
Drug: Placebo Patch
First Posted Date
2012-07-20
Last Posted Date
2018-04-04
Lead Sponsor
UCB Pharma
Target Recruit Count
346
Registration Number
NCT01646255
Locations
🇨🇳

Sp1037 006, Wuhan, China

🇨🇳

Sp1037 001, Beijing, China

🇨🇳

Sp1037 002, Beijing, China

and more 21 locations

Safety, Pharmacokinetics and Efficacy Study of CVT-301 Inpatients With Parkinson's Disease and "Off" Episodes

Phase 2
Completed
Conditions
Idiopathic Parkinson's Disease
Interventions
First Posted Date
2012-06-12
Last Posted Date
2017-07-27
Lead Sponsor
Acorda Therapeutics
Target Recruit Count
25
Registration Number
NCT01617135
Locations
🇬🇧

Civitas Clinical Site #1, Glasgow, United Kingdom

🇬🇧

Civitas Clinical Site #2, Norwich, United Kingdom

🇬🇧

Civitas Clinical Site #3, Newcastle, United Kingdom

and more 4 locations

Evaluation of the Subjective and Objective Painful Threshold in Multiple System Atrophy Pain and Multiple System Atrophy

Not Applicable
Completed
Conditions
Pain Threshold
Multiple System Atrophy
Interventions
Procedure: determination of objective and subjective pain threshold
First Posted Date
2012-04-16
Last Posted Date
2013-11-11
Lead Sponsor
University Hospital, Toulouse
Target Recruit Count
42
Registration Number
NCT01577992
Locations
🇫🇷

University Hospital, neurology, Toulouse, France

Efficacy and Safety of BIA 9-1067 in Idiopathic Parkinson's Disease Patients With "Wearing-off" Phenomenon

Phase 3
Completed
Conditions
Parkinson's Disease
Interventions
First Posted Date
2012-04-02
Last Posted Date
2015-09-18
Lead Sponsor
Bial - Portela C S.A.
Target Recruit Count
600
Registration Number
NCT01568073
Locations
🇵🇹

Bial - Portela & Cª, S.A., S. Mamede do Coronado, Portugal

Cardiovascular Events in Parkinson's Disease Patients

Completed
Conditions
Cardiovascular Event
Parkinson Disease
Interventions
First Posted Date
2012-03-07
Last Posted Date
2017-05-16
Lead Sponsor
GlaxoSmithKline
Target Recruit Count
1
Registration Number
NCT01545856

Evaluation of the Role of the Noradrenergic System in Pain Perception in Parkinson's Disease

Phase 3
Completed
Conditions
Parkinson's Disease
Interventions
Drug: injection of placebo of apomorphine
Drug: injection of placebo of L-Dopa
First Posted Date
2012-01-05
Last Posted Date
2017-02-23
Lead Sponsor
University Hospital, Toulouse
Target Recruit Count
28
Registration Number
NCT01504178
Locations
🇫🇷

CIC, Purpan Hospital, Toulouse, France

Imaging the Neurobiology of Behavioral and Medication Treatment for Cocaine Dependence

Phase 2
Completed
Conditions
Cocaine Dependence
Interventions
First Posted Date
2011-11-09
Last Posted Date
2018-05-22
Lead Sponsor
New York State Psychiatric Institute
Target Recruit Count
23
Registration Number
NCT01468012
Locations
🇺🇸

STARS, New York, New York, United States

Behavioral and Physiological Effects of Cocaine in Cocaine-dependent Participants Treated With Levodopa in Combination With Carbidopa and Entacapone (LCE)

Phase 1
Completed
Conditions
Cocaine Abuse
Interventions
First Posted Date
2011-09-20
Last Posted Date
2018-05-21
Lead Sponsor
New York State Psychiatric Institute
Target Recruit Count
15
Registration Number
NCT01437293
Locations
🇺🇸

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

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