MedPath

Carbidopa

Generic Name
Carbidopa
Brand Names
Dhivy, Duodopa, Duopa, Lodosyn, Parcopa, Rytary, Sinemet, Stalevo
Drug Type
Small Molecule
Chemical Formula
C10H14N2O4
CAS Number
28860-95-9
Unique Ingredient Identifier
KR87B45RGH
Background

Carbidopa presents a chemical denomination of N-amino-alpha-methyl-3-hydroxy-L-tyrosine monohydrate. It potently inhibits aromatic amino acid decarboxylase (DDC) and due to its chemical properties, it does not cross the blood-brain barrier. Due to its activity, carbidopa is always administered concomitantly with levodopa. An individual formulation containing solely carbidopa was generated to treat nausea in patients where the combination therapy levodopa/carbidopa is not efficient reducing nausea.

The first approved product by the FDA containing only carbidopa was developed by Amerigens Pharmaceuticals Ltd and approved on 2014. On the other hand, the combination treatment of carbidopa/levodopa was originally developed by Watson Labs but the historical information by the FDA brings back to the approval of this combination therapy developed by Mayne Pharma in 1992.

Indication

Carbidopa is indicated with levodopa for the treatment of symptoms of idiopathic Parkinson disease, postencephalitic parkinsonism and symptomatic parkinsonism followed by carbon monoxide or manganese intoxication.

The combination therapy is administered for the reduction of levodopa-driven nausea and vomiting.

The product of carbidopa should be used in patients where the combination therapy of carbidopa/levodopa provide less than the adequate daily dosage.

As well carbidopa can be used in patients where the dosages of carbidopa and levodopa require individual titration.

Associated Conditions
Parkinson's Disease (PD), Parkinsonism post encephalitic, Symptomatic Parkinson Disease, Levodopa-driven nausea and vomiting

Pharmacokinetic-Pharmacodynamic Interaction Between Four Different Single Doses of BIA 3-202 and a Single Dose of Levodopa/Carbidopa (100/25 mg)

Phase 1
Completed
Conditions
Parkinson's Disease
Interventions
First Posted Date
2016-05-05
Last Posted Date
2016-05-05
Lead Sponsor
Bial - Portela C S.A.
Target Recruit Count
19
Registration Number
NCT02763839
Locations
🇵🇹

Human Pharmacology Unit - BIAL - Portela & Ca, S.A., S. Mamede do Coronado, Portugal

A Study of the Safety and Pharmacokinetics of Levodopa Following Administration of CVT 301 (Levodopa Inhalation Powder) in Adults With Asthma

Phase 1
Completed
Conditions
Asthma
Interventions
Drug: CVT-301 (levodopa inhalation powder)
Other: Placebo
First Posted Date
2015-12-17
Last Posted Date
2016-06-13
Lead Sponsor
Acorda Therapeutics
Target Recruit Count
25
Registration Number
NCT02633007
Locations
🇺🇸

Site 002, Daytona Beach, Florida, United States

🇺🇸

Site 003, Dallas, Texas, United States

🇺🇸

Site 001, North Dartmouth, Massachusetts, United States

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

A Study to Assess the Safety and Efficacy of the of the Gastric-retentive AP-CD/LD in Advanced Parkinson's Patients

Phase 3
Conditions
Parkinson's Disease
Interventions
Drug: Accordion Pill™ Carbidopa/Levodopa
Drug: Placebo- Sinemet
Drug: Placebo -AP-CD/LD
First Posted Date
2015-11-16
Last Posted Date
2019-08-08
Lead Sponsor
Intec Pharma Ltd.
Target Recruit Count
420
Registration Number
NCT02605434
Locations
🇩🇪

Praxis für Neurologie und Psychiatrie, Westerstede, Germany

🇺🇸

Charlottesville Medical Research, Charlottesville, Virginia, United States

🇬🇧

Fairfield General Hospital, Bury, United Kingdom

and more 92 locations

Carbidopa for the Treatment of Excessive Blood Pressure Variability

Phase 2
Completed
Conditions
Dysautonomia, Familial
Baroreflex Failure Syndrome
Interventions
First Posted Date
2015-09-17
Last Posted Date
2022-02-09
Lead Sponsor
NYU Langone Health
Target Recruit Count
22
Registration Number
NCT02553265
Locations
🇺🇸

NYU Langone Medical Center, Dyautonomia Center, Suite 9Q, New York, New York, United States

🇺🇸

NYU Medical Center, New York, New York, United States

Clock and Narcolepsy Genetic Variants and the Effects of Stalevo® (Levodopa/Carbidopa/Entacapone) on Sleep Disorders in Parkinson's Disease

Not Applicable
Conditions
Parkinson Disease
Sleep Disorders
Interventions
First Posted Date
2015-05-22
Last Posted Date
2016-07-13
Lead Sponsor
Asan Medical Center
Target Recruit Count
100
Registration Number
NCT02452606
Locations
🇰🇷

Asan Medical Center, Seoul, Korea, Republic of

A Study to Compare Plasma Levels of Levodopa, Carbidopa and Entacapone After TRIGEL or Duodopa Infusion in PD Patients

Phase 1
Completed
Conditions
Parkinson's Disease
Interventions
First Posted Date
2015-05-20
Last Posted Date
2016-05-23
Lead Sponsor
LobSor Pharmaceuticals AB
Target Recruit Count
11
Registration Number
NCT02448914
Locations
🇸🇪

Clinical Trial Consultants AB, Uppsala, Sweden

Effect of Serotonin and Levodopa in Ischemic Stroke

Phase 4
Completed
Conditions
Stroke
Interventions
First Posted Date
2015-03-12
Last Posted Date
2019-11-26
Lead Sponsor
Hospital de Granollers
Target Recruit Count
39
Registration Number
NCT02386475
Locations
🇪🇸

Granollers General Hospital, Granollers, Barcelnoa, Spain

A Study to Assess the PK and Pharmacodynamics of IPX203 in Patients With Advanced Parkinson's Disease

Phase 2
Completed
Conditions
Parkinson's Disease
Interventions
Drug: CD-LD IR
Drug: IPX203 180 mg
Drug: IPX203 270 mg
First Posted Date
2014-10-22
Last Posted Date
2019-11-06
Lead Sponsor
Impax Laboratories, LLC
Target Recruit Count
26
Registration Number
NCT02271503
Locations
🇺🇸

Muhammad Ali Movement Disorder Center (MAMDC), Phoenix, Arizona, United States

🇺🇸

Parkinson's Disease and Movement Disorders Center of Boca Raton, Boca Raton, Florida, United States

🇺🇸

QUEST Research Institute, Farmington Hills, Michigan, United States

and more 8 locations

Pharmacokinetic-pharmacodynamic Interaction Between Each of Three Different Single Doses of BIA 9-1067 and a Single-dose of Controlled-release 100/25 mg Levodopa/Carbidopa

Phase 1
Completed
Conditions
Parkinson's Disease (PD)
Interventions
First Posted Date
2014-06-23
Last Posted Date
2015-01-21
Lead Sponsor
Bial - Portela C S.A.
Target Recruit Count
12
Registration Number
NCT02169453
Locations
🇨🇦

Algorithme Pharma Inc, Mount-Royal, Quebec, Canada

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