Sinemet Cr

Parkinson Disease, advanced Motor fluctuations, Carbon Monoxide Poisoning + 5 more

Treatment

10 FDA approvals

20 Active Studies for Sinemet Cr

What is Sinemet Cr

Levodopa

The Generic name of this drug

Treatment Summary

Levodopa is a drug used to treat Parkinson's disease. It is able to cross the blood-brain barrier, which allows it to increase levels of dopamine in the brain. Levodopa is usually taken with a dopa decarboxylase inhibitor like carbidopa to prevent it from being broken down until after it has crossed the blood-brain barrier. The first FDA approved product containing levodopa and carbidopa was called Sinemet and was approved in 1975.

Sinemet

is the brand name

image of different drug pills on a surface

Sinemet Cr Overview & Background

Brand Name

Generic Name

First FDA Approval

How many FDA approvals?

Sinemet

Levodopa

1975

272

Approved as Treatment by the FDA

Levodopa, also called Sinemet, is approved by the FDA for 10 uses including Parkinson Disease and Paralysis agitans .

Parkinson Disease

Used to treat Parkinsonism in combination with Carbidopa

Paralysis agitans

Used to treat Paralysis agitans in combination with Carbidopa

carbon monoxide intoxication

Used to treat carbon monoxide intoxication in combination with Carbidopa

Parkinson Disease

Used to treat Paralysis agitans in combination with Carbidopa

Parkinson's Disease (PD)

Used to treat Parkinson's Disease (PD) in combination with Carbidopa

Parkinsonism

Used to treat Parkinsonism in combination with Carbidopa

Parkinson's Disease

Used to treat Parkinson's Disease (PD) in combination with Carbidopa

Parkinsonism post encephalitic

Used to treat Parkinsonism post encephalitic in combination with Carbidopa

Manganese Poisoning

Used to treat manganese intoxication in combination with Carbidopa

Carbon Monoxide Poisoning

Used to treat carbon monoxide intoxication in combination with Carbidopa

Effectiveness

How Sinemet Cr Affects Patients

Levodopa, unlike dopamine, is able to cross the blood-brain barrier. Taking a dopa decarboxylase inhibitor along with levodopa helps it pass through the blood-brain barrier, allowing more of it to reach the brain. Once it reaches the brain, it is converted to dopamine by a specific enzyme.

How Sinemet Cr works in the body

Levodopa enters the brain, where it is changed into dopamine. This dopamine helps to stimulate special receptors in the brain, allowing it to make up for the natural decrease of dopamine in the brain.

When to interrupt dosage

The prescribed dosage of Sinemet Cr is reliant upon the determined condition, including manganese intoxication, Parkinson's Disease and Restless Legs Syndrome (RLS). The amount of dosage is contingent upon the method of delivery provided in the table below.

Condition

Dosage

Administration

Parkinson's Disease

, 100.0 mg, 250.0 mg, 200.0 mg, 50.0 mg, 75.0 mg, 125.0 mg, 150.0 mg, 95.0 mg, 145.0 mg, 195.0 mg, 245.0 mg, 20.0 mg/mL, 175.0 mg, 42.0 mg, 33.0 mg

Tablet - Oral, , Oral, Tablet, Tablet, extended release, Tablet, extended release - Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, orally disintegrating, Tablet, orally disintegrating - Oral, Enteral, Gel - Enteral, Gel, Capsule, extended release, Capsule, extended release - Oral, Suspension - Enteral, Suspension, Capsule - Oral, Capsule, Respiratory (inhalation), Capsule - Respiratory (inhalation)

Manganese Poisoning

, 100.0 mg, 250.0 mg, 200.0 mg, 50.0 mg, 75.0 mg, 125.0 mg, 150.0 mg, 95.0 mg, 145.0 mg, 195.0 mg, 245.0 mg, 20.0 mg/mL, 175.0 mg, 42.0 mg, 33.0 mg

Tablet - Oral, , Oral, Tablet, Tablet, extended release, Tablet, extended release - Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, orally disintegrating, Tablet, orally disintegrating - Oral, Enteral, Gel - Enteral, Gel, Capsule, extended release, Capsule, extended release - Oral, Suspension - Enteral, Suspension, Capsule - Oral, Capsule, Respiratory (inhalation), Capsule - Respiratory (inhalation)

Parkinson Disease

, 100.0 mg, 250.0 mg, 200.0 mg, 50.0 mg, 75.0 mg, 125.0 mg, 150.0 mg, 95.0 mg, 145.0 mg, 195.0 mg, 245.0 mg, 20.0 mg/mL, 175.0 mg, 42.0 mg, 33.0 mg

Tablet - Oral, , Oral, Tablet, Tablet, extended release, Tablet, extended release - Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, orally disintegrating, Tablet, orally disintegrating - Oral, Enteral, Gel - Enteral, Gel, Capsule, extended release, Capsule, extended release - Oral, Suspension - Enteral, Suspension, Capsule - Oral, Capsule, Respiratory (inhalation), Capsule - Respiratory (inhalation)

Restless Legs Syndrome

, 100.0 mg, 250.0 mg, 200.0 mg, 50.0 mg, 75.0 mg, 125.0 mg, 150.0 mg, 95.0 mg, 145.0 mg, 195.0 mg, 245.0 mg, 20.0 mg/mL, 175.0 mg, 42.0 mg, 33.0 mg

Tablet - Oral, , Oral, Tablet, Tablet, extended release, Tablet, extended release - Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, orally disintegrating, Tablet, orally disintegrating - Oral, Enteral, Gel - Enteral, Gel, Capsule, extended release, Capsule, extended release - Oral, Suspension - Enteral, Suspension, Capsule - Oral, Capsule, Respiratory (inhalation), Capsule - Respiratory (inhalation)

advanced Motor fluctuations

, 100.0 mg, 250.0 mg, 200.0 mg, 50.0 mg, 75.0 mg, 125.0 mg, 150.0 mg, 95.0 mg, 145.0 mg, 195.0 mg, 245.0 mg, 20.0 mg/mL, 175.0 mg, 42.0 mg, 33.0 mg

Tablet - Oral, , Oral, Tablet, Tablet, extended release, Tablet, extended release - Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, orally disintegrating, Tablet, orally disintegrating - Oral, Enteral, Gel - Enteral, Gel, Capsule, extended release, Capsule, extended release - Oral, Suspension - Enteral, Suspension, Capsule - Oral, Capsule, Respiratory (inhalation), Capsule - Respiratory (inhalation)

Carbon Monoxide Poisoning

, 100.0 mg, 250.0 mg, 200.0 mg, 50.0 mg, 75.0 mg, 125.0 mg, 150.0 mg, 95.0 mg, 145.0 mg, 195.0 mg, 245.0 mg, 20.0 mg/mL, 175.0 mg, 42.0 mg, 33.0 mg

Tablet - Oral, , Oral, Tablet, Tablet, extended release, Tablet, extended release - Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, orally disintegrating, Tablet, orally disintegrating - Oral, Enteral, Gel - Enteral, Gel, Capsule, extended release, Capsule, extended release - Oral, Suspension - Enteral, Suspension, Capsule - Oral, Capsule, Respiratory (inhalation), Capsule - Respiratory (inhalation)

Parkinson Disease

, 100.0 mg, 250.0 mg, 200.0 mg, 50.0 mg, 75.0 mg, 125.0 mg, 150.0 mg, 95.0 mg, 145.0 mg, 195.0 mg, 245.0 mg, 20.0 mg/mL, 175.0 mg, 42.0 mg, 33.0 mg

Tablet - Oral, , Oral, Tablet, Tablet, extended release, Tablet, extended release - Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, orally disintegrating, Tablet, orally disintegrating - Oral, Enteral, Gel - Enteral, Gel, Capsule, extended release, Capsule, extended release - Oral, Suspension - Enteral, Suspension, Capsule - Oral, Capsule, Respiratory (inhalation), Capsule - Respiratory (inhalation)

Parkinsonism post encephalitic

, 100.0 mg, 250.0 mg, 200.0 mg, 50.0 mg, 75.0 mg, 125.0 mg, 150.0 mg, 95.0 mg, 145.0 mg, 195.0 mg, 245.0 mg, 20.0 mg/mL, 175.0 mg, 42.0 mg, 33.0 mg

Tablet - Oral, , Oral, Tablet, Tablet, extended release, Tablet, extended release - Oral, Tablet, film coated, Tablet, film coated - Oral, Tablet, orally disintegrating, Tablet, orally disintegrating - Oral, Enteral, Gel - Enteral, Gel, Capsule, extended release, Capsule, extended release - Oral, Suspension - Enteral, Suspension, Capsule - Oral, Capsule, Respiratory (inhalation), Capsule - Respiratory (inhalation)

Warnings

Sinemet Cr Contraindications

Condition

Risk Level

Notes

Malignant Neoplasms

Do Not Combine

Pulse Frequency

Do Not Combine

cutaneous lesions

Do Not Combine

There are 20 known major drug interactions with Sinemet Cr.

Common Sinemet Cr Drug Interactions

Drug Name

Risk Level

Description

Azelastine

Major

Levodopa may increase the central nervous system depressant (CNS depressant) activities of Azelastine.

Ethanol

Major

Levodopa may increase the central nervous system depressant (CNS depressant) activities of Ethanol.

Macimorelin

Major

The therapeutic efficacy of Macimorelin can be decreased when used in combination with Levodopa.

Methylene blue

Major

Levodopa may increase the serotonergic activities of Methylene blue.

Mirtazapine

Major

Levodopa may increase the serotonergic activities of Mirtazapine.

Sinemet Cr Toxicity & Overdose Risk

Levodopa has not been tested for use in pregnant women. In rabbits, giving levodopa and carbidopa has resulted in smaller litters and deformities in the offspring. Taking levodopa may reduce the amount of prolactin in the body, which could make it harder to breastfeed. Levodopa can also be passed to a baby through breast milk, so it's important to consider this before giving levodopa to a nursing mother. There is not yet enough information to say whether levodopa is safe and effective for children. People over 65 may be more likely to experience side effects from taking levodopa

image of a doctor in a lab doing drug, clinical research

Sinemet Cr Novel Uses: Which Conditions Have a Clinical Trial Featuring Sinemet Cr?

48 active studies are presently being conducted to determine the efficacy of Sinemet Cr in treating Parkinson's Disease, Parkinsonism and Carbon Monoxide Intoxication.

Condition

Clinical Trials

Trial Phases

Carbon Monoxide Poisoning

0 Actively Recruiting

Manganese Poisoning

0 Actively Recruiting

Parkinson Disease

0 Actively Recruiting

Restless Legs Syndrome

3 Actively Recruiting

Not Applicable

Parkinson's Disease

39 Actively Recruiting

Not Applicable, Phase 1, Phase 4, Phase 2, Phase 3, Early Phase 1

Parkinsonism post encephalitic

0 Actively Recruiting

advanced Motor fluctuations

0 Actively Recruiting

Parkinson Disease

0 Actively Recruiting

Sinemet Cr Reviews: What are patients saying about Sinemet Cr?

5

Patient Review

6/8/2021

Sinemet Cr for Parkinson's Disease

I was diagnosed with Parkinson's disease a couple of years ago and ended up bedridden as a result. After taking Sinemet for several weeks, though, I gradually became more mobile again. I'm now able to walk and even work again. There is some fatigue involved, but it comes from the disease itself rather than the medication.

5

Patient Review

11/5/2007

Sinemet Cr for Parkinson's Disease

4

Patient Review

5/12/2012

Sinemet Cr for Parkinson's Disease

The medication does not last very long, and sometimes I have to take it multiple times in one hour.

3

Patient Review

10/28/2013

Sinemet Cr for Parkinson's Disease

The effects of this medication only last for a few hours.
image of drug pills surrounding a glass of water symbolizing drug consumption

Patient Q&A Section about sinemet cr

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is Sinemet CR still available?

"Merck will no longer be selling Sinemet CR 50 mg/200 mg tablets as of November 2019. Mylan will have carbidopa and levodopa extended-release tablets available as of February 2020."

Answered by AI

How many hours does Sinemet CR last?

"The lower dosage may help to reduce or eliminate unwanted side-effects, such as those related to the digestive system and heart. 'Sinemet CR' and 'Half Sinemet CR' are designed to release their active ingredients over the course of four to six hours."

Answered by AI

What is the difference between Sinemet and Sinemet CR?

"Sinemet comes in two forms: an immediate release tablet and a controlled release tablet. The immediate release tablet reaches peak levels in half an hour, while the controlled release tablet takes about two hours to reach peak levels. Both forms of Sinemet decline after reaching peak levels."

Answered by AI

What does CR mean in Sinemet?

"Its empirical formula is C10H14N2O4, and it has the following structural formula:

SINEMET CR is a combination of two drugs, carbidopa and levodopa, for the treatment of Parkinson's disease and syndrome. Carbidopa is an inhibitor of aromatic amino acid decarboxylation, and is a white, crystalline compound with a molecular weight of 244.3. Its empirical formula is C10H14N2O4, and it has the following structural formula:"

Answered by AI

Clinical Trials for Sinemet Cr

Image of Invicro (dba Perceptive) in New Haven, United States.

[18F]MK-0947 for Parkinson's Disease

18 - 80
All Sexes
New Haven, CT

This clinical study is being conducted to learn more about a new imaging drug called \[18F\]MK-0947, which is designed to help doctors see changes in the brain related to Parkinson's disease (PD). PD is a condition that affects movement, balance, and thinking. The drug works with a type of scan called PET (Positron Emission Tomography) to show areas of the brain where a protein called α-synuclein builds up. This buildup is linked to PD and other brain disorders. The main goal of this study is to find out if \[18F\]MK-0947 is safe for people and if it works well to show α-synuclein in the brain. The study will also look at how the drug moves through the body and how much radiation it gives off. Researchers hope this information will help develop better tools for diagnosing PD and tracking how it changes over time. Who can join? Adults who have PD or who are healthy may be able to take part. Participants will have screening tests to make sure they qualify. What does participation involve? People in the study will have PET scans, blood tests, and other safety checks. Some participants will also have an MRI scan. The study is divided into two parts: Part 1 looks at how the drug works in the brain of PD patients and healthy elderly participants, and Part 2 measures radiation levels in healthy participants. Why is this important? There is currently no cure for PD, and better imaging tools could help researchers develop new treatments. By joining this study, participants will help advance research that may improve care for people with PD and similar conditions in the future.

Phase < 1
Recruiting

Invicro (dba Perceptive)

Merck Sharp & Dohme LLC

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Image of Rhode Island Hospital in Providence, United States.

Peroneal Nerve Stimulation for Restless Legs Syndrome

18+
Female
Providence, RI

The goal of this study is to evaluate whether peroneal electrical nerve stimulation (PNS) using the TOMAC™ device is a feasible, acceptable, and safe non-pharmacologic intervention for managing Restless Legs Syndrome (RLS) during pregnancy. This pilot study will also collect preliminary information on symptom relief, sleep quality, and maternal-fetal safety associated with device use. The main questions the study aims to answer are: Is TOMAC™ PNS a feasible and acceptable intervention for RLS in pregnant individuals? Are there any maternal, fetal, or neonatal safety concerns with PNS use during pregnancy? What are the patterns of adherence, tolerance, and usability of the TOMAC™ device in this population? Participants will: Use a non-invasive TOMAC™ peroneal nerve stimulator during 30-minute sessions as needed, for 8 weeks. Complete questionnaires assessing feasibility, acceptability, symptom severity, and sleep quality (including AIM, IAM, FIM, IRLS, PGI-I, PSQI, ESS, FOSQ, and MOS-II). Wear an actigraphy monitor to collect objective sleep data at baseline and at 4 weeks. Attend scheduled follow-up visits and phone check-ins for maternal vital signs, uterine contraction and fetal monitoring, and neonatal outcome assessment. This is a prospective, open-label, single-arm pilot study enrolling 15 pregnant participants between 21 and 26 weeks' gestation. Findings will provide the first dataset on the feasibility, acceptability, and safety of TOMAC™ PNS in pregnancy and inform the design of a future randomized controlled trial.

Recruiting
Has No Placebo

Rhode Island Hospital

Image of Centre for Brain and Mind, Western University in London, Canada.

Cognitive Cueing + Video Intervention for Parkinson's Disease

40 - 99
All Sexes
London, Canada

The goal of this clinical trial is to learn if cognitive cueing (eg., prompting individuals to think about taking big-long steps while walking), either as a stand- alone intervention or combined with a personalized gait training video, can improve gait (walking), mobility, and balance confidence for individuals with Parkinson's Disease. The main questions it aims to answer are: 1. Does focusing on cognitive cues while walking improve gait, mobility, and balance confidence for individuals with Parkinson's Disease? 2. Does incorporating a personalized gait training video alongside cognitive cueing lead to amplified improvements in gait, mobility, and balance confidence for individuals with Parkinson's Disease? Researchers will compare how gait, mobility, balance confidence and quality of life change over time for participants when they practice walking with and without a cognitive cue alone, and when they practice with using a personalized gait training video. The researchers are also interested in how participation in this trial will affect quality of life and conscious attention to gait. Participants will * Complete walking trials on an instrumented mat that records data on their walking ability. These trials will be undertaken without a cognitive cue and while participants mentally rehearse a series of 3 cognitive cues (Take big long steps; Walk heel-toe; Stand up straight). * Be informed about which of the 3 cues best improved their walking and will receive a personalized gait training video for at home practice. * Complete online surveys that ask questions about their Parkinson's Disease, mobility, balance confidence quality of life and conscious attention to gait. * Visit the research facility 3 to 4 times during the study to have their gait (walking), mobility, balance confidence, quality of life and conscious attention to gait assessed and reassessed. * Practice both with and without their personalized video at home and keep a diary to record their practice sessions * Participate in a brief interview to discuss their experiences with the training and their perceptions of the effectiveness of cognitive cues and video-recorded feedback

Waitlist Available
Has No Placebo

Centre for Brain and Mind, Western University

Image of Sunnybrook Health Sciences Centre in Toronto, Canada.

Cannabis for Restless Legs Syndrome

18+
All Sexes
Toronto, Canada

Restless Legs Syndrome (RLS) is a disorder that causes painful and uncomfortable sensations in the legs, and its symptoms have a significant impact on sleep and quality of life. Cannabis has been used by some RLS patients as a treatment due to its painkilling and drowsiness effects, however there has never been a clinical research trial investigating cannabis in patients with RLS. A controlled trial is needed to establish how safe and feasible cannabis is as a treatment for RLS. The investigators plan to randomize 30 participants with moderate-to-severe RLS to receive either cannabis or placebo for 8 weeks. The investigators will measure patients sleep quality and quality of life at baseline and 8-week follow-up. The investigators will also monitor patients for any adverse reactions to the study drug.

Recruiting
Drug

Sunnybrook Health Sciences Centre (+1 Sites)

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Image of University of Kentucky in Lexington, United States.

Peripheral Nerve Tissue Implantation for Parkinson's Disease

45 - 75
All Sexes
Lexington, KY

The investigators propose a Phase I single surgical-center, double-blinded randomized parallel clinical trial involving bilateral autologous peripheral nerve tissue (PNT) delivery into the NBM or the alternate target also affecting cognition in this population, the substantia nigra (SN), to address "repair cell" support of these areas. Twenty-four participants with idiopathic Parkinson's Disease (PD) who have selected, qualified and agreed to receive as standard of care deep brain stimulation (DBS) will be enrolled and randomly allocated to receive bilateral PNT deployment to either the NBM or SN at the time of DBS surgery. Participants will be allocated equally among both assignments over the course of three years (8 Year 1, 10 Year 2, 6 Year 3). Participants will be evaluated for neurocognitive, motoric function, activities of daily living, and quality of life at enrollment before surgery, two-weeks after surgery, and 6, 12, and 24 months after surgery.

Phase 1
Recruiting

University of Kentucky

Craig G van Horne, MD, PhD

Image of Austin Clinic PPD in Austin, United States.

LY3962681 for Parkinson's Disease

30 - 80
All Sexes
Austin, TX

The purpose of this study is to evaluate the safety, tolerability, and PK/PD of LY3962681 in healthy volunteers and patients with Parkinson's disease. The study will be comprised of two parts, the Single Ascending Dose (SAD) study and the Multiple Ascending Doses (MAD) study. During the SAD portion of the study, healthy volunteers will receive a single dose of LY3962681 or placebo (artificial cerebrospinal fluid (aCSF), no active drug) given into the spinal fluid. During the MAD portion of the study, patients with Parkinson's disease will receive two doses of either LY3962681 or placebo (aCSF) administered into the spinal fluid. * The treatment period in the SAD study will be 1 day. The treatment period in the MAD study will be 2 days, 12 to 24 weeks apart. * The follow-up period in the SAD study will be up to 52 weeks. The follow-up period in the MAD study will be up to 52 weeks post Dose 2.

Phase 1
Recruiting

Austin Clinic PPD

Travis Lewis

Prevail Therapeutics

Image of Edward Hines Jr. VA Hospital, Hines, IL in Hines, United States.

Non-Invasive Vagal Nerve Stimulation for Parkinson's Disease

50 - 88
All Sexes
Hines, IL

More than 110,000 US Veterans living with Parkinson's disease (PD) currently receive PD-related care and services from the VA. Fall prevention is a priority for Veterans living PD. Gait disturbances are a major cause for functional dependence and the largest risk factor for falls, institutionalization, and death in PD. This SPiRE addresses the need to advance nonpharmacological rehabilitative health care of Veterans and maximizing functional outcomes by developing a non-invasive, neuromodulatory transcutaneous cervical Vagal Nerve Stimulation as an at-home intervention to improve gait and balance. This pilot clinical trial will assist with future efforts and priorities of the VA to prolong independent living and quality of life by minimizing gait and balance dysfunction experienced by Veterans living with PD.

Waitlist Available
Has No Placebo

Edward Hines Jr. VA Hospital, Hines, IL

Sandra L. Kletzel, PhD BA

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