Neupro

Parkinson's Disease, Restless Legs Syndrome, Restless Legs Syndrome

Treatment

6 FDA approvals

20 Active Studies for Neupro

What is Neupro

Rotigotine

The Generic name of this drug

Treatment Summary

Rotigotine (Neupro) is a patch that is worn on the skin and slowly releases medication over 24 hours to treat Parkinson’s Disease and Restless Legs Syndrome. It may also have antidepressant effects. Rotigotine was developed by Aderis Pharmaceuticals and licensed to Schwarz Pharma in 1998. It was approved by the EMA in 2006 and the FDA in 2007, but was recalled in 2008 due to delivery problems. Since then, it has been authorized as a treatment for RLS.

Neupro

is the brand name

image of different drug pills on a surface

Neupro Overview & Background

Brand Name

Generic Name

First FDA Approval

How many FDA approvals?

Neupro

Rotigotine

2012

7

Approved as Treatment by the FDA

Rotigotine, also called Neupro, is approved by the FDA for 6 uses including Moderate restless legs syndrome (RLS) and Severe restless legs syndrome (RLS) .

Moderate restless legs syndrome (RLS)

Helps manage Moderate restless legs syndrome (RLS)

Severe restless legs syndrome (RLS)

Helps manage Severe restless legs syndrome (RLS)

Parkinson's Disease (PD)

Helps manage Parkinson's Disease (PD)

Parkinson's Disease

Helps manage Parkinson's Disease (PD)

Restless Legs Syndrome

Helps manage Moderate restless legs syndrome (RLS)

Restless Legs Syndrome

Helps manage Severe restless legs syndrome (RLS)

Effectiveness

How Neupro Affects Patients

Rotigotine binds to dopamine receptors (D1-D5, with the highest affinity to D3) and has effects on other receptors such as alpha-2-adrenergic and 5HT1A. It also stops dopamine from being taken up and prevents the release of prolactin. Studies have found that even at doses up to 24 mg/24 hours, there is no indication of rotigotine causing a prolonged QT/QTc interval. This was confirmed in a trial with male and female patients with advanced-stage Parkinson's disease where a positive-controlled (moxifloxacin) showed assay

How Neupro works in the body

Rotigotine is a drug that mimics the effects of the chemical dopamine. It is administered through a patch worn on the skin that needs to be replaced every 24 hours. Rotigotine works by activating dopamine receptors in the body, although it is not yet clear exactly how it helps treat Restless Legs Syndrome.

When to interrupt dosage

The recommended dosage of Neupro is contingent upon the determined condition, such as Restless Legs Syndrome, Parkinson's Disease and Restless Legs Syndrome. The measure of dosage is dependent upon the technique of delivery (e.g. Patch - Transdermal or Patch) featured in the table beneath.

Condition

Dosage

Administration

Parkinson's Disease

, 0.2 mg/hour, 0.4 mg/hour, 0.3 mg/hour, 0.6 mg/hour, 0.8 mg/hour, 0.1 mg/hour

, Patch, Transdermal, Patch - Transdermal, Patch, extended release, Patch, extended release - Transdermal

Restless Legs Syndrome

, 0.2 mg/hour, 0.4 mg/hour, 0.3 mg/hour, 0.6 mg/hour, 0.8 mg/hour, 0.1 mg/hour

, Patch, Transdermal, Patch - Transdermal, Patch, extended release, Patch, extended release - Transdermal

Restless Legs Syndrome

, 0.2 mg/hour, 0.4 mg/hour, 0.3 mg/hour, 0.6 mg/hour, 0.8 mg/hour, 0.1 mg/hour

, Patch, Transdermal, Patch - Transdermal, Patch, extended release, Patch, extended release - Transdermal

Warnings

There are 20 known major drug interactions with Neupro.

Common Neupro Drug Interactions

Drug Name

Risk Level

Description

Astemizole

Major

The metabolism of Astemizole can be decreased when combined with Rotigotine.

Azelastine

Major

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

Dacomitinib

Major

The metabolism of Dacomitinib can be decreased when combined with Rotigotine.

Enasidenib

Major

The metabolism of Enasidenib can be decreased when combined with Rotigotine.

Erlotinib

Major

The metabolism of Erlotinib can be decreased when combined with Rotigotine.

Neupro Toxicity & Overdose Risk

Overdosing on a dopamine agonist can cause symptoms such as nausea, vomiting, low blood pressure, involuntary movements, hallucinations, confusion, seizures, and other signs of too much dopamine in the body.

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

Neupro Novel Uses: Which Conditions Have a Clinical Trial Featuring Neupro?

Currently, 45 active clinical trials are investigating the potential of Neupro to alleviate Restless Legs Syndrome, Restless Legs Syndrome and Parkinson's Disease.

Condition

Clinical Trials

Trial Phases

Parkinson's Disease

39 Actively Recruiting

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

Restless Legs Syndrome

0 Actively Recruiting

Restless Legs Syndrome

6 Actively Recruiting

Phase 4, Not Applicable, Phase 1, Phase 2

Neupro Reviews: What are patients saying about Neupro?

5

Patient Review

3/1/2016

Neupro for Parkinson's Disease

Neupro has been awesome for decreasing my tremors and stiffness. The only downside is that it's caused some insomnia; but, all things considered, the pros definitely outweigh the cons.

5

Patient Review

5/28/2020

Neupro for Extreme Discomfort in Calves when Sitting or Lying Down

I've been using these patches for four years now and they've done wonders for my restless legs. The only downside is that it doesn't always stick well, depending on where I put it. Other than that, no negative side effects like weight gain or anything else.

5

Patient Review

8/22/2016

Neupro for Parkinson's Disease

The patches are more difficult to apply when the backing is on a diagonal cut; I prefer when it's cut at a 90 degree angle.

5

Patient Review

12/10/2020

Neupro for Parkinson's Disease

I sleep better than I ever have since taking this medication; however, it has caused constipation to be a problem for me.

5

Patient Review

9/29/2015

Neupro for Parkinson's Disease

I have a lot more confidence in this treatment because it provides 24-hour relief.

4.3

Patient Review

1/13/2021

Neupro for Extreme Discomfort in Calves when Sitting or Lying Down

While it has caused me some depression and fatigue, this medication is really effective for treating my restless leg syndrome.

4

Patient Review

5/27/2015

Neupro for Parkinson's Disease

Neupro has been effective in controlling my PD symptoms; however, I now have difficulty sleeping through the night and often wake up with leg cramps. Are these common side effects that I should expect?

4

Patient Review

2/25/2016

Neupro for Parkinson's Disease

After wearing neupro patch for some time, I developed an itchy rash under the patch.

3

Patient Review

1/30/2017

Neupro for Extreme Discomfort in Calves when Sitting or Lying Down

This treatment has been helpful for my restless legs, but it's not perfect. The patch falls off pretty easily, so I have to tape it on every day. Some days are better than others, but this definitely isn't a cure-all.

3

Patient Review

6/17/2022

Neupro for Extreme Discomfort in Calves when Sitting or Lying Down

The patches are sometimes difficult to keep on, which is an issue because they need to stay on for a full day. That said, when I was able to get them to stick, the treatment effectively relieved my restless leg syndrome.

2.7

Patient Review

7/9/2020

Neupro for Parkinson's Disease

I didn't notice any improvements in my balance or walking after a month of using this treatment, and it's quite pricey.

2.3

Patient Review

5/10/2021

Neupro for Parkinson's Disease

I found the patches to be very irritating and difficult to keep on. They also caused some skin irritation for me, so I had to stop using them. While I was using them, they did seem to help somewhat.
image of drug pills surrounding a glass of water symbolizing drug consumption

Patient Q&A Section about neupro

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

Is NEUPRO patch a narcotic?

"Neupro is a non-controlled substance containing rotigotine. It is a dopamine agonist that is approved to treat Parkinson's disease and restless legs syndrome. The classification is thought to work by stimulating dopamine receptors in the brain."

Answered by AI

What is NEUPRO used for?

"NEUPRO is a prescription medicine used for treating Parkinson's disease and moderate-to-severe primary Restless Legs Syndrome."

Answered by AI

How does NEUPRO make you feel?

"The following are potential side effects of NEUPRO that patients should be aware of: hallucinations, confusion, excessive suspicion, aggressive behavior, agitation, delusional beliefs, and disorganized thinking. These symptoms can either start or worsen when taking NEUPRO."

Answered by AI

What drug class is NEUPRO?

"The active drug in Neupro is rotigotine, which is a dopamine agonist. These drugs work in a similar way and Neupro is applied to the skin as patches every day."

Answered by AI

Clinical Trials for Neupro

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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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 Kennedy Krieger Institute in Baltimore, United States.

Iron Supplementation for ADHD and Restless Sleep

8 - 18
All Sexes
Baltimore, MD

The goal of this clinical trial is to learn if iron supplementation works to restless sleep in youth with ADHD. A second goal is to learn if iron supplementation helps to ease ADHD symptoms. The main questions that this trial aims to answer are: Does 3 months of iron supplementation treatment improve parent- and youth self-reported sleep difficulties more than placebo? Does 3 months of iron supplementation treatment improve sleep as measured by actigraphy more than placebo? Does 3 months of iron supplementation treatment improve parent-reported and/or objectively measured attention more than placebo? Researchers will compare over-the-counter iron supplementation treatment to a placebo (a look-alike substance that contains no drug) to see if iron supplementation works to treat sleep difficulties in youth with ADHD. Participants will: * Take iron supplements every day for 3 months * Visit the clinic once before treatment begins and once at the end of treatment to complete tests and rating scales related to sleep and attention * Wear motion-monitoring leg bands while sleeping for one 2-week period before treatment begins and one 2-week period at the end of treatment

Phase 1 & 2
Waitlist Available

Kennedy Krieger Institute

Alison E Pritchard, PhD

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

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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

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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

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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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