Mirapex Er

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

Treatment

20 Active Studies for Mirapex Er

What is Mirapex Er

Pramipexole

The Generic name of this drug

Treatment Summary

Pramipexole is a medication used to treat the symptoms of Parkinson's Disease. It helps to reduce tremors, stiffness, and slowness of movement caused by the condition. Pramipexole was first approved by the FDA in 1997 and is used to help people with Parkinson's Disease manage their daily activities. The number of people living with Parkinson's Disease has increased over the years and is now estimated to be 6.1 million worldwide. In addition to treating Parkinson's, pramipexole was also approved by the FDA in 2006 to treat Restless Legs Syndrome (RLS). RLS is a sleep disorder

Mirapex

is the brand name

image of different drug pills on a surface

Mirapex Er Overview & Background

Brand Name

Generic Name

First FDA Approval

How many FDA approvals?

Mirapex

Pramipexole

2003

318

Effectiveness

How Mirapex Er Affects Patients

**Parkinson's Disease** Pramipexole helps improve the symptoms of Parkinson's Disease by stimulating dopamine receptors. This is important because people with Parkinson's Disease have lower levels of dopamine in the brain, which affects their ability to control their movements. **Restless Legs Syndrome** Pramipexole helps restore balance to the dopaminergic system which helps to control the symptoms of Restless Legs Syndrome. This condition is caused by dysfunction of the dopaminergic system, which causes unpleasant feelings in the legs. **Other effects

How Mirapex Er works in the body

Pramipexole is used to treat Parkinson's disease, but we don't know exactly how it works. It's thought that the drug stimulates dopamine receptors in the brain, which helps regulate certain functions. Studies in animals show that it can increase the rate of nerve transmission in the brain. Pramipexole binds to dopamine receptors, particularly the D2 and D3 subtypes. Scientists don't know what this binding does, but it is believed to be important for its effects.

When to interrupt dosage

The measure of Mirapex Er is contingent upon the determined illness, such as Restless Legs Syndrome, Parkinson's Disease and Restless Legs Syndrome. The magnitude of dosage vacillates, as indicated by the arrangement of administration featured in the table below.

Condition

Dosage

Administration

Restless Legs Syndrome

, 0.125 mg, 0.25 mg, 0.5 mg, 1.0 mg, 1.5 mg, 0.75 mg, 0.375 mg, 3.0 mg, 4.5 mg, 2.25 mg, 3.75 mg, 0.088 mg, 0.18 mg, 1.1 mg, 0.7 mg, 0.35 mg, 0.26 mg, 0.52 mg, 1.05 mg, 2.1 mg, 3.15 mg, 1.57 mg, 2.62 mg

Tablet, Tablet - Oral, , Oral, Tablet, extended release, Tablet, extended release - Oral, Kit

Parkinson's Disease

, 0.125 mg, 0.25 mg, 0.5 mg, 1.0 mg, 1.5 mg, 0.75 mg, 0.375 mg, 3.0 mg, 4.5 mg, 2.25 mg, 3.75 mg, 0.088 mg, 0.18 mg, 1.1 mg, 0.7 mg, 0.35 mg, 0.26 mg, 0.52 mg, 1.05 mg, 2.1 mg, 3.15 mg, 1.57 mg, 2.62 mg

Tablet, Tablet - Oral, , Oral, Tablet, extended release, Tablet, extended release - Oral, Kit

Restless Legs Syndrome

, 0.125 mg, 0.25 mg, 0.5 mg, 1.0 mg, 1.5 mg, 0.75 mg, 0.375 mg, 3.0 mg, 4.5 mg, 2.25 mg, 3.75 mg, 0.088 mg, 0.18 mg, 1.1 mg, 0.7 mg, 0.35 mg, 0.26 mg, 0.52 mg, 1.05 mg, 2.1 mg, 3.15 mg, 1.57 mg, 2.62 mg

Tablet, Tablet - Oral, , Oral, Tablet, extended release, Tablet, extended release - Oral, Kit

Warnings

Mirapex Er Contraindications

Condition

Risk Level

Notes

Severe Hypersensitivity Reactions

Do Not Combine

Pramipexole may interact with Pulse Frequency

There are 20 known major drug interactions with Mirapex Er.

Common Mirapex Er Drug Interactions

Drug Name

Risk Level

Description

Abacavir

Minor

Pramipexole may decrease the excretion rate of Abacavir which could result in a higher serum level.

Acebutolol

Minor

The risk or severity of adverse effects can be increased when Pramipexole is combined with Acebutolol.

Aclidinium

Minor

Pramipexole may decrease the excretion rate of Aclidinium which could result in a higher serum level.

Acrivastine

Minor

Pramipexole may decrease the excretion rate of Acrivastine which could result in a higher serum level.

Albutrepenonacog alfa

Minor

Pramipexole may decrease the excretion rate of Albutrepenonacog alfa which could result in a higher serum level.

Mirapex Er Toxicity & Overdose Risk

The toxic dose of Pramipexole in rats is more than 800mg/kg. No increased risk of cancer has been found in mice or rats, and no mutagenic effects have been observed. Animal studies have shown that Pramipexole can cause birth defects, but there are no studies on its effects in humans. Pramipexole is considered a pregnancy Category C drug, and should only be used if the potential benefits outweigh the possible risks to the fetus. It is not known if Pramipexole is excreted in human milk, so a decision should be made about whether to take the drug

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

Mirapex Er Novel Uses: Which Conditions Have a Clinical Trial Featuring Mirapex Er?

45 active studies are currently underway to evaluate the efficacy of Mirapex ER in providing relief from Restless Legs Syndrome, Idiopathic 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

6 Actively Recruiting

Phase 4, Not Applicable, Phase 1, Phase 2

Restless Legs Syndrome

0 Actively Recruiting

Mirapex Er Reviews: What are patients saying about Mirapex Er?

5

Patient Review

12/26/2012

Mirapex Er for Extreme Discomfort in Calves when Sitting or Lying Down

I'm a 55-year-old man who was placed on this medication by my neurologist due to sudden onset RLS/PLMD. The previous medication I was only lasted for about four hours and the symptoms returned. Mirapex ER has completely stopped all these symptoms, but I now have chronic severe insomnia and nausea each day with stomach bloating. I'm happy with the results except for the side effect, which means another call to the neurologist.

5

Patient Review

8/17/2013

Mirapex Er for Parkinson's Disease

This drug does an incredible job at managing the symptoms of my Parkinson's Disease. My mobility has improved greatly, and I no longer have to worry about drooling. The only downside is how expensive it is; $450 for a month's supply.

4.3

Patient Review

3/19/2011

Mirapex Er for Parkinson's Disease

I am currently taking Mirapex per my doctor's orders. I have been wondering if I may have Parkinson's disease, but will raise this question with him when I have my appointment later this month. One symptom that has me concerned is waking up to find things near me that disappear moments after waking up.

4.3

Patient Review

9/23/2010

Mirapex Er for Parkinson's Disease

Mirapex has dramatically improved my quality of sleep. I used to have restless legs and would often wake up in the middle of the night. However, ever since taking this medication, I've been sleeping soundly through the night.

4

Patient Review

4/4/2012

Mirapex Er for Parkinson's Disease

The doctor and I came to the decision that taking 3.0 mg twice a day would be more effective for me than 4.5 mg once a day. This new dosage doesn't give me as many tremors and seems to make the medication last longer throughout the day. The only downside is the cost, which insurance unfortunately does not completely cover.

4

Patient Review

6/16/2010

Mirapex Er for Extreme Discomfort in Calves when Sitting or Lying Down

4

Patient Review

6/24/2010

Mirapex Er for Extreme Discomfort in Calves when Sitting or Lying Down

At first, this medication really helped me get my mobility back. However, I started to experience a rash that spread quickly over my body. Once I stopped taking the medication, the rash went away within a day.

3.7

Patient Review

6/12/2010

Mirapex Er for Disorder characterized by Stiff, Tender & Painful Muscles

3.3

Patient Review

2/29/2012

Mirapex Er for Parkinson's Disease

At first, I had difficulty falling asleep due to the medication. But then my doctor switched me to a timed-release pill and it's helped a lot. I've also experienced some relief from restless leg syndrome and Parkinson's. Overall, I'm pretty happy with the results. However, it can be tough to make the copayments when you're on a fixed income.

2.7

Patient Review

3/8/2011

Mirapex Er for Parkinson's Disease

I've had issues with restless legs for a few years now, and I've tried a lot of different things to no avail. However, when my doctor gave me some samples of this medication, I found relief immediately. It's been a wonder drug for me.

1.7

Patient Review

2/6/2013

Mirapex Er for Disorder characterized by Stiff, Tender & Painful Muscles

I was extremely disappointed with this medication. I have severe fibromyalgia and it did nothing to help me. I feel like a guinea pig, trying all these different medications with no relief.
image of drug pills surrounding a glass of water symbolizing drug consumption

Patient Q&A Section about mirapex er

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

When do you take Mirapex ER?

"You should take Mirapex ER tablets once a day, with or without food. Swallow them whole and don't chew, crush or divide them."

Answered by AI

What are the side effects of Mirapex?

"These are some of the possible side effects of this medication. If you experience any of these side effects, talk to your doctor. Taking this medication may also cause dizziness or lightheadedness. If this happens, get up slowly when standing up to avoid falling."

Answered by AI

What is Mirapex ER used for?

"Pramipexole is also used to treat restless legs syndrome (RLS).

The drug Pramipexole is used to treat Parkinson's disease, either by itself or in combination with other medications. It improves the patient's ability to move and decreases tremors, stiffness, slowed movement, and unsteadiness. Additionally, it may also decrease the number of episodes of not being able to move ("on-off syndrome"). Pramipexole is also used to treat restless legs syndrome (RLS)."

Answered by AI

Is there a generic for Mirapex ER?

"Dr. Reddy's Laboratories announced the launch of Pramipexole Dihydrochloride Extended-Release Tablets, the generic version of Boehringer Ingelheim's Mirapex ER. Mirapex ER is a non-ergot dopamine agonist indicated for the treatment of idiopathic Parkinson's disease."

Answered by AI

Clinical Trials for Mirapex Er

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 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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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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