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Mirapex

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1. Mirapex

Mirapex Mirapex Toggle navigation Brain Head & Neck Chest Endocrine Abdomen Musculoskeletal Skin Infectious Disease Hematology & Oncology Cohorts Diagnostics Emergency Findings Procedures Prevention & Management Pharmacy Resuscitation Trauma Emergency Procedures Ultrasound Cardiovascular Emergencies Lung Emergencies Infectious Disease Pediatrics Neurologic Emergencies Skin Exposure Miscellaneous Abuse Cancer Administration 4 Mirapex Mirapex Aka: Mirapex , Pramipexole II. Indications Symptoms (...) for at least 2 days/week for 3 months III. Mechanism Non-ergot selective receptor agonist IV. Adverse Effects (common) Drowsiness (Limited to higher dosages) May be sudden, severe without warning May occur up to one year after starting Mirapex Has resulted in falling asleep while driving Augmentation of Restless Leg Symptoms Occurs in 25% of RLS patients on longterm therapy May progress in severity, and involve arms, trunk Often better if dose timing changed to earlier in day May be worse if dose increased

2018 FP Notebook

2. Mirapex

Mirapex Mirapex Toggle navigation Brain Head & Neck Chest Endocrine Abdomen Musculoskeletal Skin Infectious Disease Hematology & Oncology Cohorts Diagnostics Emergency Findings Procedures Prevention & Management Pharmacy Resuscitation Trauma Emergency Procedures Ultrasound Cardiovascular Emergencies Lung Emergencies Infectious Disease Pediatrics Neurologic Emergencies Skin Exposure Miscellaneous Abuse Cancer Administration 4 Mirapex Mirapex Aka: Mirapex , Pramipexole II. Indications Symptoms (...) for at least 2 days/week for 3 months III. Mechanism Non-ergot selective receptor agonist IV. Adverse Effects (common) Drowsiness (Limited to higher dosages) May be sudden, severe without warning May occur up to one year after starting Mirapex Has resulted in falling asleep while driving Augmentation of Restless Leg Symptoms Occurs in 25% of RLS patients on longterm therapy May progress in severity, and involve arms, trunk Often better if dose timing changed to earlier in day May be worse if dose increased

2015 FP Notebook

3. Study to Observe the Effect of Mirapex ER® Once-daily (QD) Versus Twice-daily (BID)

Study to Observe the Effect of Mirapex ER® Once-daily (QD) Versus Twice-daily (BID) Study to Observe the Effect of Mirapex ER® Once-daily (QD) Versus Twice-daily (BID) - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail Saved Studies Save this study Warning You have reached the maximum number of saved studies (100). Please remove one or more studies before (...) adding more. Study to Observe the Effect of Mirapex ER® Once-daily (QD) Versus Twice-daily (BID) The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our for details. ClinicalTrials.gov Identifier: NCT01515774 Recruitment Status : Unknown Verified January 2012 by BS Jeon, Seoul National University Hospital. Recruitment status was: Recruiting First Posted

2012 Clinical Trials

4. Mirapex ER Tablets (pramipexole dihydrochloride)

Mirapex ER Tablets (pramipexole dihydrochloride) Drug Approval Package: Mirapex ER (pramipexole dihydrochloride) NDA #022514 Drug Approval Package U.S. Food & Drug Administration Search FDA Drug Approval Package - Mirapex ER Tablets (pramipexole dihydrochloride) Company: Boehringer Ingelheim Pharmaceuticals, Inc. Application No.: 022514 Approval Date: 3/19/2010 Persons with disabilities having problems accessing the PDF files below may call (301) 796-3634 for assistance. (PDF) (PDF) (PDF) (PDF

2010 FDA - Drug Approval Package

5. Safety and Effect of Mirapex(Pramipexole) Tablet Among Korean RLS

Safety and Effect of Mirapex(Pramipexole) Tablet Among Korean RLS Safety and Effect of Mirapex(Pramipexole) Tablet Among Korean RLS - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail Saved Studies Save this study Warning You have reached the maximum number of saved studies (100). Please remove one or more studies before adding more. Safety and Effect (...) of Mirapex(Pramipexole) Tablet Among Korean RLS The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our for details. ClinicalTrials.gov Identifier: NCT01170091 Recruitment Status : Completed First Posted : July 27, 2010 Results First Posted : September 11, 2012 Last Update Posted : April 11, 2014 Sponsor: Boehringer Ingelheim Information provided

2010 Clinical Trials

6. Pramipexole Dihydrochloride Extended-Release Tablets (Mirapex)

Pramipexole Dihydrochloride Extended-Release Tablets (Mirapex) CENTER FOR DRUG EVALUATION AND RESEARCH APPLICATION NUMBER: 22-514 MEDICAL REVIEW(S) CLINICAL REVIEW Application Type NDA Application Number(s) 22514 Priority or Standard Standard Submit Date(s) 21 May 2009 Received Date(s) 22 May 2009 PDUFA Goal Date 22 March 2010 Reviewer Name(s) Kenneth Bergmann, MD, FAAN Review Completion Date 17 March 2010 Established Name Pramipexole Dihydrochloride Extended-Release Tablets (Proposed) Trade (...) Name MIRAPEX ER Therapeutic Class Dopamine agonist Applicant Boehringer Ingelheim Formulation(s) Extended Release 0.375, 0.75, 1.5, 3.0, and 4.5 mg Dosing Regimen Once daily Indication(s) Parkinson’s Disease Intended Population(s) Adults with PD Clinical Review Kenneth Bergmann, MD, FAAN NDA 22-514 Mirapex ER / pramipexole dihydrochloride extended-release tablets TABLE OF CONTENTS 1 RECOMMENDATIONS/RISK BENEFIT ASSESSMENT 9 1.1 Recommendation on Regulatory Action 9 1.2 Risk Benefit Assessment 9 1.3

2009 FDA - Drug Approval Package

9. The art of medicine is needed to prevent migraine headaches

been alluded to by Willis in the 1600s, and nobody seemed to make much of its association with iron deficiency. It was with the introduction of medications like Mirapex and Requip that RLS rose from obscurity to everyday parlance. Over the past few months, I have encountered several patients who, even though they knew they had migraines, had never sought or been offered preventive treatment. There is much awareness of the many medications that treat attacks, and several of those have been cash cows

2018 KevinMD blog

10. The SUSTAIN Study Compares the Effects of Sustained and Immediate-release Pramipexole on the noctUrnal Symptoms of paTients With Advanced ParkInsoN's Disease Who Also Take L-Dopa

+ Treated Patients With Advanced Parkinson's Disease (PD) Actual Study Start Date : July 3, 2018 Estimated Primary Completion Date : December 7, 2019 Estimated Study Completion Date : December 16, 2019 Resource links provided by the National Library of Medicine related topics: related topics: available for: Arms and Interventions Go to Arm Intervention/treatment Experimental: Pramipexole SR Drug: Pramipexole SR Tablets Other Name: MIRAPEX®/SIFROL Active Comparator: Pramipexole IR Drug: Pramipexole IR (...) Tablets Other Name: MIRAPEX®/SIFROL Outcome Measures Go to Primary Outcome Measures : Change from baseline to week 18 in Parkinson's Disease Sleep Scale 2nd version (PDSS-2) total score [ Time Frame: Baseline and Week 18 ] PDSS-2 means Parkinson's Disease Sleep Scale 2nd version Secondary Outcome Measures : Scale for outcomes in Parkinson's disease (SCOPA)-Sleep score (change from baseline) [ Time Frame: Baseline and Week 18 ] SCOPA means Scale for outcomes in Parkinson's disease Early Morning Off

2018 Clinical Trials

11. Measuring Parkinson's Disease Progression

without nicotine for 3-4 hours would be uncomfortable Currently taking an extended-release formulation of a dopamine agonist (like Mirapex ER or Requip XL) Contacts and Locations Go to Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03205956 Contacts Layout table for location

2017 Clinical Trials

12. Ropinirole

at bedtime Stopping: No titration needed IV. Adverse Effects (similar to Mirapex) (common) Drowsiness (Limited to higher dosages) May be sudden, severe without warning May occur up to one year after starting Has resulted in falling asleep while driving Augmentation of Restless Leg Symptoms Occurs in 25% of RLS patients on longterm therapy May progress in severity, and involve arms, trunk Often better if dose timing changed to earlier in day May be worse if dose increased Other uncommon adverse effects

2018 FP Notebook

13. Neurophysiological Effects on tPCS and tDCS on Healthy Subjects and on Patients With Chronic Visceral Pain

or chronic obstructive pulmonary disease, acute thrombosis History of head injury resulting in more than a momentary loss of consciousness during the last two years History of unexplained fainting spells or loss of consciousness as self-reported during the last two years Contraindication to tPCS or tDCS Metallic brain implants Implanted brain electronic medical devices Pregnancy or trying to become pregnant during the next month Use of carbamazepine oxcarbazepine, phenytoin, pramipexole (Mirapex

2015 Clinical Trials

14. Targeting Cognition in Bipolar Disorder With Pramipexole

will be initiated at 0.25 mg on night one, followed by 0.25 mg twice-a-day day two onward, and increased every week to a target of 4.5 mg/day for the 12-week duration of the study. Drug: Pramipexole Up to 4.5mg, PO, (by mouth) per day of the 12-week study. Other Name: Mirapex Placebo Comparator: Placebo Placebo, by mouth. Dosing will be initiated at 0.25 mg on night one, followed by 0.25 mg twice-a-day day two onward, and increased every week to a target of 4.5 mg/day for the 12-week duration of the study. Drug

2015 Clinical Trials

15. Study of Dexpramipexole Chronic Sinusitis With Nasal Polyps and Eosinophilia

or 5-half-lives, whichever is longer Treatment with a monoclonal antibody therapy including omalizumab (Xolair®), within 5-half-lives Treatment with zileuton (Zyflo®) within 4 weeks of baseline Treatment with pramipexole (Mirapex®) within 4 weeks of baseline History of malignancy, including solid tumors and hematologic malignancies (except basal cell and squamous cell cancers of the skin that have been completely excised and cured) History of human immunodeficiency virus (HIV) or hepatitis B or C

2014 Clinical Trials

16. Study to Investigate Pharmacokinetics (PK) of Pramipexole in Pediatric Patients Who Are Individually Optimized to Stable Pramipexole Doses for the Treatment of Idiopathic Restless Legs Syndrome (RLS)

the pharmacokinetics (PK) of pramipexole (PPX) after administration of a single dose orally (p.o.) in pediatric patients with the diagnosis of RLS Condition or disease Intervention/treatment Phase Restless Legs Syndrome Drug: MIRAPEX® - low Drug: MIRAPEX® - medium Drug: MIRAPEX® - high Phase 2 Study Design Go to Layout table for study information Study Type : Interventional (Clinical Trial) Actual Enrollment : 26 participants Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: None (Open (...) : related topics: available for: Arms and Interventions Go to Arm Intervention/treatment Experimental: MIRAPEX® - low Drug: MIRAPEX® - low Experimental: MIRAPEX® - medium Drug: MIRAPEX® - medium Experimental: MIRAPEX® - high Drug: MIRAPEX® - high Outcome Measures Go to Primary Outcome Measures : Cmax,ss [ Time Frame: 0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1. ] Maximum concentration of the Pramipexole (PPX

2014 Clinical Trials

17. Post Marketing Surveillance And Special Surveillance for Mirapex® Tablet in Patients With Idiopathic Parkinson's Disease

Post Marketing Surveillance And Special Surveillance for Mirapex® Tablet in Patients With Idiopathic Parkinson's Disease Post Marketing Surveillance And Special Surveillance for Mirapex® Tablet in Patients With Idiopathic Parkinson's Disease - Full Text View - ClinicalTrials.gov Hide glossary Glossary Study record managers: refer to the if submitting registration or results information. Search for terms x × Study Record Detail Saved Studies Save this study Warning You have reached the maximum (...) number of saved studies (100). Please remove one or more studies before adding more. Post Marketing Surveillance And Special Surveillance for Mirapex® Tablet in Patients With Idiopathic Parkinson's Disease The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our for details. ClinicalTrials.gov Identifier: NCT02248168 Recruitment Status : Completed First

2014 Clinical Trials

18. Butrans for Treatment of Restless Legs Syndrome

provided by John Winkelman, MD, PhD, Massachusetts General Hospital: Restless Legs Syndrome Willis Ekbom Disease Twitchy Legs Periodic Limb Movements Leg Movements Augmentation Requip ropinirole Mirapex pramipexole gabapentin Horizant Neupro rotigotine Additional relevant MeSH terms: Layout table for MeSH terms Syndrome Psychomotor Agitation Restless Legs Syndrome Disease Pathologic Processes Dyskinesias Neurologic Manifestations Nervous System Diseases Psychomotor Disorders Neurobehavioral

2014 Clinical Trials

19. Imaging Dopamine Release in Depression

topics: available for: Arms and Interventions Go to Arm Intervention/treatment Experimental: Pramipexole Six weeks of treatment with oral pramipexole, initiated at 0.25 mg/day and titrated to a maximum daily dose of 2.5 mg. Drug: Pramipexole Dose will be started at 0.125 mg bid, and increased by 0.25 mg/day every 3-4 days to a target range of 1.0 - 2.5 mg/day. Other Name: Mirapex (brand name) No Intervention: Healthy Control Healthy volunteers were matched to MDD group subjects by age, gender

2014 Clinical Trials

20. Parkinson Disease in Young Adults (Overview)

of symptomatic treatment of motor features of Parkinson disease. It provides the greatest antiparkinsonian benefit with the fewest adverse effects in the short term. However, its long-term use is associated with the development of fluctuations and dyskinesias. Moreover, the disease continues to progress, and patients accumulate long-term disability. (See Treatment.) Dopamine agonists such as pramipexole (Mirapex) and ropinirole (Requip) can be used as monotherapy to improve symptoms in early Parkinson

2014 eMedicine.com

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