MIRAPEX SUMMARY
MIRAPEX® (pramipexole dihydrochloride) Tablets con-tain pramipexole, a dopamine agonist indicated for the treatment of the signs and symptoms of idiopathic Park-inson's disease. The chemical name of pramipexole dihydrochloride is (S)-2-amino-4,5,6,7-tetrahydro-6-(propylamino)benzothiazole dihydrochloride monohydrate.
MIRAPEX (pramipexole dihydrochloride) Tablets are indicated for the treatment of the signs and symptoms of idiopathic Parkinson's disease.
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NEWS HIGHLIGHTSMedia Articles Related to Mirapex (Pramipexole)
Sleep disturbances, common in Parkinson's disease, can be early indicator of disease onset
Source: Sleep / Sleep Disorders / Insomnia News From Medical News Today [2014.07.14]
Up to 70% of Parkinson's disease (PD) patients experience sleep problems that negatively impact their quality of life.
Tozadenant Phase 2b Parkinson's disease study published in Lancet Neurology
Source: Clinical Trials / Drug Trials News From Medical News Today [2014.07.09]
Biotie announces that full data from the positive Phase 2b study evaluating tozadenant, an adenosine A2a antagonist, in Parkinson's disease patients experiencing end of dose wearing off have been...
Parkinson's Disease
Source: MedicineNet amantadine Specialty [2013.12.04]
Title: Parkinson's Disease
Category: Diseases and Conditions
Created: 12/31/1997 12:00:00 AM
Last Editorial Review: 12/4/2013 12:00:00 AM
Parkinson's Disease Quiz: Test Your Medical IQ
Source: MedicineNet amantadine Specialty [2011.08.31]
Title: Parkinson's Disease Quiz: Test Your Medical IQ
Category: MedicineNet Quiz
Created: 8/23/2011 12:53:00 PM
Last Editorial Review: 8/31/2011 2:27:29 PM
Human neurodegenerative diseases may be impacted by discovery of a new cellular garbage control pathway
Source: Huntingtons Disease News From Medical News Today [2014.07.22]
Several human neurodegenerative diseases, including Alzheimer's disease, Parkinson's disease and Huntington's disease but also ageing, are linked to an accumulation of abnormal and aggregated...
Published Studies Related to Mirapex (Pramipexole)
Role and clinical utility of pramipexole extended release in the treatment of
early Parkinson's disease. [2012]
The aim of this article is to provide a short review of the most relevant
pharmacological and clinical data on pramipexole extended release (ER) as well as
to address the clinical utility and potential advantages of a once-daily
formulation especially in the treatment of early Parkinson's disease (PD)...
A multicenter randomized placebo-controlled clinical trial of pramipexole for
Tourette's syndrome. [2012]
dopamine hypersensitivity in Tourette's syndrome... CONCLUSIONS: There was no evidence that pramipexole has efficacy in suppressing
Efficacy and safety of pramipexole in chinese patients with restless legs
syndrome: results from a multi-center, randomized, double-blind,
placebo-controlled trial. [2012]
restless legs syndrome patients... CONCLUSION: Pramipexole was effective and well-tolerated in Chinese patients with
Extended-release pramipexole in early Parkinson disease: a 33-week randomized controlled trial. [2011.08.23]
OBJECTIVE: To assess the clinical efficacy of a novel once-daily extended-release (ER) formulation of the dopamine agonist pramipexole as monotherapy in patients with early Parkinson disease (PD) and establish its noninferiority vs standard immediate-release (IR) pramipexole... CONCLUSIONS: As monotherapy for early PD, pramipexole ER was noninferior to pramipexole IR and significantly more effective than placebo. Tolerability and safety did not differ between the formulations. CLASSIFICATION OF EVIDENCE: This study provides Class I evidence that pramipexole ER is not inferior to pramipexole IR in patients with early PD.
Extended-release pramipexole in advanced Parkinson disease: a randomized controlled trial. [2011.08.23]
BACKGROUND: In advanced Parkinson disease (PD), immediate-release pramipexole, taken 3 times daily, improves symptoms and quality of life. A once-daily extended-release formulation may be an effective and simple alternative therapy... CONCLUSIONS: Extended-release pramipexole significantly improved UPDRS score and off-time compared with placebo, with similar efficacy, tolerability, and safety of immediate-release pramipexole compared with placebo. CLASSIFICATION OF EVIDENCE: This study provides Class I evidence that the extended-release form of pramipexole, taken once daily, is efficacious as an adjunct to levodopa in advanced PD.
Clinical Trials Related to Mirapex (Pramipexole)
Overnight Switch Trial From Pramipexole Immediate Release (IR) to Pramipexole Extended Release (ER) in Patients With Early Parkinson Disease [Completed]
The objectives of this trial conducted in early Parkinson?s disease (PD) patients are:
- To assess if patients with early Parkinson?s disease (PD) can be successfully switched
(overnight switching) from Pramipexole IR to Pramipexole ER. A successful switch at a
specific visit is defined as no worsening of the UPDRS parts II+III score by more than
15% from visit 2 and no drug-related adverse events leading to withdrawal;
- To establish if this successful switch can be obtained with or without dose-adaptation;
- To provide information about the conversion ratio (mg: mg) from Pramipexole IR to
Pramipexole ER.
Pramipexole as a Treatment for Cocaine Dependence [Recruiting]
The purposes of this study are as follows: 1. To assess the cardiovascular and subjective
effects of cocaine during treatment with pramipexole and placebo. 2. To assess the
reinforcing effects of cocaine, measured using choice procedures, during treatment with
pramipexole and placebo.
Study to Observe the Effect of Mirapex ERŪ Once-daily (QD) Versus Twice-daily (BID) [Recruiting]
1. In order to observe the benefit, side effects, and patient preference of Mirapex ER
when used in once-daily (QD) or twice-daily (BID) dosing
2. In order to estimate the conversion rate of dopamine agonists into Mirapex ER
Pramipexole for Binge Eating Disorder [Recruiting]
A 6 Week Trial to Study the Efficacy and Safety of a Starting Dose 0.25 mg Pramipexole (Mirapex) in Patients With RLS [Completed]
This trial is a 6-week, double-blind, randomized, active and placebo-controlled
parallel-group study with a primary objective of comparison of starting doses of pramipexole
fixed-dose (0. 25 mg daily) and pramipexole titrated-dose (0. 125 mg qd for 1 week, then 0. 25
mg qd for the remaining 5 weeks) wi th placebo to evaluate efficacy and safety in treating
RLS symptoms in patients diagnosed with idiop athic RLS. The secondary objectives of this
study will be to assess the onset of action of symptomatic relief o f RLS for pramipexole
with daily assessment of PGI and modified IRLS during two intervals of the fir st 2 weeks
(Days 2, 3 and 4 and Days 9, 10, and 11) and assessment of IRLS, PGI and CGI-I at Weeks 1
, 2, 4 and 6 (CGI-I additionally on Day 3).
Reports of Suspected Mirapex (Pramipexole) Side Effects
Obsessive-Compulsive Disorder (99),
Pathological Gambling (99),
Emotional Distress (84),
Pain (83),
Compulsive Shopping (44),
Suicidal Ideation (31),
Hypersexuality (30),
Depression (30),
Somnolence (27),
Hyperphagia (19), more >>
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PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 6 ratings/reviews, Mirapex has an overall score of 7. The effectiveness score is 9 and the side effect score is 7. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.
| | Mirapex review by 53 year old female patient | | | Rating |
| Overall rating: | |  |
| Effectiveness: | | Highly Effective |
| Side effects: | | Mild Side Effects | | |
Treatment Info |
| Condition / reason: | | Restless Leg Syndrome |
| Dosage & duration: | | 100 mg at bedtime taken daily for the period of ongoing |
| Other conditions: | | high blood pressure; heartburn |
| Other drugs taken: | | toprol xl; nexium | | |
Reported Results |
| Benefits: | | First treatment in 50 years that helped the constant but elusive pain in my nervous system, causing me to sleep an hour or two at a time at best. The pain is 100% gone when I take the mirapex ... back when I do not. |
| Side effects: | | Can fall asleep at my desk or driving without much notice. Reduced the amount I was taking from 200 mg to the 100mg. |
| Comments: | | I take it at bedtime nightly. |
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| | Mirapex review by 50 year old female patient | | | Rating |
| Overall rating: | |  |
| Effectiveness: | | Marginally Effective |
| Side effects: | | Moderate Side Effects | | |
Treatment Info |
| Condition / reason: | | pain in legs (diagnosis Restless Leg Syndrome) |
| Dosage & duration: | | 50 mg taken 1 time per day for the period of 1 month |
| Other conditions: | | none |
| Other drugs taken: | | none | | |
Reported Results |
| Benefits: | | I had been to several doctors regarding pain in my thigh mostly. I had seen Orthopedic Dr, Family practice (2), Endocrinologist and finally Nuerologist, who prescribed the Mirapex. I did note slight improvement in leg pain however the weight gain issue was totally unacceptable to me and the benefit was only slight. I have had much better results with Lyrica. |
| Side effects: | | Basically, I only noticed a huge weight gain of approximately 15 pounds. I do not really recall any further side effects. There were however, other side effects listed on the prescription contraindication form. I do not recall what the side effects listed on that form were now. |
| Comments: | | he Doctor told me to take he medication at bed time each evening. she also suggested that I might find it useful to sleep with a contour pillow between my thighs. She said to get up and walk around rather than lie in bed tossing if I could not sleep. As for the weight gain, it was recommended that I try to excercise more and reduce caloric intake. |
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| | Mirapex review by medical professional caring for 50 year old male patient | | | Rating |
| Overall rating: | | |
| Effectiveness: | | Highly Effective |
| Side effects: | | Extremely Severe Side Effects | | |
Treatment Info |
| Condition / reason: | | Parkinson's |
| Dosage & duration: | | 0.125 mg taken 1 x day for the period of 5 years |
| Other conditions: | | HBV, HCV, opiate & cocaine addictions DIRECTLY pursuant to Pramipexole use |
| Other drugs taken: | | Sinemet/Levodopa, Amantadine, Diphenhydramine, beer (Rx by neurologist), heroin & crack (self Rx) | | |
Reported Results |
| Benefits: | | Mirapex: tremor control |
| Side effects: | | Mirapex: impulse control absence, induction of OCD symptoms, drug addiction (heroin, crack, etc.) and hepatitis B & C all pursuant to massive sexual and substance risk taking behaviors, loss of professional license, theft of $1million of clients' funds, gambled EVERYTHING away, lost everything, began inappropriate sexual relationships with prostitutes in home town and in Central America as well as with underaged females (who were often teenaged crack addicts), theft of EVERY SINGLE ITEM of any value from his extremely elderly wealthy father and from the rest of us, left crack in our young adult daughter's car, severing of relationships: WE have to protect ourselves from him and his evil-Mirapex reactions |
| Comments: | | Subsequently: he got DBS implanted and has been able to reduce the Mirapex - BUT THE DAMAGE IS DONE |
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Page last updated: 2014-07-22
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