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)
Findings That Should Speed The Development Of Drugs For Parkinson's Disease
Source: Health News from Medical News Today [2009.11.19]
Australian scientists have significantly advanced our understanding of dopamine release from nerve cells, findings that should speed the development of more effective drugs for treating Parkinson's Disease. People with Parkinson's Disease suffer from muscle rigidity, tremor, a slowing of physical movement and, in extreme cases, a loss of physical movement.
Progression Of Parkinson's Disease May Be Prevented By Widely Used Cholesterol-Lowering Drug
Source: Statins News From Medical News Today [2009.10.31]
Simvastatin, a commonly used, cholesterol-lowering drug, may prevent Parkinson's disease from progressing further. Neurological researchers at Rush University Medical Center conducted a study examining the use of the FDA-approved medication in mice with Parkinson's disease and found that the drug successfully reverses the biochemical, cellular and anatomical changes caused by the disease.
Avian Influenza Strain Primes Brain For Parkinson's Disease
Source: Bird Flu / Avian Flu News From Medical News Today [2009.08.11]
At least one strain of the H5N1 avian influenza virus leaves survivors at significantly increased risk for Parkinson's disease and possibly other neurological problems later in life, according to new research from St. Jude Children's Research Hospital.
Parkinson's Disease
Source: MedicineNet Amyotrophic Lateral Sclerosis Specialty [2009.04.28]
Title: Parkinson's Disease
Category: Diseases and Conditions
Created: 12/31/1997
Last Editorial Review: 4/28/2009
NC State Researchers Advance Understanding Of Stem Cells
Source: Genetics News From Medical News Today [2009.11.19]
Researchers from North Carolina State University have identified a gene that tells embryonic stem cells in the brain when to stop producing nerve cells called neurons. The research is a significant advance in understanding the development of the nervous system, which is essential to addressing conditions such as Parkinson's disease, Alzheimer's disease and other neurological disorders.
Published Studies Related to Mirapex (Pramipexole)
A dose-ranging study of pramipexole for the symptomatic treatment of restless legs syndrome: polysomnographic evaluation of periodic leg movements and sleep disturbance. [2009.06]
Objective: To evaluate, both polysomnographically and by subjective scales, the efficacy and safety profile of pramipexole for restless legs syndrome (RLS) via a 3-week, double-blind, placebo-controlled, parallel-group, dose-ranging study. Methods: At baseline and after 3 weeks, periodic limb movements (PLM) and sleep parameters were assessed by polysomnography, and patients self-assessed their sleep disturbance and overall RLS severity using the international RLS study group rating scale (IRLS)...
Long-term effect of initiating pramipexole vs levodopa in early Parkinson disease. [2009.05]
OBJECTIVE: To compare the long-term outcomes of subjects initially treated with pramipexole dihydrochloride with those of subjects initially treated with levodopa in the Comparison of the Agonist Pramipexole With Levodopa on Motor Complications of Parkinson's Disease (CALM-PD) trial... CONCLUSIONS: The policies of initial pramipexole and initial levodopa use followed by open-label levodopa use resulted in similar self-reported disability 6 years after randomization. Persistent differences favoring initial pramipexole were seen in the rates of dopaminergic motor complications, with less severe somnolence favoring initial levodopa. Trial Registration clinicaltrials.gov Identifier: NCT00804479.
Dopamine and cognitive functioning in de novo subjects with Parkinson's disease: effects of pramipexole and pergolide on working memory. [2009.04]
Very few studies have investigated the relationship between dopaminergic therapy and working memory (WM) functioning in Parkinson's disease (PD) patients. The aim of the present study was to explore the effects of pharmacological treatment with pergolide (a D1+D2 receptor agonist) and pramipexole (a D2+D3 receptor agonist) on performance in visual-spatial, visual-object, and verbal WM tasks in PD patients...
The effect of pramipexole on mood and motivational symptoms in Parkinson's disease: a meta-analysis of placebo-controlled studies. [2009.01]
BACKGROUND: Mood and motivational symptoms have been reported in up to 35% and 51%, respectively, of patients with Parkinson's disease (PD). Preliminary evidence indicates that pramipexole may have a positive effect on these symptoms. OBJECTIVE: This analysis was conducted to evaluate the effects of pramipexole on mood and motivational symptoms in patients with PD... CONCLUSIONS: This meta-analysis of 7 randomized controlled trials suggests that pramipexole had a beneficial effect on mood and motivational symptoms in PD patients who did not have major depressive disorder. The clinical value of pramipexole in the treatment of depressive and apathetic syndromes requires further investigation.
Effect of pramipexole on RLS symptoms and sleep: a randomized, double-blind, placebo-controlled trial. [2008.12]
BACKGROUND: Patients with Restless Legs Syndrome (RLS) often seek treatment because of sleep problems related to nocturnal symptoms. Our goal was to test the ability of pramipexole to improve sleep in RLS patients and to reconfirm its efficacy for primary RLS symptoms... CONCLUSIONS: Pramipexole is effective and well-tolerated for RLS and related sleep disturbance.
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.
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).
Efficacy, Safety, Tolerability of Pramipexol ER Versus Pramipexol IR Versus Placebo in Early PD Patients [Active, not recruiting]
The objectives of this trial conducted in early PD patients are to determine the efficacy
(as measured by the change from baseline to the end of the maintenance phase in the total
score for UPDRS Parts II and III combined), safety, and tolerability of Pramipexole ER
(in daily doses from 0. 375mg to 4. 5mg q. d.) in comparison to placebo, and to test for
non-inferiority between the two formulations (ER and IR) of pramipexole.
In addition, the efficacy of Pramipexole IR will be compared to placebo, for assay
sensitivity
Pramipexole (Mirapex®) in Patients With Idiopathic Restless Legs Syndrome for 12 Weeks [Completed]
A 12 week clinical trial was conducted in the United States in order to compare pramipexole
(Mirapex®) vs. placebo for the ability to reduce the symptoms of restless legs syndrome in
adult subjects.
Long-Term Efficacy, Safety and Tolerability of Pramipexole in Patients With Idiopathic Moderate to Severe RLS [Active, not recruiting]
The primary objective of the current study will be the evaluation of long-term efficacy of a
26-weeks treatment with pramipexole in patients with idiopathic moderate to severe Restless
Legs Syndrome in comparison to placebo.
The key secondary objectives are to assess the effects on clinical global impressions -
global improvement (based on CGI-I responder rate) and on RLS (based on IRLS responder rate)
for 26 weeks under pramipexole in comparison to placebo. Further secondary objectives are to
investigate the incidence and severity of augmentation and rebound and to assess the effects
on patient global impression (based on PGI responder rate), on RLS symptoms (based on the
RLS-6 scales), on associated mood disturbance (based on item 10 of the IRLS), on pain in
limbs (based on a visual analogue scale), on quality of life in RLS (based on Johns Hopkins
RLS-QoL), on general quality of life (SF-36) and on safety (based on AE profile) of
pramipexole in comparison to placebo.
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PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 2 ratings/reviews, Mirapex has an overall score of 6. The effectiveness score is 7 and the side effect score is 7. The scores are on ten point scale: 10 - best, 1 - worst.
| | Mirapex review by 54 year old female patient | | | Rating |
| Overall rating: | |   |
| Effectiveness: | | Highly Effective |
| Side effects: | | Mild Side Effects | | |
Treatment Info |
| Condition / reason: | | restless leg syndrome |
| Dosage & duration: | | 0.5 mg taken 1 pill at noon, 2 pills at night for the period of over 7 years |
| Other conditions: | | high blood pressure |
| Other drugs taken: | | atenlol, cymbalta | | |
Reported Results |
| Benefits: | | The benefits were remarkable and fast. Before taking the mirapex, the patient got very little sleep and consequently was irritable. After taking the mirapex, the restless legs calmed down immediately. The patient can now go to a movie, take a trip in a car and sleep with a reasonable amount of comfort. The restless legs are not totally cured, but it is manageable now. Even working 8 hours a day is much more manageable. |
| Side effects: | | The only side effect that the patient experienced was drowsiness and that has weakened as time has gone by. With only taking one pill at noon, the drowsiness is not marked and does not interfere with work or anything else. The patient takes 2 pills around 8 or 9:00 at night so the drowsiness is not a problem. |
| Comments: | | The patient developed restless leg syndrome around the age of 35 after a boating accident where her back was injured. The doctors do not know if the back injury brought on the restless legs or not. The patient went to many doctors and neurologists. The doctors tried many medicines but with no success. Finally the patient found a neurologist in central Kansas that figured out immediately what was wrong. The doctor put the patient on mirapex on a trial basis after performing many tests to rule out other causes or problems. The patient has never been on another medicine for restless legs since going on the mirapex. The patient does take a multivitamin with iron in it to help with the restless legs and the patient also does not have caffeine drinks. |
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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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Page last updated: 2009-11-19
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