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Mysoline (Primidone) - Summary

 
 



MYSOLINE SUMMARY

Mysoline (primidone) raises electro- or chemoshock seizure thresholds or alters seizure patterns in experimental animals. The mechanism(s) of primidone’s antiepileptic action is not known.

Primidone per se has anticonvulsant activity as do its two metabolites, phenobarbital and phenylethylmalonamide (PEMA). In addition to its anticonvulsant activity, PEMA potentiates the anticonvulsant activity of phenobarbital in experimental animals.

Mysoline, used alone or concomitantly with other anticonvulsants, is indicated in the control of grand mal, psychomotor, and focal epileptic seizures. It may control grand mal seizures refractory to other anticonvulsant therapy.


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NEWS HIGHLIGHTS

Published Studies Related to Mysoline (Primidone)

Comparison of add-on valproate and primidone in carbamazepine-unresponsive patients with partial epilepsy. [2009.03]
PURPOSE: Evaluation of the efficacy of add-on valproate (VPA) or primidone (PRM) in patients with partial epilepsy unresponsive to carbamazepine (CBZ)... CONCLUSION: Our results indicated that the efficacy of the CBZ/VPA combination tends to be greater than the efficacy of the CBZ/PRM combination.

Use of primidone in low doses (250 mg/day) versus high doses (750 mg/day) in the management of essential tremor. Double-blind comparative study with one-year follow-up. [2003.10]
Essential tremor is the most common involuntary movement; we studied 113 affected subjects (54 men, 59 women) with an average age of 63.9 years and average duration of 9.05 years. These patients participated in a double-blind study with a 1-year follow-up to compare treatment efficiency using primidone dosages of 250 mg/day (G 250, 56 patients) versus 750 mg/day (G 750, 57 patients)...

Randomized trial comparing primidone initiation schedules for treating essential tremor. [2002.03]
Early side effects are common when primidone is used to treat essential tremor, with as many as one-third of patients failing to tolerate the tablets. Lower doses can be prescribed initially using a suspension formulation... If anything, compliance tended to be worse when compared with the tablet formulation, though the study was under-powered to reject the null hypothesis of equivalence.

Lack of in vivo/in vitro correlations for 50 mg and 250 mg primidone tablets. [1998.07]
PURPOSE: To determine if large differences in the in vitro dissolution profiles for primidone tablets would result in significant bioavailability differences... CONCLUSIONS: Even though there were large differences in the in vitro dissolution of the 50 mg and the 250 mg primidone tablets, the two 50 mg tablets were shown to be bioequivalent, as were the four 250 mg tablets.

Comparison of add-on valproate and primidone in carbamazepine-unresponsive patients with partial epilepsy. [2008.07.29]
PURPOSE: Evaluation of the efficacy of add-on valproate (VPA) or primidone (PRM) in patients with partial epilepsy unresponsive to carbamazepine (CBZ)... CONCLUSION: Our results indicated that the efficacy of the CBZ/VPA combination tends to be greater than the efficacy of the CBZ/PRM combination.

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Clinical Trials Related to Mysoline (Primidone)

Bioequivalence Study of Primidone Tablets 50 mg of Dr. Reddy's Under Fasting Conditions [Completed]
The purpose of this study is to assess the bioavailability of Primidone 50 mg tablets of Dr. Reddy's comparing with that of Mysoline@ tablets of Yamanouchi Pharma Technologies Inc, in healthy, adult, human subjects under fasting conditions.

Fasted Bioequivalence Study of Primidone Tablets and Mysoline Tablets [Completed]

Effect of Primidone on Platelet Responsiveness in Patients Determined to be Clopidogrel Resistant [Enrolling by invitation]
The purpose of this study is to determine whether adding primidone will improve the metabolism of clopidogrel thereby increasing metabolite levels within the blood stream and platelet response to clopidogrel in patients who were previously found to lack adequate response to clopidogrel. This information could help overcome clopidogrel resistance in patients who are at risk for stroke or transient ischemic attack (TIA).

Clinical and Economic Burden of Uncontrolled Epilepsy: Analyses From a Medicaid Database and a Private Health Plan Database [Completed]
Antiepileptic drugs (AEDs) are the main therapeutic option for patients with epilepsy; however, complete seizure control remains elusive for many patients. Uncontrolled or refractory epilepsy is associated with a higher risk of mortality, physical injuries, and depression or anxiety compared with patients with controlled epilepsy. Higher resource utilization for patients with poor control is likely to be associated with higher economic costs. While diagnostic criteria for uncontrolled epilepsy are debated by neurologists, recent studies suggest that a diagnosis of uncontrolled epilepsy requires 1.) at least one seizure per month and 2.) a history of drug failures. The objective of this study is to identify patients with uncontrolled epilepsy in both a Medicaid database and a private health plan database, to describe patient characteristics and AED treatment patterns between cohorts of patients with uncontrolled versus well-controlled epilepsy, and to evaluate the economic burden of uncontrolled versus well-controlled epilepsy. For this evaluation, the data sources are medical and pharmacy claims in Medicaid databases from Florida (Third quarter 1997 to second quarter 2008), Iowa (First quarter 1998 to second quarter 2006), Kansas (First quarter 2001 to second quarter 2009), Missouri (First quarter 1997 to second quarter 2008) and New Jersey (First quarter 1997 to fourth quarter 2008) and medical and pharmacy claims in an private health plan database. The study design is a retrospective, longitudinal, matched-cohort study. Eligible patient records will be assigned to one of three mutually-exclusive cohorts: uncontrolled epilepsy (at least 2 consecutive changes in AED therapy in at least 30 days, and at least 1 epilepsy-related inpatient or emergency department (ED) visit within 365 days), well-controlled epilepsy (no AED changes and no epilepsy-related inpatient or ED visits), and intermediate epilepsy (not classified as uncontrolled or well-controlled).

Ph. I Dasatinib/Protracted Temozolomide in Recurrent Malignant Glioma [Withdrawn]
The primary objective of this study is to determine the maximum tolerated dose (MTD) and dose limiting toxicity (DLT) of dasatinib when combined with protracted, daily temozolomide (TMZ). Secondary objectives are: To further evaluate the safety and tolerability of dasatinib plus protracted, daily TMZ; 2. To evaluate the pharmacokinetics of dasatinib when administered with protracted, daily TMZ among recurrent malignant glioma patients who are on and not on CYP-3A enzyme inducing anti-epileptic drugs (EIAEDs); 3. To evaluate for anti-tumor activity with this regimen in this patient population.

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Page last updated: 2009-10-20

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