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Primidone (Primidone) - Summary



Primidone, USP is a white, crystalline, highly stable substance, M. P. 279-284° C. It is poorly soluble in water (60 mg per 100 mL at 37° C) and in most organic solvents. It possesses no acidic properties, in contrast to its barbiturate analog. Chemical name: 5-ethyldihydro-5-phenyl-4,6 (1H, 5H)-pyrimidinedione.

Primidone tablets, USP, 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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Published Studies Related to 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.

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Clinical Trials Related to Primidone

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

Ph. I Dasatinib/Protracted Temo in Recurrent Malignant Glioma [Not yet recruiting]
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.

Clinical Trial Characterizing the Bioavailability of 1-Octanol in Adults With Ethanol-Responsive Essential Tremor [Active, not recruiting]

Essential tremor (ET) is a common movement disorder affecting 0. 4% of the general population and up to 14% of people 65 years and older. Response to medications such as beta blockers and primidone may be of benefit, but are often accompanied by intolerable side effects. Response to ethanol, on the other hand, has a roughly 80% chance of significant tremor reduction, though daily use of this as a treatment has potentially serious medical, social, and legal consequences.

The leading hypothesis for ET pathophysiology is an unmasking of spontaneous oscillations originating in neurons of the inferior olive. Both ethanol and 1-octanol have been shown to reduce these spontaneous oscillations in an animal model of ET; however, 1-octanol does this at a dose much lower than that leading to intoxication, suggesting in may be useful in the treatment of essential tremor. Our initial studies with 1-octanol have shown it to be safe at dosages up to 64mg/kg without signs of intoxication, while at the same time showing benefit.


We plan to evaluate the efficacy of different 1-octanol formulations in humans based on accelerometry and spirography. We will also evaluate drug and metabolite bioavailabilities using a high performance liquid chromatography (HPLC) detection method from plasma and urine samples.


We will study adult subjects with ethanol-responsive Essential Tremor (ET).


This study is designed as a two-phase unblinded inpatient study of adults with ET receiving weight-adjusted oral dosages of 2 different formulations of 1-octanol in a crossover fashion. Phase I of the study is designed to develop an octanol detection assay using GC. Four subjects will receive daily escalating dosages (1-16 mg/kg) of a single 1-octanol formulation followed by a crossover trial of both formulations at a dosage of 32 mg/kg. Phase II will study 20 subjects receiving one of the two formulations as 32 mg/kg on inpatient day 1 followed by a 24 hour period of close monitoring. The second formulation will be given on day 3 and the patient will again undergo close monitoring for 24 hours.


The primary outcome measures for the study will be efficacy based on tremor ratings from accelerometry and spirography. Secondary outcome measures will be the determination of bioavailability, pharmacodynamic and pharmacokinetic profiles of octanol #61864 and octanol #68751 and their metabolites.

The Efficacy of Botulinum Toxin in Disabling Multiple Sclerosis (MS) Tremor [Recruiting]
The incidence of tremor in Multiple Sclerosis (MS) has been estimated to affect up to 2/3rds of patients. Over half of the tremors involve the upper limb and frequently lead to further disability. Medical treatment of MS tremor is generally unrewarding, although carbamazepine, clonazepam, glutethimide, hyoscine, isoniazid, ondansetron, primidone, and tetrahydrocannabinol have been reported to have some beneficial effect but published evidence of effectiveness is very limited. The investigators' experience to date suggests that many of the upper limb tremors may potentially be responsive to Botulinum toxin injection therapy. Aims: 1. The investigators aim to determine the efficacy of commonly used doses of BOTOX on the patients with symptomatic unilateral or bilateral arm tremor due to MS; and any side effects associated with this treatment.

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Reports of Suspected Primidone Side Effects

Maternal Exposure Timing Unspecified (10)Microtia (9)Patent Ductus Arteriosus (9)Syndactyly (8)Coloboma (5)Convulsion (5)Choanal Atresia (5)Maternal Drugs Affecting Foetus (4)Drug Ineffective (4)Speech Disorder (4)more >>

Page last updated: 2009-10-20

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