PRIMIDONE SUMMARY
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.
Primidone tablets, used alone or concomitantly with other anticonvulsants, are 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 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.
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]
OVERVIEW
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.
OBJECTIVE
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.
STUDY POPULATION
We will study adult subjects with ethanol-responsive Essential Tremor (ET).
DESIGN
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.
OUTCOME MEASURES
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.
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