NEWS HIGHLIGHTS
Published Studies Related to Dynacirc CR (Isradipine)
Phase II safety, tolerability, and dose selection study of isradipine as a
potential disease-modifying intervention in early Parkinson's disease
(STEADY-PD). [2013]
Isradipine, a dihydropyridine calcium channel antagonist, has been shown to be
neuroprotective in animal models of Parkinson's disease (PD). To establish a
dosage of isradipine controlled-release (CR) that is tolerable and demonstrates
preliminary efficacy for use in a future pivotal efficacy trial a Phase 2,
randomized, double-blind, parallel group trial (Safety, Tolerability and Efficacy
Assessment of Dynacirc CR in Parkinson Disease [STEADY-PD]) was undertaken in
subjects with early PD not requiring dopaminergic therapy (dopamine agonists or
levodopa) randomized 1:1:1:1 to 5, 10, or 20 mg of isradipine CR or matching
placebo daily...
Effects of isradipine on cocaine-induced changes in cognitive performance in recently abstinent cocaine-dependent individuals. [2005.12]
Recently abstinent cocaine-dependent individuals, compared with healthy controls, appear more likely to exhibit deficits in cognitive performance and attention. Individuals with such cognitive deficits might be less able to avail themselves of rehabilitative or relapse-prevention efforts.
Effects of isradipine, a dihydropyridine-class calcium-channel antagonist, on d-methamphetamine's subjective and reinforcing effects. [2005.06]
In healthy human volunteers, we have previously shown that isradipine, a dihydropyridine-class calcium-channel antagonist, reduces some methamphetamine-induced positive subjective effects associated with its abuse liability, presumably by antagonizing cortico-mesolimbic dopamine pathways... Depending upon conditioning status, isradipine can reduce some methamphetamine-induced positive subjective and reinforcing effects associated with its abuse liability in methamphetamine addicts.
Effects of isradipine on methamphetamine-induced changes in attentional and perceptual-motor skills of cognition. [2005.03]
CONCLUSION: Our results do not support the further testing of isradipine as a medication for improving the cognitive impairments that have been associated with chronic methamphetamine use.
Kinetic and cardiovascular comparison of immediate-release isradipine and sustained-release isradipine among non-treatment-seeking, cocaine-dependent individuals. [2005.01]
The authors sought to determine whether sustained-release (SR) isradipine provided comparable systemic availability to that of immediate-release (IR) isradipine in non-treatment-seeking, cocaine-dependent individuals.The more favorable cardiovascular profile of SR isradipine would, however, make it more appropriate as an investigational medication for the treatment of stimulant dependence and related neurovascular disorders.
Clinical Trials Related to Dynacirc CR (Isradipine)
Parkinson's Disease Isradipine Safety Study [Recruiting]
The objective of this study is to establish the safety and tolerability of isradipine,
sustained release preparation in patients with PD. This study is a logical continuation of
the project that is being completed now and is conducted in preparation to NIH submission of
the pivotal study on the efficacy of this agent for neuroprotection in PD. This study is
conducted in parallel with Dr. Surmeier's work on further development of the preclinical
data. The focus of his work now is to establishing the correlation between the dose that
demonstrated neuroprotective effect in animal model and the dose used for clinical practice.
Hypothesis 1: Patients with PD will be able to tolerate isradipine across the FDA
recommended dose range. We expect 10% attrition due to hypotensive effect of the agent.
Hypothesis 2: Patients with PD and concomitant stable hypertension will be able to tolerate
isradipine provided that the dose of the concomitant antihypertensive agent is adjusted
based on the blood pressure reading.
Safety, Tolerability and Efficacy Assessment of Dynacirc CR in Parkinson Disease [Recruiting]
The Parkinson Study Group is conducting a research study of Dynacirc CR (Isradipine) to find
out if it can be used safely, is tolerated by patients with Parkinson Disease (PD) and if it
slows the progress of the disease. This is a randomized, double blind, placebo controlled
study lasting approximately 54 weeks. Isradipine CR is approved by the FDA and marketed in
the United States for the treatment of high blood pressure. It is now being studied in
Parkinson Disease. Each study participant is randomly assigned to one of the 4 doses being
studied: placebo (inactive medication) or isradipine CR 5, 10 or 20 mg.
Study to Evaluate the Incidence of Gastric Ulcers Following Administration of Either PN 200 or Naproxen in Subjects Who Are at Risk for Developing NSAID-Associated Ulcers. [Completed]
The purpose of this study is to evaluate the incidence of gastric ulcers following
administration of either PN 200 or Naproxen in subjects who are at risk for developing
NSAID-associated ulcers.
An Open-Label, Randomized, Comparative 3-Way Cross-Over Study to Evaluate the Effect of Food on the 24-Hour Intragastric pH at Day 5 After Twice Daily Oral Administration of PN 200 (Omeprazole/Naproxen) in Healthy Volunteers [Active, not recruiting]
Primary: To compare the pharmacodynamic efficacy of PN 200 in controlling intragastric pH
(percent time pH> 4. 0) following twice daily administration at different dosing times
relative to food (30 or 60 minutes prior to food or taken togeterh with food) on Day 5.
Adjunctive Isradipine for the Treatment of Bipolar Depression [Recruiting]
This study investigates the medication isradipine, which is currently approved by the FDA to
treat high blood pressure, in the treatment of depression in bipolar disorder. Isradipine or
placebo (contains no active medication) will be used as an "add-on" to lithium, valproate,
and/or atypical antipsychotics for individuals currently experiencing a major depressive
episode. Our hypothesis is that isradipine will be superior to placebo in improving
depressive symptoms.
Reports of Suspected Dynacirc CR (Isradipine) Side Effects
Blood Pressure Inadequately Controlled (3),
Blood Pressure Increased (3),
Product Quality Issue (3),
Medication Residue (2),
Diabetes Mellitus Inadequate Control (2),
Weight Increased (1),
Oedema Peripheral (1),
Dizziness (1),
Drug Effect Decreased (1),
Musculoskeletal Pain (1), more >>
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