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Nimotop (Nimodipine) - Summary

 
 



DO NOT ADMINISTER NIMOTOP INTRAVENOUSLY OR BY OTHER PARENTERAL ROUTES. DEATHS AND SERIOUS, LIFE THREATENING ADVERSE EVENTS HAVE OCCURRED WHEN THE CONTENTS OF NIMOTOP CAPSULES HAVE BEEN INJECTED PARENTERALLY (See WARNINGS and DOSAGE AND ADMINISTRATION).

 

NIMOTOP SUMMARY

Nimotop® (nimodipine) belongs to the class of pharmacological agents known as calcium channel blockers.

Nimotop® (nimodipine) is indicated for the improvement of neurological outcome by reducing the incidence and severity of ischemic deficits in patients with subarachnoid hemorrhage from ruptured intracranial berry aneurysms regardless of their post-ictus neurological condition (i.e., Hunt and Hess Grades I-V).


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NEWS HIGHLIGHTS

Published Studies Related to Nimotop (Nimodipine)

Nimodipine plasma concentration and retinal blood flow in healthy subjects. [2006.08]
PURPOSE: Calcium antagonists are strong vasodilators, and nimodipine is known to improve cerebral blood flow. The purpose of this study was to measure retinal blood flow and nimodipine plasma concentrations during repeated oral dosing... CONCLUSIONS: Oral nimodipine significantly increases retinal perfusion in healthy subjects.

Intravenous magnesium versus nimodipine in the treatment of patients with aneurysmal subarachnoid hemorrhage: a randomized study. [2006.06]
OBJECTIVE: The prophylactic use of nimodipine in patients with aneurysmal subarachnoid hemorrhage reduces the risk of ischemic brain damage. However, its efficacy seems to be rather moderate. The question arises whether other types of calcium antagonists offer better protection. Magnesium, nature's physiological calcium antagonist, is neuroprotective in animal models, promotes dilatation of cerebral arteries, and has an established safety profile. The aim of the current pilot study is to evaluate the efficacy of magnesium versus nimodipine to prevent delayed ischemic deficits after aneurysmal subarachnoid hemorrhage... CONCLUSION: The efficacy of magnesium in preventing delayed ischemic neurological deficits in patients with aneurysmal subarachnoid hemorrhage seems to be comparable with that of nimodipine. The difference in their pharmacological properties makes studies on the combined administration of magnesium and nimodipine seem promising.

Efficacy and safety of nimodipine in subcortical vascular dementia: a randomized placebo-controlled trial. [2005.03]
BACKGROUND AND PURPOSE: Evidence of drug efficacy in vascular dementia (VaD) is scanty. Therapeutic trials should address VaD subtypes. We studied the efficacy and safety of the calcium antagonist nimodipine in subcortical VaD... CONCLUSIONS: Nimodipine may be of some benefit in subcortical VaD. Confirming previous results, the safety analysis of this study shows that in this high-risk population, nimodipine might protect against cardiovascular comorbidities.

Effect of nimodipine on ocular blood flow and colour contrast sensitivity in patients with normal tension glaucoma. [2005.01]
AIM: To investigate the effects of oral nimodipine on ocular haemodynamic parameters and colour contrast sensitivity in patients with normal tension glaucoma (NTG). DESIGN: The study was performed in a randomised, placebo controlled, double masked, crossover design. PARTICIPANTS: Nimodipine (60 mg) or placebo was administered to 14 consecutive NTG patients... CONCLUSIONS: The results indicate that nimodipine increases ONH and choroidal blood flow in NTG patients and improves CCS. The latter effect does not, however, seem to be a direct consequence of the blood flow improvement.

[The effect of intraoperative continuous nimodipine infusion on cerebral vasospasm during intracranial aneurysm surgery] [2004.12.22]
OBJECTIVE: To evaluate the effect of intraoperative continuous nimodipine infusion on cerebral vasospasm during intracranial aneurysm surgery... CONCLUSION: Intraoperative nimodipine infusion may prevent cerebral vasospasm during intracranial aneurysm surgery.

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Clinical Trials Related to Nimotop (Nimodipine)

Use of a Calcium Channel Blocker to Prevent Premature Luteinizing Hormone Surges in Infertility Patients [Active, not recruiting]
Nimodipine (Nimotop® Bayer Pharmaceuticals Corporation), unlike other calcium channel blockers is fat soluble and therefore is able to cross the blood-brain barrier1. Gonadotropin releasing hormone (GnRH) neurons are clustered in the hypothalamus and are dependent on calcium flux to release GnRH responsible for the release of follicle-stimulating hormone (FSH) and luteinizing hormone (LH) from the anterior pituitary. In a natural menstrual cycle a spontaneous LH surge occurs mid-cycle which triggers ovulation. The investigators hypothesized that nimodipine, by blocking calcium channels, may effectively suppress the release of GnRH and consequently the natural LH surge. In this prospective double-blinded randomized study the investigators will evaluate the efficacy of nimodipine to inhibit the natural LH surge in women undergoing controlled ovarian stimulation (COS) and intrauterine insemination (IUI). Nimodipine, if successful, may represent an inexpensive oral medication as an alternative to the currently used GnRH agonists or GnRH antagonists in assisted reproductive technologies like IVF.

Dose Finding Study of Nimodipine for the Treatment of Progranulin Insufficiency From GRN Gene Mutations [Active, not recruiting]
The purpose of this study is to determine the maximum tolerated dose of nimodipine as well as the safety and tolerability of oral nimodipine in progranulin mutation carriers in preparation for longer term efficacy studies in patients with frontotemporal dementia due to progranulin gene mutations.

Effectiveness of Nimodipine Plus Antidepressant Medication in Treating Vascular Depression [Completed]
This study will examine whether combined use of an antidepressant medication and the medication nimodipine reduces risk of depression relapse in patients with vascular depression.

Nimodipine to Prevent LH Surge During Ovulation Induction: Blinded Placebo-controlled RCT [Active, not recruiting]
The main purpose of this study is to test the effectiveness of nimodipine in preventing a luteinizing hormone (LH) surge in women undergoing ovulation induction with clomiphene citrate. It is important to prevent the premature LH surge in controlled ovarian stimulation to allow adequate recruitment of follicles, proper maturation of a dominant follicle before ovulation, and effectively time insemination with semen to allow fertilization of a mature egg to occur. The investigators are also conducting this study to determine medication side effect profile (including lightheadedness or dizziness from low blood pressure or rapid heart rate, headache, and nausea), patient treatment compliance, and clinical pregnancy (positive pregnancy test and ultrasound evidence of fetal heart rate). Finally, LH and follicle stimulating hormone (FSH) serum levels will be measured to determine effect of nimodipine on these hormones. As a calcium channel blocker, nimodipine has been shown to block calcium mediated release of gonadotropin releasing hormone in animal and preliminary human studies. The investigators hypothesize that nimodipine, a calcium channel blocker, will prevent or delay the LH surge during controlled ovarian stimulation cycles using clomiphene citrate in subfertile patients undergoing assisted reproduction with intrauterine insemination (IUI).

Safety and Tolerability Study of EG-1962 in Aneurysmal Subarachnoid Hemorrhage [Active, not recruiting]
Phase 1/2a Multicenter, Controlled, Randomized, Open Label, Dose Escalation, Safety, Tolerability, and Pharmacokinetic Study Comparing EG-1962 and Nimodipine in Patients with Aneurysmal Subarachnoid Hemorrhage

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Page last updated: 2006-11-04

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