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Migranal (Dihydroergotamine Mesylate Nasal) - Summary

 
 



WARNING

Serious and/or life-threatening peripheral ischemia has been associated with the coadministration of DIHYDROERGOTAMINE with potent CYP 3A4 inhibitors including protease inhibitors and macrolide antibiotics. Because CYP 3A4 inhibition elevates the serum levels of DIHYDROERGOTAMINE, the risk for vasospasm leading to cerebral ischemia and/or ischemia of the extremities is increased. Hence, concomitant use of these medications is contraindicated.
(See also CONTRAINDICATIONS and WARNINGS section)

 

MIGRANAL SUMMARY

Migranal®
(dihydroergotamine mesylate, USP)
Nasal Spray
The solution used in Migranal (dihydroergotamine mesylate, USP) Nasal Spray (4 mg/mL) is intended for intranasal use and must not be injected.
Rx Only

Migranal® is ergotamine hydrogenated in the 9,10 position as the mesylate salt.

Migranal® (dihydroergotamine mesylate, USP) Nasal Spray is indicated for the acute treatment of migraine headaches with or without aura.

Migranal® (dihydroergotamine mesylate, USP) Nasal Spray is not intended for the prophylactic therapy of migraine or for the management of hemiplegic or basilar migraine.


See all Migranal indications & dosage >>

NEWS HIGHLIGHTS

Published Studies Related to Migranal (Dihydroergotamine Nasal)

Assessing acute systemic effects of an inhaled drug with serial echocardiography: a placebo-controlled comparison of inhaled and intravenous dihydroergotamine. [2013]
CONCLUSION: These results indicate the effects 1 mg of orally inhaled DHE on the

Effects of a supratherapeutic dose of investigational orally inhaled dihydroergotamine (MAP0004) on QT interval: a randomized, double-blind, active- and placebo-controlled crossover study in healthy volunteers. [2012]
the QT interval as required for regulatory approval of a new product... CONCLUSIONS: A supratherapeutic dose of MAP0004 was not associated with prolonged

MAP0004, orally inhaled dihydroergotamine for acute treatment of migraine: efficacy of early and late treatments. [2011.10]
OBJECTIVE: To evaluate the efficacy of MAP0004, an orally inhaled dihydroergotamine, for acute treatment of migraine when administered at various time points from within 1 hour to more than 8 hours after migraine onset... CONCLUSION: This post hoc subanalysis shows that MAP0004 was effective in treating migraine irrespective of the time of treatment, even more than 8 hours after onset of migraine pain.

Where is dihydroergotamine mesylate in the changing landscape of migraine therapy? [2010.12]
IMPORTANCE OF THE FIELD: Migraine affects approximately 18% of women and 6% of men, and has an immense impact on quality of life and productivity. Advancement in therapeutic options has been slow.The side-effect profile of DHE is more benign than is often perceived and should not be a deterrent for use in well-chosen cases.

Outpatient home-based continuous intravenous dihydroergotamine therapy for intractable migraine. [2010.05]
BACKGROUND: Established consecutive-day inpatient intravenous dihydroergotamine protocols administered by bolus intravenous injection or continuous infusion injection in the hospital have demonstrated efficacy and safety in modifying the course of daily intractable headache. We conducted a study to determine efficacy, tolerability, and feasibility to treat patients with daily intractable headache with continuous intravenous dihydroergotamine in an outpatient home-based setting... CONCLUSIONS: Efficacy and safety of our outpatient home-based intravenous dihydroergotamine program compared favorably to that of established inpatient intravenous pulse injection and continuous infusion protocols for the treatment of intractable migraine. The use of outpatient continuous intravenous dihydroergotamine is an effective and well-tolerated therapy for intractable migraine but without the added cost and inconvenience of hospitalization.

more studies >>

Clinical Trials Related to Migranal (Dihydroergotamine Nasal)

A Research Study Examining Migranal and Skin Sensitivity in Subjects With Migraine [Completed]
This is a research study looking at Migranal (study drug) in the treatment of two migraine attacks in patients who have a history of cutaneous allodynia (pronounced q-tay-nee-us al-o-din-ee-a). Cutaneous allodynia is an increased skin sensitivity experienced during a headache. It has been noted in several studies that in patients with migraine, seventy nine percent of the patients experienced allodynia on the facial skin on the same side as the headache. Understanding more about allodynia may help us understand how the pain system works in migraine. This study will compare the differences, if any, in attacks treated early with study drug (at 1-hour from onset) and attacks treated later (at 4-hours). You will be asked to treat one attack early and one attack late for this study. If the first attack you treat is early (at 1 hour following onset of throbbing pain) then the second attack you treat should be late (at 4 hours following onset of throbbing pain). It is hoped that this study will provide information on the use of Migranal in subjects who have cutaneous allodynia. The results from this study may be used in the development of larger clinical trials. The study drug is a medication that is taken in the form of nasal spray.

Pharmacodynamic Study to Compare Acute Effects of Dihydroergotamine Mesylate (DHE) on Pulmonary Arterial Pressure [Completed]

Pharmacokinetics & Tolerability Study of MAP0004 Co-administered With Ketoconazole [Completed]
Compare the DHE pharmacokinetic profiles observed following administration of: 1. MAP0004 (oral inhalation DHE) 2. MAP0004 co-administered with oral Ketoconazole 3. Intravenous (IV) DHE (D. H.E. 45, the approved reference therapy) Compare the tolerability of MAP0004, IV DHE, and MAP0004 with co-administration of Ketoconazole.

A Study Examining the Use of a Migraine Medicine in the Treatment of Two Migraine Attacks in Patients Who Have Increased Skin Sensitivity [Completed]
This is a research study examining a migraine medicine dihydroergotamine mesylate (DHE-45).It will be used to treat two migraine attacks in subjects who have a history of skin sensitivity associated with their headaches. This skin sensitivity is called cutaneous allodynia (pronounced q-tay-nee-us al-o-din-ee-uh).Cutaneous allodynia is a sensation of pain when a non-noxious stimulus is applied to normal skin. It has been noted in several studies that in subjects with migraine, seventy nine percent of the subjects experienced allodynia on the facial skin on the same side as the headache. It has also been shown that that once allodynia develops, other migraine medicines that would normally be very effective for migraine pain, become much less effective or ineffective. This study will compare the differences,if any, in attacks treated early with this study drug and treated later with the same study drug. It is hoped that that this trial will provide information on the use of DHE-45 in subjects who have cutaneous allodynia. Understanding more about allodynia may help us understand how the pain system works in migraine.

Pharmacokinetics & Tolerability Study of MAP0004 in Smoking and Non-Smoking Adult Volunteers [Completed]
Compare the pharmacokinetics of Dihydroergotamine Mesylate (DHE) delivered by oral inhalation (MAP0004) or Intravenous (IV) DHE in smokers versus non-smokers. Identify whether there are clinically significant differences in the tolerability of MAP0004 between smokers and non-smokers.

more trials >>


Page last updated: 2014-11-30

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