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Manufactured by: Manufactured for:
Ben Venue Laboratories, Inc. Bedford Laboratories™
Bedford, OH 44146 Bedford, OH 44146
January 2004
BOX WARNING
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.)
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NEWS HIGHLIGHTS
Published Studies Related to Dihydroergotamine (Dihydroergotamine Subcutaneous)
Inpatient treatment of status migraine with dihydroergotamine in children and adolescents. [2009.01]
OBJECTIVE: To assess the effectiveness of aggressive therapy of status migraine in children and adolescents. BACKGROUND: Inpatient management of pediatric status migraine and intractable headache is limited because of a lack of studies and guidelines. Adult treatment is often based on anecdotal experience, although a few controlled studies have been reported. Added to that is the discomfort of general pediatricians and neurologists in using available effective treatments in pediatric patients (such as dihydroergotamine: DHE)... CONCLUSION: From our review, DHE is very effective in treating and aborting an episode of status migraine and should be offered to children and adolescent patients who have failed their usual abortive therapy to prevent further severe disability that mainly affects their schooling and social activities.
History of the use of ergotamine and dihydroergotamine in migraine from 1906 and onward. [2008.08]
Dale showed in 1906 in a seminal work that ergot inhibits the pressor effect of adrenaline.Recently, oral ergotamine, which has an oral bioavailability of < 1%, has been inferior to oral triptans in randomized clinical trials.
Intrapulmonary and intravenous administrations of dihydroergotamine mesylate have similar cardiovascular effects in the conscious dog. [2008.07]
BACKGROUND AND PURPOSE: The effects of intrapulmonary artery (i.p.a.) administration of dihydroergotamine mesylate (DHE) were evaluated. EXPERIMENTAL APPROACH: Conscious beagle dogs (n=4) were given DHE via the i.p.a... The risk of cardiovascular complications is unlikely to be greater following inhalation of DHE.
History of the use of ergotamine and dihydroergotamine in migraine from 1906 and onward. [2008.05.05]
Dale showed in 1906 in a seminal work that ergot inhibits the pressor effect of adrenaline.Recently, oral ergotamine, which has an oral bioavailability of < 1%, has been inferior to oral triptans in randomized clinical trials.
Safety and pharmacokinetics of dihydroergotamine mesylate administered via a Novel (Tempo) inhaler. [2008.03]
OBJECTIVE: We investigated the pulmonary absorption of dihydroergotamine (DHE) mesylate and compared the safety, pharmacokinetic, and metabolic profile of 4 different doses of orally inhaled DHE delivered by the Tempo Inhaler (MAP Pharmaceuticals Inc., Mountain View, CA, USA) with 1.0 mg intravenously (IV) administered DHE in 18 healthy subjects... CONCLUSION: The 4-actuation delivery was well tolerated and provided systemic levels of DHE and 8'OH-DHE slightly lower than IV administration and predicted levels.
Clinical Trials Related to Dihydroergotamine (Dihydroergotamine Subcutaneous)
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 examinining a migraine medicine called 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).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.
A Research Study Examining Migranal and Skin Sensitivity in Subjects With Migraine [Recruiting]
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.
A Research Study to Examine Cutaneous Allodynia and Cluster Headache [Recruiting]
This is a research study examining cutaneous (q-tan-ee-us) allodynia (all-o-din-ee-uh) and
cluster headaches. Cutaneous allodynia means the feeling of pain or unpleasant sensation
when normally non-painful stimuli (e. g. light touch) are applied to the skin. Many studies
have been performed looking at the presence of cutaneous allodynia in patients with
migraine; however, few studies have examined it in cluster headache patients. There is
still much to be learned about the brain and how it functions if we are to understand the
underlying causes of cluster headache. It is important to explore cutaneous allodynia in
cluster headache as it may help guide physicians with the care of these individuals. Sixty
patients will be screened for this study, in order to enroll sixty subjects. Thomas
Jefferson University is the only center enrolling patients in this research study.
Phase 3 Study of MAP0004 in Adult Migraineurs [Not yet recruiting]
This is a randomized, double blind, placebo controlled, parallel group study of MAP0004 in
adult migraineurs. Subjects will self administer study drug in the outpatient setting.
Continuous Fetal Monitoring During Vacuum Delivery [Not yet recruiting]
The investigators have added an additional electrode to the vacuum device for birth in which
they can monitor the fetus during delivery.
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