Manufactured by: Manufactured for:
Ben Venue Laboratories, Inc. Bedford Laboratories™
Bedford, OH 44146 Bedford, OH 44146
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.)
Published Studies Related to Dihydroergotamine (Dihydroergotamine Subcutaneous)
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. 
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.
Dihydroergotamine: role in the treatment of migraine. [2009.09]
BACKGROUND: Dihydroergotamine belongs to the oldest migraine-specific drugs. Mainly used by headache experts today, its properties are unfamiliar to many physicians. OBJECTIVE: To evaluate the modes of administration, effectiveness and safety profile of dihydroergotamine in the treatment of migraine... CONCLUSION: Evidence-based data are scarce. Parenteral dihydroergotamine seems to be as effective as or less effective than triptans with regard to pain control, but more effective than other drugs used in the treatment of attacks. The nasal spray is more effective than placebo, but less effective than triptans. Additional reports suggest that dihydroergotamine is particularly useful in migraineurs not satisfactorily responding to analgesics, in those with long attacks or headache recurrence, and those at risk of medication-overuse headache. Effectiveness of the oral formulation in migraine prevention is not substantiated by clinical trials. The adverse effect profile is very favorable compared to other ergot alkaloids.
Clinical Trials Related to Dihydroergotamine (Dihydroergotamine Subcutaneous)
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
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
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.
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.
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.