A Study to Assess an Auto-injector Being Used to Treat a Migraine Attack
The purpose of this research study is to evaluate an investigational auto-injector system for delivering sumatriptan under the skin for a single migraine attack.
The study could take approximately 5 weeks and will include about 3 office visits to the study doctor, the patient will be contacted every 2 weeks until the patient experiences a migraine and uses the auto-injector. The last visit will be done by a telephone follow-up call.
1. Screening Visit [Visit 0 / 0-14 days prior to receipt of study drug]
2. Baseline Visit [Visit 1 / Provision of study drug and subject training]
3. Treatment Visit [Visit 2 / within 72 hours after study drug administration]
4. Follow-up Visit [Visit 3 / Telephone follow-up 7-10 days after study drug administration]
Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
"Investigational"Auto-injector (sumatriptan succinate)
San Francisco Clinical Research Center
Results (where available)
- Source: http://clinicaltrials.gov/show/NCT00510419
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
A serotonin agonist that acts selectively at 5HT1 receptors. It is used in the treatment of MIGRAINE DISORDERS.
Enzymes that catalyze the first step leading to the oxidation of succinic acid by the reversible formation of succinyl-CoA from succinate and CoA with the concomitant cleavage of ATP to ADP (EC 220.127.116.11) or GTP to GDP (EC 18.104.22.168) and orthophosphate. Itaconate can act instead of succinate and ITP instead of GTP.EC 6.2.1.-.
An enzyme that plays a role in the GLUTAMATE and butanoate metabolism pathways by catalyzing the oxidation of succinate semialdehyde to SUCCINATE using NAD+ as a coenzyme. Deficiency of this enzyme, causes 4-hydroxybutyricaciduria, a rare inborn error in the metabolism of the neurotransmitter 4-aminobutyric acid (GABA).
A flavoprotein containing oxidoreductase that catalyzes the dehdyrogenation of SUCCINATE to fumerate. In most eukaryotic organisms this enzyme is a component of mitochondrial electron transport complex II.
A class of disabling primary headache disorders, characterized by recurrent unilateral pulsatile headaches. The two major subtypes are common migraine (without aura) and classic migraine (with aura or neurological symptoms). (International Classification of Headache Disorders, 2nd ed. Cephalalgia 2004: suppl 1)
This study will be conducted to collect cases treated by self-injection of sumatriptan 3mg kit product for the treatment of migraine or cluster headache attacks in clinical settings, to de...
This is a randomized, double-blind, placebo-controlled, crossover, two-attack, out-patient, early-intervention evaluation of subjects who have migraine with or without aura and who discont...
The objective of this study is to compare the rate and extent of absorption of sumatriptan from a test formulation of Sumatriptan Succinate 100 mg Tablets versus the reference Imitrex® 10...
This is a pharmacokinetic (PK) study designed to investigate a combination product containing sumatriptan succinate and naproxen sodium administered at 3 single doses (10mg sumatriptan/60m...
This study was designed to determine efficacy of TREXIMA compared to placebo for the treatment of a menstrual migraine.
There are different options to manage benign headache in the emergency department. The costs, side effects, and efficacies of the drugs used are significantly different. The aim of this study was to c...
Initial concerns about the coronary side-effect potential of the anti-migraine drug sumatriptan and second-generation triptans initiated cranioselectivity studies using proximal human coronary arterie...
Abstract The present investigation is aimed at development and characterization of sumatriptan succinate orodispersible tablets (ODTs) prepared by freeze drying technology. The tablet excipients were...
- Diagnostic criteria for vestibular migraine have recently been formulated.- The diagnosis of vestibular migraine is based on a history of migraine and episodes of vertigo, not necessarily accompanie...
Succinate is an intermediate of the tricarboxylic acid (TCA) cycle, and plays a crucial role in adenosine triphosphate (ATP) generation in mitochondria. Recently, new roles for succinate outside metab...