A Study to Assess an Auto-injector Being Used to Treat a Migraine Attack
Summary
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.
Description
Investigational Plan:
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]
Study Design
Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Migraine
Intervention
"Investigational"Auto-injector (sumatriptan succinate)
Location
San Francisco Clinical Research Center
San Francisco
California
United States
94109
Status
Completed
Source
King Pharmaceuticals
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00510419
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Sumatriptan
A serotonin agonist that acts selectively at 5HT1 receptors. It is used in the treatment of MIGRAINE DISORDERS.
Succinate-coa Ligases
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 6.2.1.5) or GTP to GDP (EC 6.2.1.4) and orthophosphate. Itaconate can act instead of succinate and ITP instead of GTP.EC 6.2.1.-.
Succinate-semialdehyde Dehydrogenase
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).
Succinate Dehydrogenase
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.
Migraine Disorders
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)
Clinical Trials
Study Of Sumatriptan Succinate Injection Kit In Patients With Migraine or Cluster Headache In Japan
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...
Sumatriptan Succinate 100 mg Tablets Under Fasting Conditions
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...
TREXIMA For Menstrual Migraine in Women With Dysmenorrhea
This study was designed to determine efficacy of TREXIMA compared to placebo for the treatment of a menstrual migraine.
PubMed Articles
Frequency and torment caused by migraines direct patients toward a variety of remedies. Few studies to date have proposed ginger derivates for migraine relief. This study aims to evaluate the efficacy...
Evaluation of the use of sumatriptan-naproxen sodium for menstrual migraine and dysmenorrhea.
Evaluation of: Cady RK, Diamond ML, Diamond MP et al. Sumatriptan-naproxen sodium for menstrual migraine and dysmenorrhea: satisfaction, productivity, and functional disability outcomes. Headache 51(5...
Migraine: Transdermal sumatriptan delivery shows promise in patients with migraine.
Therapeutic Applications for Subcutaneous Triptans in the Acute Treatment of Migraine.
Abstract Background: The features of migraine attacks and the contexts in which migraine attacks occur vary from attack to attack and from patient to patient. Current treatment strategies, which are d...
Basilar artery occlusion in migraine-like headache: a possible triggering effect of sumatriptan.
Headache is a common symptom at the onset of acute ischemic cerebrovascular disease. Simultaneous development of migraine-like headache and stroke in the same patient makes it difficult to differentia...
