Randomized Evaluation of Octreotide Versus Compazine for Emergency Department Treatment of Migraine Headache - Full Text View

Sponsor:	C.R.Darnall Army Medical Center
Information provided by:	C.R.Darnall Army Medical Center
ClinicalTrials.gov Identifier:	NCT00274170

Purpose

Headaches are a common complaint presenting to the emergency department (ED), accounting for 1-2% of all ED visits, with migraines as the second most common primary headache syndrome. Patients that ultimately present to the ED have failed outpatient therapy and exhibit severe and persistent symptoms. Treatment options have been traditionally with a parenteral opiod, generally Demerol. Unfortunately, patients with chronic painful conditions like migraines have been prone to dependency. In 1986, a nonopioid, compazine was noted serendipitously to relieve migraine headache pain. 1 Nonopioid regimens have evolved as standard therapy in the treatment of migrainne headache in the ED. Today, there are a number of nonopioid treatment options, but not without their own individual concerns. Ergotamine and dihydroergotamine are effective, but commonly cause nausea and vomiting. Sumatriptan is expensive has recurrence rate, is ineffective in about 20-30%, and is contra-indicated in patients with cardiac disease. Metoclopramide, a dopamine receptor antagonist, commonly used as an anti-emetic agent, has been widely studied for use with acute migraines. Its side effects include drowsiness and dystonic reactions. Compazine has been successfully used to treat migraine headaches for the past several decades, and has been accepted as standard treatment of headaches in the ED. 2 Its side effect profile includes extrapyramidal effects, dysphoria, drowsiness and akathisias. The ideal medication for treating headaches would have no addictive properties, few side effects, quick onset, be highly effective and have a low rate of recurrence. Somatostatin is known to have an inhibitory effect on a number of neuropetides, which have been implicated in migraine. Native somatostatin is an unstable compound and is broken down in minutes, but octreotide, a somatostatin analogue has a longer half life. Intravenous somatostatin has been shown to be as effective as ergotamine in the acute treatment of cluster headache. 3 The analgesic effect of octreotide with headaches associated with growth hormone secreting tumor has been established. 4 Five somatostatin receptors have been cloned with octreotide acting predominantely on sst2 and sst5. The distribution of sst2 within the central nervous system strongly suggests that this particular somatostatin receptor has a role in cranial nociception, being highly expressed in the trigeminal nucleus caudalis and periaqueductal grey. Kapicioglu et.al performed a double blind study comparing octreotide to placebo in treating migraine. They found there to be a significantly greater relief of pain with octreotide at 2 and 6 hours compared to placebo (76% vs 25%, p<0.02). They noted that 47% of those in the octreotide group had complete relief compared to no patients in the placebo group. They went on to note that those patients in the octreotide group had earlier relief of symptoms and no side effects. The only minor adverse event related to the administration of octreotide was a local reaction in 3 patients (18%). In a study performed recently in Netherlands, no clinically relevant changes in vital signs, routine chemistry, and urinalysis were observed with octreotide use. Electrocardiogram analyses showed no newly occurring or worsening of known cardiac abnormalities 2 and 24 h after injection with octreotide. 5 Levy et. al also compared octreotide to placebo in a double blinded study but found no difference. This was a poorly designed study, in that the patients treated themselves at home with an injection of either placebo or octreotide for 2 episodes of headache and recorded their level of pain relief at 2 hours. Matharu et. al also performed a double blind study comparing octreotide to placebo, but looking at cluster headaches rather than migraines. They found there to be a significant improvement with the use of octreotide over placebo (52% vs 36%). At Darnall Army Community Hospital the cost of 100 mcg Octreotide and10 mg Compazine, is $10.46, $2.02-8.00, respectively.

Condition	Intervention	Phase
Migraine Headache	Drug: Octreotide	Phase I Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Randomized Evaluation of Octreotide Versus Compazine for Emergency Department Treatment of Migraine Headache

Resource links provided by NLM:

Genetics Home Reference related topics: familial hemiplegic migraine

MedlinePlus related topics: Headache Migraine Nausea and Vomiting

Drug Information available for: Prochlorperazine Octreotide acetate Octreotide Prochlorperazine maleate Prochlorperazine edisylate

U.S. FDA Resources

Further study details as provided by C.R.Darnall Army Medical Center:

Primary Outcome Measures:

Patient Satisfaction
Improvement of Pain
Improvement of Nausea

Estimated Enrollment:	56
Study Start Date:	January 2006
Estimated Study Completion Date:	February 2007

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Migraine Headache

Exclusion Criteria:

Pregnancy and lactation,
Pre-medication within six hours of being enrolled in the study,
More than six prior headaches per month,
Allergy to the study drugs,
Non-migraine headache,
Substance abuse,
Alcohol abuse,
Diabetes mellitus, or a coexisting condition that might expose the patients to a disproportionately increased risk of a significant adverse event: ischaemic heart disease, peripheral vascular disease, cerebrovascular disease, uncontrolled hypertension (blood pressure >160/95), epilepsy, use of cimetidine, dopamine agonist, cyclopsorin, or oral hypoglycemic agents, hepatic or renal failure, and thyroid disorder.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00274170

Contacts

Contact: Michael A Miller, MD

254-288-8303

michael.miller3@amedd.army.mil

Locations

United States, Texas
CR Darnall Army Medical Center	Recruiting
Ft. Hood, Texas, United States, 76544

Sponsors and Collaborators

C.R.Darnall Army Medical Center

Investigators

Principal Investigator:

Alex Rosin, MD

C.R.Darnall Army Medical Center

More Information

No publications provided

Study ID Numbers:	C.2006.014
Study First Received:	January 9, 2006
Last Updated:	February 27, 2007
ClinicalTrials.gov Identifier:	NCT00274170 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by C.R.Darnall Army Medical Center:

Migraine
Octreotide
Prochlorperazine

Additional relevant MeSH terms:

Prochlorperazine
Neurotransmitter Agents
Disease Attributes
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Psychotropic Drugs
Octreotide
Antiemetics
Headache Disorders, Primary
Pain
Brain Diseases
Headache Disorders
Signs and Symptoms
Pathologic Processes

Migraine Disorders
Therapeutic Uses
Headache
Tranquilizing Agents
Antineoplastic Agents, Hormonal
Nervous System Diseases
Gastrointestinal Agents
Central Nervous System Depressants
Central Nervous System Diseases
Dopamine Antagonists
Antipsychotic Agents
Pharmacologic Actions
Autonomic Agents
Neurologic Manifestations
Emergencies

ClinicalTrials.gov processed this record on November 09, 2009