Randomized Evaluation of Octreotide Versus Compazine for Emergency Department Treatment of Migraine Headache

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2007 by C.R.Darnall Army Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
C.R.Darnall Army Medical Center
ClinicalTrials.gov Identifier:
NCT00274170
First received: January 9, 2006
Last updated: February 27, 2007
Last verified: February 2007
  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 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Randomized Evaluation of Octreotide Versus Compazine for Emergency Department Treatment of Migraine Headache

Resource links provided by NLM:


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

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

Keywords provided by C.R.Darnall Army Medical Center:
Migraine
Octreotide
Prochlorperazine

Additional relevant MeSH terms:
Emergencies
Headache
Migraine Disorders
Disease Attributes
Pathologic Processes
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Octreotide
Prochlorperazine
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Gastrointestinal Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Dopamine Antagonists

ClinicalTrials.gov processed this record on April 15, 2014