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Status Migrainosus - Differentiating Between Responders and Non-responders

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ClinicalTrials.gov Identifier: NCT03066544
Recruitment Status : Recruiting
First Posted : February 28, 2017
Last Update Posted : May 11, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The main goal of this study is to determine whether it is possible - in the setup of routine clinical care - to identify in individual patients who are clear responders to drug X, common denominators that are absent in individual patients who are non-responders to the same drug, and vice versa. All currently available knowledge about migraine pathophysiology will be utilized, using as much time as is needed to ask as many questions as are necessary, in an attempt to profile clear responders and clear non-responders.

Condition or disease Intervention/treatment Phase
Migraine Drug: Bupivacaine Drug: Naratriptan Pill Drug: Dexamethasone Drug: Ketorolac Phase 1 Phase 2

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This will be a prospective, non-blinded, non-randomized, proof-of-concept study.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Status Migrainosus - Differentiating Between Responders and Non-responders in the Setup of Real-life Clinical Practice
Actual Study Start Date : November 30, 2016
Estimated Primary Completion Date : December 31, 2017
Estimated Study Completion Date : June 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: bupivacaine (Exparel)
subjects assigned by clinician's judgment - standard care choice A
Drug: Bupivacaine
Nerve blocks with bupivacaine will be performed at initial visit
Other Name: Exparel
Active Comparator: naratriptan pill (Amerge)
subjects assigned by clinician's judgment - standard care choice B
Drug: Naratriptan Pill
one pill will be administered twice each day for 5 days
Other Name: Amerge
Active Comparator: dexamethasone tablet (Decadron)
subjects assigned by clinician's judgment - standard care choice C
Drug: Dexamethasone
one tablet will be administered twice each day for 3 days
Other Name: Decadron
Active Comparator: ketorolac (Toradol)
subjects assigned by clinician's judgment - standard care choice D
Drug: Ketorolac
ketorolac will be administered intramuscularly (IM) or intravenously (IV) at initial visit
Other Name: Toradol


Outcome Measures

Primary Outcome Measures :
  1. time to headache relief [ Time Frame: first week ]
    time to headache relief


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • males and females
  • ≥18 years old with no upper age limit
  • patients with status migrainosus - defined as a severe migraine headache without aura lasting longer than 72 hours and considered primarily as a complication of migraine
  • patients who are willing and able to provide written, informed consent

Exclusion Criteria:

  • <18 years old
  • unable or unwilling to provide written, informed consent
  • females who are pregnant, breastfeeding, or who are trying to become pregnant
  • patients who do not speak English
  • any medical condition or other reason that in the opinion of the investigators makes the patient unfit or at risk to participate in the study
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03066544


Contacts
Contact: Brooke Pellegrino, PhD (860) 696-2925 Brooke.Pellegrino@hhchealth.org

Locations
United States, Connecticut
Hartford HealthCare Headache Center Recruiting
Wethersfield, Connecticut, United States, 06109
Contact: Brooke Pellegrino, PhD    860-696-2925    Brooke.Pellegrino@hhchealth.org   
Principal Investigator: Brian Grosberg, MD         
Sponsors and Collaborators
Hartford HealthCare
Investigators
Principal Investigator: Brian Grosberg, MD physician
More Information

Responsible Party: David O'Sullivan, statistician/senior scientist, Hartford HealthCare
ClinicalTrials.gov Identifier: NCT03066544     History of Changes
Other Study ID Numbers: HHC-2016-0221
First Posted: February 28, 2017    Key Record Dates
Last Update Posted: May 11, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by David O'Sullivan, Hartford HealthCare:
migraine
responder
non-responder
treatment

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Dexamethasone acetate
Dexamethasone
Ketorolac
Ketorolac Tromethamine
Bupivacaine
BB 1101
Naratriptan
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anesthetics, Local
Anesthetics
Central Nervous System Depressants