Recruiting
Phase 1
Phase 2

Observational Study

Sponsor:

Hartford HealthCare

Code:

NCT03066544

Conditions

Migraine

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Bupivacaine

Naratriptan Pill

Dexamethasone

Ketorolac

Study Details

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.

Conditions

Migraine

Study ID

NCT03066544

Start date

Nov 30, 2016

Status verified date

Aug, 2018

Completion date

Jun 30, 2020

Anticipated

Primary completion date

Dec 31, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

50 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: bupivacaine (Exparel)

subjects assigned by clinician's judgment - standard care choice A

active comparator: naratriptan pill (Amerge)

subjects assigned by clinician's judgment - standard care choice B

active comparator: dexamethasone tablet (Decadron)

subjects assigned by clinician's judgment - standard care choice C

active comparator: ketorolac (Toradol)

subjects assigned by clinician's judgment - standard care choice D

Interventions

Bupivacaine

Nerve blocks with bupivacaine will be performed at initial visit

Naratriptan Pill

one pill will be administered twice each day for 5 days

Dexamethasone

one tablet will be administered twice each day for 3 days

Ketorolac

ketorolac will be administered intramuscularly (IM) or intravenously (IV) at initial visit

Primary outcome measure

  • time to headache relief [ Time Frame: first week ]

Central Contacts and Locations

Central contacts

Raymond Rich-Fiondella

860-231-0718Raymond.Rich-Fiondella@hhchealth.org

Locations

Hartford HealthCare Headache Center

Recruiting

Wethersfield, Connecticut, United States, 06109

Contacts

Brooke Pellegrino, PhD

860-696-2925Brooke.Pellegrino@hhchealth.org

Principal Investigator:

Brian Grosberg, MD

More Information

Sponsor

Hartford HealthCare

Last update posted

Aug 31, 2018

Last verified

Aug, 2018

Keywords

  • migraine
  • responder
  • non-responder
  • treatment

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Hartford HealthCare on 2018-08-31.