Status Migrainosus - Differentiating Between Responders and Non-responders
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Nov 2016
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 30, 2016
CompletedFirst Submitted
Initial submission to the registry
February 21, 2017
CompletedFirst Posted
Study publicly available on registry
February 28, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2020
CompletedAugust 31, 2018
August 1, 2018
3.1 years
February 21, 2017
August 29, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
time to headache relief
time to headache relief
first week
Study Arms (4)
bupivacaine (Exparel)
ACTIVE COMPARATORsubjects assigned by clinician's judgment - standard care choice A
naratriptan pill (Amerge)
ACTIVE COMPARATORsubjects assigned by clinician's judgment - standard care choice B
dexamethasone tablet (Decadron)
ACTIVE COMPARATORsubjects assigned by clinician's judgment - standard care choice C
ketorolac (Toradol)
ACTIVE COMPARATORsubjects assigned by clinician's judgment - standard care choice D
Interventions
Nerve blocks with bupivacaine will be performed at initial visit
one pill will be administered twice each day for 5 days
one tablet will be administered twice each day for 3 days
ketorolac will be administered intramuscularly (IM) or intravenously (IV) at initial visit
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- \<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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hartford HealthCare Headache Center
Wethersfield, Connecticut, 06109, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Brian Grosberg, MD
physician
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- statistician/senior scientist
Study Record Dates
First Submitted
February 21, 2017
First Posted
February 28, 2017
Study Start
November 30, 2016
Primary Completion
December 31, 2019
Study Completion
June 30, 2020
Last Updated
August 31, 2018
Record last verified: 2018-08
Data Sharing
- IPD Sharing
- Will not share