NCT02991430

Brief Summary

This study will assess the efficacy of a neuromodulation device for the treatment of episodic migraine headache.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2017

Geographic Reach
2 countries

10 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 4, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 13, 2016

Completed
7 months until next milestone

Study Start

First participant enrolled

June 30, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 11, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 11, 2018

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

June 19, 2019

Completed
Last Updated

June 19, 2019

Status Verified

June 1, 2019

Enrollment Period

11 months

First QC Date

December 4, 2016

Results QC Date

May 9, 2019

Last Update Submit

June 15, 2019

Conditions

Intervention

Keywords

migraine headache, episodic

Outcome Measures

Primary Outcomes (1)

  • Change in Migraine Headache Days (MHD)

    comparison of MHD recorded in baseline month versus 3rd month of treatment

    1 month of baseline recordation followed by 84 days of device use

Secondary Outcomes (9)

  • Normalized Reduction in Migraine Headache Days

    1 month of baseline recordation followed by 84 days of device use

  • Change in Medication Usage

    1 month of baseline recordation followed by 84 days of device use

  • Change in Headache Pain

    1 month of baseline recordation followed by 84 days of device use

  • Change in Quality of Life

    1 month of baseline recordation followed by 84 days of device use

  • Change in Depression

    1 month of baseline recordation followed by 84 days of device use

  • +4 more secondary outcomes

Study Arms (2)

active

ACTIVE COMPARATOR

active neuromodulation

Device: active neuromodulation for episodic migraine headache

placebo

PLACEBO COMPARATOR

placebo neuromodulation

Device: placebo neuromodulation for episodic migraine headache

Interventions

active neuromodulation for episodic migraine headacheDEVICE

Non-invasive brainstem neuromodulator. Active and placebo devices appear identical

active
placebo neuromodulation for episodic migraine headacheDEVICE

Sham non-invasive brainstem neuromodulator. Active and placebo devices appear identical

placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • diagnosed with episodic migraine at least 6 months before study
  • at least 3 consecutive months of stable migraine headaches before study
  • at least 4-14 headache days per month, of which 4-14 may be migraines
  • must not have failed on more than 2 classes of migraine preventatives

You may not qualify if:

  • previous use of the experimental device
  • pregnant
  • using more than 1 concurrent migraine preventive
  • history of cardiovascular disease
  • work night shifts
  • diagnosed with vestibular migraine
  • menstrual migraines exclusively
  • diagnosed with post-traumatic migraine
  • have a history of unstable mood or anxiety disorder
  • use a hearing aid
  • have a cochlear implant
  • have chronic tinnitus
  • have temporomandibular joint disease
  • diagnosed with traumatic brain injury
  • diagnosed with neurological disease other than headaches
  • +10 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Mayo Clinic

Scottsdale, Arizona, 85259, United States

Location

Neurology Research Institute

West Palm Beach, Florida, 33407, United States

Location

Diamond Headache Clinic

Chicago, Illinois, 60642, United States

Location

Michigan Headache Pain & Neurological Inst.

Ann Arbor, Michigan, 48104, United States

Location

Study Metrix Research

City of Saint Peters, Missouri, 63303, United States

Location

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Jefferson Headache Center

Philadelphia, Pennsylvania, 19107, United States

Location

King's College London

London, Denmark Hill, SE5 9PJ, United Kingdom

Location

University of Kent

Canterbury, Kent, CT2 7NP, United Kingdom

Location

MeSH Terms

Conditions

Migraine DisordersRecurrence

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Dr. Robert Black
Organization
Scion NeuroStim, LLC
rblack@scionneurostim.com
(919) 260-5528

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 4, 2016

First Posted

December 13, 2016

Study Start

June 30, 2017

Primary Completion

May 11, 2018

Study Completion

May 11, 2018

Last Updated

June 19, 2019

Results First Posted

June 19, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share

Locations

US(8)GB(2)