NCT02969642

Brief Summary

This study evaluates the treatment of migraine pain using low energy laser light to quench migraine signals issuing from the sphenopalatine ganglion (SPG).

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Mar 2016

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

March 1, 2016

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 20, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 21, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

December 2, 2016

Status Verified

December 1, 2016

Enrollment Period

1.2 years

First QC Date

October 20, 2016

Last Update Submit

December 1, 2016

Conditions

Migraine Headache

Outcome Measures

Primary Outcomes (1)

  • Differences between treatment groups in pain free rates at 2 hours post treatment.

    2 hours post treatment

Study Arms (2)

Sham

SHAM COMPARATOR

Sham low energy laser using approximately 1/1000 th energy of treatment laser.

Device: Argus Migraine Treatment device

Treatment

ACTIVE COMPARATOR

Treatment laser.

Device: Argus Migraine Treatment device

Interventions

Argus Migraine Treatment deviceDEVICE

treatment of Migraines targeting Sphenopalatine ganglion

Also known as: low energy laser therapy
ShamTreatment

Eligibility Criteria

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

You may qualify if:

  • male or female
  • aged 18 or older;
  • subject diagnosed with migraine according to The International Classification of Headache Disorders- Version 3;
  • headache days per month;
  • history of at least moderate pain if migraine left untreated.

You may not qualify if:

  • headache on greater than 25 days/month on average for preceding 3 months;
  • headache on greater than 25 days in present month;
  • headache attributed to: head or neck trauma, cluster headache, specific migraine variants such as basilar artery, ophthalmoplegic, hemiplegic, etc;
  • women of child bearing age not using acceptable method of contraception;
  • pregnant or nursing women;
  • history of malignancy of any organ
  • uncontrolled: hypertension, severe psychiatric disorders, or known use of narcotics, analgesic or alcohol abuse;
  • light sensitivity;
  • retinal disease;
  • intranasal pathology.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

San Francisco Clinical Research Center

San Francisco, California, 94109, United States

RECRUITING

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, PrimaryHeadache DisordersBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 20, 2016

First Posted

November 21, 2016

Study Start

March 1, 2016

Primary Completion

May 1, 2017

Study Completion

July 1, 2017

Last Updated

December 2, 2016

Record last verified: 2016-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)