Recruiting
Phase 2

Low-level Laser Therapy

Sponsor:

The San Francisco Clinical Research Center

Code:

NCT02969642

Conditions

Migraine Headache

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Argus Migraine Treatment device

Study Details

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).

Conditions

Migraine Headache

Study ID

NCT02969642

Start date

Mar, 2016

Status verified date

Dec, 2016

Completion date

Jul, 2017

Anticipated

Primary completion date

May, 2017

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria

  • male or female
  • aged 18 or older;
  • subject diagnosed with migraine according to The International Classification of Headache Disorders- Version 3;
  • 1-20 headache days per month;
  • history of at least moderate pain if migraine left untreated.

Exclusion Criteria:

  • 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.

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

sham comparator: Sham

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

active comparator: Treatment

Treatment laser.

Interventions

Argus Migraine Treatment device

treatment of Migraines targeting Sphenopalatine ganglion

Primary outcome measure

  • Differences between treatment groups in pain free rates at 2 hours post treatment. [ Time Frame: 2 hours post treatment ]

Central Contacts and Locations

Locations

San Francisco Clinical Research Center

Recruiting

San Francisco, California, United States, 94109

Contacts

Jerome Goldstein, MD

415-673-4600JGoldstein@sfcrc.org

Principal Investigator:

Jerome Goldstein, MD

More Information

Sponsor

The San Francisco Clinical Research Center

Last update posted

Dec 2, 2016

Last verified

Dec, 2016

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The San Francisco Clinical Research Center on 2016-12-02.