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Study of Low-level Laser Therapy in the Acute Treatment of Migraine

Primary Purpose

Migraine Headache

Status

Unknown status

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Argus Migraine Treatment device

About this trial

This is an interventional treatment trial for Migraine Headache

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

San Francisco Clinical Research CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Active Comparator

Arm Label

Sham

Treatment

Arm Description

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

Treatment laser.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

NCT ID

NCT02969642

First Posted

October 20, 2016

Last Updated

December 1, 2016

Sponsor

The San Francisco Clinical Research Center

1. Study Identification

Unique Protocol Identification Number

NCT02969642

Brief Title

Study of Low-level Laser Therapy in the Acute Treatment of Migraine

Official Title

A Single-center, Sham-controlled, Single Attack Study of Laser Therapy to the Sphenopalatine Ganglion (SPG) in the Acute Treatment of Migraine

Study Type

Interventional

2. Study Status

Record Verification Date

December 2016

Overall Recruitment Status

Unknown status

Study Start Date

March 2016 (undefined)

Primary Completion Date

May 2017 (Anticipated)

Study Completion Date

July 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

The San Francisco Clinical Research Center

4. Oversight

Data Monitoring Committee

5. Study Description

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).

Detailed Description

This is a double blinded, two arm study, comprising a sham laser and a treatment laser. The sham laser emits approximately 1/1000 the energy of the treatment laser. It is presumed that pain relief from the treatment laser is achieved by exhausting the release of neurotransmitters from the SPG following laser stimulation. Subjects will be treated and subsequently queried at time intervals for their self-assessment of pain score (VAS). The time intervals include queries at 5 minutes through 2 hours post treatment. Subjects will be further contacted 24 hours and one month post treatment. Adverse events will be monitored and recorded.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Migraine Headache

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Sham

Arm Type

Sham Comparator

Arm Description

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

Arm Title

Treatment

Arm Type

Active Comparator

Arm Description

Treatment laser.

Intervention Type

Device

Intervention Name(s)

Argus Migraine Treatment device

Other Intervention Name(s)

low energy laser therapy

Intervention Description

treatment of Migraines targeting Sphenopalatine ganglion

Primary Outcome Measure Information:

Title

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

Time Frame

2 hours post treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Facility Information:

Facility Name

San Francisco Clinical Research Center

City

San Francisco

State/Province

California

ZIP/Postal Code

94109

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jerome Goldstein, MD

Phone

415-673-4600

JGoldstein@sfcrc.org

First Name & Middle Initial & Last Name & Degree

Jerome Goldstein, MD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Study of Low-level Laser Therapy in the Acute Treatment of Migraine

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