Migraine HeadachePhase 2NCT02969642
Study of Low-level Laser Therapy in the Acute Treatment of Migraine
A Phase 2 study testing Argus Migraine Treatment device in people with Migraine Headache, run by The San Francisco Clinical Research Center at 1 site in United States.
Trial summary
This study evaluates the treatment of migraine pain using low energy laser light to quench migraine signals issuing from the sphenopalatine ganglion (SPG). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Migraine Headache
- What is being tested?
- Argus Migraine Treatment device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2016to Jul 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- uncontrolled: hypertension, severe psychiatric disorders, or known use of narcotics, analgesic or alcohol abuse;
- light sensitivity;
- retinal disease;
- intranasal pathology.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
San Francisco Clinical Research Center
San Francisco, California, 94109
Jerome Goldstein, MD, 415-673-4600, JGoldstein@sfcrc.org
Jerome Goldstein, MD
About this study
Official title: A Single-center, Sham-controlled, Single Attack Study of Laser Therapy to the Sphenopalatine Ganglion (SPG) in the Acute Treatment of Migraine
This study evaluates the treatment of migraine pain using low energy laser light to quench migraine signals issuing from the sphenopalatine ganglion (SPG).
Read the 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.
- Conditions
- Migraine Headache
- Being tested
- Argus Migraine Treatment device
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Argus Migraine Treatment deviceDevice
Also called low energy laser therapy
treatment of Migraines targeting Sphenopalatine ganglion
| Study group | Role | What they receive |
|---|---|---|
| Sham | Sham comparator | Sham low energy laser using approximately 1/1000 th energy of treatment laser. Receives: Device: Argus Migraine Treatment device |
| Treatment | Active comparator | Treatment laser. Receives: Device: Argus Migraine Treatment device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences between treatment groups in pain free rates at 2 hours post treatment.
Measured: 2 hours post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2016 (estimated)
- Study startMar 2016
- Primary completionMay 2017 (estimated)
- Study completionJul 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Migraine HeadacheStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The San Francisco Clinical Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02969642
- Sponsor's protocol ID
- AP 1001
- Status last verified
- Dec 2016
- First submitted
- 20 Oct 2016
- Last updated
- 2 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Sham-controlled, Single Attack Study of Laser Therapy to the Sphenopalatine Ganglion (SPG) in the Acute Treatment of Migraine
- ClinicalTrials.gov ID
- NCT02969642
- Acronym / sponsor ID
- AP 1001
- Conditions
- Migraine Headache
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- The San Francisco Clinical Research CenterUniversity, hospital or other
- Study start
- Mar 2016
- Primary completion
- May 2017 (estimated)
- Study completion
- Jul 2017 (estimated)
- First posted
- 21 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sham | Sham comparator | Device: Argus Migraine Treatment deviceSham low energy laser using approximately 1/1000 th energy of treatment laser. |
| Treatment | Active comparator | Device: Argus Migraine Treatment deviceTreatment laser. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Argus Migraine Treatment deviceAlso: low energy laser therapytreatment of Migraines targeting Sphenopalatine ganglion | Device | Sham, Treatment |
Primary outcome
Differences between treatment groups in pain free rates at 2 hours post treatment.
Time frame: 2 hours post treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Argus Migraine Treatment device in people with Migraine Headache, run by The San Francisco Clinical Research Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences between treatment groups in pain free rates at 2 hours post treatment. (time frame: 2 hours post treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2016.