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MigrainesPhase 4KSPNNCT01807234

Comparison of Ketorolac Nasal Spray to Sumatriptan Nasal Spray and Placebo for Acute Treatment of Migraine

A Phase 4 study testing Ketorolac and Sumatriptan in people with Migraines, run by Johns Hopkins University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The investigators propose to test the efficacy of ketorolac nasal spray versus sumatriptan nasal spray versus placebo for acute abortive therapy of migraine head pain as well as for migraine associated symptoms including nausea and allodynia. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Migraines
What is being tested?
Ketorolac and Sumatriptan
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
72 participants
Where
1 siteUnited States
Study dates
Feb 2013to Dec 2014
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • At the Screening Visit, a subject must meet the following criteria to participate in this study:
  • 1.18-65 years of age 2.Fulfills International Classification of Headache Disorders (ICHD)-II Criteria of migraine as noted below in Table 1 3.History of migraines for at least one year 4.Migraine onset prior to the age of 50 years of age 5.Headache frequency (of any headaches, migraine or non-migraine) < 9 days per month 6.At visit 2, participants must report two or more headache days during the 28-day run-in period on the headache diary. 7.At least 48 hours of freedom from headache between treated migraine attacks. 8.If currently using headache preventive medications, must be on a stable dose for at least 3 months prior to enrollment and throughout the study period and be on no more than one prophylactic agent. 9.Able to complete all study procedures, including the questionnaire (assessing demographics, headache characteristics, headache comorbidities and medical history at the initial visit and headache characteristics) and the required headache calendars, and all study visits; 10.Able to understand, read and sign an informed consent (English).

Who cannot join

  • Any condition (history or presence of) which contraindicates the use of triptans or NSAIDs including:
  • Known hypersensitivity or intolerance to triptans or NSAIDs
  • Contraindications to triptan use (uncontrolled hypertension, ischemic heart disease, prinz-metal angina, cardiac arrhythmias, multiple risk factors for atherosclerotic vascular disease, primary vasculopathies, and basilar and hemiplegic migraine)
  • Cerebrovascular disease except for mild non-specific white matter disease
  • Peripheral vascular disease or any other ischemic disease including myocardial infarction
  • Uncontrolled hypertension (systolic BP 160 mmHg or diastolic BP 95 mmHg or (both)
Show all 24Show fewer
  • Migraine aura fulfilling ICHD-II criteria for hemiplegic or basilar-type migraine
  • Any history of chronic renal or hepatic impairment
  • Use of an ergotamine-containing medication or monamine oxidase inhibitor
  • Known or suspected pregnancy, negative pregnancy test
  • Lactation
  • Bleeding dsycrasias including gastritis, peptic ulcer disease,gastrointestinal bleeding
  • Physician diagnosis of any pain syndrome other than migraine
  • Classification as treatment resistant by investigator
  • Known drug or substance abuse
  • Any opioid use in past 2 months
  • Use of any medication, which could interfere with study assessments
  • History of noncompliance with taking medication;
  • Use of any experimental drug or device within 30 days prior to the Screening Visit (Visit 1);
  • Any abnormal finding or condition deemed clinically significant by the investigator on history, screening, or physical exam that contraindicates the use of triptans or NSAIDs or that might interfere with the patient's safety, study participation, or which might confound the interpretation of the study results.
  • Any history of chronic renal or hepatic disease already excluded above under number 1; plus see exclusion 9.
  • History of chronic pulmonary disorder including nasal polyps (see 1) and asthma.
  • History of upper respiratory infection or other respiratory tract condition that could interfere with the absorption of the nasal spray or with assessment of AEs including rhinitis medicamentosa (chronic daily use of topical decongestants).
  • History of nasal surgery.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • The Johns Hopkins Bayview Headache Center

    Baltimore, Maryland, 21224

Other trials in United States

About this study

Official title: Comparison of Ketorolac Nasal Spray to Sumatriptan Nasal Spray and Placebo for Acute Treatment of Migraine (The KSPN Migraine Study)

The investigators propose to test the efficacy of ketorolac nasal spray versus sumatriptan nasal spray versus placebo for acute abortive therapy of migraine head pain as well as for migraine associated symptoms including nausea and allodynia.

Read the detailed description

Participants are randomized to Ketorolac NS 31.5 mg, Sumatriptan NS 20 mg or placebo to treat three moderate to severe migraine attacks and switched treatments with each attack so that they received each treatment only once.

For each treated attack (moderate to severe migraine attack), participants utilized two study treatments (A and B). Study treatment A administered as one spray in each nostril, and study treatment B administered as one spray in one nostril.

Randomized to Ketorolac, A=Ketorolac, B=Placebo Randomized to Sumatriptan, A=Placebo, B=Sumatriptan Randomized to Placebo, A=Placebo, B=Placebo

Conditions
Migraines
Being tested
Ketorolac, Sumatriptan, Placebo
Medical subject headings
Migraine Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • KetorolacDrug

    Also called Sprix

    Single dose of Ketorolac (Sprix) nasal spray 31.5 mg, one spray in each nostril for an acute migraine attack.

  • SumatriptanDrug

    Also called Imitrex

    Sumatriptan (Imitrex) 20 mg one single dose of nasal spray for an acute migraine attack.

  • PlaceboDrug

    Placebo one spray in each nostril and placebo one nasal spray.

Study groups in NCT01807234
Study groupRoleWhat they receive
Ketorolac/PlaceboExperimentalKetorolac 31.5 mg single dose nasal spray and Placebo
Receives: Drug: Ketorolac; Drug: Placebo
Sumatriptan/PlaceboExperimentalSumatriptan 20 mg single dose nasal spray and placebo
Receives: Drug: Sumatriptan; Drug: Placebo
Ketorolac Placebo/Sumatriptan placeboPlacebo comparatorsingle dose Ketorolac placebo, single dose Sumatriptan placebo
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 2- Hour Pain Relief

    The primary outcome was 2-hour headache relief; headache relief was defined as headache pain from moderate or severe pain to none or mild pain. Pain was assessed using a 4-point scale (none, mild, moderate, and severe)

    Measured: 2 hours

Secondary outcomes (9)

  1. Pain Freedom

    1. Pain Freedom: Pain Freedom at 2 hours is defined as being free of pain. Pain was assessed using a 4-point scale (none, mild, moderate, and severe).

    Measured: 2-hours

  2. Absence of Photophobia

    1. Defined as reduction of photophobia to none. Symptom was assessed using a 4-point scale (none, mild, moderate, and severe)

    Measured: 2-hours

  3. Absence of Phonophobia

    1. Defined as reduction of phonophobia to none. Symptom was assessed using a 4-point scale (none, mild, moderate, and severe)

    Measured: 2-hours

  4. Absence of Nausea

    1. Defined as reduction of nausea to none. Symptom was assessed using a 4-point scale (none, mild, moderate, and severe)

    Measured: 2-hours

  5. Absence of Allodynia

    1. Absence of allodynia The presence of allodynia was assessed based on a series of 8 questions inquiring as to the presence of allodynia. Participants answering 2 or more questions positively were considered to have allodynia.

    Measured: 2-hours

  6. Self-assessment of Disability: Percentage of Participants With Moderate or Severe Disability

    Participants' self-assessment of disability was assessed using 4-point scales (none, mild, moderate, and severe). A binary outcome variable was created grouping none and mild vs moderate to severe. .

    Measured: 2-hours

  7. Sustained Pain Relief (SPR)

    1. 24 and 48 hours sustained pain relief (SPR) Defined as the reduction of pain to none or mild from moderate or severe, on a 4-point scale (none, mild, moderate, and severe).

    Measured: 24 and 48 hours

  8. Sustained Pain Freedom (SPF)

    1. 24 and 48 hours sustained pain freedom (SPF); Defined as the reduction of pain to none. Pain was assessed using a 4-point scale (none, mild, moderate, and severe).

    Measured: 24 and 48 hours

  9. Time to Pain Relief

    1. The time, in minutes, will be measured from the time study drug is taken to the time when significant pain relief is first observed and maintained through 2 hours with no rescue medication use at or prior to this point.

    Measured: following each treated migraine attack

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Mar 2013 (estimated)
  2. Study startFeb 2013
  3. Primary completionDec 2014
  4. Study completionDec 2014

Resources

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
72 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01807234
Sponsor's protocol ID
NA00075486
Acronym
KSPN
Status last verified
Mar 2017
First submitted
6 Mar 2013
Last updated
13 Mar 2017
Data monitoring committee
No
Individual data sharing
Undecided

Publications

  • Rao AS, Gelaye B, Kurth T, Dash PD, Nitchie H, Peterlin BL. A Randomized Trial of Ketorolac vs. Sumatripan vs. Placebo Nasal Spray (KSPN) for Acute Migraine. Headache. 2016 Feb;56(2):331-40. doi: 10.1111/head.12767. Epub 2016 Feb 3.

    PubMed 26840902

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Ketorolac and Sumatriptan in people with Migraines, run by Johns Hopkins University 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 2 inclusion and 24 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: finished, as of the sponsor's last update on 13 Mar 2017. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Mar 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

2- Hour Pain Relief (time frame: 2 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01807234, which also lists 1 linked publication.

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 13 Mar 2017.

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