ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01807234
Recruitment Status : Completed
First Posted : March 8, 2013
Results First Posted : March 13, 2017
Last Update Posted : March 13, 2017
Sponsor:
Collaborator:
Luitpold Pharmaceuticals
Information provided by (Responsible Party):
Drs Barbara Peterlin, Johns Hopkins University

Brief 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.

Condition or disease Intervention/treatment Phase
Migraines Drug: Ketorolac Drug: Sumatriptan Drug: Placebo Phase 4

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


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 72 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Comparison of Ketorolac Nasal Spray to Sumatriptan Nasal Spray and Placebo for Acute Treatment of Migraine (The KSPN Migraine Study)
Study Start Date : February 2013
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Headache Migraine

Arm Intervention/treatment
Experimental: Ketorolac/Placebo
Ketorolac 31.5 mg single dose nasal spray and Placebo
Drug: Ketorolac
Single dose of Ketorolac (Sprix) nasal spray 31.5 mg, one spray in each nostril for an acute migraine attack.
Other Name: Sprix

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

Experimental: Sumatriptan/Placebo
Sumatriptan 20 mg single dose nasal spray and placebo
Drug: Sumatriptan
Sumatriptan (Imitrex) 20 mg one single dose of nasal spray for an acute migraine attack.
Other Name: Imitrex

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

Placebo Comparator: Ketorolac Placebo/Sumatriptan placebo
single dose Ketorolac placebo, single dose Sumatriptan placebo
Drug: Placebo
Placebo one spray in each nostril and placebo one nasal spray.




Primary Outcome Measures :
  1. 2- Hour Pain Relief [ Time Frame: 2 hours ]
    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)


Secondary Outcome Measures :
  1. Pain Freedom [ Time Frame: 2-hours ]
    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).

  2. Absence of Photophobia [ Time Frame: 2-hours ]
    2) Defined as reduction of photophobia to none. Symptom was assessed using a 4-point scale (none, mild, moderate, and severe)

  3. Absence of Phonophobia [ Time Frame: 2-hours ]
    3) Defined as reduction of phonophobia to none. Symptom was assessed using a 4-point scale (none, mild, moderate, and severe)

  4. Absence of Nausea [ Time Frame: 2-hours ]
    4) Defined as reduction of nausea to none. Symptom was assessed using a 4-point scale (none, mild, moderate, and severe)

  5. Absence of Allodynia [ Time Frame: 2-hours ]
    5) 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.

  6. Self-assessment of Disability: Percentage of Participants With Moderate or Severe Disability [ Time Frame: 2-hours ]
    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. .

  7. Sustained Pain Relief (SPR) [ Time Frame: 24 and 48 hours ]
    7) 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).

  8. Sustained Pain Freedom (SPF) [ Time Frame: 24 and 48 hours ]
    8) 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).

  9. Time to Pain Relief [ Time Frame: following each treated migraine attack ]
    9) 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion/Exclusion Criteria

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).

Exclusion Criteria:

  1. 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)
    • 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
  2. Physician diagnosis of any pain syndrome other than migraine
  3. Classification as treatment resistant by investigator
  4. Known drug or substance abuse
  5. Any opioid use in past 2 months
  6. Use of any medication, which could interfere with study assessments
  7. History of noncompliance with taking medication;
  8. Use of any experimental drug or device within 30 days prior to the Screening Visit (Visit 1);
  9. 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.
  10. Any history of chronic renal or hepatic disease already excluded above under number 1; plus see exclusion 9.
  11. History of chronic pulmonary disorder including nasal polyps (see 1) and asthma.
  12. 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).
  13. History of nasal surgery.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01807234


Locations
United States, Maryland
The Johns Hopkins Bayview Headache Center
Baltimore, Maryland, United States, 21224
Sponsors and Collaborators
Johns Hopkins University
Luitpold Pharmaceuticals

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Drs Barbara Peterlin, Director, The Johns Hopkins Bayview Headache Research, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT01807234     History of Changes
Other Study ID Numbers: NA00075486
First Posted: March 8, 2013    Key Record Dates
Results First Posted: March 13, 2017
Last Update Posted: March 13, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Ketorolac
Ketorolac Tromethamine
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Sumatriptan
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents