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

NCT01807234 | Completed Phase 4 Results

• 1 other identifier: NA00075486
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Migraines

Outcome Measures

Primary Outcomes (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)

  2 hours

Secondary Outcomes (9)

• Pain Freedom

  2-hours

• Absence of Photophobia

  2-hours

• Absence of Phonophobia

  2-hours

• Absence of Nausea

  2-hours

• Absence of Allodynia

  2-hours

Study Arms (3)

Ketorolac/Placebo

EXPERIMENTAL

Ketorolac 31.5 mg single dose nasal spray and Placebo

Drug: Ketorolac; Drug: Placebo

Sumatriptan/Placebo

EXPERIMENTAL

Sumatriptan 20 mg single dose nasal spray and placebo

Drug: Sumatriptan; Drug: Placebo

Ketorolac Placebo/Sumatriptan placebo

PLACEBO COMPARATOR

single dose Ketorolac placebo, single dose Sumatriptan placebo

Drug: Placebo

Interventions

Ketorolac DRUG

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

Also known as: Sprix

Ketorolac/Placebo

Sumatriptan DRUG

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

Also known as: Imitrex

Sumatriptan/Placebo

Placebo DRUG

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

Ketorolac Placebo/Sumatriptan placebo; Ketorolac/Placebo; Sumatriptan/Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• At the Screening Visit, a subject must meet the following criteria to participate in this study:
• 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).
• 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
• Physician diagnosis of any pain syndrome other than migraine

Sponsors & Collaborators

• Johns Hopkins University: lead
• American Regent, Inc.: collaborator

Study Sites (1)

The Johns Hopkins Bayview Headache Center

Baltimore, Maryland, 21224, United States

Location

Related Publications (1)

• 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.

  PMID: 26840902 DERIVED

MeSH Terms

Conditions

Migraine Disorders

Interventions

Ketorolac; Sumatriptan

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Indomethacin; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Sulfonamides; Amides; Organic Chemicals; Sulfones; Sulfur Compounds; Tryptamines

Limitations and Caveats

Small study size (n=54)

Results Point of Contact

• Title: Dr. B. Lee Peterlin
• Organization: Johns Hopkins University School of Medicine

hnitchi1@jhmi.edu

410-550-9550

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, The Johns Hopkins Bayview Headache Research

Study Record Dates

• First Submitted: March 6, 2013
• First Posted: March 8, 2013
• Study Start: February 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: March 13, 2017
• Results First Posted: March 13, 2017

Record last verified: 2017-03

Locations

US (1)