Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05175521
Other study ID # 1718502
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 11, 2021
Est. completion date December 23, 2024

Study information

Verified date October 2023
Source HonorHealth Research Institute
Contact Angelina Cooper
Phone 480-583-3193
Email ancooper@honorhealth.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The goal of this study is to compare the efficacy and adverse events of inhaled isopropyl alcohol vapor (IAV) versus placebo (inhaled eucalyptus scent (IES) (1:20 dilution in mineral oil) for treating nausea associated with acute migraine attacks.


Description:

The main goal of this study is to examine the efficacy of (nausea reduction and time to use of other anti-nausea medications) and side effects of inhaled isopropyl alcohol vapor (IAV) for treating nausea among migraine patients using a double blind randomized control methodology. IAV is being compared inhaled eucalyptus scent (IES) (1:20 dilution in mineral oil) which has not shown benefit for treating nausea or migraine and is therefore considered placebo in this study.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date December 23, 2024
Est. primary completion date July 23, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Patients 18 to 65 years old with nausea associated migraines at least twice per month Exclusion Criteria: - Patients <18 or >65 years old - Patients without a diagnosis of acute migraine

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Eucalyptus Oil Scent
Eucalyptus oil in mineral (1:20) will be inhaled at least 30 minutes after onset of nausea associated with a migraine attack
Isopropyl Alcohol Vapors
Isopropyl Alcohol 70% will be inhaled at least 30 minutes after onset of nausea associated with a migraine attack

Locations

Country Name City State
United States HonorHealth Bob Bové Neuroscience Institute Scottsdale Arizona

Sponsors (1)

Lead Sponsor Collaborator
HonorHealth Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change of Severity of Nausea on Nausea Scale Change in Nausea, modified visual analog score from 0-10 with 10 severe nausea with vomiting, 5 moderate nausea, 1 mild nausea and 0 no nausea. ½ hour or to the end of treatment
Secondary Side effects associated with interventional substance Patient written report ½ hour, but likely less than 2 hours
Secondary Use of anti-nausea medication/Time to use of anti-nausea medication Did using IAV vs eucalyptus oil change the time until use of oral anti-emetic? ½ hour or to the end of treatment
Secondary Time to Clinically Relevant Nausea Change Did IAV vs eucalyptus oil reduce the amount of time the patient experienced nausea with their migraine? ½ hour or to the end of treatment
See also
  Status Clinical Trial Phase
Completed NCT05525611 - Cabergoline as a Preventive Treatment for Chronic Migraine N/A
Completed NCT06192173 - Patent Foramen Ovale Closure in Migraine
Recruiting NCT03832998 - Efficacy and Safety of Erenumab in Pediatric Subjects With Chronic Migraine Phase 3
Enrolling by invitation NCT04196933 - Analysis of Vestibular Compensation Following Clinical Intervention for Vestibular Schwannoma N/A
Not yet recruiting NCT06428838 - Eptinezumab as an Adjunct to Standard of Care for Migraine in an Acute Emergency Context Phase 3
Completed NCT06304675 - Manageable Environmental Factors in Migraine
Completed NCT04084314 - Assessment of Prolonged Safety and tOLerability of in Migraine Patients in a Long-term OpeN-label Study Phase 4
Recruiting NCT05517200 - Pilot Study for a Machine Learning Test for Migraine
Completed NCT04179474 - Safety, Tolerability and Drug- Drug Interaction Study of Ubrogepant With Erenumab or Galcanezumab in Participants With Migraine Phase 1
Recruiting NCT04603976 - Registry for Migraine - Clinical Core Phase 4
Completed NCT03597529 - CHOCOlate MeLatonin for AdolescenT MigrainE Phase 2
Completed NCT04197349 - Safety, Tolerability and Pharmacokinetics of ALD1910 in Healthy Men and Woman Phase 1
Recruiting NCT05891808 - miR-155 Expression in Episodic and Chronic Migraine
Active, not recruiting NCT05064371 - Long-Term Extension Study With Eptinezumab as Preventive Treatment in Participants With Migraine in Japan Phase 3
Suspended NCT04069572 - Vibratory Stimulation for the Treatment of Chronic Pain N/A
Not yet recruiting NCT04859374 - Chronic Pain and Conditioned Pain Modulation After on Line-behavioral Approach N/A
Not yet recruiting NCT03083860 - Evaluation of Migraine Management Mobile App Combined With Electrophysiological Measurements for Identification of Migraine Attack Risk and Beneficial Preventive Actions. N/A
Completed NCT02905227 - A Study of the Pulmonary Safety and Pharmacokinetics of Zolmitriptan Inhalation Powder Phase 1
Enrolling by invitation NCT02532023 - The Combined Effects of omega3 Fatty Acids and Curcumin Supplementation on Inflammatory and Endothelial Factors in Migraine Patients Phase 4
Completed NCT02108678 - One-Day Intervention for Depression and Impairment in Migraine Patients N/A