A prospective, multi-centre, randomized, double-blind, sham-controlled, parallel-group, group-sequential study to investigate safety and effectiveness of the Rehaler partial rebreathing device, in adults suffering from migraine with aura
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
142
Partial Rebreathing Device
Sham breathing device
Stanford University - Stanford Headache Clinic
Palo Alto, California, United States
Profound Research-Southern California Neurology Consultants
Pasadena, California, United States
Absence of Moderate or Severe Pain at 2 Hours (AMSP2)
The percentage of attacks in which the participant reported absence of headache of moderate or severe intensity at 2 hours post-treatment initiation
Time frame: 2 hours
Pain Freedom at 2 Hours (PF2)
The percentage of attacks with absence of headache pain two hours after treatment initiation
Time frame: 2 hours
Freedom From Most Bothersome Symptom at 2 Hours (MBSF2)
The percentage of attacks with absence of MBS two hours after treatment initiation
Time frame: 2 hours
Sustained Pain Freedom at 24 Hours (SPF24)
The percentage of attacks having no headache pain at 2 hours after treatment initiation, with no use of rescue medication and no relapse of headache pain within 24 hours
Time frame: 24 hours
Headache Score at 2 Hours (HS2)
Headache Score 2 hours after treatment initiation. Measured on Likert four-point scale: 0 = no headache; 1 = mild headache; 2 = moderate headache; 3 = severe headache.
Time frame: 2 hours
Most Bothersome Symptom Score at 2 Hours (MBS2).
Most Bothersome Symptom score two hours after treatment initiation. Measured on Likert four-point scale: 0 = symptom absent; 1 = mild degree of symptom; 2 = moderate degree of symptom; 3 = severe degree of symptom.
Time frame: 2 hours
Functional Disability Score at 2 Hours (FDS2)
Functional Disability Score two hours after treatment initiation. Measured on Likert four-point scale: 0 = no functional disability; 1 = mild functional disability; 2 = moderate functional disability; 3 = severe functional disability.
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Artemis Institute for Clinical Research
Riverside, California, United States
Yale University
New Haven, Connecticut, United States
MedStar Health Research Institute
Washington D.C., District of Columbia, United States
University of Miami
Miami, Florida, United States
PharmaSite Research
Baltimore, Maryland, United States
Clinvest Research
Springfield, Missouri, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
Charité University Hospital
Berlin, Germany
...and 5 more locations
Time frame: 2 hours
Attacks With Use of Rescue Medication From the 2 Hours' Time Point Until 24 Hours (Res24)
The percentage of attacks with use of rescue medication from the 2 hours' time point until 24 hours (Res24)
Time frame: 24 hours
Participant Satisfaction at 48 Hours (PS48)
Participant's overall satisfaction with the acute treatment effect on attack, evaluated at 48 hours after treatment initiation (5 point satisfaction scale: 5 = Satisfied, 4 = Partially Satisfied, 3 = Neutral, 2 = Partially Unsatisfied, 1 = Unsatisfied)
Time frame: 48 hours
Light Sensitivity Score at 2 Hours (LSS2)
Photophobia (light sensitivity) score two hours after treatment initiation. Measured on Likert four-point scale: 0 = no photophobia; 1 = mild photophobia; 2 = moderate photophobia; 3 = severe photophobia.
Time frame: 2 hours
Nausea Score at 2 Hours (NS2)
Nausea Score two hours after treatment initiation. Measured on Likert four-point scale: 0 = no nausea; 1 = mild nausea; 2 = moderate nausea; 3 = severe nausea.
Time frame: 2 hours
Sound Sensitivity Score at 2 Hours (SSS2)
Phonophobia (sound sensitivity) score two hours after treatment initiation. Measured on Likert four-point scale: 0 = no phonophobia; 1 = mild phonophobia; 2 = moderate phonophobia; 3 = severe phonophobia.
Time frame: 2 hours
Freedom From Relapse at 48 Hours (FR48)
The percentage of attacks having no headache pain at 2 hours after dose, with no use of rescue medication and no relapse of headache pain within 48 hours
Time frame: 48 hours