Trial Outcomes & Findings for PArtial REbreathing for Migraine With Aura 1 (NCT NCT05546385)

NCT ID: NCT05546385

Last Updated: 2025-03-25

Results Overview

The percentage of attacks in which the participant reported absence of headache of moderate or severe intensity at 2 hours post-treatment initiation

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 142 participants
• Primary outcome timeframe: 2 hours
• Results posted on: 2025-03-25

Participant Flow

Participant milestones

Measure	Active Device Partial Rebreathing Device: Partial Rebreathing Device	Sham Device Sham breathing device: Sham breathing device
Overall Study STARTED	72	70
Overall Study COMPLETED	13	15
Overall Study NOT COMPLETED	59	55

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

PArtial REbreathing for Migraine With Aura 1

Baseline characteristics by cohort

Measure	Active Device n=72 Participants Partial Rebreathing Device: Partial Rebreathing Device	Sham Device n=70 Participants Sham breathing device: Sham breathing device	Total n=142 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	72 Participants n=5 Participants	70 Participants n=7 Participants	142 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	38.10 years STANDARD_DEVIATION 10.32 • n=5 Participants	40.31 years STANDARD_DEVIATION 11.38 • n=7 Participants	39.19 years STANDARD_DEVIATION 10.87 • n=5 Participants
Sex: Female, Male Female	62 Participants n=5 Participants	55 Participants n=7 Participants	117 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	15 Participants n=7 Participants	25 Participants n=5 Participants
Race/Ethnicity, Customized Asian	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Race/Ethnicity, Customized Black/African-American	7 Participants n=5 Participants	6 Participants n=7 Participants	13 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic/Latino	6 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants
Race/Ethnicity, Customized White/Caucasian	53 Participants n=5 Participants	54 Participants n=7 Participants	107 Participants n=5 Participants
Race/Ethnicity, Customized Other	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Region of Enrollment United States	55 participants n=5 Participants	55 participants n=7 Participants	110 participants n=5 Participants
Region of Enrollment Germany	17 participants n=5 Participants	15 participants n=7 Participants	32 participants n=5 Participants

PRIMARY outcome

Timeframe: 2 hours

Population: Each participant could report more than one attack. In the study, 67 participants reported a total of 136 attacks.

The percentage of attacks in which the participant reported absence of headache of moderate or severe intensity at 2 hours post-treatment initiation

Outcome measures

Measure	Active Device n=70 Number of attacks Partial Rebreathing Device: Partial Rebreathing Device	Sham Device n=66 Number of attacks Sham breathing device: Sham breathing device
Absence of Moderate or Severe Pain at 2 Hours (AMSP2)	60.0 percentage of attacks	69.7 percentage of attacks

SECONDARY outcome

Timeframe: 2 hours

Population: Each participant could report more than one attack. In the study, 67 participants reported a total of 136 attacks.

The percentage of attacks with absence of headache pain two hours after treatment initiation

Outcome measures

Measure	Active Device n=70 Number of attacks Partial Rebreathing Device: Partial Rebreathing Device	Sham Device n=66 Number of attacks Sham breathing device: Sham breathing device
Pain Freedom at 2 Hours (PF2)	21.4 percentage of attacks	18.2 percentage of attacks

SECONDARY outcome

Timeframe: 2 hours

Population: Each participant could report more than one attack. In the study, 67 participants reported a total of 136 attacks.

The percentage of attacks with absence of MBS two hours after treatment initiation

Outcome measures

Measure	Active Device n=70 Number of attacks Partial Rebreathing Device: Partial Rebreathing Device	Sham Device n=66 Number of attacks Sham breathing device: Sham breathing device
Freedom From Most Bothersome Symptom at 2 Hours (MBSF2)	37.1 percentage of attacks	39.7 percentage of attacks

SECONDARY outcome

Timeframe: 24 hours

Population: Each participant could report more than one attack. In the study, 67 participants reported a total of 136 attacks.

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

Outcome measures

Measure	Active Device n=70 Number of attacks Partial Rebreathing Device: Partial Rebreathing Device	Sham Device n=66 Number of attacks Sham breathing device: Sham breathing device
Sustained Pain Freedom at 24 Hours (SPF24)	16.7 percentage of attacks	15.9 percentage of attacks

SECONDARY outcome

Timeframe: 2 hours

Population: Each participant could report more than one attack. In the study, 67 participants reported a total of 136 attacks.

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.

Outcome measures

Measure	Active Device n=70 Number of attacks Partial Rebreathing Device: Partial Rebreathing Device	Sham Device n=66 Number of attacks Sham breathing device: Sham breathing device
Headache Score at 2 Hours (HS2)	1.29 score on a scale Standard Deviation 0.92	1.21 score on a scale Standard Deviation 0.85

SECONDARY outcome

Timeframe: 2 hours

Population: Each participant could report more than one attack. In the study, 67 participants reported a total of 136 attacks.

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.

Outcome measures

Measure	Active Device n=70 Number of attacks Partial Rebreathing Device: Partial Rebreathing Device	Sham Device n=66 Number of attacks Sham breathing device: Sham breathing device
Most Bothersome Symptom Score at 2 Hours (MBS2).	0.87 score on a scale Standard Deviation 0.83	0.95 score on a scale Standard Deviation 0.99

SECONDARY outcome

Timeframe: 2 hours

Population: Each participant could report more than one attack. In the study, 67 participants reported a total of 136 attacks.

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.

Outcome measures

Measure	Active Device n=70 Number of attacks Partial Rebreathing Device: Partial Rebreathing Device	Sham Device n=66 Number of attacks Sham breathing device: Sham breathing device
Functional Disability Score at 2 Hours (FDS2)	0.77 score on a scale Standard Deviation 0.87	0.88 score on a scale Standard Deviation 1.06

SECONDARY outcome

Timeframe: 24 hours

Population: Each participant could report more than one attack. In the study, 67 participants reported a total of 136 attacks.

The percentage of attacks with use of rescue medication from the 2 hours' time point until 24 hours (Res24)

Outcome measures

Measure	Active Device n=70 Number of attacks Partial Rebreathing Device: Partial Rebreathing Device	Sham Device n=66 Number of attacks Sham breathing device: Sham breathing device
Attacks With Use of Rescue Medication From the 2 Hours' Time Point Until 24 Hours (Res24)	53.7 percentage of attacks	34.4 percentage of attacks

SECONDARY outcome

Timeframe: 48 hours

Population: Each participant could report more than one attack. In the study, 67 participants reported a total of 136 attacks.

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)

Outcome measures

Measure	Active Device n=70 Number of attacks Partial Rebreathing Device: Partial Rebreathing Device	Sham Device n=66 Number of attacks Sham breathing device: Sham breathing device
Participant Satisfaction at 48 Hours (PS48)	3.72 score on a scale Standard Deviation 1.17	3.65 score on a scale Standard Deviation 1.14

SECONDARY outcome

Timeframe: 2 hours

Population: Each participant could report more than one attack. In the study, 67 participants reported a total of 136 attacks.

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.

Outcome measures

Measure	Active Device n=70 Number of attacks Partial Rebreathing Device: Partial Rebreathing Device	Sham Device n=66 Number of attacks Sham breathing device: Sham breathing device
Light Sensitivity Score at 2 Hours (LSS2)	0.89 score on a scale Standard Deviation 0.83	0.86 score on a scale Standard Deviation 0.97

SECONDARY outcome

Timeframe: 2 hours

Population: Each participant could report more than one attack. In the study, 67 participants reported a total of 136 attacks.

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.

Outcome measures

Measure	Active Device n=70 Number of attacks Partial Rebreathing Device: Partial Rebreathing Device	Sham Device n=66 Number of attacks Sham breathing device: Sham breathing device
Nausea Score at 2 Hours (NS2)	0.36 score on a scale Standard Deviation 0.57	0.56 score on a scale Standard Deviation 0.86

SECONDARY outcome

Timeframe: 2 hours

Population: Each participant could report more than one attack. In the study, 67 participants reported a total of 136 attacks.

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.

Outcome measures

Measure	Active Device n=70 Number of attacks Partial Rebreathing Device: Partial Rebreathing Device	Sham Device n=66 Number of attacks Sham breathing device: Sham breathing device
Sound Sensitivity Score at 2 Hours (SSS2)	0.64 score on a scale Standard Deviation 0.82	0.64 score on a scale Standard Deviation 0.82

SECONDARY outcome

Timeframe: 48 hours

Population: Each participant could report more than one attack. In the study, 67 participants reported a total of 136 attacks.

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

Outcome measures

Measure	Active Device n=70 Number of attacks Partial Rebreathing Device: Partial Rebreathing Device	Sham Device n=66 Number of attacks Sham breathing device: Sham breathing device
Freedom From Relapse at 48 Hours (FR48)	10.2 percentage of attacks	16.1 percentage of attacks

Adverse Events

Active Device

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Sham Device

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Active Device n=72 participants at risk Partial Rebreathing Device: Partial Rebreathing Device	Sham Device n=70 participants at risk Sham breathing device: Sham breathing device
General disorders Heavy salivation	0.00% 0/72 • Variable between patients according to their enrolment date (earliest enrolled patients had longer period to report data than latest enrolled patients). Patient with longest duration of period for collecting adverse event = 449 days. Patient with shortest duration of period for collecting adverse event = 14 days.	1.4% 1/70 • Number of events 1 • Variable between patients according to their enrolment date (earliest enrolled patients had longer period to report data than latest enrolled patients). Patient with longest duration of period for collecting adverse event = 449 days. Patient with shortest duration of period for collecting adverse event = 14 days.
Respiratory, thoracic and mediastinal disorders Heavy breathing	2.8% 2/72 • Number of events 2 • Variable between patients according to their enrolment date (earliest enrolled patients had longer period to report data than latest enrolled patients). Patient with longest duration of period for collecting adverse event = 449 days. Patient with shortest duration of period for collecting adverse event = 14 days.	0.00% 0/70 • Variable between patients according to their enrolment date (earliest enrolled patients had longer period to report data than latest enrolled patients). Patient with longest duration of period for collecting adverse event = 449 days. Patient with shortest duration of period for collecting adverse event = 14 days.
General disorders Dry mouth	0.00% 0/72 • Variable between patients according to their enrolment date (earliest enrolled patients had longer period to report data than latest enrolled patients). Patient with longest duration of period for collecting adverse event = 449 days. Patient with shortest duration of period for collecting adverse event = 14 days.	1.4% 1/70 • Number of events 3 • Variable between patients according to their enrolment date (earliest enrolled patients had longer period to report data than latest enrolled patients). Patient with longest duration of period for collecting adverse event = 449 days. Patient with shortest duration of period for collecting adverse event = 14 days.

Additional Information

Troels Johansen

Rehaler A/S

Phone: 004540977313

Email: tj@rehaler.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place