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Interim analysis lack-of-effect stopping condition was met
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| Name | Class |
|---|---|
| Qmed Consulting A/S | INDUSTRY |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active device | Active Comparator |
| |
| Sham device | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Partial Rebreathing Device | Device | Partial Rebreathing Device |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 2 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Freedom at 2 Hours (PF2) | The percentage of attacks with absence of headache pain two hours after treatment initiation | 2 hours |
| Freedom From Most Bothersome Symptom at 2 Hours (MBSF2) | The percentage of attacks with absence of MBS two hours after treatment initiation |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University - Stanford Headache Clinic | Palo Alto | California | 94304 | United States | ||
| Profound Research-Southern California Neurology Consultants |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41272403 | Derived | Gaul C, Ferreira S, Johansen T. Partial rebreathing is not effective for early treatment of migraine with aura attacks: Results of a double-blind, randomized, controlled trial (PAREMA1). Headache. 2026 Feb;66(2):417-427. doi: 10.1111/head.15090. Epub 2025 Nov 21. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Active Device | Partial Rebreathing Device: Partial Rebreathing Device |
| FG001 | Sham Device | Sham breathing device: Sham breathing device |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Active Device | Partial Rebreathing Device: Partial Rebreathing Device |
| BG001 | Sham Device | Sham breathing device: Sham breathing device |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Each participant could report more than one attack. In the study, 67 participants reported a total of 136 attacks. | Posted | Number | percentage of attacks | 2 hours | Number of attacks | Number of attacks |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Active Device | Partial Rebreathing Device: Partial Rebreathing Device | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Heavy salivation | General disorders | Non-systematic Assessment | Sham device |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Troels Johansen | Rehaler A/S | 004540977313 | tj@rehaler.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 5, 2024 | Feb 11, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 9, 2024 | Feb 11, 2025 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D020325 | Migraine with Aura |
| ID | Term |
|---|---|
| D008881 | Migraine Disorders |
| D051270 | Headache Disorders, Primary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
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Prospective, multi-centre, randomized, double-blind, sham-controlled, parallel-group, group-sequential study
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Sham device
| Sham breathing device |
| Device |
Sham breathing device |
|
| 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 | 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. | 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. | 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. | 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) | 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) | 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. | 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. | 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. | 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 | 48 hours |
| Pasadena |
| California |
| 91105 |
| United States |
| Artemis Institute for Clinical Research | Riverside | California | 92503 | United States |
| Yale University | New Haven | Connecticut | 06519 | United States |
| MedStar Health Research Institute | Washington D.C. | District of Columbia | 20010 | United States |
| University of Miami | Miami | Florida | 33136 | United States |
| PharmaSite Research | Baltimore | Maryland | 21208 | United States |
| Clinvest Research | Springfield | Missouri | 65807 | United States |
| Thomas Jefferson University Hospital | Philadelphia | Pennsylvania | 33136 | United States |
| Charité University Hospital | Berlin | 10117 | Germany |
| Essen University Hospital-West German Headache Center | Essen | 45147 | Germany |
| Frankfurt Headache Center | Frankfurt | 65929 | Germany |
| University Hospital Freiburg | Freiburg im Breisgau | 79106 | Germany |
| Jena University Hospital | Jena | 07747 | Germany |
| Munich University Hospital | Munich | 80336 | Germany |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
| Number of attacks |
|
|
| Secondary | Pain Freedom at 2 Hours (PF2) | The percentage of attacks with absence of headache pain two hours after treatment initiation | Each participant could report more than one attack. In the study, 67 participants reported a total of 136 attacks. | Posted | Number | percentage of attacks | 2 hours | Number of attacks | Number of attacks |
|
|
|
| Secondary | Freedom From Most Bothersome Symptom at 2 Hours (MBSF2) | The percentage of attacks with absence of MBS two hours after treatment initiation | Each participant could report more than one attack. In the study, 67 participants reported a total of 136 attacks. | Posted | Number | percentage of attacks | 2 hours | Number of attacks | Number of attacks |
|
|
|
| Secondary | 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 | Each participant could report more than one attack. In the study, 67 participants reported a total of 136 attacks. | Posted | Number | percentage of attacks | 24 hours | Number of attacks | Number of attacks |
|
|
|
| Secondary | 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. | Each participant could report more than one attack. In the study, 67 participants reported a total of 136 attacks. | Posted | Mean | Standard Deviation | score on a scale | 2 hours | Number of attacks | Number of attacks |
|
|
|
| Secondary | 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. | Each participant could report more than one attack. In the study, 67 participants reported a total of 136 attacks. | Posted | Mean | Standard Deviation | score on a scale | 2 hours | Number of attacks | Number of attacks |
|
|
|
| Secondary | 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. | Each participant could report more than one attack. In the study, 67 participants reported a total of 136 attacks. | Posted | Mean | Standard Deviation | score on a scale | 2 hours | Number of attacks | Number of attacks |
|
|
|
| Secondary | 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) | Each participant could report more than one attack. In the study, 67 participants reported a total of 136 attacks. | Posted | Number | percentage of attacks | 24 hours | Number of attacks | Number of attacks |
|
|
|
| Secondary | 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) | Each participant could report more than one attack. In the study, 67 participants reported a total of 136 attacks. | Posted | Mean | Standard Deviation | score on a scale | 48 hours | Number of attacks | Number of attacks |
|
|
|
| Secondary | 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. | Each participant could report more than one attack. In the study, 67 participants reported a total of 136 attacks. | Posted | Mean | Standard Deviation | score on a scale | 2 hours | Number of attacks | Number of attacks |
|
|
|
| Secondary | 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. | Each participant could report more than one attack. In the study, 67 participants reported a total of 136 attacks. | Posted | Mean | Standard Deviation | score on a scale | 2 hours | Number of attacks | Number of attacks |
|
|
|
| Secondary | 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. | Each participant could report more than one attack. In the study, 67 participants reported a total of 136 attacks. | Posted | Mean | Standard Deviation | score on a scale | 2 hours | Number of attacks | Number of attacks |
|
|
|
| Secondary | 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 | Each participant could report more than one attack. In the study, 67 participants reported a total of 136 attacks. | Posted | Number | percentage of attacks | 48 hours | Number of attacks | Number of attacks |
|
|
|
| 72 |
| 0 |
| 72 |
| 2 |
| 72 |
| EG001 | Sham Device | Sham breathing device: Sham breathing device | 0 | 70 | 0 | 70 | 2 | 70 |
| Heavy breathing | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Dry mouth | General disorders | Non-systematic Assessment |
|
Not provided
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| D002493 |
| Central Nervous System Diseases |
| D009422 | Nervous System Diseases |