A Phase 3 interventional study of MAP0004 and Placebo in Migraine Disorders, sponsored by Allergan. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2014-01-09.
Sponsored by Allergan · Phase 3, Interventional, and Treatment
This is a randomized, double blind, placebo controlled, parallel group study of MAP0004 in adult migraineurs. Subjects will self administer study drug in the outpatient setting.
1,528 studies on the registry are indexed under Migraine Disorders; 299 are open to participants now.
This study's enrollment of 902 is above the median of 80 across 1,175 interventional studies indexed under Migraine Disorders.
Browse Migraine Disorders studies →Allergan is the lead sponsor of 499 studies on the registry; none are open to participants now.
Of its 91 completed or terminated interventional studies of FDA-regulated products, 89 (98%) have results posted.
Counted across the registry records on this site, refreshed daily.
Major Inclusion Criteria:
Major Exclusion Criteria:
MAP0004 1.0mg inhaled to treat a qualifying migraine up to 8 weeks followed by MAP0004 1.0mg inhaled to treat qualifying migraines for up to an additional 52 weeks.
Drug: MAP0004
Placebo 1.0mg inhaled to treat a qualifying migraine up to 8 weeks followed by MAP0004 1.0mg inhaled to treat qualifying migraines for up to 52 weeks.
Drug: MAP0004 · Drug: Placebo
MAP0004 1.0mg inhaled to treat a qualifying migraine up to 8 weeks followed by MAP0004 1.0mg inhaled to treat qualifying migraines for up to an additional 52 weeks. Placebo treated patients will receive MAP0004 1.0mg inhaled to treat qualifying migraines for up to 52 weeks only.
Placebo 1.0mg inhaled to treat a qualifying migraine up to 8 weeks.
Number of Subjects With Pain Relief at 2 Hours From Time of First Dose
Pain relief at 2 hours was defined as change in rating from severe or moderate (score 3 or 2) to a rating of none or mild (score 0 or 1) at the 2-hour time point and no usage of rescue medications from the time of first dose to 2 hours. The 4-point scale from the International Headache Society was used: 0 = none; 1 = mild symptom, not interfering with normal daily activities; 2 = moderate symptom, causing some restriction to normal activities; 3 = severe, leading to inability to perform daily activities
Time frame: 2 hours from time of first dose
Number of Subjects Photophobia Free at 2 Hours From Time of First Dose
Photophobia free at 2 hours was defined as a rating of none (score 0) at the 2-hour time point and no usage of rescue medications from the time of first dose to 2 hours. The 4-point scale from the International Headache Society was used: 0 = none; 1 = mild symptom, not interfering with normal daily activities; 2 = moderate symptom, causing some restriction to normal activities; 3 = severe, leading to inability to perform daily activities
Time frame: 2 hours from time of first dose
Number of Subjects Phonophobia Free at 2 Hours From Time of First Dose
Phonophobia free at 2 hours was defined as a rating of none (score 0) at the 2-hour time point and no usage of rescue medications from the time of first dose to 2 hours. The 4-point scale from the International Headache Society was used: 0 = none; 1 = mild symptom, not interfering with normal daily activities; 2 = moderate symptom, causing some restriction to normal activities; 3 = severe, leading to inability to perform daily activities
Time frame: 2 hours from time of first dose
Number of Subjects Nausea Free at 2 Hours From Time of First Dose
Nausea free was defined as a rating of none (score 0) at the 2-hour time point and no usage of rescue medications from the time of first dose to 2 hours post-dose. The 4-point scale from the International Headache Society was used: 0 = none; 1 = mild symptom, not interfering with normal daily activities; 2 = moderate symptom, causing some restriction to normal activities; 3 = severe, leading to inability to perform daily activities
Time frame: 2 hours from time of first dose
Number of Subjects With Sustained Pain Relief From 2 to 24 Hours
Sustained Pain Relief was defined as a rating of none or mild (score 0 or 1) at the 2-hour time point that was maintained during the 2-24 hour post-dose period and no use of rescue medication from the time of first dose to 24 hours. The 4-point scale from the International Headache Society was used: 0 = none; 1 = mild symptom, not interfering with normal daily activities; 2 = moderate symptom, causing some restriction to normal activities; 3 = severe, leading to inability to perform daily activities
Time frame: From 2 to 24 hours from time of first dose
Number of Subjects Whose Time to Pain Relief Occurred Within 2 Hours
The number of subjects who reported pain relief (score of 0 or 1) at any time within the 2 hours following the time of first dose and who did not use rescue medication on or prior to this point. Subjects who did not reach pain relief by the end of the time period were not included. The 4-point scale from the International Headache Society was used: 0 = none; 1 = mild symptom, not interfering with normal daily activities; 2 = moderate symptom, causing some restriction to normal activities; 3 = severe, leading to inability to perform daily activities
Time frame: 2 hours from the first dose
Number of Subjects With Pain Relief at 4 Hours
Pain Relief at 4 hours was defined as a change in rating from severe or moderate (score 3 or 2) to none or mild (score 0 or 1) at the 4-hour time point and no use of rescue medication from the time of first dose to 4 hours. The 4-point scale from the International Headache Society was used: 0 = none; 1 = mild symptom, not interfering with normal daily activities; 2 = moderate symptom, causing some restriction to normal activities; 3 = severe, leading to inability to perform daily activities
Time frame: 4 hours from time of first dose
Number of Subjects With Pain Relief at 10 Minutes
Pain Relief at 10 minutes was defined as a change in rating from severe or moderate (score 3 or 2) to none or mild (score 0 or 1) at the 10 minute time point and no use of rescue medication from the time of first dose to 2 hours. The 4-point scale from the International Headache Society was used: 0 = none; 1 = mild symptom, not interfering with normal daily activities; 2 = moderate symptom, causing some restriction to normal activities; 3 = severe, leading to inability to perform daily activities
Time frame: 2 hours from time of first dose
| Milestone | Placebo | MAP0004 |
|---|---|---|
| Started | 452 | 450 |
| Completed | 419 | 422 |
| Not completed | 33 | 28 |
| Milestone | Placebo | MAP0004 |
|---|---|---|
| Started | 0 | 675 |
| Completed | 0 | 263 |
| Not completed | 0 | 412 |
Pain relief at 2 hours was defined as change in rating from severe or moderate (score 3 or 2) to a rating of none or mild (score 0 or 1) at the 2-hour time point and no usage of rescue medications from the time of first dose to 2 hours. The 4-point scale from the International Headache Society was used: 0 = none; 1 = mild symptom, not interfering with normal daily activities; 2 = moderate symptom, causing some restriction to normal activities; 3 = severe, leading to inability to perform daily activities
| participants | Placebo | MAP0004 |
|---|---|---|
| Number of Subjects With Pain Relief at 2 Hours From Time of First Dose | 136 | 231 |
Photophobia free at 2 hours was defined as a rating of none (score 0) at the 2-hour time point and no usage of rescue medications from the time of first dose to 2 hours. The 4-point scale from the International Headache Society was used: 0 = none; 1 = mild symptom, not interfering with normal daily activities; 2 = moderate symptom, causing some restriction to normal activities; 3 = severe, leading to inability to perform daily activities
| participants | Placebo | MAP0004 |
|---|---|---|
| Number of Subjects Photophobia Free at 2 Hours From Time of First Dose | 107 | 182 |
Phonophobia free at 2 hours was defined as a rating of none (score 0) at the 2-hour time point and no usage of rescue medications from the time of first dose to 2 hours. The 4-point scale from the International Headache Society was used: 0 = none; 1 = mild symptom, not interfering with normal daily activities; 2 = moderate symptom, causing some restriction to normal activities; 3 = severe, leading to inability to perform daily activities
| participants | Placebo | MAP0004 |
|---|---|---|
| Number of Subjects Phonophobia Free at 2 Hours From Time of First Dose | 133 | 208 |
Nausea free was defined as a rating of none (score 0) at the 2-hour time point and no usage of rescue medications from the time of first dose to 2 hours post-dose. The 4-point scale from the International Headache Society was used: 0 = none; 1 = mild symptom, not interfering with normal daily activities; 2 = moderate symptom, causing some restriction to normal activities; 3 = severe, leading to inability to perform daily activities
| participants | Placebo | MAP0004 |
|---|---|---|
| Number of Subjects Nausea Free at 2 Hours From Time of First Dose | 234 | 266 |
Sustained Pain Relief was defined as a rating of none or mild (score 0 or 1) at the 2-hour time point that was maintained during the 2-24 hour post-dose period and no use of rescue medication from the time of first dose to 24 hours. The 4-point scale from the International Headache Society was used: 0 = none; 1 = mild symptom, not interfering with normal daily activities; 2 = moderate symptom, causing some restriction to normal activities; 3 = severe, leading to inability to perform daily activities
| participants | Placebo | MAP0004 |
|---|---|---|
| Number of Subjects With Sustained Pain Relief From 2 to 24 Hours | 76 | 166 |
The number of subjects who reported pain relief (score of 0 or 1) at any time within the 2 hours following the time of first dose and who did not use rescue medication on or prior to this point. Subjects who did not reach pain relief by the end of the time period were not included. The 4-point scale from the International Headache Society was used: 0 = none; 1 = mild symptom, not interfering with normal daily activities; 2 = moderate symptom, causing some restriction to normal activities; 3 = severe, leading to inability to perform daily activities
| participants | Placebo | MAP0004 |
|---|---|---|
| Number of Subjects Whose Time to Pain Relief Occurred Within 2 Hours | 156 | 244 |
Pain Relief at 4 hours was defined as a change in rating from severe or moderate (score 3 or 2) to none or mild (score 0 or 1) at the 4-hour time point and no use of rescue medication from the time of first dose to 4 hours. The 4-point scale from the International Headache Society was used: 0 = none; 1 = mild symptom, not interfering with normal daily activities; 2 = moderate symptom, causing some restriction to normal activities; 3 = severe, leading to inability to perform daily activities
| participants | Placebo | MAP0004 |
|---|---|---|
| Number of Subjects With Pain Relief at 4 Hours | 145 | 254 |
Pain Relief at 10 minutes was defined as a change in rating from severe or moderate (score 3 or 2) to none or mild (score 0 or 1) at the 10 minute time point and no use of rescue medication from the time of first dose to 2 hours. The 4-point scale from the International Headache Society was used: 0 = none; 1 = mild symptom, not interfering with normal daily activities; 2 = moderate symptom, causing some restriction to normal activities; 3 = severe, leading to inability to perform daily activities
| participants | Placebo | MAP0004 |
|---|---|---|
| Number of Subjects With Pain Relief at 10 Minutes | 30 | 37 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Double-blind Placebo | — | 0/404 (0%) | 60/404 (14.9%) |
| Double-blind MAP0004 | — | 0/410 (0%) | 86/410 (21%) |
| Open-label MAP0004 | — | 14/638 (2.2%) | 454/638 (71.2%) |
| Event | Double-blind Placebo | Double-blind MAP0004 | Open-label MAP0004 |
|---|---|---|---|
| Suicide attemptPsychiatric disorders | 0/404 | 0/410 | 2/638 |
| Aplastic anemiaBlood and lymphatic system disorders | 0/404 | 0/410 | 1/638 |
| Acute myocardial infarctionCardiac disorders | 0/404 | 0/410 | 1/638 |
| Inguinal herniaGastrointestinal disorders | 0/404 | 0/410 | 1/638 |
| Rectal haemorrhageGastrointestinal disorders | 0/404 | 0/410 | 1/638 |
| Umbilical herniaGastrointestinal disorders | 0/404 | 0/410 | 1/638 |
| GastroenteritisInfections and infestations | 0/404 | 0/410 | 1/638 |
| AppendicitisInfections and infestations | 0/404 | 0/410 | 1/638 |
| Septic shockInfections and infestations | 0/404 | 0/410 | 1/638 |
| Decompression sicknessInjury, poisoning and procedural complications | 0/404 | 0/410 | 1/638 |
| Event | Double-blind Placebo | Double-blind MAP0004 | Open-label MAP0004 |
|---|---|---|---|
| Upper Respiratory Tract InfectionInfections and infestations | 12/404 | 11/410 | 93/638 |
| NauseaGastrointestinal disorders | 7/404 | 18/410 | 78/638 |
| NasopharyngitisInfections and infestations | 15/404 | 8/410 | 67/638 |
| SinusitisInfections and infestations | 5/404 | 3/410 | 65/638 |
| Pharmaceutical Product CompaintSocial circumstances | 11/404 | 25/410 | 51/638 |
| InfluenzaInfections and infestations | 0/404 | 3/410 | 35/638 |
| VomitingGastrointestinal disorders | 3/404 | 8/410 | 33/638 |
| CoughRespiratory, thoracic and mediastinal disorders | 7/404 | 10/410 | 32/638 |
mITT population was defined as all randomized subjects who reported a qualifying migraine and received at least one dose of study treatment, and had at least one post-treatment efficacy evaluation.
| Age, Continuous(years) | Placebo | MAP0004 | Total |
|---|---|---|---|
| Mean | 39.6 ± 11.67 | 40.5 ± 11.30 | 40.1 ± 11.49 |
| Sex: Female, Male(Participants) | Placebo | MAP0004 | Total |
|---|---|---|---|
| Female | 362 | 365 | 727 |
| Male | 35 | 32 | 67 |
This study is completed, as verified in Dec 2013. You cannot join it, but the record below documents what was studied.
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