Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00806546 | An Open-Label Study to Evaluate the Safety of NP101 in the Treatment of Acute Migraine Over Twelve Months | PHASE3 | COMPLETED | 514 | — | — | Feb 1, 2009 | May 1, 2011 | Feb 4, 2016 | 31 | United States |
| NCT00792103 | An Open-Label Study to Evaluate the Safety of NP101 in the Treatment of Acute Migraine Over 12 Months | PHASE3 | COMPLETED | 198 | — | — | Jan 1, 2009 | Sep 1, 2010 | Feb 4, 2016 | 34 | United States |
For each patch application, subjects performed a self-examination of skin irritation using a 5-point scale (0=no redness; 1=minimal skin redness; 2=moderate skin redness with sharp borders; 3=intense skin redness with or without swelling; 4=intense skin redness with blisters or broken skin).
| Arm | Type | Description |
|---|---|---|
| NP101 | EXPERIMENTAL | sumatriptan iontophoretic transdermal patch |
| Name | Type | Description |
|---|---|---|
| NP101 | DRUG | NP101 study patch four hour application |
Inclusion Criteria: * Subject is an adult male or female, age range 18 years to 65 years. * Subject has a diagnosis of migraine headache, with or without aura, as defined in the ICHD-II and the diagnosis was made before the age of 50. * Subject experiences mild to severe headaches during a migraine...