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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01662492 | A Study Using Botulinum Toxin Type A as Headache Prophylaxis in Adolescents With Chronic Migraine | PHASE3 | COMPLETED | 125 | — | — | Oct 1, 2012 | Aug 1, 2016 | Sep 5, 2017 | 22 | United States |
| NCT00168428 | A Study Using Botulinum Toxin Type A as Headache Prophylaxis for Migraine Patients With Frequent Headaches | PHASE3 | COMPLETED | 705 | — | — | Mar 1, 2006 | Aug 1, 2008 | Nov 18, 2013 | 6 | United States, Canada +4 |
| NCT00156910 | A Study Using Botulinum Toxin Type A as Headache Prophylaxis for Migraine Patients With Frequent Headaches | PHASE3 | COMPLETED | 679 | — | — | Feb 1, 2006 | Jul 1, 2008 | Nov 18, 2013 | 2 | United States, Canada |
Change from baseline in the frequency of headache days during the 28-day period, ending with Week 12 in the Intent-to-Treat population. A headache day for a patient is defined as a calendar day with 1 or more total hours of headache as recorded by the patient in the electronic diary.
Mean change from baseline in frequency (number) of headache days during the 28 day period ending with Week 24. Headache day defined as a calendar day \[00:00 to 23:59\] for which the patient reported \>= 4 continuous hours of headache.
Mean change from baseline in frequency (number) of headache episodes during the 28 day period ending with Week 24. Headache episode defined as patient-reported headache with a start and stop time indicating that the pain lasted \>= 4 continuous hours.
| Arm | Type | Description |
|---|---|---|
| Botulinum toxin type A Dose 1 | EXPERIMENTAL | Botulinum toxin type A Dose 1 intramuscular injections into specified muscles. |
| Botulinum toxin type A Dose 2 | EXPERIMENTAL | Botulinum toxin type A Dose 2 intramuscular injections into specified muscles. |
| Placebo (Normal Saline) | PLACEBO_COMPARATOR | Placebo (Normal Saline) intramuscular injections into specified muscles. |
| botulinum toxin Type A | EXPERIMENTAL | Two treatment sessions in the double-blind phase and three treatment sessions in the open-label extension phase. Total minimum dose is 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas with the total maximum dose of 195 U with 39 head/neck injections. |
| Placebo (saline) | PLACEBO_COMPARATOR | Two treatment sessions in the double-blind phase. Total minimum dose in 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas and the total maximum dose is 195 U with 39 head/neck injections. |
| Name | Type | Description |
|---|---|---|
| Botulinum toxin type A Dose 1 | BIOLOGICAL | Botulinum toxin type A Dose 1 intramuscular injections into specified muscles. |
| Botulinum toxin type A Dose 2 | BIOLOGICAL | Botulinum toxin type A Dose 2 intramuscular injections into specified muscles. |
| Placebo (Normal Saline) | DRUG | Placebo (Normal Saline) intramuscular injections into specified muscles. |
| Botulinum Toxin Type A | BIOLOGICAL | Two treatment sessions in the double-blind phase and three treatment sessions in the open-label phase. Total minimum dose is 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas with the total maximum dose of 195 U with 39 head/neck injections. |
| placebo (saline) | OTHER | Two treatment sessions in the double-blind phase. Total minimum dose in 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas and the total maximum dose is 195 U with 39 head/neck injections. |
Inclusion Criteria: * Medical history of chronic migraine for at least 6 months * 15 or more headache days during a 4 week period Exclusion Criteria: * Previous use of any botulinum toxin of any serotype for any reason * Diagnosis of Myasthenia gravis, Eaton-Lambert Syndrome, Amyotrophic Lateral ...