Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Botulinum toxin type A Dose 1 · 3 trials · 1 indication
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 ...
Botulinum Toxin Type A is an investigational biologic being studied for Overactive Bladder, Osteoarthritis, Migraine Disorders, Masseter Muscle Prominence, Upper Facial Rhytides, and Masseter Muscle Hypertrophy. It is in Phase 2 clinical development for these conditions.
Botulinum Toxin Type A is being developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker ABBV.
Botulinum Toxin Type A is in Phase 2 clinical development. It is an investigational drug and is not approved by the FDA. Four clinical trials have been completed, with no active trials currently ongoing.
Botulinum Toxin Type A has completed four clinical trials. These include NCT00168402 for axillary hyperhidrosis, NCT00168428 for migraine prophylaxis, NCT00168441 for postherpetic neuralgia, and NCT01662492 for chronic migraine in adolescents.
Botulinum Toxin Type A is the active ingredient in BOTOX, a brand name product. The clinical trials listed for Botulinum Toxin Type A are studying this same active substance for various indications.