Trials / Completed
CompletedNCT01662492
A Study Using Botulinum Toxin Type A as Headache Prophylaxis in Adolescents With Chronic Migraine
191622-103 BOTOX® (Botulinum Toxin Type A) Purified Neurotoxin Complex as Headache Prophylaxis in Adolescents (Children 12 to < 18 Years of Age) With Chronic Migraine
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 125 (actual)
- Sponsor
- Allergan · Industry
- Sex
- All
- Age
- 12 Years – 17 Years
- Healthy volunteers
- Not accepted
Summary
To evaluate the efficacy and safety of Botulinum Toxin Type A versus placebo (normal saline) as headache prophylaxis in adolescents (children 12 to 17) with chronic migraine.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Botulinum toxin type A Dose 1 | Botulinum toxin type A Dose 1 intramuscular injections into specified muscles. |
| BIOLOGICAL | Botulinum toxin type A Dose 2 | Botulinum toxin type A Dose 2 intramuscular injections into specified muscles. |
| DRUG | Placebo (Normal Saline) | Placebo (Normal Saline) intramuscular injections into specified muscles. |
Timeline
- Start date
- 2012-10-01
- Primary completion
- 2016-08-01
- Completion
- 2016-08-01
- First posted
- 2012-08-10
- Last updated
- 2017-09-05
- Results posted
- 2017-09-05
Locations
22 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT01662492. Inclusion in this directory is not an endorsement.