Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Strattera · 1 trial · 3 indications
| Arm | Type | Description |
|---|---|---|
| 1 | ACTIVE_COMPARATOR | Atomoxetine HCL (Strattera) |
| 2 | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Strattera | DRUG | escalating dosage: 0.5 mg/kg, 1.0 mg/kg, and 1.4 mg/kg titrated up or down according to adverse effects to therapy |
| Placebo | DRUG | 0.25 mg/kg, 0.5 mg/kg, 1.0 mg/kg, or 1.4 mg/kg once each morning with breakfast. |
Inclusion Criteria: * Patient must be between the ages of 4 and 11 years at the time of entry into the study. * Patients must meet diagnostic criteria for FASD * Patient must meet DSM-IV criteria for ADHD, any subtype and must have an ADHDRS-IV score of \> or = to 90%ile for age and gender for eith...
Strattera is being studied for use in children with Fetal Alcohol Syndrome and attention deficit hyperactivity disorder (ADHD) or attention deficit disorder (ADD). It is an investigational small molecule in Phase 1 clinical development for this indication, with one completed trial involving 38 participants.
Strattera is a small molecule that targets the norepinephrine transporter, increasing norepinephrine levels in the brain. This mechanism is thought to improve attention and reduce hyperactivity and impulsivity in conditions like ADHD, which is relevant to its study in Fetal Alcohol Syndrome.
Strattera is developed by Eli Lilly and Company, a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol LLY. The company is conducting clinical research to evaluate the drug's effectiveness in children with Fetal Alcohol Syndrome and comorbid ADHD or ADD.
Strattera is in Phase 1 clinical development for Fetal Alcohol Syndrome. The single trial, NCT00417794, has been completed, and the drug remains investigational for this indication. It is not approved for this use, and further clinical development would be needed to establish safety and efficacy.
Strattera has one completed clinical trial, NCT00417794, titled 'Assess the Effectiveness of Atomoxetine in Children With Fetal Alcohol Syndrome and ADD/ADHD.' This Phase 1, randomized, double-blind, placebo-controlled study enrolled 38 children aged 4 years and older in the United States.
Yes, Strattera is the brand name for atomoxetine. The clinical trial NCT00417794 refers to atomoxetine as the study drug, and Strattera is the marketed name for this molecule. Both names refer to the same medication being investigated for Fetal Alcohol Syndrome with ADHD or ADD.