Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Guanfacine · 5 trials · 3 indications
Systolic Blood pressure was measured at supine and standing position and mean supine systolic blood pressure was reported here. Final Assessment is the last valid assessment obtained after Baseline (Visit 2/Day 0) whilst on investigational product and before first dose taper medication \[Visit 19/Early Termination (ET)/Day 714\].
Diastolic Blood pressure was measured at supine and standing position and mean supine diastolic blood pressure was reported here. Final Assessment is the last valid assessment obtained after Baseline (Visit 2/Day 0) whilst on investigational product and before first dose taper medication (Visit 19/ET/Day 714).
Pulse was measured at supine and standing position and mean supine pulse was reported here. Final Assessment is the last valid assessment obtained after Baseline (Visit 2/Day 0) whilst on investigational product and before first dose taper medication (Visit 19/ET/Day 714).
Final Assessment is the last valid assessment obtained after Baseline (Visit 2/Day 0) whilst on investigational product and before first dose taper medication (Visit 19/ET/Day 714).
Final Assessment is the last valid assessment obtained after Baseline (Visit 2/Day 0) whilst on investigational product and before first dose taper medication (Visit 19/ET/Day 714).
Final Assessment is the last valid assessment obtained after Baseline (Visit 2/Day 0) whilst on investigational product and before first dose taper medication (Visit 19/ET/Day 714).
Final Assessment is the last valid assessment obtained after Baseline (Visit 2/Day 0) whilst on investigational product and before first dose taper medication (Visit 19/ET/Day 714).
C-SSRS is a clinician rated assessment of suicidal behavior and / or intent categorized as: Suicidal behavior=a "yes" response to any of 5 suicidal behavior questions (preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt, and completed suicide); Suicidal ideation=a "yes" response to any one of 5 suicidal ideation questions which includes wish to be dead, and 4 different categories of active suicidal ideation (thought, thought with method, thought with intent, thought with plan and intent).
The ADHD-RS-IV consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54.
The ADHD-RS-IV consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54. Outcome measure is at 10 weeks for ages 6-12 years and at 13 weeks for ages 13-17 years.
Treatment failure was defined as \>= 50% increase (worsening) in ADHD-RS-IV total score and a \>= 2 point increase (worsening) in CGI-S score compared with the respective scores at the Double-blind Randomized-withdrawal Baseline Visit at 2 consecutive Double-blind Randomized-withdrawal Phase visits. Subjects meeting these criteria were regarded as treatment failures regardless of whether or not they were withdrawn. All subjects who discontinued the study for any reason were regarded as treatment failures for the primary analysis.
The ADHD-RS-IV consists of 18 items scored on a 4-point scale ranging from 0 (no symptoms) to 3 (severe symptoms) with total score ranging from 0 to 54.
| Arm | Type | Description |
|---|---|---|
| Extended-release Guanfacine HCl | EXPERIMENTAL | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Extended-release Guanfacine Hydrochloride | EXPERIMENTAL | - |
| Atomoxetine Hydrochloride | OTHER | Active Reference |
| Extended-release Guanfacine Hydrochloride (SPD503) AM | EXPERIMENTAL | - |
| SPD503 PM | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Extended-release Guanfacine HCl (Intuniv, SPD503) | DRUG | Subjects will be dosed orally once-daily in the AM at 1, 2, 3, 4, 5, 6, or 7 mg according to subjects weight and age |
| Extended-release Guanfacine Hydrochloride | DRUG | The test product will be provided as 1, 2, 3, and 4mg tablets. Subjects will be administered a once-daily dose between 1-7mg/day depending on weight. |
| Placebo | OTHER | Matching placebo will be provided as 1,2,3, and 4mg tablets. Subjects will be administered a once-daily dose of placebo between 1-7mg/day depending on weight. |
| Atomoxetine Hydrochloride | DRUG | Capsule, once daily, optimised dose (10mg to 100mg based on weight), 8-9-weeks maintenance duration on optimised dose |
| Placebo Comparator | DRUG | Placebo |
| extended-release guanfacine hydrochloride (SPD503) | DRUG | dosed in AM |
Inclusion Criteria: 1. Subjects where Study SPD503-318 was not available at the time of their final visit in the antecedent study (SPD503-315 or SPD503-316), may still be screened unless they are well-controlled on another ADHD medication with acceptable tolerability and the parent/caregiver is sat...
Guanfacine is used for Attention Deficit Hyperactivity Disorder (ADHD) in children and adolescents. It is an extended-release formulation being developed by Takeda Pharmaceutical Company Limited. The drug is currently in Phase 3 clinical development for this psychiatric condition.
Guanfacine is a small molecule that acts as an alpha-2A adrenergic receptor agonist. It is thought to improve ADHD symptoms by enhancing noradrenergic signaling in the prefrontal cortex, which is involved in attention and impulse control.
Guanfacine is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. The company is conducting Phase 3 clinical trials for the extended-release formulation of Guanfacine in ADHD.
Guanfacine is in Phase 3 clinical development. It is an investigational drug and has not been approved by the FDA. All Phase 3 trials for Guanfacine in ADHD have been completed, with no active trials currently ongoing.
Guanfacine has completed three Phase 3 trials for ADHD. These include NCT00997984, a study of AM and PM dosing in children aged 6-12; NCT01081132, a dose-optimization study in adolescents aged 13-17; and NCT01081145, a maintenance of efficacy study in children and adolescents.
Yes, Guanfacine is the same as extended-release guanfacine HCl. The clinical trials for this drug use the extended-release hydrochloride salt formulation, which is designed for once-daily dosing to manage ADHD symptoms.