Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
LDX · 2 trials · 2 indications
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 Permanent Product Measure of Performance (PERMP) is a skill adjusted math test. The PERMP score is the sum of the number of math problems attempted plus the number of math problems answered correctly in a 10-minute session. The scores range from 0-800 with higher scores indicating better performance.
| Arm | Type | Description |
|---|---|---|
| Lisdexamfetamine Dimesylate (LDX) 30 mg | ACTIVE_COMPARATOR | - |
| LDX 50 mg | ACTIVE_COMPARATOR | - |
| LDX 70 mg | ACTIVE_COMPARATOR | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Lisdexamfetamine Dimesylate (LDX, SPD489) | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| LDX 30 mg | DRUG | Eligible subjects will be randomized in a 1:1:1:1 ratio to a daily morning dose of LDX (30, 50, or 70mg/day) or placebo for a double-blind stepwise forced dose titration (3 weeks) followed by a 1-week Dose Maintenance Period. The test product is LDX, available in 30, 50, and 70mg capsules. All test products will appear identical to placebo to protect the study blind. |
| LDX 50 mg | DRUG | Eligible subjects will be randomized in a 1:1:1:1 ratio to a daily morning dose of LDX (30, 50, or 70mg/day) or placebo for a double-blind stepwise forced dose titration (3 weeks) followed by a 1-week Dose Maintenance Period. The test product is LDX, available in 30, 50, and 70mg capsules. All test products will appear identical to placebo to protect the study blind. |
| LDX 70 mg | DRUG | Eligible subjects will be randomized in a 1:1:1:1 ratio to a daily morning dose of LDX (30, 50, or 70mg/day) or placebo for a double-blind stepwise forced dose titration (3 weeks) followed by a 1-week Dose Maintenance Period. The test product is LDX, available in 30, 50, and 70mg capsules. All test products will appear identical to placebo to protect the study blind. |
| Placebo | DRUG | Placebo will be identical to test product. |
| LDX | DRUG | oral, 30, 50, or 70 mg once-daily for 4 weeks during dose optimization, and then for 1 week during each crossover during the adult workplace environment setting |
Inclusion Criteria: * Meet DSM-IV-TR criteria for a primary diagnosis of ADHD * Baseline ADHD-RS-IV score \>=28 * BP w/in 95th percentile for age, gender, and height Exclusion Criteria: * Subject has controlled or uncontrolled comorbid psychiatric diagnosis * Subject has conduct disorder * Suicid...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Supernus Pharmaceuticals, Inc. | SUPN | 1 | PHASE3 | SPN-812 |
LDX, or lisdexamfetamine dimesylate, is an investigational small molecule being studied for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adults and adolescents. It has also been evaluated in healthy volunteers for drug interaction studies. The drug is in Phase 3 clinical development for ADHD.
LDX is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. The drug is a small molecule in the psychiatry therapeutic area, targeting Attention Deficit Hyperactivity Disorder (ADHD).
LDX is in Phase 3 clinical development for Attention Deficit Hyperactivity Disorder (ADHD). It has completed Phase 3 trials in adults and adolescents with ADHD, as well as a Phase 1 trial in healthy volunteers. The drug is investigational and not yet approved.
LDX has completed several clinical trials, including NCT00697515, a Phase 3 study in adults with ADHD, and NCT00735371, a Phase 3 study in adolescents with ADHD. A Phase 1 trial, NCT01235338, evaluated co-administration of LDX with venlafaxine XR in healthy volunteers.
Yes, LDX is the same as lisdexamfetamine dimesylate. The drug is referred to by both names in clinical trials, with LDX being the abbreviation used in study titles and descriptions.