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Also known as LDX
LDX+ Venlafaxine · 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 |
| Axsome Therapeutics, Inc. | AXSM | 3 | PHASE3 | Solriamfetol |
LDX+ Venlafaxine is an investigational combination therapy being developed by Takeda Pharmaceutical Company Limited for Attention Deficit Hyperactivity Disorder (ADHD). It combines lisdexamfetamine dimesylate, a small molecule stimulant, with venlafaxine, a non-stimulant antidepressant. The combination is in Phase 3 clinical development and has not been approved by the FDA.
LDX+ Venlafaxine is being studied for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in adolescents and adults. The clinical program includes a Phase 3 trial in adolescents aged 13 years and older and a Phase 3 trial in adults aged 18 years and older. It is not yet approved for any indication.
LDX+ Venlafaxine is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. Takeda is the sponsor of the clinical trials evaluating this combination in ADHD.
LDX+ Venlafaxine is in Phase 3 clinical development. One Phase 3 trial has been completed, and no active trials are currently listed. The completed trial was a randomized, double-blind, placebo-controlled study. The drug has not been approved by the FDA and remains investigational.
LDX+ Venlafaxine has been evaluated in two completed Phase 3 trials. NCT00735371 studied lisdexamfetamine dimesylate in 314 adolescents with ADHD in the United States. NCT00697515 studied it in 142 adults with ADHD in a workplace environment, also in the United States. Both trials are completed.