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To evaluate the sensitivity and responsiveness of a standardized, validated, computer-based, battery of neuro-psychometric tests in adults with ADHD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LDX + MAS-IR Placebo | Active Comparator | Lisdexamfetamine Dimesylate (LDX) + Immediate Release Mixed Amphetamine Salts (MAS-IR) placebo |
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| MAS-IR + LDX Placebo | Active Comparator | Immediate Release Mixed Amphetamine Salts (MAS-IR) + Lisdexamfetamine Dimesylate (LDX) placebo |
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| Placebo | Placebo Comparator | Lisdexamfetamine Dimesylate (LDX) Placebo + Immediate Release Mixed Amphetamine Salts (MAS-IR) Placebo |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lisdexamfetamine Dimesylate (LDX) | Drug | Lisdexamfetamine Dimesylate (LDX) + Immediate Release Mixed Amphetamine Salts (MAS-IR) placebo |
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| Measure | Description | Time Frame |
|---|---|---|
| Power of Attention Score | The Power of Attention score reflects the ability to focus attention, and is calculated as the sum of the reaction time, measured in milliseconds, from 3 attention tests (Simple Reaction Time, Choice Reaction Time, and Digit Vigilance Speed). Faster performance (lower times) reflects more intense concentration. A decrease in the Power of Attention score indicates improvement. | pre-dose and at 1, 2, 3, 4, 5, 8, 12, 14 and 16 hours post-dose on Day 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Conners Adult ADHD Rating Scales-Self Report: Short Version (CAARS-S:S) Subscale Total Score (T-Score): Inattention/Memory Problems | Consists of 5 items with each item rated on a scale of 0-3 (not at all, just a little, pretty much, very much). The T-score is then calculated as: T = 50 + 10 * (raw score - mean)/Standard Deviation. The average score is 50. Scores below 50 are better than scores above 50. |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Claghorn-Lesem Research Clinic | Houston | Texas | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24297663 | Result | Martin PT, Corcoran M, Zhang P, Katic A. Randomized, double-blind, placebo-controlled, crossover study of the effects of lisdexamfetamine dimesylate and mixed amphetamine salts on cognition throughout the day in adults with attention-deficit/hyperactivity disorder. Clin Drug Investig. 2014 Feb;34(2):147-57. doi: 10.1007/s40261-013-0156-z. |
| Label | URL |
|---|---|
| FDA recall information | View source |
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Each of the 3 treatment regimens was administered daily for 7 days (a total of 21 days of treatment). There was no washout between regimens.
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| ID | Title | Description |
|---|---|---|
| FG000 | LDX 50 mg First, Then MAS-IR 20 mg, Then Placebo | Lisdexamfetamine Dimesylate (LDX) 50 mg + Immediate Release Mixed Amphetamine Salts (MAS-IR) placebo first, then MAS-IR 20 mg + LDX placebo, then LDX placebo + MAS-IR placebo |
| FG001 | LDX 50 mg First, Then Placebo, Then MAS-IR 20 mg |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| First Intervention |
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| Immediate Release Mixed Amphetamine Salts (MAS-IR) | Drug | Immediate Release Mixed Amphetamine Salts (MAS-IR) + Lisdexamfetamine Dimesylate (LDX) placebo |
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| LDX Placebo + MAS-IR Placebo | Drug | Lisdexamfetamine Dimesylate (LDX) Placebo + Immediate Release Mixed Amphetamine Salts (MAS-IR) Placebo |
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| 2 and 14 hours post-dose on Day 7 |
| CAARS-S:S Subscale T-Score: Hyperactivity/Restlessness | Consists of 5 items with each item rated on a scale of 0-3 (not at all, just a little, pretty much, very much). The T-score is then calculated as: T = 50 + 10 * (raw score - mean)/Standard Deviation. The average score is 50. Scores below 50 are better than scores above 50. | 2 and 14 hours post-dose on Day 7 |
| CAARS-S:S Subscale T-Score: Impulsivity/Emotional Liability | Consists of 5 items with each item rated on a scale of 0-3 (not at all, just a little, pretty much, very much). The T-score is then calculated as: T = 50 + 10 * (raw score - mean)/Standard Deviation. The average score is 50. Scores below 50 are better than scores above 50. | 2 and 14 hours post-dose on Day 7 |
| CAARS-S:S Subscale T-Score: Problems With Self-Concept | Consists of 5 items with each item rated on a scale of 0-3 (not at all, just a little, pretty much, very much). The T-score is then calculated as: T = 50 + 10 * (raw score - mean)/Standard Deviation. The average score is 50. Scores below 50 are better than scores above 50. | 2 and 14 hours post-dose on Day 7 |
| CAARS-S:S Subscale T-Score: Attention Deficit Hyperactivity Disorder (ADHD) Index | Consists of 12 items with each item rated on a scale of 0-3 (not at all, just a little, pretty much, very much). The T-score is then calculated as: T = 50 + 10 * (raw score - mean)/Standard Deviation. The average score is 50. Scores below 50 are better than scores above 50. | 2 and 14 hours post-dose on Day 7 |
LDX 50 mg + MAS-IR placebo first, then LDX placebo + MAS-IR placebo, then MAS-IR 20 mg + LDX placebo |
| FG002 | Placebo First, Then LDX 50 mg, Then MAS-IR 20 mg | LDX placebo + MAS-IR placebo first, then LDX 50 mg + MAS-IR placebo, then MAS-IR 20 mg + LDX placebo |
| FG003 | Placebo First, Then MAS-IR 20 mg, Then LDX 50 mg | LDX placebo + MAS-IR placebo first, then MAS-IR 20 mg + LDX placebo, then LDX 50 mg + MAS-IR placebo |
| FG004 | MAS-IR 20 mg First, Then LDX 50 mg, Then Placebo | MAS-IR 20 mg + LDX placebo first, then LDX 50 mg + MAS-IR placebo, then LDX placebo + MAS-IR placebo |
| FG005 | MAS-IR 20 mg First, Then Placebo, Then LDX 50 mg | MAS-IR 20 mg + LDX placebo first, then LDX placebo + MAS-IR placebo, then LDX 50 mg + MAS-IR placebo |
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| NOT COMPLETED |
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| Second Intervention |
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| Third Intervention |
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| ID | Title | Description |
|---|---|---|
| BG000 | LDX 50 mg First, Then MAS-IR 20 mg, Then Placebo | |
| BG001 | LDX 50 mg First, Then Placebo, Then MAS-IR 20 mg | |
| BG002 | Placebo First, Them LDX 50 mg, Then MAS-IR 20 mg | |
| BG003 | Placebo First, Then MAS-IR 20 mg, Then LDX 50 mg | |
| BG004 | MAS-IR 20 mg First, Then LDX 50 mg, Then Placebo | |
| BG005 | MAS-IR 20 mg First, Then Placebo, Then LDX 50 mg | |
| BG006 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Age, Customized | Count of Participants | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||
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| Primary | Power of Attention Score | The Power of Attention score reflects the ability to focus attention, and is calculated as the sum of the reaction time, measured in milliseconds, from 3 attention tests (Simple Reaction Time, Choice Reaction Time, and Digit Vigilance Speed). Faster performance (lower times) reflects more intense concentration. A decrease in the Power of Attention score indicates improvement. | The Pharmacodynamic Set (PD) is all subjects in the Safety Set who had at least 1 post-dose assessment of the pharmacodynamic variables. The Safety Set contains all enrolled subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment. | Posted | Mean | Standard Error | milliseconds | pre-dose and at 1, 2, 3, 4, 5, 8, 12, 14 and 16 hours post-dose on Day 7 |
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| Secondary | Conners Adult ADHD Rating Scales-Self Report: Short Version (CAARS-S:S) Subscale Total Score (T-Score): Inattention/Memory Problems | Consists of 5 items with each item rated on a scale of 0-3 (not at all, just a little, pretty much, very much). The T-score is then calculated as: T = 50 + 10 * (raw score - mean)/Standard Deviation. The average score is 50. Scores below 50 are better than scores above 50. | PD | Posted | Mean | Standard Error | Units on a scale | 2 and 14 hours post-dose on Day 7 |
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| Secondary | CAARS-S:S Subscale T-Score: Hyperactivity/Restlessness | Consists of 5 items with each item rated on a scale of 0-3 (not at all, just a little, pretty much, very much). The T-score is then calculated as: T = 50 + 10 * (raw score - mean)/Standard Deviation. The average score is 50. Scores below 50 are better than scores above 50. | PD | Posted | Mean | Standard Error | Units on a scale | 2 and 14 hours post-dose on Day 7 |
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| Secondary | CAARS-S:S Subscale T-Score: Impulsivity/Emotional Liability | Consists of 5 items with each item rated on a scale of 0-3 (not at all, just a little, pretty much, very much). The T-score is then calculated as: T = 50 + 10 * (raw score - mean)/Standard Deviation. The average score is 50. Scores below 50 are better than scores above 50. | PD | Posted | Mean | Standard Error | Units on a scale | 2 and 14 hours post-dose on Day 7 |
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| Secondary | CAARS-S:S Subscale T-Score: Problems With Self-Concept | Consists of 5 items with each item rated on a scale of 0-3 (not at all, just a little, pretty much, very much). The T-score is then calculated as: T = 50 + 10 * (raw score - mean)/Standard Deviation. The average score is 50. Scores below 50 are better than scores above 50. | PD | Posted | Mean | Standard Error | Units on a scale | 2 and 14 hours post-dose on Day 7 |
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| Secondary | CAARS-S:S Subscale T-Score: Attention Deficit Hyperactivity Disorder (ADHD) Index | Consists of 12 items with each item rated on a scale of 0-3 (not at all, just a little, pretty much, very much). The T-score is then calculated as: T = 50 + 10 * (raw score - mean)/Standard Deviation. The average score is 50. Scores below 50 are better than scores above 50. | PD | Posted | Mean | Standard Error | Units on a scale | 2 and 14 hours post-dose on Day 7 |
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Safety Set includes all enrolled subjects who took at least 1 dose of investigational product and had at least 1 post-dose safety assessment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | LDX 50 mg | 0 | 18 | 12 | 18 | |||
| EG001 | MAS-IR 20 mg | 0 | 17 | 9 | 17 | |||
| EG002 | Placebo | 0 | 17 | 8 | 17 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dizziness | Nervous system disorders |
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| Headache | Nervous system disorders |
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| Paraesthesia | Nervous system disorders |
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| Sedation | Nervous system disorders |
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| Bruxism | Psychiatric disorders |
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| Insomnia | Psychiatric disorders |
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| Nervousness | Psychiatric disorders |
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| Obsessive-Compulsive Disorder | Psychiatric disorders |
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| Dysuria | Renal and urinary disorders |
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| Micturition Disorder | Renal and urinary disorders |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders |
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| Palpitations | Cardiac disorders |
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| Abdominal pain | Gastrointestinal disorders |
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| Diarrhea | Gastrointestinal disorders |
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| Dry Mouth | Gastrointestinal disorders |
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| Nausea | Gastrointestinal disorders |
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| Chest Pain | General disorders |
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| Fatigue | General disorders |
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| Feeling Jittery | General disorders |
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| Irritability | General disorders |
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| Heart Rate Increased | Investigations |
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| Decreased Appetite | Metabolism and nutrition disorders |
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| Sensation of Heaviness | Musculoskeletal and connective tissue disorders |
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If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Shire | +1 866 842 5335 | ClinicalTransparency@shire.com |
| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
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| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
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| D000069478 | Lisdexamfetamine Dimesylate |
| ID | Term |
|---|---|
| D003913 | Dextroamphetamine |
| D000661 | Amphetamine |
| D000662 | Amphetamines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
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| Between 18 and 55 years |
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| >=56 years |
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| Male |
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