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| ID | Type | Description | Link |
|---|---|---|---|
| 42603ATT4053 | |||
| NCT00783835 |
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The purpose of this study is to evaluate the efficacy, safety and to assess the impact of the treatment on quality of life of long-acting methylphenidate in adult participants with Attention Deficit Hyperactivity Disorder (ADHD). ADHD is a clinical condition beginning in childhood and is characterized by inadequate levels of attention, hyperactivity and impulsiveness.
This is an open-label (all people know the identity of the intervention), multi-center (when more than one hospital or medical school team work on a medical research study), single arm study of multiple doses of long-acting methylphenidate in participants with ADHD. The study will consist of 2 phases; a screening phase and a treatment phase. The duration of participation in the study for an individual participant will be up to 12 weeks. Participants will be given 18 milligram (mg) of long-acting methylphenidate daily in the morning and titrated up (slow increase in drug dosage guided by participant's responses) to 36 mg per day (mg/day) on Day 8. Depending on response, tolerability and clinician's judgment, the dose could be escalated to the next dose level of 54 mg/day on Day 28 to a maximum of 72 mg/day on Day 56, until each participant achieved optimal dose. Participant's safety will be monitored throughout the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Methylphenidate | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Long-Acting Methylphenidate | Drug | Long-Acting Methylphenidate within the range of 18, 36, 54 and 76 milligram will be orally administered once daily up to Day 56. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Adult Attention Deficit Hyperactivity Disorder (ADHD) Self-Report Scale (ASRS) Total Score at Week 4 | Adult ASRS assesses 18 core ADHD symptoms corresponding to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) diagnostic symptoms for adult participant based on the participant's own rating for each of the symptoms using a 4 point scale (0=none, 1=mild, 2=moderate, 3=severe). If a single item is missing the score is imputed and if more than one item is missing, the total score is treated as missing. The ASRS total score is derived by summing the score assigned to each of the 18 symptoms (low=0, high=54, a higher score signifies a greater severity of symptoms). | Baseline and Week 4 |
| Change From Baseline in Adult Attention Deficit Hyperactivity Disorder (ADHD) Self-Report Scale (ASRS) Total Score at Week 8 | Adult ASRS assesses 18 core ADHD symptoms corresponding to DSM-IV diagnostic symptoms for adult participant based on the participant's own rating for each of the symptoms using a 4 point scale (0=none, 1=mild, 2=moderate, 3=severe). If a single item is missing the score is imputed and if more than one item is missing, the total score is treated as missing. The ASRS total score is derived by summing the score assigned to each of the 18 symptoms (low=0, high=54, a higher score signifies a greater severity of symptoms). | Baseline and Week 8 |
| Change From Baseline in Adult Attention Deficit Hyperactivity Disorder (ADHD) Self-Report Scale (ASRS) Total Score at Week 12 | Adult ASRS assesses 18 core ADHD symptoms corresponding to DSM-IV diagnostic symptoms for adult participant based on the participant's own rating for each of the symptoms using a 4 point scale (0=none, 1=mild, 2=moderate, 3=severe). If a single item is missing the score is imputed and if more than one item is missing, the total score is treated as missing. The ASRS total score is derived by summing the score assigned to each of the 18 symptoms (low=0, high=54, a higher score signifies a greater severity of symptoms). | Baseline and Week 12 |
| Change From Baseline in Adult ADHD Quality of Life (AAQoL) Scale Score at Week 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Screening in Clinical Global Impression-Severity of Illness (CGI-S) Score at Weeks 4, 8 and 12 | The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 = "Normal, not at all ill" and a rating of 7 = "Among the most extremely ill participants". Higher scores indicate worsening. | Screening (Week -2), 4, 8 and 12 |
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Inclusion Criteria
Exclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Janssen-Cilag Farmaceutica Ltda. Clinical Trial | Janssen-Cilag Farmaceutica Ltda. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Belo Horizonte | Brazil | |||||
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| ID | Title | Description |
|---|---|---|
| FG000 | Methylphenidate | Oral long acting methylphenidate tablets were administered daily at a starting dose of 18 milligram (mg) and slowly increased to 36 mg on Day 8. Depending on response, tolerability and clinician's discretion, the dose could be increased to 54 mg on Day 28 to a maximum of 72 mg per day on Day 56, until each participant achieved optimal dose. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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The AAQoL is a validated 29-item scale consisting of 4 subscales:life productivity (11 items), psychological health (6 items), life outlook (7 items) and relationships (5 items). Participants rate each item on a 5-point Likert - like scale ranging from 1 (not at all/never) to 5 (extremely/very often). These scores are then transformed to a 0-100 point scale, higher scores indicating better quality of life. Total score=average of individual 29 item scores (range= 0-100, where higher total score indicates better quality of life). Change from baseline in total score for AAQoL is reported. |
| Baseline and Week 4 |
| Change From Baseline in Adult ADHD Quality of Life (AAQoL) Scale Score at Week 12 | The AAQoL is a validated 29-item scale consisting of 4 subscales:life productivity (11 items), psychological health (6 items), life outlook (7 items) and relationships (5 items). Participants rate each item on a 5-point Likert - like scale ranging from 1 (not at all/never) to 5 (extremely/very often). These scores are then transformed to a 0-100 point scale, higher scores indicating better quality of life. Total score=average of individual 29 item scores (range= 0-100, where higher total score indicates better quality of life). Change from baseline in total score for AAQoL is reported. | Baseline and Week 12 |
| Clinical Global Impression-Improvement (CGI-I) Score | The CGI-I is a 7-point scale that requires the clinician to assess how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as (1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse). | Week 4, 8 and 12 |
| Change From Baseline in the State-Trait Anxiety Inventory (STAI) Scale | The STAI scale consists of total 40 items on separate scales measuring state (20 items) and trait (20 items) anxiety. The participant reports how they feel right now at this moment for state anxiety and how they generally feel for trait anxiety. The state items are scored as: 1 (not at all), 2 (somewhat true), 3 (moderately true), 4 (very true). The trait items are scored as: 1 (almost never), 2 (sometimes), 3 (often), 4 (almost always). The total scores range from 4-80 for each scale. Higher scores indicate more impaired participants. | Baseline, Week 4, 8 and 12 |
| Change From Screening in the Hamilton Depression Rating (HAM-D) Scale Score at Week 4 and 12 | It is a 21-item clinician-rated scale that evaluates depressed mood as well as the vegetative and cognitive symptoms of depression. 11 items are scored on a 3 point scale (0=none/absent to 2=most severe), 2 items are scored on a 4 point scale (0=none/absent to 3=most severe) and 8 items are scored on a 5 point scale (0=none/absent to 4=most severe). The individual items are summed to yield the HAM-D total score that ranges from 0-60, where higher scores indicate worsening. | Screening (Week -2), 4 and 12 |
| Porto Alegre |
| Brazil |
| Rio de Janeiro | Brazil |
| Salvador | Brazil |
| São Paulo | Brazil |
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| ID | Title | Description |
|---|---|---|
| BG000 | Methylphenidate | Oral long acting methylphenidate tablets were administered daily at a starting dose of 18 milligram (mg) and slowly increased to 36 mg on Day 8. Depending on response, tolerability and clinician's discretion, the dose could be increased to 54 mg on Day 28 to a maximum of 72 mg per day on Day 56, until each participant achieved optimal dose. |
| Units | Counts |
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| 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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| Sex: Female, Male | 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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Adult Attention Deficit Hyperactivity Disorder (ADHD) Self-Report Scale (ASRS) Total Score at Week 4 | Adult ASRS assesses 18 core ADHD symptoms corresponding to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) diagnostic symptoms for adult participant based on the participant's own rating for each of the symptoms using a 4 point scale (0=none, 1=mild, 2=moderate, 3=severe). If a single item is missing the score is imputed and if more than one item is missing, the total score is treated as missing. The ASRS total score is derived by summing the score assigned to each of the 18 symptoms (low=0, high=54, a higher score signifies a greater severity of symptoms). | Intent to treat efficacy evaluation (ITTe) included all participants who received at least 1 dose of study medication and provided at least 1 post-baseline measure of effectiveness. | Posted | Mean | Standard Error | Unit on a scale | Baseline and Week 4 |
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| Primary | Change From Baseline in Adult Attention Deficit Hyperactivity Disorder (ADHD) Self-Report Scale (ASRS) Total Score at Week 8 | Adult ASRS assesses 18 core ADHD symptoms corresponding to DSM-IV diagnostic symptoms for adult participant based on the participant's own rating for each of the symptoms using a 4 point scale (0=none, 1=mild, 2=moderate, 3=severe). If a single item is missing the score is imputed and if more than one item is missing, the total score is treated as missing. The ASRS total score is derived by summing the score assigned to each of the 18 symptoms (low=0, high=54, a higher score signifies a greater severity of symptoms). | ITTe included all participants who received at least 1 dose of study medication and provided at least 1 post-baseline measure of effectiveness. | Posted | Mean | Standard Error | Unit on a scale | Baseline and Week 8 |
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| Primary | Change From Baseline in Adult Attention Deficit Hyperactivity Disorder (ADHD) Self-Report Scale (ASRS) Total Score at Week 12 | Adult ASRS assesses 18 core ADHD symptoms corresponding to DSM-IV diagnostic symptoms for adult participant based on the participant's own rating for each of the symptoms using a 4 point scale (0=none, 1=mild, 2=moderate, 3=severe). If a single item is missing the score is imputed and if more than one item is missing, the total score is treated as missing. The ASRS total score is derived by summing the score assigned to each of the 18 symptoms (low=0, high=54, a higher score signifies a greater severity of symptoms). | ITTe included all participants who received at least 1 dose of study medication and provided at least 1 post-baseline measure of effectiveness. | Posted | Mean | Standard Error | Unit on a scale | Baseline and Week 12 |
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| Primary | Change From Baseline in Adult ADHD Quality of Life (AAQoL) Scale Score at Week 4 | The AAQoL is a validated 29-item scale consisting of 4 subscales:life productivity (11 items), psychological health (6 items), life outlook (7 items) and relationships (5 items). Participants rate each item on a 5-point Likert - like scale ranging from 1 (not at all/never) to 5 (extremely/very often). These scores are then transformed to a 0-100 point scale, higher scores indicating better quality of life. Total score=average of individual 29 item scores (range= 0-100, where higher total score indicates better quality of life). Change from baseline in total score for AAQoL is reported. | ITTe included all participants who received at least 1 dose of study medication and provided at least 1 post-baseline measure of effectiveness. | Posted | Mean | Standard Error | Unit on a scale | Baseline and Week 4 |
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| Primary | Change From Baseline in Adult ADHD Quality of Life (AAQoL) Scale Score at Week 12 | The AAQoL is a validated 29-item scale consisting of 4 subscales:life productivity (11 items), psychological health (6 items), life outlook (7 items) and relationships (5 items). Participants rate each item on a 5-point Likert - like scale ranging from 1 (not at all/never) to 5 (extremely/very often). These scores are then transformed to a 0-100 point scale, higher scores indicating better quality of life. Total score=average of individual 29 item scores (range= 0-100, where higher total score indicates better quality of life). Change from baseline in total score for AAQoL is reported. | ITTe included all participants who received at least 1 dose of study medication and provided at least 1 post-baseline measure of effectiveness. | Posted | Mean | Standard Error | Unit on a scale | Baseline and Week 12 |
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| Secondary | Change From Screening in Clinical Global Impression-Severity of Illness (CGI-S) Score at Weeks 4, 8 and 12 | The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 = "Normal, not at all ill" and a rating of 7 = "Among the most extremely ill participants". Higher scores indicate worsening. | ITTe included all participants who received at least 1 dose of study medication and provided at least 1 post-baseline measure of effectiveness. | Posted | Mean | Standard Error | Unit on a scale | Screening (Week -2), 4, 8 and 12 |
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| Secondary | Clinical Global Impression-Improvement (CGI-I) Score | The CGI-I is a 7-point scale that requires the clinician to assess how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as (1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse). | ITTe included all participants who received at least 1 dose of study medication and provided at least 1 post-baseline measure of effectiveness. | Posted | Mean | Standard Error | Unit on a scale | Week 4, 8 and 12 |
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| Secondary | Change From Baseline in the State-Trait Anxiety Inventory (STAI) Scale | The STAI scale consists of total 40 items on separate scales measuring state (20 items) and trait (20 items) anxiety. The participant reports how they feel right now at this moment for state anxiety and how they generally feel for trait anxiety. The state items are scored as: 1 (not at all), 2 (somewhat true), 3 (moderately true), 4 (very true). The trait items are scored as: 1 (almost never), 2 (sometimes), 3 (often), 4 (almost always). The total scores range from 4-80 for each scale. Higher scores indicate more impaired participants. | ITTe included all participants who received at least 1 dose of study medication and provided at least 1 post-baseline measure of effectiveness. | Posted | Mean | Standard Error | Unit on a scale | Baseline, Week 4, 8 and 12 |
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| Secondary | Change From Screening in the Hamilton Depression Rating (HAM-D) Scale Score at Week 4 and 12 | It is a 21-item clinician-rated scale that evaluates depressed mood as well as the vegetative and cognitive symptoms of depression. 11 items are scored on a 3 point scale (0=none/absent to 2=most severe), 2 items are scored on a 4 point scale (0=none/absent to 3=most severe) and 8 items are scored on a 5 point scale (0=none/absent to 4=most severe). The individual items are summed to yield the HAM-D total score that ranges from 0-60, where higher scores indicate worsening. | ITTe included all participants who received at least 1 dose of study medication and provided at least 1 post-baseline measure of effectiveness. | Posted | Mean | Standard Error | Unit on a scale | Screening (Week -2), 4 and 12 |
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Baseline up to end of study.
An adverse event may be an undesirable and unintended sign (including an abnormal measurement), symptom or disease which is related to the study drug in terms of time regardless of the existence of a causal relationship with the study drug.
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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 | Methylphenidate | Oral long acting methylphenidate tablets were administered daily at a starting dose of 18 milligram (mg) and slowly increased to 36 mg on Day 8. Depending on response, tolerability and clinician's discretion, the dose could be increased to 54 mg on Day 28 to a maximum of 72 mg per day on Day 56, until each participant achieved optimal dose. | 0 | 60 | 48 | 60 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tachycardia | Cardiac disorders | MedDRA Version 15.0 | Non-systematic Assessment |
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| Dry mouth | Gastrointestinal disorders | MedDRA Version 15.0 | Non-systematic Assessment |
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| Irritability | General disorders | MedDRA Version 15.0 | Non-systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA Version 15.0 | Non-systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA Version 15.0 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA Version 15.0 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA Version 15.0 | Non-systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA Version 15.0 | Non-systematic Assessment |
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| Affect lability | Psychiatric disorders | MedDRA Version 15.0 | Non-systematic Assessment |
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| Anxiety | Psychiatric disorders | MedDRA Version 15.0 | Non-systematic Assessment |
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| Initial insomnia | Nervous system disorders | MedDRA Version 15.0 | Non-systematic Assessment |
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| Insomnia | Nervous system disorders | MedDRA Version 15.0 | Non-systematic Assessment |
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| Libido decreased | Nervous system disorders | MedDRA Version 15.0 | Non-systematic Assessment |
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| Nervousness | Nervous system disorders | MedDRA Version 15.0 | Non-systematic Assessment |
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| Sleep disorder | Nervous system disorders | MedDRA Version 15.0 | Non-systematic Assessment |
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The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days from the time submitted to the sponsor for review. The sponsor can require changes to the communication and can extend the embargo.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Manager | Janssen-Cilag Farmaceutica Ltda | +55 11 30302738 |
| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D008774 | Methylphenidate |
| ID | Term |
|---|---|
| D010648 | Phenylacetates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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