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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-000210-19 |
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This study will evaluate the long-term safety of methylphenidate hydrochloride extended release in adults with attention deficit/hyperactivity disorder
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ritalin LA | Experimental | All participants started with Ritalin LA 20 mg/day and increased at weekly intervals in increments of 20 mg/day until reaching the patient's optimal dose 40, 60 or 80 mg/day). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ritalin LA (methylphenidate hydrochloride extended release) | Drug | Ritalin LA 20 mg or 30 mg (a racemic mixture of d- and l-thre-Methylphenidate Hydrocloride (MPH), Extended release hard capsules) taken orally once daily in doses of 40, 60, or 80 mg. For 40mg dose patients took (2) Ritalin LA 20mg daily, for 60mg patients took (2) Ritalin LA 30mg daily and for 80mg patients took (2) Ritalin LA 30mg daily + (1) Ritalin LA 20mg daily for their optimal dose. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events, Serious Adverse Events and Deaths. | Adverse Events, Serious Adverse Events and Deaths were monitored from week 40 to week 66. | Week 40 - Week 66 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Extension Baseline (Week 40) to End of Study (Week 66) in on DSM-IV Attention-Deficit/Hyperactivity Disorder Rating Scale (DSM-IV ADHD RS) Total Score. | Attention-Deficit/Hyperactivity Disorder Rating Scale (DSM-IV ADHD RS) total score consists of 18 items directly adapted from the ADHD symptom list according to the DSM-IV. The DSM-IV ADHD RS total score was calculated as the sum of the Inattentive and the Hyperactive-Impulsive subscores. The 18 items are rated from 0 ("rarely or never") to 3 ("Very often"). The total score ranges from 0 to 54. Decrease in the DSM-IV ADHD RS total score indicates improvement, therefore a greater decrease (change at Final Visit compared to baseline) indicates a greater improvement in ADHD symptoms. Last Observation Carried Forward (LOCF) applied for each patient with data in extension period. If no post-baseline is available, it is considered as missing. |
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Inclusion Criteria:
1. Completion of the 40-week core study CRIT124D2302 and Week 40 (End of Study) assessments or Patients who meet predefined criteria for treatment failure, were withdrawn from the core study, and have completed core-study week 40 assessments (Premature Discontinuation Visit)
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Little Rock | Arkansas | 72205 | United States | ||
| Novartis Investigative Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35201607 | Derived | Boesen K, Paludan-Muller AS, Gotzsche PC, Jorgensen KJ. Extended-release methylphenidate for attention deficit hyperactivity disorder (ADHD) in adults. Cochrane Database Syst Rev. 2022 Feb 24;2(2):CD012857. doi: 10.1002/14651858.CD012857.pub2. | |
| 25183661 | Derived | Ginsberg Y, Arngrim T, Philipsen A, Gandhi P, Chen CW, Kumar V, Huss M. Long-term (1 year) safety and efficacy of methylphenidate modified-release long-acting formulation (MPH-LA) in adults with attention-deficit hyperactivity disorder: a 26-week, flexible-dose, open-label extension to a 40-week, double-blind, randomised, placebo-controlled core study. CNS Drugs. 2014 Oct;28(10):951-62. doi: 10.1007/s40263-014-0180-4. |
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Actual enrolment was 299 but one patient entered the extension but did not receive a single dose of the study medication and was subsequently excluded from the All Extension Patients Population
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| ID | Title | Description |
|---|---|---|
| FG000 | Ritalin LA | All participants started with Ritalin LA 20 mg/day and increased at weekly intervals in increments of 20 mg/day until reaching the patient's optimal dose 40, 60 or 80 mg/day). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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|
|
| week 40 - week 66 |
| Change From Extension Baseline (Week 40) to End of Study (Week 66) on Sheehan Disability Scale (SDS) Total Score | SDS,5-self-rated questionnaire to measure the extent a pt's disability due to an illness/health problem interferes with work/school,social life/leisure,family life/home. First 3 items, pts are asked how their symptoms disrupted their regular activities over the past 7d in each using a scale from 0(not at all)-10(extremely) Each subscale(work disability, social life disability, family life disability)can be scored independently or combined into a total score(sum of the non-missing responses for items 1-3)from 0-30,higher scores indicate significant functional impairment. Subscale scores>5 suggest impairment in that subscale area. Final 2 items ask pts about the # of days their symptoms caused them to miss school/work and # of days their symptoms caused them to be underproductive at school/work.(These items were not included in the total score.) Before responding to SDS items 1-3, pts were verbally instructed to recall the past 7d, items 4-5 refer to the last week w/in the item wording. | week 40 - week 66 |
| Beverly Hills |
| California |
| 90210 |
| United States |
| Novartis Investigative Site | Spring Valley | California | 91978-1522 | United States |
| Novartis Investigative Site | Bradenton | Florida | 34208 | United States |
| Novartis Investigative Site | Orlando | Florida | 32806 | United States |
| Novartis Investigative Site | West Plam Beach | Florida | 33407 | United States |
| Novartis Investigative Site | Libertyville | Illinois | 60048 | United States |
| Novartis Investigative Site | Owensboro | Kentucky | 42301 | United States |
| Novartis Investigative Site | Las Vegas | Nevada | 89119 | United States |
| Novartis Investigative Site | Las Vegas | Nevada | 89128 | United States |
| Novartis Investigative Site | Fargo | North Dakota | 58103 | United States |
| Novartis Investigative Site | Columbus | Ohio | 43210 | United States |
| Novartis Investigative Site | Philadelphia | Pennsylvania | 19149 | United States |
| Novartis Investigative Site | Houston | Texas | 77007 | United States |
| Novartis Investigative Site | Bellevue | Washington | 98004 | United States |
| Novartis Investigative Site | Seattle | Washington | 98104 | United States |
| Novartis Investigative Site | Bruges | Belgium | 8310 | Belgium |
| Novartis Investigative Site | Heusden-Zolder | Belgium | 3550 | Belgium |
| Novartis Investigative Site | Uccle | Belgium | 1180 | Belgium |
| Novartis Investigative Site | Kessel-Lo | 3010 | Belgium |
| Novartis Investigative Site | Mechelen | 2800 | Belgium |
| Novartis Investigative Site | Santa Fe de Antioquia | Antioquia | 0000 | Colombia |
| Novartis Investigative Site | Antioquia | Colombia |
| Novartis Investigative Site | Århus C | 8000 | Denmark |
| Novartis Investigative Site | Bamberg | Germany | 96047 | Germany |
| Novartis Investigative Site | Berlin | Germany | 12203 | Germany |
| Novartis Investigative Site | Hamburg | Germany | 20259 | Germany |
| Novartis Investigative Site | Ludwigsburg | Germany | 71636 | Germany |
| Novartis Investigative Site | Mainz | Germany | 55131 | Germany |
| Novartis Investigative Site | München | Germany | 80333 | Germany |
| Novartis Investigative Site | Naumburg | Germany | 06618 | Germany |
| Novartis Investigative Site | Nuremberg | Germany | 90419 | Germany |
| Novartis Investigative Site | Wolfsburg | Germany | 38444 | Germany |
| Novartis Investigative Site | Berlin | 10629 | Germany |
| Novartis Investigative Site | Dresden | 01129 | Germany |
| Novartis Investigative Site | Freiburg im Breisgau | 79104 | Germany |
| Novartis Investigative Site | Freiburg im Breisgau | 79106 | Germany |
| Novartis Investigative Site | Homburg | 66421 | Germany |
| Novartis Investigative Site | Landau | 76829 | Germany |
| Novartis Investigative Site | Leipzig | 04157 | Germany |
| Novartis Investigative Site | Limburg | 65549 | Germany |
| Novartis Investigative Site | Mannheim | 68159 | Germany |
| Novartis Investigative Site | Siegen | 57076 | Germany |
| Novartis Investigative Site | Ulm | 89081 | Germany |
| Novartis Investigative Site | Westerstede/Oldenburg | 26655 | Germany |
| Novartis Investigative Site | Würzburg | 97070 | Germany |
| Novartis Investigative Site | Luleå | 972 35 | Sweden |
| Novartis Investigative Site | Malmö | 211 53 | Sweden |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Ritalin LA | All participants started with Ritalin LA 20 mg/day and increased at weekly intervals in increments of 20 mg/day until reaching the patient's optimal dose 40, 60 or 80 mg/day). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| 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 | Number of Participants With Adverse Events, Serious Adverse Events and Deaths. | Adverse Events, Serious Adverse Events and Deaths were monitored from week 40 to week 66. | All Extension Patients(AEP) analysis set was used for all efficacy and safety analyses of the extension study. AEP was ALL patients who had entered the extension study & received at least 1 dose of Ritalin LA. Enrolment was 299, but 1 pt entered the extension but didn't receive 1 dose of Ritalin LA and was excluded from AEP Population analysis. | Posted | Number | participants | Week 40 - Week 66 |
|
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Change From Extension Baseline (Week 40) to End of Study (Week 66) in on DSM-IV Attention-Deficit/Hyperactivity Disorder Rating Scale (DSM-IV ADHD RS) Total Score. | Attention-Deficit/Hyperactivity Disorder Rating Scale (DSM-IV ADHD RS) total score consists of 18 items directly adapted from the ADHD symptom list according to the DSM-IV. The DSM-IV ADHD RS total score was calculated as the sum of the Inattentive and the Hyperactive-Impulsive subscores. The 18 items are rated from 0 ("rarely or never") to 3 ("Very often"). The total score ranges from 0 to 54. Decrease in the DSM-IV ADHD RS total score indicates improvement, therefore a greater decrease (change at Final Visit compared to baseline) indicates a greater improvement in ADHD symptoms. Last Observation Carried Forward (LOCF) applied for each patient with data in extension period. If no post-baseline is available, it is considered as missing. | All Extension Patients(AEP) analysis set was used for all efficacy and safety analyses of the extension study. AEP was ALL patients who had entered the extension study & received at least 1 dose of Ritalin LA. Enrolment was 299, but 1 pt entered the extension but didn't receive 1 dose of Ritalin LA and was excluded from AEP Population analysis. | Posted | Mean | Standard Deviation | scores on a scale | week 40 - week 66 |
| |||||||||||||||||||||||||||||||||||||
| Secondary | Change From Extension Baseline (Week 40) to End of Study (Week 66) on Sheehan Disability Scale (SDS) Total Score | SDS,5-self-rated questionnaire to measure the extent a pt's disability due to an illness/health problem interferes with work/school,social life/leisure,family life/home. First 3 items, pts are asked how their symptoms disrupted their regular activities over the past 7d in each using a scale from 0(not at all)-10(extremely) Each subscale(work disability, social life disability, family life disability)can be scored independently or combined into a total score(sum of the non-missing responses for items 1-3)from 0-30,higher scores indicate significant functional impairment. Subscale scores>5 suggest impairment in that subscale area. Final 2 items ask pts about the # of days their symptoms caused them to miss school/work and # of days their symptoms caused them to be underproductive at school/work.(These items were not included in the total score.) Before responding to SDS items 1-3, pts were verbally instructed to recall the past 7d, items 4-5 refer to the last week w/in the item wording. | All Extension Patients(AEP) analysis set was used for all efficacy and safety analyses of the extension study. AEP was ALL patients who had entered the extension study & received at least 1 dose of Ritalin LA. Enrolment was 299, but 1 pt entered the extension but didn't receive 1 dose of Ritalin LA and was excluded from AEP Population analysis. | Posted | Mean | Standard Deviation | Scores on a scale | week 40 - week 66 |
|
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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 | Ritalin LA | All participants started with Ritalin LA 20 mg/day and increased at weekly intervals in increments of 20 mg/day until reaching the patient's optimal dose 40, 60 or 80 mg/day). | 2 | 298 | 163 | 298 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pancreatitis | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Exostosis | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
| |
| Non-Hodgkin's lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Palpitations | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Depressed mood | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Initial insomnia | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Sleep disorder | Psychiatric disorders | MedDRA | Systematic Assessment |
| |
| Dysmenorrhoea | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
|
Principal Investigators are NOT employed by the organization sponsoring the study. Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of pooled data (i.e.,data from all sites) in clinical trial.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director | Novartis Pharmaceuticals | 8627788300 |
| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| D013035 | Spasm |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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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| Title | Measurements |
|---|---|
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| Units | Counts |
|---|---|
| Participants |
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