Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 36 of 439 for:    Methylphenidate

Open-label Extension Evaluating Methylphenidate Hydrochloride Extended Release in Adults With Attention Deficit/Hyperactivity Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01338818
Recruitment Status : Completed
First Posted : April 20, 2011
Results First Posted : May 26, 2014
Last Update Posted : November 24, 2014
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Attention Deficit/Hyperactivity Disorder
Intervention Drug: Ritalin LA (methylphenidate hydrochloride extended release)
Enrollment 299
Recruitment Details 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
Pre-assignment Details  
Arm/Group Title Ritalin LA
Hide Arm/Group Description 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).
Period Title: Overall Study
Started 298
Completed 262
Not Completed 36
Reason Not Completed
Adverse Event             8
Lack of Efficacy             5
no longer require study drug             1
Withdrawal by Subject             11
Lost to Follow-up             4
Administrative problems             3
Protocol Deviation             4
Arm/Group Title Ritalin LA
Hide Arm/Group Description 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).
Overall Number of Baseline Participants 298
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 298 participants
36.3  (11.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 298 participants
Female
138
  46.3%
Male
160
  53.7%
1.Primary Outcome
Title Number of Participants With Adverse Events, Serious Adverse Events and Deaths.
Hide Description Adverse Events, Serious Adverse Events and Deaths were monitored from week 40 to week 66.
Time Frame Week 40 - Week 66
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Ritalin LA
Hide Arm/Group Description:
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).
Overall Number of Participants Analyzed 298
Measure Type: Number
Unit of Measure: participants
Adverse Events (Serious and Non Serious) 208
Serious Adverse Events 2
Deaths 0
2.Secondary Outcome
Title 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.
Hide Description 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.
Time Frame week 40 - week 66
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Ritalin LA
Hide Arm/Group Description:
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).
Overall Number of Participants Analyzed 298
Mean (Standard Deviation)
Unit of Measure: scores on a scale
-7.2  (11.00)
3.Secondary Outcome
Title Change From Extension Baseline (Week 40) to End of Study (Week 66) on Sheehan Disability Scale (SDS) Total Score
Hide Description 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.
Time Frame week 40 - week 66
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Ritalin LA
Hide Arm/Group Description:
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).
Overall Number of Participants Analyzed 298
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-4.8  (6.88)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ritalin LA
Hide Arm/Group Description 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).
All-Cause Mortality
Ritalin LA
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Ritalin LA
Affected / at Risk (%)
Total   2/298 (0.67%) 
Gastrointestinal disorders   
Pancreatitis  1  1/298 (0.34%) 
Musculoskeletal and connective tissue disorders   
Exostosis  1  1/298 (0.34%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Non-Hodgkin's lymphoma  1  1/298 (0.34%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Ritalin LA
Affected / at Risk (%)
Total   163/298 (54.70%) 
Cardiac disorders   
Palpitations  1  6/298 (2.01%) 
Tachycardia  1  8/298 (2.68%) 
Gastrointestinal disorders   
Diarrhoea  1  6/298 (2.01%) 
Dry mouth  1  20/298 (6.71%) 
Nausea  1  15/298 (5.03%) 
General disorders   
Fatigue  1  9/298 (3.02%) 
Infections and infestations   
Gastroenteritis  1  10/298 (3.36%) 
Nasopharyngitis  1  57/298 (19.13%) 
Sinusitis  1  11/298 (3.69%) 
Upper respiratory tract infection  1  14/298 (4.70%) 
Investigations   
Weight decreased  1  6/298 (2.01%) 
Metabolism and nutrition disorders   
Decreased appetite  1  23/298 (7.72%) 
Nervous system disorders   
Headache  1  42/298 (14.09%) 
Psychiatric disorders   
Agitation  1  7/298 (2.35%) 
Anxiety  1  11/298 (3.69%) 
Depressed mood  1  6/298 (2.01%) 
Initial insomnia  1  8/298 (2.68%) 
Insomnia  1  11/298 (3.69%) 
Sleep disorder  1  7/298 (2.35%) 
Reproductive system and breast disorders   
Dysmenorrhoea  1  6/298 (2.01%) 
Respiratory, thoracic and mediastinal disorders   
Oropharyngeal pain  1  8/298 (2.68%) 
Skin and subcutaneous tissue disorders   
Hyperhidrosis  1  7/298 (2.35%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
Phone: 8627788300
Layout table for additonal information
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01338818     History of Changes
Other Study ID Numbers: CRIT124D2302E1
2011-000210-19
First Submitted: April 15, 2011
First Posted: April 20, 2011
Results First Submitted: February 5, 2014
Results First Posted: May 26, 2014
Last Update Posted: November 24, 2014