Trial Outcomes & Findings for Open-label Extension Evaluating Methylphenidate Hydrochloride Extended Release in Adults With Attention Deficit/Hyperactivity Disorder (NCT NCT01338818)
NCT ID: NCT01338818
Last Updated: 2014-11-24
Results Overview
Adverse Events, Serious Adverse Events and Deaths were monitored from week 40 to week 66.
COMPLETED
PHASE3
299 participants
Week 40 - Week 66
2014-11-24
Participant Flow
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
Participant milestones
| Measure |
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).
|
|---|---|
|
Overall Study
STARTED
|
298
|
|
Overall Study
COMPLETED
|
262
|
|
Overall Study
NOT COMPLETED
|
36
|
Reasons for withdrawal
| Measure |
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).
|
|---|---|
|
Overall Study
Adverse Event
|
8
|
|
Overall Study
Lack of Efficacy
|
5
|
|
Overall Study
no longer require study drug
|
1
|
|
Overall Study
Withdrawal by Subject
|
11
|
|
Overall Study
Lost to Follow-up
|
4
|
|
Overall Study
Administrative problems
|
3
|
|
Overall Study
Protocol Deviation
|
4
|
Baseline Characteristics
Open-label Extension Evaluating Methylphenidate Hydrochloride Extended Release in Adults With Attention Deficit/Hyperactivity Disorder
Baseline characteristics by cohort
| Measure |
Ritalin LA
n=298 Participants
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).
|
|---|---|
|
Age, Continuous
|
36.3 years
STANDARD_DEVIATION 11.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
138 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
160 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 40 - Week 66Population: 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.
Adverse Events, Serious Adverse Events and Deaths were monitored from week 40 to week 66.
Outcome measures
| Measure |
Ritalin LA
n=298 Participants
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).
|
|---|---|
|
Number of Participants With Adverse Events, Serious Adverse Events and Deaths.
Adverse Events (Serious and Non Serious)
|
208 participants
|
|
Number of Participants With Adverse Events, Serious Adverse Events and Deaths.
Serious Adverse Events
|
2 participants
|
|
Number of Participants With Adverse Events, Serious Adverse Events and Deaths.
Deaths
|
0 participants
|
SECONDARY outcome
Timeframe: week 40 - week 66Population: 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.
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.
Outcome measures
| Measure |
Ritalin LA
n=298 Participants
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).
|
|---|---|
|
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.
|
-7.2 scores on a scale
Standard Deviation 11.00
|
SECONDARY outcome
Timeframe: week 40 - week 66Population: 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.
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.
Outcome measures
| Measure |
Ritalin LA
n=298 Participants
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).
|
|---|---|
|
Change From Extension Baseline (Week 40) to End of Study (Week 66) on Sheehan Disability Scale (SDS) Total Score
|
-4.8 Scores on a scale
Standard Deviation 6.88
|
Adverse Events
Ritalin LA
Serious adverse events
| Measure |
Ritalin LA
n=298 participants at risk
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).
|
|---|---|
|
Gastrointestinal disorders
Pancreatitis
|
0.34%
1/298
|
|
Musculoskeletal and connective tissue disorders
Exostosis
|
0.34%
1/298
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's lymphoma
|
0.34%
1/298
|
Other adverse events
| Measure |
Ritalin LA
n=298 participants at risk
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).
|
|---|---|
|
Cardiac disorders
Palpitations
|
2.0%
6/298
|
|
Cardiac disorders
Tachycardia
|
2.7%
8/298
|
|
Gastrointestinal disorders
Diarrhoea
|
2.0%
6/298
|
|
Gastrointestinal disorders
Dry mouth
|
6.7%
20/298
|
|
Gastrointestinal disorders
Nausea
|
5.0%
15/298
|
|
General disorders
Fatigue
|
3.0%
9/298
|
|
Infections and infestations
Gastroenteritis
|
3.4%
10/298
|
|
Infections and infestations
Nasopharyngitis
|
19.1%
57/298
|
|
Infections and infestations
Sinusitis
|
3.7%
11/298
|
|
Infections and infestations
Upper respiratory tract infection
|
4.7%
14/298
|
|
Investigations
Weight decreased
|
2.0%
6/298
|
|
Metabolism and nutrition disorders
Decreased appetite
|
7.7%
23/298
|
|
Nervous system disorders
Headache
|
14.1%
42/298
|
|
Psychiatric disorders
Agitation
|
2.3%
7/298
|
|
Psychiatric disorders
Anxiety
|
3.7%
11/298
|
|
Psychiatric disorders
Depressed mood
|
2.0%
6/298
|
|
Psychiatric disorders
Initial insomnia
|
2.7%
8/298
|
|
Psychiatric disorders
Insomnia
|
3.7%
11/298
|
|
Psychiatric disorders
Sleep disorder
|
2.3%
7/298
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
2.0%
6/298
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
2.7%
8/298
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
2.3%
7/298
|
Additional Information
Study Director
Novartis Pharmaceuticals
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER