Trial · NCT01259492
Efficacy and Safety Study of Methylphenidate Hydrochloride Extended Release in Adults With Childhood-onset Attention Deficit/Hyperactivity Disorder (ADHD)
NCT01259492, Phase 3, Completed, Novartis Pharmaceuticals; results first posted 2014-04-29
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety Study of Methylphenidate Hydrochloride Extended Release in Adults With Childhood-onset Attention Deficit/Hyperactivity Disorder (ADHD). Trials, record NCT01259492. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01259492
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety Study of Methylphenidate Hydrochloride Extended Release in Adults With Childhood-onset Attention Deficit/Hyperactivity Disorder (ADHD)
- NCT number
- NCT01259492
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 725 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Attention Deficit/Hyperactivity Disorder
- Interventions
- Placebo, Ritalin LA 20 mg, Ritalin LA 30 mg
- First posted
- 2010-12-14
- Last updated
- 2014-10-07
- Other registries' IDs
- eudract:2010-021533-31
- Results first posted
- 2014-04-29
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline of Period 1 (Baseline 1) to End of Period 1 on Attention-Deficit/Hyperactivity Disorder Rating Scale (DSM-IV ADHD RS) Total Score by Treatment | Baseline 1 to End of Period 1 (Week 9) | 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 ("Never") to 4 ("Very often"). The total score ranges from 0(least symptomatic) to 72 (most symptomatic). 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. 30% improvement: 100×(DSM-IV ADHD RS total score during Period 1 - DSM-IV ADHD RS total score at randomization(visit 2))/DSM-IV ADHD RS total score at randomization (visit 2) \<= - 30%. |
| Primary | Change From Baseline Period 1 (Baseline 1) to End of Period 1 on Sheehan Disability Scale (SDS) Total Score by Treatment | Baseline 1 to End of Period 1 (Week 9) | SDS, a 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 reg. activities over the past 7d in ea. using a scale from 0(not at all)-10(extremely) Ea. 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 impairmt. 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. |
| Primary | Percentage of Participants With Treatment Failures During Period 3 | Baseline Period 1 (Baseline 1) and Baseline Period 3 (Baseline 2) to End of Week 40 | Treatment failure is defined as: 100×(DSM-IV ADHD RS total score during Period 3 - DSM-IV ADHD RS total score at re-randomization (visit 13))/DSM-IV ADHD RS total score at re-randomization (visit 13) \>= 30% AND 100×(DSM-IV ADHD RS total score during Period 3 - DSM-IV ADHD RS total score at randomization (visit 2))/DSM-IV ADHD RS total score at randomization (visit 2) \> - 30%. The ADHD-RS-IV is an 180item clinician rated scale to assess ADHD by DSM-IV-TR, defined criteria using symptom terminology appropriate for the adult population. Each item pertains to inattention (odd-numbered) or hyperactivity/impulsivity (even-numbered) and is scored on a scale of 0 (no symptoms) to 3 (severe symptoms). A total added score can range from 0-54 |
| Secondary | Percentage of Patients With Improvement on Clinical Global Impression - Improvement Scale (CGI-I) From Baseline Period 1 (Baseline 1) to End of Period 1 | Baseline 1 to End of Period 1 (Week 9) | On the CGI-I scale, a lower score reflects greater improvement between 1 and 3, a score of 4 is "no change", scores higher than 4 reflect worsening. The CGI-I consists of 7 ratings that range from 1 = "Very much improved" to 7 ="Very much worse". Improvement on the CGI-I scale is defined as a visit rating of 1 "very much improved" or 2 "much improved" on the CGI-I scale. Percentage has been calculated from the evaluable patients (N) as Percentage = n/N \* 100. |
| Secondary | Change From Baseline 1 in DSM-IVADHD RS Total Score, SDS Total Score, The Conners' Adult ADHD Rating Scale Observer Short Version (CAARS-O:S) Total Score and Adult Self-Report Scale (ASRS) Total Score at the End of Period 2 (Visit 13/ Week 14) | Baseline 1 to End of Period 2 (Week 14) | DSM-IV ADHD RS consists of 18 items directly adapted from the ADHD symptom list according to the DSM-IV. The SDS is a five-item, self-rated questionnaire that has been used widely in clinical trials and observational studies. CAARS-O: S consists of 26 items and 6 subscales: Inattention/Memory Problems, Hyperactivity/Restlessness, Impulsivity/Emotional Lability, Problems with Self-Concept, ADHD Index, and Inconsistency Index and is rated by someone close to the patient in their daily life such as a spouse, friend, or coworker. The Adult Self-Report Scale (ASRS) is a self-rating scale designed to assess Attention-Deficit/Hyperactivity Disorder (ADHD) symptoms. The 18 items are written to reflect the DSM-IV diagnostic criteria for ADHD and are rated from 0 ("Never") to 4 ("Very often"). |
| Secondary | Number of Participants With Clinical Global Impression - Improvement Scale (CGI-I) Rating at the End of Period 2 (Visit 13/ Week 14) | Baseline 1 to End of Period 2 (Week 14) | CGI-I assesses the overall change of illness relative to baseline. CGI-I consists of 7 ratings that range from 1 = "very much improved", 2 = "much improved", 3 = "minimally improved", 4 = "no change from baseline", 5 = "minimally worse", 6 = "much worse" 7 = "very much worse" |
| Secondary | Number of Participants With Clinical Global Impression - Improvement Scale Severity of Illness (CGI-S) Rating at the End of Period 2 (Visit 13/ Week 14) | Baseline 1 to End of Period 2 (Week 14) | CGI-S assesses the patient's current illness state. CGI-S consists of 7 ratings that range from 1 = "normal, not at all ill" , 2 = "borderline mentally ill", 3 =" mildly ill", 4 = "moderately ill", 5 = "markedly ill", 6 = "severely ill", 7 = "among the most extremely ill patients" |
| Secondary | Change From Baseline Period 3 (Baseline 2) to End of Period 3 on DSM-IV Attention-Deficit/Hyperactivity Disorder Rating Scale ADHD RS Total Score by Treatment | Baseline 2 to end of Period 3 (end of withdrawal period 40 weeks) | The ADHD-RS-IV is an 180 item clinician rated scale to assess ADHD by DSM-IV-TR, defined criteria using symptom terminology appropriate for the adult population. Each item pertains to inattention (odd-numbered) or hyperactivity/impulsivity (even-numbered) and is scored on a scale of 0 (no symptoms) to 3 (severe symptoms). A total added score can range from 0-54. |
| Secondary | Change From Baseline Period 3 (Baseline 2) to End of Period 3 on SDS Total Score by Treatment | Baseline 2 to end of Period 3 (end of withdrawal period 40 weeks) | The Sheehan Disability Scale (SDS) is a self-rating scale designed to assess the extent to which the patient's work social life/leisure activities and home life are impaired by his or her symptoms. The scale generates 4 scores: a work disability score, a social life disability score, a family life disability score and a total score. To get a total score the 3 individual scores (work: social life: family life) are totaled. The maximum possible score is 30 The higher the score, the more "impaired" a patient's work, social life, family life is. |
| Secondary | Number of Patients With Worsening on CGI-I Scale From Baseline Period 3 (Baseline 2) to End of Period 3 by Treatment | Baseline 2 to end of Period 3 (end of withdrawal period 40 weeks) | On the CGI-I scale, a lower score reflects greater improvement between 1 and 3, a score of 4 is "no change", scores higher than 4 reflect worsening. The CGI-I consists of 7 ratings that range from 1 = "Very much improved" to 7 ="Very much worse". Improvement on the CGI-I scale is defined as a visit rating of 1 "very much improved" or 2 "much improved" on the CGI-I scale. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline of Period 1 (Baseline 1) to End of Period 1 on Attention-Deficit/Hyperactivity Disorder Rating Scale (DSM-IV ADHD RS) Total Score by Treatment | Baseline 1 to End of Period 1 (Week 9) | Full Analysis Set for Period 1 (FAS P1) - all randomized patients who take one dose of study medication in period 1. Patients will be assigned to their randomized fixed dose. Patients with both baseline and post-baseline (end of week 9) assessments were included. | Units on a Scale | MEAN |
| PRIMARY | Change From Baseline Period 1 (Baseline 1) to End of Period 1 on Sheehan Disability Scale (SDS) Total Score by Treatment | Baseline 1 to End of Period 1 (Week 9) | Full Analysis Set for Period 1 (FAS P1) - all randomized patients who take one dose of study medication in period 1. Patients will be assigned to their randomized fixed dose. Patients with both baseline and post-baseline (end of week 9) assessments were included. | Units on a Scale | MEAN |
| PRIMARY | Percentage of Participants With Treatment Failures During Period 3 | Baseline Period 1 (Baseline 1) and Baseline Period 3 (Baseline 2) to End of Week 40 | Full Analysis Set for Period 3 (FAS P3) - all re-randomized patients who take one dose of study medication in period 3. One patient in Ritalin LA 80mg did not have post baseline 2 measurements and was not included in the categories under without imputation. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Patients With Improvement on Clinical Global Impression - Improvement Scale (CGI-I) From Baseline Period 1 (Baseline 1) to End of Period 1 | Baseline 1 to End of Period 1 (Week 9) | Full Analysis Set for Period 1 (FAS P1) - all randomized patients who take one dose of study medication in period 1. Patients will be assigned to their randomized fixed dose. Evaluable patients with both baseline and post-baseline (end of week 9) assessments were included. | Percentage of Patients | NUMBER |
| SECONDARY | Change From Baseline 1 in DSM-IVADHD RS Total Score, SDS Total Score, The Conners' Adult ADHD Rating Scale Observer Short Version (CAARS-O:S) Total Score and Adult Self-Report Scale (ASRS) Total Score at the End of Period 2 (Visit 13/ Week 14) | Baseline 1 to End of Period 2 (Week 14) | Full Analysis Set for Period 2 (FAS P2) - all randomized patients who took one dose of study medication in Period 2 | Score on Scale | MEAN |
| SECONDARY | Number of Participants With Clinical Global Impression - Improvement Scale (CGI-I) Rating at the End of Period 2 (Visit 13/ Week 14) | Baseline 1 to End of Period 2 (Week 14) | Full Analysis Set for Period 2 (FAS P2) - all randomized patients who took one dose of study medication in Period 2 Patients with CGI-I assessment both at Baseline 1 and Period 2 was included. | number of participants | NUMBER |
| SECONDARY | Number of Participants With Clinical Global Impression - Improvement Scale Severity of Illness (CGI-S) Rating at the End of Period 2 (Visit 13/ Week 14) | Baseline 1 to End of Period 2 (Week 14) | Full Analysis Set for Period 2 (FAS P2) - all randomized patients who took one dose of study medication in Period 2; Patients with CGI-S assessment both at Baseline 1 and Period 2 was included. | number of participants | NUMBER |
| SECONDARY | Change From Baseline Period 3 (Baseline 2) to End of Period 3 on DSM-IV Attention-Deficit/Hyperactivity Disorder Rating Scale ADHD RS Total Score by Treatment | Baseline 2 to end of Period 3 (end of withdrawal period 40 weeks) | Full Analysis Set for Period 3 (FAS P3) - all re-randomized patients who take one dose of study medication in period 3. Patients will be assigned to their re-randomized treatment; Ritalin (pooled doses) or placebo. | Units on a Scale | MEAN |
| SECONDARY | Change From Baseline Period 3 (Baseline 2) to End of Period 3 on SDS Total Score by Treatment | Baseline 2 to end of Period 3 (end of withdrawal period 40 weeks) | Full Analysis Set for Period 3 (FAS P3) - all re-randomized patients who take one dose of study medication in period 3. Patients will be assigned to their re-randomized treatment; Ritalin (pooled doses) or placebo. | Units on a Scale | MEAN |
| SECONDARY | Number of Patients With Worsening on CGI-I Scale From Baseline Period 3 (Baseline 2) to End of Period 3 by Treatment | Baseline 2 to end of Period 3 (end of withdrawal period 40 weeks) | Full Analysis Set for Period 3 (FAS P3) - all re-randomized patients who take one dose of study medication in period 3. Patients will be assigned to their re-randomized treatment; Ritalin (pooled doses) or placebo. Evaluable patients with both baseline 2 and post-baseline (end of week 40) assessments were included. | participants | NUMBER |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group74
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline of Period 1 (Baseline 1) to End of Period 1 on Attention-Deficit/Hyperactivity Disorder Rating Scale (DSM-IV ADHD RS) Total Score by Treatment | Ritalin LA 40 mg | 16.0 | Standard Deviation 12.18 | Units on a Scale | |
| Change From Baseline of Period 1 (Baseline 1) to End of Period 1 on Attention-Deficit/Hyperactivity Disorder Rating Scale (DSM-IV ADHD RS) Total Score by Treatment | Ritalin LA 60 mg | 14.7 | Standard Deviation 10.12 | Units on a Scale | |
| Change From Baseline of Period 1 (Baseline 1) to End of Period 1 on Attention-Deficit/Hyperactivity Disorder Rating Scale (DSM-IV ADHD RS) Total Score by Treatment | Ritalin LA 80 mg | 16.8 | Standard Deviation 11.36 | Units on a Scale | |
| Change From Baseline of Period 1 (Baseline 1) to End of Period 1 on Attention-Deficit/Hyperactivity Disorder Rating Scale (DSM-IV ADHD RS) Total Score by Treatment | Placebo | 9.7 | Standard Deviation 11.05 | Units on a Scale | |
| Change From Baseline Period 1 (Baseline 1) to End of Period 1 on Sheehan Disability Scale (SDS) Total Score by Treatment | Ritalin LA 40 mg | 6.4 | Standard Deviation 7.54 | Units on a Scale | |
| Change From Baseline Period 1 (Baseline 1) to End of Period 1 on Sheehan Disability Scale (SDS) Total Score by Treatment | Ritalin LA 60 mg | 4.7 | Standard Deviation 7.08 | Units on a Scale | |
| Change From Baseline Period 1 (Baseline 1) to End of Period 1 on Sheehan Disability Scale (SDS) Total Score by Treatment | Ritalin LA 80 mg | 6.1 | Standard Deviation 7.31 | Units on a Scale | |
| Change From Baseline Period 1 (Baseline 1) to End of Period 1 on Sheehan Disability Scale (SDS) Total Score by Treatment | Placebo | 2.9 | Standard Deviation 7.47 | Units on a Scale | |
| Percentage of Participants With Treatment Failures During Period 3 | Ritalin LA 40 mg | Without Imputation - Treatment failure | 11.8 | 7.54 | Percentage of participants |
| Percentage of Participants With Treatment Failures During Period 3 | Ritalin LA 60 mg | Without Imputation - Treatment failure | 20.3 | 7.08 | Percentage of participants |
1 to 10 of 74Source ClinicalTrials.gov
See all 74 results by groupParticipant flow44
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Period 1 (9 Weeks) | STARTED | Ritalin LA 40 mg | 181 | |
| Period 1 (9 Weeks) | STARTED | Ritalin LA 60 mg | 182 | |
| Period 1 (9 Weeks) | STARTED | Ritalin LA 80 mg | 181 | |
| Period 1 (9 Weeks) | STARTED | Placebo | 181 | |
| Period 1 (9 Weeks) | Full Analysis Set | Ritalin LA 40 mg | 174 | |
| Period 1 (9 Weeks) | Full Analysis Set | Ritalin LA 60 mg | 175 | |
| Period 1 (9 Weeks) | Full Analysis Set | Ritalin LA 80 mg | 179 | |
| Period 1 (9 Weeks) | Full Analysis Set | Placebo | 172 | |
| Period 1 (9 Weeks) | COMPLETED | Ritalin LA 40 mg | 152 | |
| Period 1 (9 Weeks) | COMPLETED | Ritalin LA 60 mg | 141 |
1 to 10 of 44Source ClinicalTrials.gov
See all 44 participant flowAdverse events110
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Palpitations | Cardiac disorders | All Ritalin LA | 63 | 695 | |
| other | Palpitations | Cardiac disorders | Placebo | 2 | 275 | |
| other | Tachycardia | Cardiac disorders | All Ritalin LA | 56 | 695 | |
| other | Tachycardia | Cardiac disorders | Placebo | 0 | 275 | |
| other | Vertigo | Ear and labyrinth disorders | All Ritalin LA | 18 | 695 | |
| other | Vertigo | Ear and labyrinth disorders | Placebo | 2 | 275 | |
| other | Abdominal pain upper | Gastrointestinal disorders | All Ritalin LA | 29 | 695 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Placebo | 8 | 275 | |
| other | Diarrhoea | Gastrointestinal disorders | All Ritalin LA | 31 | 695 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 14 | 275 |
1 to 10 of 110Source ClinicalTrials.gov
See all 110 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | All Ritalin LA | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | All Ritalin LA | 517 | 695 |
| Total, other adverse events | Placebo | 104 | 275 |
| Total, serious adverse events | All Ritalin LA | 9 | 695 |
| Total, serious adverse events | Placebo | 4 | 275 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 24371021 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| All Ritalin LA vs Placebo: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
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