Phase 3
Completed N=725
Efficacy and Safety Study of Methylphenidate Hydrochloride Extended Release in Adults With Childhood-onset Attention Deficit/Hyperactivity Disorder (ADHD)
Source: ClinicalTrials.gov NCT01259492 ↗Enrolled (actual)
725
Serious AEs
1.3%
Results posted
Apr 2014
Primary outcomePrimary: 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 — 16.0; 14.7; 16.8; 9.7 Units on a Scale
Summary
This study will evaluate efficacy and safety of methylphenidate hydrochloride extended release compared to placebo in adult patients with childhood-onset attention deficit/hyperactivity disorder (ADHD).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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 |
16.0; 14.7; 16.8; 9.7 | — |
| PRIMARY Change From Baseline Period 1 (Baseline 1) to End of Period 1 on Sheehan Disability Scale (SDS) Total Score by Treatment |
6.4; 4.7; 6.1; 2.9 | — |
| PRIMARY Percentage of Participants With Treatment Failures During Period 3 |
11.8; 20.3; 17.5; 43.5; 54.5; 50.0 | — |
| 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 |
56.3; 54.8; 57.1; 31.7 | — |
| 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) |
24.8; 10.1; 15.5; 23.2 | — |
| SECONDARY Number of Participants With Clinical Global Impression - Improvement Scale (CGI-I) Rating at the End of Period 2 (Visit 13/ Week 14) |
195; 230; 42; 16; 7; 2 | — |
| 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) |
91; 151; 193; 50; 7; 0 | — |
| 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 |
3.0; 5.1; 2.6; 9.3 | — |
| SECONDARY Change From Baseline Period 3 (Baseline 2) to End of Period 3 on SDS Total Score by Treatment |
2.1; 2.3; 2.0; 5.0 | — |
| SECONDARY Number of Patients With Worsening on CGI-I Scale From Baseline Period 3 (Baseline 2) to End of Period 3 by Treatment |
6; 13; 5; 21 | — |
| SECONDARY Number of Patients With Worsening on CGI-S Scale From Baseline Period 3 (Baseline 2) to End of Period 3 by Treatment |
39; 50; 35; 72 | — |
| SECONDARY Change From Baseline Period 3 (Baseline 2) to End of Period 3 in Conners Adult ADHD Rating Scales Observer: Short Version (CAARS-O:S:) Total Score by Treatment |
-2.7; 1.7; -0.2; 2.9 | — |
| SECONDARY Change From Baseline Period 3 (Baseline 2) to End of Period 3 in ASRS Total Score by Treatment |
3.0; 3.8; 3.0; 8.0 | — |
Eligibility Criteria
Inclusion criteria
- Diagnosis of attention deficit/hyperactivity disorder (ADHD) which started in childhood
- Female patients of childbearing potential must be practicing an acceptable method of contraception.
Exclusion criteria
- Patients with body mass index (BMI) less than 18.5 kg/m2 or more than 35 kg/m2
- History of alcohol or substance abuse within the last six months.
- History of seizures or use of anticonvulsant medication.
- Any psychiatric condition that requires medication or may interfere with study participation.
- Pre-existing cardiovascular disorders including severe hypertension, heart failure, myocardial infraction, etc.
- Significant respiratory, hepatic, gastrointestinal, renal, hematological or oncologic disorder
- Diagnosis of glaucoma, hyperthyroidism, pheochromocytoma
- Diagnosis or family history of Tourette's syndrome
- Pre-existing cerebrovascular disorders such as cerebral aneurysm, vascular abnormalities including vasculitis or stroke
Other protocol-defined inclusion/exclusion criteria may apply
Data sourced from ClinicalTrials.gov (NCT01259492). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.