Phase 3
N=298
Open-label Extension Evaluating Methylphenidate Hydrochloride Extended Release in Adults With Attention Deficit/Hyperactivity Disorder
Attention Deficit/Hyperactivity Disorder
Bottom Line
View on ClinicalTrials.gov: NCT01338818 ↗Enrolled (actual)
298
Serious AEs
0.7%
Results posted
May 2014
Primary outcome: Primary: Number of Participants With Adverse Events, Serious Adverse Events and Deaths. — 208; 2; 0 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Ritalin LA (methylphenidate hydrochloride extended release) (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Feb 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events, Serious Adverse Events and Deaths. |
208; 2; 0 | — |
| 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. |
-7.2 | — |
| SECONDARY Change From Extension Baseline (Week 40) to End of Study (Week 66) on Sheehan Disability Scale (SDS) Total Score |
-4.8 | — |
Summary
This study will evaluate the long-term safety of methylphenidate hydrochloride extended release in adults with attention deficit/hyperactivity disorder
Eligibility Criteria
Inclusion Criteria
- 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and Week 40 (End of Study) assessments or Patients who meet predefined criteria for treatment failure, were withdrawn from the core study, and have completed core-study week 40 assessments (Premature Discontinuation Visit)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
- Patients who, during the core study, developed any psychiatric condition that requires treatment with medication or that may interfere with study participation and /or study assessments.
- Patients who during the core study developed cardiovascular disorders.
- Pregnant women.
- Patients who developed seizures during the core study.
- Diagnosis of glaucoma, hyperthyroidism, pheochromocytoma.
- Diagnosis or family history of Tourette's syndrome.
- Patients who during the core study developed cerebrovascular disorders such as cerebral aneurysm, vascular abnormalities including vasculitis and stroke
Other protocol-defined inclusion/exclusion criteria may apply
Data sourced from ClinicalTrials.gov (NCT01338818). 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.