13 completed, 2 terminated. 15 Phase 3, 1 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 15 | Completed 13, Terminated 2 |
| Phase 2 | 1 | Completed 1 |
Follow Methylphenidate Hydrochloride: new trials by email Literature Review of Methylphenidate Hydrochloride trials Research Report on Methylphenidate Hydrochloride
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Randomized, Double-blind Safety and Efficacy Study of Lisdexamfetamine Dimesylate (LDX) in Children and Adolescents Aged 6-17 Lisdexamfetamine Dimesylate (LDX), Methylphenidate Hydrochloride, Placebo - ADHD | Phase 3 | Completed | Shire | 336 | 2008-11-17 | 2021-06-14 |
| Quality Assurance of Administering Methylphenidate in Adults With Attention Deficit Hyperactivity Disorder (ADHD) - QUMEA methylphenidate hydrochloride, Placebo - Attention Deficit Hyperactivity Disorder | Phase 3 | Completed | Medice Arzneimittel Pütter GmbH & Co KG | 150 | 2008-09-01 | 2010-01-13 |
| Methylphenidate in Treating Patients With Fatigue Caused by Cancer methylphenidate hydrochloride, placebo - Fatigue, Unspecified Adult Solid Tumor, Protocol Specific | Phase 3 | Completed | Alliance for Clinical Trials in Oncology | 148 | 2008-02-01 | 2016-08-01 |
| Methylphenidate Treatment of Cancer-Related Fatigue Methylphenidate hydrochloride, Placebo - Cancer-related Fatigue | Phase 2 / Phase 3 | Completed | Medice Arzneimittel Pütter GmbH & Co KG | 66 | 2006-08-01 | 2010-01-13 |
| Study Examining Repeat Dosing of OROS® Methylphenidate (CONCERTA®) and Immediate Release Methylphenidate in Healthy Adults OROS methylphenidate hydrochloride, methylphenidate hydrochloride - Healthy | Phase 3 | Completed | Massachusetts General Hospital | 20 | 2006-06-01 | 2013-10-22 |
| Placebo-Controlled Comparison of Two Different Brands of Modified-Release Oral Dosage Forms Regarding Safety and Efficacy in Children With Attention Deficit Hyperactivity Disorder (ADHD) Aged 6 - 14 Methylphenidate hydrochloride - ADHD | Phase 3 | Completed | Novartis | 130 | 2005-10-01 | 2007-12-21 |
| A Study of the Effectiveness and Safety of Prolonged-release Methylphenidate Hydrochloride in Adult Patients With Attention Deficit/Hyperactivity Disorder. methylphenidate hydrochloride - Attention Deficit Disorder With Hyperactivity | Phase 3 | Completed | Janssen Pharmaceutica N.V., Belgium | 402 | 2005-03-01 | 2011-05-17 |
| A PET Study Examining Pharmacokinetics and Dopamine Transporter Receptor Occupancy Of Two Long-Acting Formulations of Methylphenidate in Adults OROS methylphenidate hydrochloride, methylphenidate hydrochloride - Healthy Volunteers | Phase 3 | Completed | Massachusetts General Hospital | 40 | 2005-03-01 | 2011-07-12 |
| Placebo-Controlled Multi-Centre Double-Blind Trial for Adults With Extended-Release Methylphenidate for ADHD methylphenidate hydrochloride, Placebo - Attention Deficit Hyperactivity Disorder | Phase 3 | Completed | Medice Arzneimittel Pütter GmbH & Co KG | 363 | 2004-11-01 | 2008-02-21 |
| Trial of a Sustained Release Methylphenidate in the Treatment of Fatigue in Cancer Patients Methylphenidate, Placebo - Breast Cancer, Fatigue | Phase 3 | Terminated | M.D. Anderson Cancer Center | 42 | 2004-08-01 | 2018-01-03 |
| Comparison of Atomoxetine Plus Either Comparator or Placebo in Children With ADHD Who Haven't Responded to Stimulant Therapy Atomoxetine Hydrochloride, Methylphenidate Hydrochloride, Placebo - Attention Deficit Hyperactivity Disorder | Phase 3 | Completed | Eli Lilly and Company | 14 | 2004-01-01 | 2007-06-13 |
| Comparison Atomoxetine Hydrochloride and Comparator in Pediatric Outpatients With ADHD Atomoxetine Hydrochloride, Methylphenidate Hydrochloride - Attention Deficit Hyperactivity Disorder | Phase 3 | Completed | Eli Lilly and Company | 330 | 2003-12-01 | 2007-06-13 |
| Methylphenidate to Improve Quality of Life in Patients Undergoing Radiation Therapy for Brain Tumors methylphenidate hydrochloride, quality-of-life assessment, radiation therapy - Brain and Central Nervous System Tumors, Cognitive/Functional Effects | Phase 3 | Terminated | Wake Forest University Health Sciences | 2002-04-01 | 2021-09-09 | |
| An Effectiveness and Safety Study of CONCERTA® (Methylphenidate Hydrochloride) in the Treatment of Adolescents With Attention Deficit Hyperactivity Disorder methylphenidate hydrochloride - Attention Deficit Disorder With Hyperactivity | Phase 3 | Completed | McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc. | 220 | 2002-03-01 | 2010-04-28 |
| Methylphenidate in Treating Patients With Melanoma methylphenidate hydrochloride, quality-of-life assessment - Fatigue, Unspecified Adult Solid Tumor, Protocol Specific | Phase 3 | Completed | Eastern Cooperative Oncology Group | 200 | 1999-10-12 | 2023-06-18 |
Attention Deficit Disorder with Hyperactivity (8) · Fatigue (5) · Astrocytoma (1) · Brain Neoplasms (1) · Breast Neoplasms (1) · Central Nervous System Neoplasms (1) · Depression (1) · Ependymoma (1) · Gastrointestinal Neoplasms (1) · Glioblastoma (1) · Glioma (1) · Glioma, Subependymal (1) · Gliosarcoma (1) · Meningioma (1) · Neoplasms (1)
Medice Arzneimittel Pütter GmbH & Co KG (3) · Eli Lilly and Company (2) · Massachusetts General Hospital (2) · Alliance for Clinical Trials in Oncology (1) · Eastern Cooperative Oncology Group (1) · Janssen Pharmaceutica N.V., Belgium (1) · M.D. Anderson Cancer Center (1) · McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc. (1) · Novartis (1) · Shire (1) · Wake Forest University Health Sciences (1)
United States (7) · Germany (5) · Belgium (1) · China (1) · France (1) · Hungary (1) · Italy (1) · Mexico (1) · Netherlands (1) · Poland (1) · Puerto Rico (1) · South Africa (1) · South Korea (1) · Spain (1) · Sweden (1)
Thomas Spencer, MD (2) · Amit Sood, MD (1) · Carmen Escalante, MD (1) · Edward G. Shaw, MD (1) · Manfred Heim, Prof. (1) · Paul R. Hutson, PharmD (1) · Roland Fischer, Dr. (1)
PMID 16389216, PMID 18206857, PMID 20578931, PMID 20625123, PMID 22780962, PMID 23332456, PMID 23708466, PMID 23893527, PMID 26409610
2008 (1)