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Last Updated: November 13, 2019

DrugPatentWatch Database Preview

CLINICAL TRIALS PROFILE FOR FOCALIN XR

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All Clinical Trials for Focalin Xr

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00361387 Use of Focalin for Fatigue in Sarcoidosis Completed University of Cincinnati Phase 4 2006-06-01 Patients diagnosed with chronic sarcoidosis with fatigue for more than 6 months. Sarcoidosis and its treatment can greatly affect your quality of life. Many patients suffer from fatigue (feeling tired), lack of focus and concentration, in ability to organize their daily activities, and memory loss. These commonly reported symptoms often get in the way of everyday life.
NCT00393042 Sleep and Tolerability Study: Comparing the Effects of Adderall XR and Focalin XR Completed Novartis Phase 3 2006-01-01 The purpose of this study is to evaluate how children and adolescents with Attention Deficit/ Hyperactivity Disorder (ADHD) respond to treatment with three differing doses of stimulant medications used to treat ADHD, Adderall XR® and Focalin XR®. Another purpose of the study is to evaluate if there are differences in sleep and other side effects, such as changes in mood or loss of appetite, which can occur with stimulant medications. A third purpose is to determine if there are differences in the characteristics of individuals who respond better to either of the medications. This research is being done because the investigators do not know if one of these two commonly used treatments is better tolerated than the other. Children and adolescents with ADHD often have a hard time sitting still, playing quietly, finishing things they start, paying attention, waiting their turn, and not distracting others. These medications improve these symptoms, but sometimes affect sleep, appetite, or mood. It is hypothesized that at effective and frequently prescribed doses, Adderall will be associated with insomnia, more stimulant side effects, and decreased tolerability during an acute trial relative to Focalin.
NCT00393042 Sleep and Tolerability Study: Comparing the Effects of Adderall XR and Focalin XR Completed University of Illinois at Chicago Phase 3 2006-01-01 The purpose of this study is to evaluate how children and adolescents with Attention Deficit/ Hyperactivity Disorder (ADHD) respond to treatment with three differing doses of stimulant medications used to treat ADHD, Adderall XR® and Focalin XR®. Another purpose of the study is to evaluate if there are differences in sleep and other side effects, such as changes in mood or loss of appetite, which can occur with stimulant medications. A third purpose is to determine if there are differences in the characteristics of individuals who respond better to either of the medications. This research is being done because the investigators do not know if one of these two commonly used treatments is better tolerated than the other. Children and adolescents with ADHD often have a hard time sitting still, playing quietly, finishing things they start, paying attention, waiting their turn, and not distracting others. These medications improve these symptoms, but sometimes affect sleep, appetite, or mood. It is hypothesized that at effective and frequently prescribed doses, Adderall will be associated with insomnia, more stimulant side effects, and decreased tolerability during an acute trial relative to Focalin.
NCT00429273 Single Versus Combination Medication Treatment for Children With Attention Deficit Hyperactivity Disorder Completed National Institute of Mental Health (NIMH) Phase 4 2007-01-01 This study will evaluate the effectiveness of a single drug versus a combination of drugs in treating attention deficit hyperactivity disorder in children.
NCT00429273 Single Versus Combination Medication Treatment for Children With Attention Deficit Hyperactivity Disorder Completed University of California, Los Angeles Phase 4 2007-01-01 This study will evaluate the effectiveness of a single drug versus a combination of drugs in treating attention deficit hyperactivity disorder in children.
NCT00564954 A Study of Dex-methylphenidate Extended Release in Children (6-12 Years) With Attention-Deficit/Hyperactivity Disorder (ADHD) Completed Novartis Pharmaceuticals Phase 4 2007-10-01 This study compared the efficacy of dex-methylphenidate extended release 20 mg versus placebo during an 8-hour laboratory classroom day.
NCT00593138 Study of Dopamine Transporter Receptor Occupancy With Long-acting Dex-methylphenidate Completed Massachusetts General Hospital Phase 1/Phase 2 2006-12-01 The objectives of this study are to document the pharmacokinetics of the adequacy of DAT receptor occupancy d-MPH formulation in three doses (20 mg, 30 mg, and 40 mg) using PET scanning with C-11 Altropane as the ligand across a range of times. It has been estimated that MPH is effective when the average CNS DAT occupancy is 50% or greater. Focalin XR has been shown to be clinically effective in an analog classroom as early as 1 hour and as late as 12 hours. Therefore, it is hypothesized that the average DAT occupancy will be adequate (50% or greater) at time periods corresponding to the times of clinical efficacy. The first objective is to examine the onset of action by testing whether average DAT occupancy will be adequate (50% or greater) at 1 hour after dosing for each dose tested (20 mg, 30 mg, 40 mg). The second objective is to test the adequacy of average DAT occupancy in a range of later times for each dose. The times chosen (8, 10 and 12 hours) correspond to times Focalin XR has been shown to be clinically effective in an analogue classroom study. A range of times have been chosen since, while effective at 12 hours, the degree of clinical effectiveness decreased with later time periods. The adequacy of DAT occupancy across this range of time periods will provide important details on the in vivo molecular action of the medicine at periods of critical clinical activity. The third exploratory objective is to examine a time period later then those previously tested with the highest dose. Since the clinical effectiveness of Focalin XR has not been tested out to 14 hours, it is unknown whether it is effective at 14 hours. If Focalin XR were to be effective at 14 hours it would be more likely at the highest dose.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Focalin Xr

Condition Name

Condition Name for Focalin Xr
Intervention Trials
Attention Deficit Hyperactivity Disorder 4
Healthy 3
Deficient Emotional Self-Regulation 1
Sarcoidosis 1
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Condition MeSH

Condition MeSH for Focalin Xr
Intervention Trials
Attention Deficit Disorder with Hyperactivity 6
Hyperkinesis 4
Disease 2
Problem Behavior 1
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Clinical Trial Locations for Focalin Xr

Trials by Country

Trials by Country for Focalin Xr
Location Trials
United States 13
Switzerland 1
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Trials by US State

Trials by US State for Focalin Xr
Location Trials
Massachusetts 3
Missouri 2
Arkansas 1
California 1
Illinois 1
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Clinical Trial Progress for Focalin Xr

Clinical Trial Phase

Clinical Trial Phase for Focalin Xr
Clinical Trial Phase Trials
Phase 4 5
Phase 3 1
Phase 2 1
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Clinical Trial Status

Clinical Trial Status for Focalin Xr
Clinical Trial Phase Trials
Completed 9
Recruiting 1
Active, not recruiting 1
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Clinical Trial Sponsors for Focalin Xr

Sponsor Name

Sponsor Name for Focalin Xr
Sponsor Trials
Massachusetts General Hospital 3
Teva Pharmaceuticals USA 2
University of Cincinnati 1
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Sponsor Type

Sponsor Type for Focalin Xr
Sponsor Trials
Other 8
Industry 4
NIH 1
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