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| Sponsor: | Chelsea Therapeutics |
|---|---|
| Information provided by: | Chelsea Therapeutics |
| ClinicalTrials.gov Identifier: | NCT00983814 |
Purpose
Attention Deficit Hyperactivity Disorder (ADHD) is a neurobiological disorder characterized by lifelong issues of inattention, distraction, organizational difficulties, forgetfulness, restlessness, talking out of turn, difficulty waiting and interrupting others. ADHD is the second most common neuropsychiatric disorder affecting 4.4% of the US adult population, or between 8-9 million individuals (Kessler et al., 2006).
Droxidopa (L-dihydroxyphenylserine (L-DOPS)) is a synthetic catecholamine which is converted to norepinephrine (NE) via decarboxylation, resulting in increased levels of NE centrally in the CNS and peripherally. Co-treatment with carboxylase inhibitors, such as carbidoba, given with droxidopa, can increase the CNS levels of NE with greater crossing of the blood-brain barrier. Droxidopa has received orphan drug approval by the FDA for the treatment of symptomatic neurogenic orthostatic hypotension in individuals with primary autonomic failure. The half-life of droxidopa is approximately 2-3 hours, resulting in administration thee times daily.
As adult ADHD is characterized as a disorder of decreased NE activity in the pre-frontal cortex, it is hypothesized that treating patients with droxidopa (in co-administration of carbidopa) will have a positive effect on adult ADHD.
| Condition | Intervention | Phase |
|---|---|---|
|
Attention Deficit Hyperactivity Disorder |
Drug: Droxidopa+Carbidopa Drug: Placebo |
Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Two-Period Trial (Open-Label and Randomized Placebo-Controlled Substitution) of Droxidopa Treatment in Adults With ADHD With Co-administration of Carbidopa |
| Estimated Enrollment: | 20 |
| Study Start Date: | October 2009 |
| Estimated Study Completion Date: | April 2011 |
| Estimated Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Droxidopa+Carbidopa: Experimental
Droxidopa (L-dihydroxyphenylserine (L-DOPS)) (200, 400, or 600mgs TID) in combination with carbidopa (25mg or 50mg TID)
|
Drug: Droxidopa+Carbidopa
Droxidopa (L-dihydroxyphenylserine (L-DOPS)) (200, 400, or 600mgs TID) in combination with carbidopa (25mg or 50mg TID, provided as oral capsules taken TID from Baseline to end of Week 8
|
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Placebo: Placebo Comparator
Placebo
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Drug: Placebo
Placebo matched oral capsules taken TID from Baseline to end of Week 8
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This will be a 12-week study of twenty enrolled subjects with DSM IV adult ADHD (age 18-55), with a goal of completing twenty subjects in the trial. The primary objective of this study is to determine the effect of droxidopa therapy on adult ADHD symptoms over the course of a six-week open-label titration period followed by a two-week double-blind, placebo-controlled period. The primary outcome measure will be changes from baseline in total score on the Adult ADHD Investigator Symptom Rating Scale (AISRS). Secondary measures will be changes in self-report ADHD symptoms on the ASRS v1.1 Symptom Checklist, global impairment on the Clinician Global Impression Scale (CGI).
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Lenard A Adler, M.D. | 212-686-7500 ext 7990 | Lenard.Adler@nyumc.org |
| United States, New York | |
| VA New York Harbor Healthcare System/New York University Langone Medical Center | Recruiting |
| New York, New York, United States, 10010 | |
| Contact: Lenard A Adler, MD 212-686-7500 ext 7990 Lenard.Adler@nyumc.org | |
| Contact: David Shaw, RN (212) 686-7500 ext 3176 David.Shaw@nyumc.org | |
| Principal Investigator: Lenard A Adler, MD | |
| Principal Investigator: | Lenard A Adler, M.D. | VA New York Harbor Healthcare System/New York University Langone Medical Center |
More Information
| Responsible Party: | VA New York Harbor Healthcare System/New York University Langone Medical Center ( Lenard A. Adler, MD ) |
| Study ID Numbers: | Droxidopa ADD201 |
| Study First Received: | September 23, 2009 |
| Last Updated: | December 7, 2009 |
| ClinicalTrials.gov Identifier: | NCT00983814 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
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Attention Deficit Hyperactivity Disorder ADHD Adult ADHD Adult Attention Deficit Hyperactivity Disorder |
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Neurotransmitter Agents Disease Molecular Mechanisms of Pharmacological Action Anti-Dyskinesia Agents Physiological Effects of Drugs Nervous System Diseases Carbidopa Antiparkinson Agents Attention Deficit and Disruptive Behavior Disorders Enzyme Inhibitors Dyskinesias Pharmacologic Actions |
Signs and Symptoms Pathologic Processes Attention Deficit Disorder with Hyperactivity Mental Disorders Therapeutic Uses Mental Disorders Diagnosed in Childhood Hyperkinesis Neurologic Manifestations Dopamine Agents Droxidopa Central Nervous System Agents |