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NCT00983814 · ClinicalTrials.gov registry record · Phase 2

Study of Droxidopa Treatment in Adults With Attention Deficit Hyperactivity Disorder With Co-administration of Carbidopa

A Phase 2 study of Attention Deficit Hyperactivity Disorder, sponsored by Chelsea Therapeutics.

Completed
Registry status
Phase 2
Development phase
20
Enrollment target
1
Study location

NCT00983814 is a Phase 2 study of Attention Deficit Hyperactivity Disorder that has completed, run by Chelsea Therapeutics. The registered enrollment target is 20 participants, below the 207-participant average among 88 other Attention Deficit Hyperactivity Disorder trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT00983814, a Phase 2 study of Attention Deficit Hyperactivity Disorder, has completed, sponsored by Chelsea Therapeutics.

COMPLETED
Registry status
Phase 2
Development phase
20 participants
Enrollment target
1
Study location

Study Summary

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 United States (US) adult population, or between 8-9 million individuals. 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 central nervous system (CNS) and peripherally. Co-treatment with carboxylase inhibitors, such as carbidopa, 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 Food and Drug Administration (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 three times daily.

Interventions

  • DRUG Droxidopa+Carbidopa

Study Locations (1)

New York

  • VA New York Harbor Healthcare System/New York University Langone Medical Center - New York

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2009-10
Est. Completion 2011-07
Phase Phase 2

Sponsor

Chelsea Therapeutics

10 total trials

What the Registry Record Tells You About NCT00983814

The ClinicalTrials.gov registry entry for NCT00983814 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 207-participant average among 88 other Attention Deficit Hyperactivity Disorder trials with a reported enrollment target (90% lower). The listed sponsor is Chelsea Therapeutics, which has 10 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Attention Deficit Hyperactivity Disorder appearing as the primary indexed condition, and to 1 intervention - of which Droxidopa+Carbidopa is the first listed.

NCT00983814 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.

Frequently Asked Questions

What is clinical trial NCT00983814 about?

NCT00983814 is a clinical study titled "Study of Droxidopa Treatment in Adults With Attention Deficit Hyperactivity Disorder With Co-administration of Carbidopa". 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 neurop...

What is the current status of trial NCT00983814?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2009-10. Estimated completion is 2011-07.

What conditions does trial NCT00983814 study?

This clinical trial studies the following conditions: Attention Deficit Hyperactivity Disorder.

What interventions are being tested in trial NCT00983814?

The interventions under investigation include: Droxidopa+Carbidopa (DRUG).

Who is sponsoring clinical trial NCT00983814?

This trial is sponsored by Chelsea Therapeutics, which has 10 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00983814 being conducted?

This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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