Study of Droxidopa Treatment in Adults With Attention Deficit Hyperactivity Disorder With Co-administration of Carbidopa (ADD201)
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|ClinicalTrials.gov Identifier: NCT00983814|
Recruitment Status : Completed
First Posted : September 24, 2009
Last Update Posted : April 4, 2013
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 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 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 or disease||Intervention/treatment||Phase|
|Attention Deficit Hyperactivity Disorder||Drug: Droxidopa+Carbidopa Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Study Start Date :||October 2009|
|Actual Primary Completion Date :||May 2011|
|Actual Study Completion Date :||July 2011|
Droxidopa (L-dihydroxyphenylserine (L-DOPS)) (200, 400, or 600mgs TID) in combination with carbidopa (25mg or 50mg TID)
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
Placebo Comparator: Placebo
Placebo matched oral capsules taken TID from Baseline to end of Week 8
- The primary outcome measure will be changes from baseline in total score on the Adult ADHD Investigator Symptom Rating Scale (AISRS). [ Time Frame: Baseline to end of week 8 treatment ]
- Changes in self-report ADHD symptoms on the ASRS v1.1 Symptom Checklist [ Time Frame: baseline to end of 8 Week treatment period ]
- Changes in global impairment on the Clinician Global Impression Scale (CGI). [ Time Frame: baseline to end of week 8 treatment period ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00983814
|United States, New York|
|VA New York Harbor Healthcare System/New York University Langone Medical Center|
|New York, New York, United States, 10010|
|Principal Investigator:||Lenard A Adler, M.D.||VA New York Harbor Healthcare System/New York University Langone Medical Center|