Study of Droxidopa Treatment in Adults With Attention Deficit Hyperactivity Disorder With Co-administration of Carbidopa
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 2

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 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.
    

Detailed description: 
      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).
    

Intervention name(s): Droxidopa+Carbidopa; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 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 matched oral capsules taken TID from Baseline to end of Week 8
Other intervention name(s): Droxidopa; L-threo-dihydroxyphenylserine; L-DOPS
Intervention MeSH terms: Carbidopa; Droxidopa
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Attention Deficit Hyperactivity Disorder; ADHD; Adult ADHD; Adult Attention Deficit Hyperactivity Disorder