Status:
COMPLETED
CX717 in the Treatment of Adult ADHD
Lead Sponsor:
RespireRx
Conditions:
Attention Deficit Hyperactivity Disorder
Eligibility:
MALE
18-50 years
Phase:
PHASE2
Brief Summary
A Randomized, Double-Blind, Two-Period Crossover Study to Assess the Efficacy And Safety of the Ampakine® Compound, CX717, versus Placebo in Adults with Attention-Deficit Hyperactivity Disorder
Detailed Description
This study examined the clinical efficacy, tolerability and safety of CX717 in the treatment of adults with ADHD. The study was a double-blind, 2-period crossover study that compared 2 different doses...
Eligibility Criteria
Inclusion
- Subject had ADHD as established by the Adult ADHD Clinical Diagnostic Scale (ACDS) Version 1.2
- Patients must have at least moderately severe ADHD symptoms:
- Subject had an ADHD-RS score of ≥22
- Subject had a CGI-S score of ≥4
- Subject was male
- Subject was 18 - 50 years old, inclusive
- Subject could read well enough to understand the informed consent form and other patient materials.
Exclusion
- Subject had a DSM-IV diagnosis of ADHD not otherwise specified
- Subject had a current or lifetime history of bipolar disorder or any psychotic disorder as established by the Structured Clinical Interview for DSM-IV (SCID) (12)
- Subject had a current history of major depression, substance abuse or dependence, generalized anxiety disorder, obsessive compulsive disorder, panic disorder, or posttraumatic stress disorder as established by SCID
- Subject had a history of epilepsy, seizures, syncope, unexplained blackout spell(s), head trauma with loss of consciousness, or febrile seizures
- Subject had a currently active medical condition (other than ADHD) that in the opinion of the Investigator could interfere with the ability of subject to participate in the study
- Subject had a history of development delay in milestones
- By history, the subject had an IQ less than 80
- In the opinion of the Investigator, the subject had not derived significant therapeutic benefit from 2 or more appropriately dosed ADHD therapies
- Subject was currently taking medication specifically for treatment of ADHD symptoms (e.g., stimulants, atomoxetine, tricyclic antidepressants, or bupropion).
- NOTE: subjects were off of stimulants for 2 weeks and off non-stimulant ADHD therapies for 4 weeks prior to the Period 1 Baseline Visit. Subject did not have evidence of a discontinuation or withdrawal reaction.
- Subject was currently taking an anti-depressant prescription medication (e.g., paroxetine, sertraline, venlafaxine, etc.) or St. John's Wort
- Subject was currently taking an anti-convulsant medication (e.g., phenytoin, carbamazepine, lamotrigine, valproic acid, etc.) or anti-psychotic medication
- Subject had a clinically relevant abnormality on Screening evaluation including physical examination, vital signs, ECG, or laboratory tests
- Subject was currently taking on a chronic basis any medication known to be primarily metabolized by a route other than the cytochrome P450 system
- Subject was unwilling to refrain from taking medications that may have interfered with the assessment of cognitive function. Examples included benzodiazepines, sedating anti-histamines, zolpidem, and zaleplon. Herbal preparations with effects on the central nervous system (e.g., St. John's Wort, melatonin) were prohibited. These medications and herbal preparations were also prohibited throughout the study.
- Subject was unwilling to refrain from taking more than 1 unit of alcohol within 24 hours of the clinic visits
- Subject had a Body Mass Index (BMI) of less than 18 or greater than 35. No waivers were allowed.
- Subject reported passive or active suicidal ideation or intent
- Subject was concurrently participating in another clinical research study or investigational drug trial or had participated within the past 1 month
- Subject was at high risk of non-compliance in the Investigator's opinion
Key Trial Info
Start Date :
July 19 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 10 2006
Estimated Enrollment :
68 Patients enrolled
Trial Details
Trial ID
NCT03375021
Start Date
July 19 2005
End Date
January 10 2006
Last Update
December 15 2017
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