CX717 in the Treatment of Adult ADHD

A Randomized, Double-Blind, Tw0-Period Crossover Study to Assess the Efficacy and Safety of the Ampakine® Compound, CX717, Versus Placebo in Adults With Attention-Deficit Hyperactive Disorder

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

Study Overview

• Status: Completed
• Conditions: Attention Deficit Hyperactivity Disorder
• Intervention / Treatment: Drug: CX717 200 mg; Drug: Placebo; Drug: CX717 800 mg

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 of CX717 with placebo. Subjects were randomized to 1 of 4 different treatment sequences: placebo - low dose; low dose - placebo; placebo - high dose; or high dose - placebo. Each treatment period was 3 weeks with a 2-week washout between treatment periods. The doses chosen were 200 mg b.i.d. and 800 mg b.i.d.

• Study Type: Interventional
• Enrollment (Actual): 68
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

1. Subject had ADHD as established by the Adult ADHD Clinical Diagnostic Scale (ACDS) Version 1.2

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
3. Subject was male
4. Subject was 18 - 50 years old, inclusive
5. Subject could read well enough to understand the informed consent form and other patient materials.

Exclusion Criteria:

1. Subject had a DSM-IV diagnosis of ADHD not otherwise specified
2. 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)
3. 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
4. Subject had a history of epilepsy, seizures, syncope, unexplained blackout spell(s), head trauma with loss of consciousness, or febrile seizures
5. 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
6. Subject had a history of development delay in milestones
7. By history, the subject had an IQ less than 80
8. In the opinion of the Investigator, the subject had not derived significant therapeutic benefit from 2 or more appropriately dosed ADHD therapies

9. 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.

10. Subject was currently taking an anti-depressant prescription medication (e.g., paroxetine, sertraline, venlafaxine, etc.) or St. John's Wort
11. Subject was currently taking an anti-convulsant medication (e.g., phenytoin, carbamazepine, lamotrigine, valproic acid, etc.) or anti-psychotic medication
12. Subject had a clinically relevant abnormality on Screening evaluation including physical examination, vital signs, ECG, or laboratory tests
13. Subject was currently taking on a chronic basis any medication known to be primarily metabolized by a route other than the cytochrome P450 system
14. 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.
15. Subject was unwilling to refrain from taking more than 1 unit of alcohol within 24 hours of the clinic visits
16. Subject had a Body Mass Index (BMI) of less than 18 or greater than 35. No waivers were allowed.
17. Subject reported passive or active suicidal ideation or intent
18. Subject was concurrently participating in another clinical research study or investigational drug trial or had participated within the past 1 month
19. Subject was at high risk of non-compliance in the Investigator's opinion

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: QUADRUPLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Sequence 1 PL; Eligible subjects were randomized to Sequence 1 PL in which they received placebo (P) followed by crossover to CX717 200 mg low dose (L) of active treatment	Drug: CX717 200 mg; CX717 200 mg capsules BID; Other Names: Low Dose; Drug: Placebo; Placebo 200 mg or 800 mg capsules BID
EXPERIMENTAL: Sequence 2 PH; Eligible subjects were randomized to Sequence 2 PH in which they received placebo (P) followed by crossover to CX717 800 mg High dose (H) of active treatment	Drug: Placebo; Placebo 200 mg or 800 mg capsules BID; Drug: CX717 800 mg; CX717 4 X 200 mg capsules BID; Other Names: High Dose
EXPERIMENTAL: Sequence 3 LP; Eligible subjects were randomized to Sequence 3 LP in which they received CX717 200 mg Low dose (L) of active treatment followed by crossover to placebo (P)	Drug: CX717 200 mg; CX717 200 mg capsules BID; Other Names: Low Dose; Drug: Placebo; Placebo 200 mg or 800 mg capsules BID
EXPERIMENTAL: Sequence 4 HP; Eligible subjects were randomized to Sequence 2 PH in which they received CX717 800 mg High dose (H) of active treatment followed by crossover to placebo (P)	Drug: Placebo; Placebo 200 mg or 800 mg capsules BID; Drug: CX717 800 mg; CX717 4 X 200 mg capsules BID; Other Names: High Dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ADHD-RS	Attention-Deficit Hyperactivity Disorder Rating Scale (ADHD-RS) with Prompts The ADHD-RS is an 18-item scale that assesses the severity ADHD symptoms based on the symptom list in the DSM-IV. It is administered by a qualified health care professional. Each item is rated 0 - 3 (0=not present and 3=severe). Thus the scale has a range from 0 to 54.	3 Weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ADHD-RS subscales	Attention Deficit Hyperactivity Disorder Rating Subscales: hyperactivity consisting of items 1-4, 8-10, 17-18, and inattentiveness consisting of items 5-7 and 11-16.	3 Weeks
CGI-I	Clinical Global Impression of Improvement	3 Weeks
HAM-A	Hamilton Rating Scale of Anxiety	3 Weeks
HAM-D	Hamilton Rating Scale of Depression	3 Weeks
PSQI	Pittsburgh Sleep Quality Index	3 Weeks
ESS	Eppworth Sleepiness Scale	3 Weeks
ADHD-SRS	Attention Deficit Hyperactivity Disorder Self Rating Scale	3 Weeks
SCWT	Stroop Color and Word Test	3 Weeks
CTMT	Comprehensive Trail Making Test	3 Weeks
CPT	Continuous Performance Task	3 Weeks
FBDS	Forward and Backward Digit Span	3 Weeks

Collaborators and Investigators

• Sponsor: RespireRx
• Investigators: Principal Investigator: Len Adler, MD, NYU School of Medicine

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 19, 2005
• Primary Completion (ACTUAL): January 10, 2006
• Study Completion (ACTUAL): January 10, 2006

Study Registration Dates

• First Submitted: December 7, 2017
• First Submitted That Met QC Criteria: December 14, 2017
• First Posted (ACTUAL): December 15, 2017

Study Record Updates

• Last Update Posted (ACTUAL): December 15, 2017
• Last Update Submitted That Met QC Criteria: December 14, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: ADHD, ampakine, Phase II clinical trial
• Additional Relevant MeSH Terms: Mental Disorders; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Attention Deficit Disorder with Hyperactivity
• Other Study ID Numbers: CX717-05-ADHD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No