CX717 in the Treatment of Adult ADHD

NCT03375021 | Completed Phase 2 FDA Drug

• 1 other identifier: CX717-05-ADHD
• Study Type: interventional
• Target: 68
• Locations: 0 countries
• Sites: N/A

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

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

ADHD, ampakine, Phase II clinical trial

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• ADHD-RS subscales

  3 Weeks

• CGI-I

  3 Weeks

• HAM-A

  3 Weeks

• HAM-D

  3 Weeks

• PSQI

  3 Weeks

Study Arms (4)

Sequence 1 PL

EXPERIMENTAL

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; Drug: Placebo

Sequence 2 PH

EXPERIMENTAL

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: CX717 800 mg; Drug: Placebo

Sequence 3 LP

EXPERIMENTAL

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; Drug: Placebo

Sequence 4 HP

EXPERIMENTAL

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: CX717 800 mg; Drug: Placebo

Interventions

CX717 200 mg DRUG

CX717 200 mg capsules BID

Also known as: Low Dose

Sequence 1 PL; Sequence 3 LP

CX717 800 mg DRUG

CX717 4 X 200 mg capsules BID

Also known as: High Dose

Sequence 2 PH; Sequence 4 HP

Placebo DRUG

Placebo 200 mg or 800 mg capsules BID

Sequence 1 PL; Sequence 2 PH; Sequence 3 LP; Sequence 4 HP

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• RespireRx: lead

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

CX717; Contraceptives, Oral

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Contraceptive Agents, Female; Contraceptive Agents; Reproductive Control Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Therapeutic Uses

Study Officials

• Len Adler, MD

  NYU School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 200 mg of drug product or placebo in matching size 0 capsules
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A Randomized, Double-Blind, Two-Period Crossover Study

Study Record Dates

• First Submitted: December 7, 2017
• First Posted: December 15, 2017
• Study Start: July 19, 2005
• Primary Completion: January 10, 2006
• Study Completion: January 10, 2006
• Last Updated: December 15, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share