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Attention Deficit Hyperactivity DisorderPhase 2NCT03375021

CX717 in the Treatment of Adult ADHD

A Phase 2 study testing CX717 200 mg and CX717 800 mg in people with Attention Deficit Hyperactivity Disorder, run by RespireRx.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 to 50 years, men only
Conditions the study is for
Attention Deficit Hyperactivity Disorder
What is being tested?
CX717 200 mg and CX717 800 mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
68 participants
Where
No sites listed yet
Study dates
19 Jul 2005to 10 Jan 2006
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • Men only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 20Show fewer
  • 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

About this study

Official title: 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

Read the 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.

Being tested
CX717 200 mg, CX717 800 mg, Placebo
Keywords
ADHD, ampakine, Phase II clinical trial
Medical subject headings
Attention Deficit Disorder with Hyperactivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CX717 200 mgDrug

    Also called Low Dose

    CX717 200 mg capsules BID

  • CX717 800 mgDrug

    Also called High Dose

    CX717 4 X 200 mg capsules BID

  • PlaceboDrug

    Placebo 200 mg or 800 mg capsules BID

Study groups in NCT03375021
Study groupRoleWhat they receive
Sequence 1 PLExperimentalEligible 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
Receives: Drug: CX717 200 mg; Drug: Placebo
Sequence 2 PHExperimentalEligible 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
Receives: Drug: CX717 800 mg; Drug: Placebo
Sequence 3 LPExperimentalEligible 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)
Receives: Drug: CX717 200 mg; Drug: Placebo
Sequence 4 HPExperimentalEligible 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)
Receives: Drug: CX717 800 mg; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 3 Weeks

Secondary outcomes (11)

  1. 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.

    Measured: 3 Weeks

  2. CGI-I

    Clinical Global Impression of Improvement

    Measured: 3 Weeks

  3. HAM-A

    Hamilton Rating Scale of Anxiety

    Measured: 3 Weeks

  4. HAM-D

    Hamilton Rating Scale of Depression

    Measured: 3 Weeks

  5. PSQI

    Pittsburgh Sleep Quality Index

    Measured: 3 Weeks

  6. ESS

    Eppworth Sleepiness Scale

    Measured: 3 Weeks

  7. ADHD-SRS

    Attention Deficit Hyperactivity Disorder Self Rating Scale

    Measured: 3 Weeks

  8. SCWT

    Stroop Color and Word Test

    Measured: 3 Weeks

  9. CTMT

    Comprehensive Trail Making Test

    Measured: 3 Weeks

  10. CPT

    Continuous Performance Task

    Measured: 3 Weeks

  11. FBDS

    Forward and Backward Digit Span

    Measured: 3 Weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Dec 2017
  2. Study start19 Jul 2005
  3. Primary completion10 Jan 2006
  4. Study completion10 Jan 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Model description
A Randomized, Double-Blind, Two-Period Crossover Study
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
68 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03375021
Sponsor's protocol ID
CX717-05-ADHD
Status last verified
Dec 2017
First submitted
7 Dec 2017
Last updated
15 Dec 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CX717 200 mg and CX717 800 mg in people with Attention Deficit Hyperactivity Disorder, run by RespireRx.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ADHD-RS (time frame: 3 Weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03375021.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2017.

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