A Trial of Dyanavel XR in Treating Co-occurring Fatigue Symptoms in Adults With Attention Deficit Hyperactivity Disorder (ADHD).

Last updated: November 18, 2024
Sponsor: Rochester Center for Behavioral Medicine
Overall Status: Active - Recruiting

Phase

4

Condition

Attention Deficit/hyperactivity Disorder (Adhd - Adults)

Pain (Pediatric)

Attention Deficit/hyperactivity Disorder (Adhd - Pediatric)

Treatment

Dyanavel XR

Placebo

Clinical Study ID

NCT06248229
Dyan24
  • Ages 18-65
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The goal of this clinical trial is to study the impact of Dyanavel on co-occuring fatigue in adults with Attention Deficit/Hyperactivity Disorder. The main question it aims to answer is whether Dyanavel XR leads to a statistically significant reduction in fatigue compared to placebo, as measured by the Fatigue Symptom Inventory.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • At screening, all subjects must have a Fatigue Symptom Inventory average score onboth of the interference and severity scales greater than 3.

  • At screening, all subjects must score in the clinically significant range on theADHD-RS-IV, meaning a score greater than 36.

  • At screening, all subjects must meet criteria for an ADHD diagnosis as determined bythe SCID-5 ADHD module.

  • All subjects must be 18-65 years of age at the time of consent.

  • All sexually active males or females of child baring potential must agree topractice two different methods of birth control or remain abstinent during thecourse of the trial. Methods of birth control or contraception will be logged. Maleand female contraception will be continued throughout the study and for 30 daysafter study discontinuation. Women of childbearing potential must test negative forpregnancy at the Screening Visit.

  • All subjects must live within the state of Michigan during the duration of the trialor be able to commute to the study site from a neighboring state with no more than a 50 mile one-way driving distance.

  • All subjects must be able to swallow intact tablets.

  • Subjects, in the opinion of the investigator, must be able to understand and complywith protocol requirements- including assessments, prescribed dosage regimens, anddiscontinuation of concomitant medications.

  • All subjects must have a minimum level of intellectual functioning without evidenceof significant general intellectual deficit, as determined by the primaryinvestigator. Specific learning disorders will not be considered generalintellectual deficits.

  • All subjects must be able to provide written, personally signed and dated informedconsent to participate in the study in accordance with the International Conferenceon Harmonisation (ICH) Good Clinical Practice (GCP) Guideline E6 and applicableregulations before completing any study related procedures.

  • All subjects must be fluent in English and have a degree of understanding sufficientto communicate suitably with the primary investigator and the study coordinator.

  • Subjects must have a negative drug screen for methamphetamine, cocaine and otherillicit drugs (illegal for recreational use in the State of Michigan) excludingcannabis due to legality of cannabis in Michigan. Subjects with a positive drugscreen for confirmed prescription or over the counter use of medications willrequire the necessary washout per PI instruction. Subjects who test positive for anyprohibited medications per PI may be permitted with PI approval. Re-tests will notbe allowed for a positive screen of an illicit drug.

  • All subjects must score at or above a 4 on the CGI-S at screening

Exclusion

Exclusion Criteria:

  • Subjects must not be an immediate family of the Investigator or others directlyaffiliated with the study.

  • Subjects must not have received treatment with a drug that has not receivedregulatory approval or participated in a clinical trial within 30 days prior toscreening.

  • Subjects must not have medical complications arising from being severely underweightor overweight.

  • Subjects must not have a current comorbid psychiatric disorder that is uncontrolledand associated with significant symptoms or that requires a prohibited medication orbehavioral modification program. Comorbid psychiatric diagnoses will be assessedduring a psychiatric intake and scoring of the SCID and MINI. The Investigator willreview on a case by case basis.

  • Subjects must not currently be considered a suicide risk (as determined by theprimary investigator and assessed by the C-SSRS). They must not have made a suicideattempt within the past two years. They cannot have current suicidal ideation withintent and plan to act, or current suicidal behavior.

  • Subjects must not have a history of substance abuse or drug dependence according toDSM-5 criteria currently or within one year prior to study participation, excludingnicotine and caffeine. This is determined through clinical history and symptomchecklist to be obtained at visit 1.

  • Subjects must not test positive for an illicit substance at the time of screening.

  • Subjects must not have a serious chronic or acute unstable medical condition orillness, including cardiovascular, renal, hepatic, respiratory, or hematologicillness, narrow angle glaucoma, or other unstable medical or psychiatric conditionsthat in the opinion of the Investigator would compromise participation or wouldlikely lead to hospitalization during the duration of the study. Subjects with ahistory of intellectual impairment or a severe learning disability are alsoexcluded.

  • Subjects must not have a history of seizure disorder (other than infantile febrileseizures), any tic disorder, current diagnosis and/or family history of Tourette'sdisorder.

  • Subjects must not have a history of organic heart disease including coronary arterydisease, past myocardial infarction, angina, arrhythmias, congestive heart failure,valvular heart disease and congenital heart disease.

  • Subjects must not be likely (as assessed by the primary investigator) to addpsychotropic medications, apart from their current regimen or the drug under study,to their treatment regimen during the course of the study.

  • Subjects must not have been previously enrolled in this study.

  • Subjects must not anticipate relocation outside the geographic range of theinvestigative site during participation in the study. Subjects must not haveextended travel plans inconsistent with the recommended visit intervals.

  • Subjects must not be taking any excluded medications that cannot be discontinuedprior to beginning treatment with study medication. Subjects' medical history willbe reviewed by the PI and current prescription regimen will be reviewed forwakefulness-promoting drugs including CNS stimulants, histaminergic, noradrenergicand dopaminergic medications, as well as CYP2D6 inhibitors. The primary investigatorwill determine on a case by case basis if concomitant use of the patient's currentprescriptions would affect response to Dyanavel XR. Stimulant medications must bewashed out prior to baseline (methylphenidate or amphetamine based).

  • Subjects must not have a known hypersensitivity, allergy intolerance or documentedhistory of non-responsivity to amphetamine-based medications.

  • Subjects who, in the opinion of the Investigator, are unsuitable in any other way toparticipate in the study.

  • Subjects who have taken an MAOI within 14 days of the beginning of the study.

  • Subjects currently taking a medication regimen that would otherwise likely interferewith the efficacy of Dyanavel XR or the integrity of study results as determined ona case by case basis by the primary investigator.

  • Subjects who have recently (within the previous 3 months) been on CNS stimulantmedications

Study Design

Total Participants: 50
Treatment Group(s): 2
Primary Treatment: Dyanavel XR
Phase: 4
Study Start date:
September 01, 2024
Estimated Completion Date:
December 01, 2026

Study Description

10-week single center, randomized, double-blind, placebo-controlled, flexible titration trial evaluating the efficacy of Dyanavel (Dyanavel XR) XR in the treatment of fatigue symptoms in adult subjects with a diagnosis of ADHD. Subjects will be randomly assigned (1:1) to a Dyanavel (Dyanavel XR) XR (flexible titration dosing) group (n = 22 to 25) or placebo group (n = 22 to 25). The study will utilize an intent to treat model and impute data, if statistically feasible, from dropouts utilizing a MNAR (missing not at random) approach.

Connect with a study center

  • Rochester Center for Behavioral Medicine

    Rochester Hills, Michigan 48307
    United States

    Active - Recruiting

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