A Phase 4 interventional study of Dyanavel XR and Placebo in Fatigue, Attention Deficit Hyperactivity Disorder and Attention Deficit Disorder, sponsored by Rochester Center for Behavioral Medicine. Recruiting at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-21.
Sponsored by Rochester Center for Behavioral Medicine · Phase 4, Interventional, and Treatment
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Among 704 studies in Fatigue with a site in United States — 92 open to participants now, 114 under way, 10 of them phase 3. Fatigue · United States.
Among the 704 studies in Fatigue with a site in United States, this one is the 287th largest by planned enrollment of the 610 interventional ones that give a count, is one of 32 that started in 2024, is one of 26 in phase 4, reaches primary completion later than 26 of the 113 other live ones, and was the 602nd registered.
2,231 studies on the registry are indexed under Fatigue; 427 are open to participants now.
Browse Fatigue studies →92 of the 704 studies in Fatigue with a site in United States are open now. Recruiting first, the newest first:
University of Iowa · Sites in United States
Ages 45–70
University of Alabama at Birmingham · Sites in United States
Ages 18–50 · Women only
Bioligent · Sites in United States
Ages 18–60 · Healthy volunteers
Qualia Life Sciences · Sites in United States
Ages 25–75 · Healthy volunteers
University of Florida · Sites in United States
Ages 6+ · Men only
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 239 Fatigue studies recruiting now, 111 (46%) set no upper age limit and 98 (41%) stop at 75 or younger; 23 take children under 18; 73 take healthy volunteers.
This study: 18 Years to 65 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
704 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 44 · Phase 2 105 · Phase 3 58 · Phase 4 26
First in 1998; this study’s year is marked. 32 started in 2024.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 50 is close to the median of 54 across 1,759 interventional studies indexed under Fatigue.
Median enrollment 47 across the 610 interventional studies, 82 across the 86 observational. Of the 537 that completed or were terminated, 174 (32%) have results posted.
This tab as a report to print or save as PDF → With an account.
84 of 704 have an industry lead sponsor. The 10 most frequent:
Rochester Center for Behavioral Medicine is the lead sponsor of 4 studies on the registry; 1 is open to participants now.
Rochester Center for Behavioral Medicine has 1 study filed under Fatigue — fewer than ten, so there is no comparison to draw.
45 of the studies in Fatigue with a site in United States that are under way reach primary completion within a year, 5 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05474846Phase 3M.D. Anderson Cancer CenterCombination Therapy for Treatment of Sleep Disturbance in Patients With Advanced Cancer | 2027-02-28 |
| NCT07455383Phase 3Alkermes, Inc.A Study to Evaluate the Efficacy and Safety of ALKS 2680 in Adults With Narcolepsy Type 1 | 2027-05 |
| NCT06085716Phase 3M.D. Anderson Cancer CenterCombination Therapy for Cancer Related Fatigue in Patients With Metastatic Cancers | 2027-08-31 |
| NCT07675135Phase 3Harmony Biosciences Management, Inc.A Phase 3 Efficacy and Safety Study of HBS-301 in Participants With Narcolepsy | 2027-10 |
| NCT07500090Phase 3Harmony Biosciences Management, Inc.A Phase 3 Efficacy and Safety Study of HBS-301 in Participants With Idiopathic Hypersomnia (IH) | 2027-10 |
Add all 45 to your calendar (.ics) → With an account.
Among the 704 studies in Fatigue with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Dyanavel 5, 10, 15 or 20 mg once daily in the morning
Drug: Dyanavel XR
Matching placebo 5, 10, 15 or 20 mg once daily in the morning
Drug: Placebo
Dosing will begin the morning following Visit 2. Subjects in the active group will begin the study on 5 mg of Dyanavel XR. Subjects will be advised to take one capsule each morning upon awakening, dosed consistently with respect to time. Subjects will be advised that tablets should be swallowed whole, not crushed, chewed, or cut. Subjects can take Dyanavel XR with or without food. Subjects will return to the study site on a weekly (and later, bi-weekly) basis for evaluation of symptoms and possible side effects. Subjects will be titrated to their optimal dose based on the dose titration schedule displayed in Section 5.1. The PI will be available to consult with patients as needed between Week 0 and Week 4 to adjust dosage per the PI's clinical judgment.
Dosing will begin the morning following Visit 2. Subjects in the placebo group will begin the study on 5 mg of placebo. Subjects will be advised to take one tablet each morning upon awakening, dosed consistently with respect to time. Subjects will be advised that tablets should be swallowed whole, not crushed, chewed, or cut. Subjects can take Dyanavel XR with or without food. Subjects will return to the study site on a weekly (and later, bi-weekly) basis for evaluation of symptoms and possible side effects. Subjects will be titrated to their optimal dose based on the dose titration schedule displayed in Section 5.1. The PI will be available to consult with patients as needed between Week 0 and Week 4 to adjust dosage per the PI's clinical judgment.
Fatigue Symptom Inventory (FSI)
Rating scale completed by study coordinator or PI. Score would be 0-10 with 10 being a worse outcome.
Time frame: Screening, Baseline, weeks 1, 2, 3, 4, 6 and 8
Behavior Rating Inventory of Executive Functioning- Adult (BRIEF-A)
Rating scale to assess subject's cognitive functioning. T scores are used to interpret the individual's level of executive functioning, and are derived from their raw scores. T-scores of 65 or over are considered clinically significant.
Time frame: Screening, Baseline, weeks 1, 2, 3, 4, 6 and 8
ADHD Rating Scale (ADHD-RS)
Rating scale to evaluate symptoms of adult ADHD. Scores range from 0-54, with higher scores indicates a worse outcome.
Time frame: Screening, Baseline, weeks 1, 2, 3, 4, 6 and 8
ADHD Quality of Life Scale (ADHDQOL)
Rating scale to assess quality of life, with possible scores ranging from 0-100. Higher scores are indicative of a better outcome.
Time frame: Screening, Baseline, weeks 1, 2, 3, 4, 6 and 8
Clinical Global Impression Scales (CGI)
Clinician's subjective rating of subject's severity on a 7-point likert scale from 0-7, with higher scores indicative of a worse outcome.
Time frame: Screening, Baseline, weeks 1, 2, 3, 4, 6 and 8
Epworth Sleepiness Scale (ESS)
Rating scale to assess level of daytime sleepiness. Scoers range from 0-24 with higher scores indicative of a worse outcome.
Time frame: Screening, Baseline, weeks 1, 2, 3, 4, 6 and 8
Insomnia Severity Index (ISI)
Rating scale to assess level of insomnia. Scores range from 0-28 with higher scores indicative of a worse outcome.
Time frame: Screening, Baseline, weeks 1, 2, 3, 4, 6 and 8
Fibromyalgia Impact Questionnaire
Rating scale to assess subject's symptoms of fibromyalgia. Scores can range from 0-80, with higher scores indicative of a worse outcome.
Time frame: Screening, Baseline, weeks 1, 2, 3, 4, 6 and 8
Plan to share: No
No publications or documents are linked to this record.
Started Sep 2024 (actual). Primary completion is estimated for Sep 2026, 24 months after the start.
Of 15 phase 4 interventional studies under Fatigue, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 55. This study's planned 24 months is below that.
How these figures are worked out, and which studies are left out of them.
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Studies of the drug tested here: Amphetamine
Rochester Center for Behavioral Medicine