A Controlled Study of Solriamfetol for Attention Deficit Hyperactivity Disorder (ADHD) in Adults

NCT04839562 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 2020P003608
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

Brief Summary

A double-blind, placebo controlled study of solriamfetol for adults age 18 to 65 with diagnosis of Attention Deficit Hyperactivity Disorder.

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

attention deficit hyperactivity disorder; clinical trial; solriamfetol

Outcome Measures

Primary Outcomes (2)

• Adult Attention Deficit Hyperactivity Disorder (ADHD) Investigator Symptom Rating Scale (AISRS) Total Score

  Difference between active and placebo for change in Adult ADHD Investigator Symptom Rating total score from baseline to week 6 visit. The minimum score on this scale is 0, the maximum score for the scale is 54 points.Higher numbers indicate more ADHD symptoms, lower scores reflect lower ADHD symptoms.

  six weeks

• A Priori Definition of Clinical Improvement

  25% reduction in ADHD symptoms as measured by the Adult ADHD Investigator Symptom Rating Scale (AISRS), and a Clinical Global Impression Improvement score of 2 (much) or 1 (very much) improved. The minimum score on the AISRS scale is 0, the maximum score for the scale is 54 points.Higher numbers indicate more ADHD symptoms, lower scores reflect lower ADHD symptoms. The Clinical Global Impression (CGI) Improvement scores range from 0 to 7, with 0=not assessed,1=very much improved), 2=much improved, through to 7=very much worse. Lower scores therefore mean better outcomes.

  six weeks

Secondary Outcomes (12)

• Number of Participants Reaching 0.5 Standard Deviation Improvement on Brief Rating Inventory of Executive Function-Adult Version (BRIEF-A): Global Executive Composite Index

  6 weeks

• Number of Participants Reaching 0.5 Standard Deviation Improvement on Brief Rating Inventory of Executive Function-Adult Version (BRIEF-A): Behavioral Regulation Index

  6 weeks

• Number of Participants Reaching 0.5 Standard Deviation Improvement on Brief Rating Inventory of Executive Function-Adult Version (BRIEF-A): Metacognition Index

  6 weeks

• Number of Participants Reaching 0.5 Standard Deviation Improvement on Brief Rating Inventory of Executive Function-Adult Version (BRIEF-A): Inhibit Subscale

  6 weeks

• Number of Participants Reaching 0.5 Standard Deviation Improvement on Brief Rating Inventory of Executive Function-Adult Version (BRIEF-A): Shift Subscale

  6 weeks

Study Arms (2)

solriamfetol

EXPERIMENTAL

Participant will receive daily doses of solriamfetol, at 75 mg at week one and 150 mg at week 2, and with intention that dosing remain stable for the last four weeks of study participation, such that investigators will ask a subject to go back down to 75 mg during any of the weeks following week 2 only if only if 150 mg is not tolerated.

Drug: Solriamfetol 75 MG; Drug: Solriamfetol 150 MG

placebo

PLACEBO COMPARATOR

Participant will receive daily doses of placebo, at 75 mg at week one and 150 mg at week 2, and with intention that dosing remain stable for the last four weeks of study participation, such that investigators will ask a subject to go back down to 75 mg during any of the weeks following week 2 only if only if 150 mg is not tolerated.

Other: Placebo

Interventions

Solriamfetol 75 MG DRUG

Daily oral consumption

Also known as: Sunosi 75 mg

solriamfetol

Solriamfetol 150 MG DRUG

Daily oral consumption

Also known as: Sunosi 150 mg

solriamfetol

Placebo OTHER

Placebo

placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults ages 18-65 years of age.
• A diagnosis of childhood-onset ADHD, meeting the Diagnostic and Statistical Manual-5 (DSM-5) criteria for ADHD in adulthood, including at least 5 current symptoms of inattentive or impulsive-hyperactive traits, and childhood onset by age 12, defined as two symptoms of inattentive or of impulsive/hyperactive traits by the age of 12.
• A score of 20 or more on the Adult ADHD Investigator Symptom Report Scale (AISRS)

You may not qualify if:

• Individuals with known renal insufficiency or renal impairment.
• A history of intolerance to solriamfetol
• Pregnant or nursing females, and individuals unwilling to use adequate contraceptive methods to avoid conception while they are receiving study agent and for 1 month after the last dose of study agent. For female subjects of childbearing potential adequate contraceptive methods will include: a medically acceptable form of birth control (such as male or female condoms with or without spermicidal agent, diaphragm or cervical cap with spermicide, medically prescribed IUD, hormonal contraceptives like birth control pills, or abstinence). For male subjects this will include use of male condom, being status post vasectomy at least 4 months prior to initiation of study drug exposure, or abstinence during the study.
• A known unstable major medical illness including hepatic, renal, gastroenterological, respiratory, cardiovascular (including hypertension ≥ 140/90 mmHg), endocrinologic (e.g. thyroid), neurologic (e.g. seizure), immunologic, hematologic, or psychiatric (including an active substance use disorder, psychosis, bipolar disorder, major depression) disorder.
• Any medical condition that the Principal Investigator (PI) believes will be exacerbated by study participation.
• A history of cancer (except localized skin cancer without metastases or in situ cervical cancer) within 5 years prior to screening.
• A known history of narrow-angle glaucoma.
• Current (within 3 months) DSM-V criteria for abuse or dependence with any psychoactive substance other than nicotine.
• Multiple adverse drug reactions, defined as previous moderate to severe adverse experiences while on two or more chemically unrelated compounds, where these reactions were unpredictable from the known pharmacology of the drug.
• Any other concomitant medication with primarily central nervous system activity that are catecholaminergic such as stimulants or atomoxetine, or have strong noradrenergic mechanisms of action such as duloxetine or venlafaxine or buproprion. Subjects may be included who are taking stable doses of agents with primary serotonergic (such as selective serotonin reuptake inhibitors or buspirone), gabaergic (such as gabapentin, pregabalin), or other anticonvulsants. We will also allow participation by individuals with rare (predicted to be less than twice a week) use of prn benzodiazepines or sedative-hypnotics.
• Current use of MAO Inhibitor or use within the past two weeks.
• Concomitant medications with high potential for dopaminergic or sympathomimetic effects.
• Investigator and his/her immediate family; defined as the investigator's spouse, parent, child, grandparent, or grandchild.
• , Reasonable suspicion of inability, in the judgement of the investigator, to appropriately monitor experiences during the study and take steps to report these experiences or respond in a manner preserving personal health and safety.
• \. Any condition, including a moderate to severe untreated sleep disorder or other mental health disorder, that renders inability, in the investigator's judgement, to determine whether ADHD symptoms are primarily due to ADHD.

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related Publications (1)

• Surman CBH, Walsh DM, Horick N, DiSalvo M, Vater CH, Kaufman D. Solriamfetol for Attention-Deficit/Hyperactivity Disorder in Adults: A Double-Blind Placebo-Controlled Pilot Study. J Clin Psychiatry. 2023 Oct 9;84(6):23m14934. doi: 10.4088/JCP.23m14934.

  PMID: 37819836 DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

solriamfetol

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Craig Surman
• Organization: Massachusetts General Hospital

csurman@partners.org

6176808489

Study Officials

• Craig Surman, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Scientific Coordinator, Adult ADHD Research Program

Study Record Dates

• First Submitted: April 6, 2021
• First Posted: April 9, 2021
• Study Start: August 6, 2021
• Primary Completion: January 27, 2023
• Study Completion: January 27, 2023
• Last Updated: March 4, 2024
• Results First Posted: March 4, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)