Open-Label Study of SPN-812 Administered With Psychostimulants in Children and Adolescents With ADHD

Completed · Phase 4

Conditions studied: Attention-Deficit/Hyperactivity Disorder (ADHD)

In brief

This open label, flexible-dose study evaluating the safety and efficacy of SPN-812 administered with psychostimulants in children and adolescents (6 to 17 years of age) with Attention-Deficit/Hyperactivity Disorder (ADHD).

Key facts

Study ID

NCT04786990

Run by

Supernus Pharmaceuticals, Inc.

People needed

96

Starts

2021-07-27

Expected to finish

2023-07-26

Last updated by the study team

2024-05-01

Who can join

Age: 6 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Is male or female, 6 to ≤17 years and 9 months of age at screening.
• Parent(s)/legal guardian(s) is able to read and understand the Informed Consent Form (ICF).
• Written informed consent obtained by parent(s)/legal guardian(s) and informed assent obtained from the subject, if applicable.
• Subject and parent(s)/legal guardian(s) are willing and able to comply with all of the procedures and requirements defined in the protocol, including parents(s)/legal guardian(s) oversight of morning and evening dosing of the SPN-812 and recording a daily medication/dosing diary for psychostimulant and/or SPN-812 during the study.
• Has lived with the same parent(s)/legal guardian(s) at same residence for at least the last 6 months prior to screening.
• Has a primary diagnosis of ADHD (inattentive, hyperactive, or combined presentation) confirmed with the Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-KID) at screening.
• Is currently on a single, stable psychostimulant regimen (see Inclusion Criterion 8 for definition) for treatment of ADHD with a partial, but inadequate efficacy response to at least 2 weeks of treatment with a psychostimulant (methylphenidate or amphetamine) prior to screening. An inadequate response is defined as an investigator-rated ADHD-RS-5 Total score ≥24 and a CGI-S score ≥3 (mildly ill or worse) at Screening and Baseline. Subjects taking additional medication for ADHD (e.g., nonstimulant) are excluded.
• Is currently and expecting to continue and remain on a stable psychostimulant regimen throughout the study. A stable stimulant regimen is defined as taking dose at least 5 days per week (morning), no significant change in dose or dosing frequency at least 2 weeks prior to baseline (Visit 2), and the investigator believes the subject's psychostimulant dose is optimized.
• Is functioning at an age-appropriate level intellectually, as judged by the Investigator.
• Is a child (6-11 years of age) with a body weight of at least 20 kg at screening or is an adolescent (12-17 years of age) with a body weight of at least 35 kg at screening.
• Has a resting (sitting) blood pressure (BP) and resting pulse rate measurement within the 95th percentile for age, sex, and height.
• Is considered medically healthy by the Investigator via assessment of physical examination, medical and psychiatric histories, clinical laboratory tests, vital signs, and electrocardiogram (ECG).
• Females of childbearing potential (FOCP) must be either sexually inactive (abstinent) or, if sexually active, must agree to use/practice one of the following acceptable, highly effective contraceptive methods beginning/during the screening period prior to the first dose of SM and throughout the study:
• Simultaneous use of male condom and intra-uterine contraceptive device placed during screening period prior to first dose of SM
• Surgically sterile male partner (e.g., vasectomized partner is sole partner)
• Barrier method: condom with spermicidal foam/gel/film/cream/suppository or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository
• Established use of oral, injected, or implanted hormonal methods of contraception
• With approval by the Investigator, subjects' parents or legal guardians may select abstinence as a form of birth control if deemed more appropriate. For the purposes of this study, all females are considered to be of childbearing potential unless they are confirmed by the Investigator to be premenarchal, biologically sterile, or surgically sterile (e.g., hysterectomy with bilateral oophorectomy, tubal ligation).
• Adolescent males, if sexually active, must:
• Use 2 methods of contraception in combination if his female partner is of childbearing potential; this combination of contraceptive methods must be used from the Baseline Visit to ≥ 1 month after the last dose of SM, or
• Have been surgically sterilized prior to the Screening Visit.

You may not qualify if…

• Is currently participating in another clinical trial or has participated in a clinical trial within 60 days prior to screening.
• Is a member of the study personnel or of their immediate families, or is a subordinate (or immediate family member of a subordinate) to any of the study personnel.
• Is a female subject who is pregnant, lactating and/or sexually active and not agreeing to use one of the acceptable contraceptive methods throughout the study.
• Has history of severe drug allergy or hypersensitivity, or known hypersensitivity, to the study medication (SPN-812).
• Has history of moderate or severe head trauma or other neurological disorder or systemic medical disease that, in the Investigator's opinion, is likely to affect central nervous system functioning. This would include subjects with:
• a current diagnosis of a major neurological disorder;
• seizures, seizure disorder or seizure-like events;
• history of seizure disorder within the immediate family (siblings, parents); or
• encephalopathy
• Note: Febrile seizures are not exclusionary and will be assessed on a case-by-case basis. If for any reason the subject received medication for a febrile seizure or has a history of complex febrile seizures, this will be exclusionary.
• Has current diagnosis or history of major psychiatric disorders or intellectual disabilities other than ADHD per DSM-5 criteria (including schizophrenia, schizoaffective disorder, bipolar disorder, borderline personality disorder, antisocial personality disorder, narcissistic personality disorder, post-traumatic stress disorder, obsessive-compulsive disorder, severe oppositional defiant disorder (ODD), conduct disorder, and disruptive mood dysregulation disorder, and autism spectrum disorders). The following is not exclusionary:
• a history of mild social anxiety disorder or generalized anxiety disorder according to DSM-5 criteria;
• a history of mild to moderate ODD according to DSM-5 criteria;
• a history of Major Depressive Disorder, if he/she has not experienced a major depressive disorder episode or required psychiatric counselling; or pharmacotherapy within the 6 months prior to screening
• Has a known history of physical, sexual, or emotional abuse in the last year prior to screening.
• Has any other disorder for which its treatment takes priority over treatment of ADHD or is likely to interfere with study treatment, impair treatment compliance, or interfere with interpretation of study results.
• Has a current diagnosis of drug abuse or dependence disorder within the 12 months prior to screening, has a history of drug abuse or dependence disorder or has an immediate family member living at study participant's' home who has current diagnosis drug abuse or dependence disorder (per DSM-5 criteria).
• Evidence of suicidality (defined as either active suicidal plan/intent or active suicidal thoughts, or more than one lifetime suicide attempt) within the six months before Screening or at Screening.
• Has positive findings on C-SSRS for suicidal ideation or behaviors at screening. Has attempted suicide within the 6 months prior to screening, or is at significant risk of suicide, either in the opinion of the Investigator or defined as a "yes" to suicidal ideation questions 4 or 5 or answering "yes" to suicidal behavior on the C-SSRS within the 6 months prior to screening.
• Is currently using, or has a positive result on the urine drug screening for, drugs of abuse (alcohol, amphetamine, barbiturates, benzodiazepines, cannabis [THC], cocaine, cotinine, methadone, methamphetamine [including ecstasy], methylphenidate, phencyclidine, propoxyphene, and opiates) with the exception of the psychostimulant prescribed for the treatment of ADHD.
• Is unable to discontinue all prohibited medication at least 7 days prior to baseline.
• Has body mass index (BMI) greater than 95th percentile for her/his appropriate age and gender (per CDC's gender specific "BMI-for-age percentiles" charts).
• Has a current diagnosis of significant systemic disease.
• Has uncontrolled thyroid disorder defined as thyroid stimulating hormone ≤ 0.8 x the lower limit of normal or ≥ 1.25 x the upper limit of normal for the reference laboratory range.
• Has resting (sitting) blood pressure and pulse rate greater than the 95th percentile for age and gender.

Where it is running

• Preferred Research Partners, Inc. — Little Rock, Arkansas, United States
• NRC Research Institute — Orange, California, United States
• Miami Clinical Research — Miami, Florida, United States
• APG Research, LLC — Orlando, Florida, United States
• Elite Clinical Trials — Blackfoot, Idaho, United States
• Elite Clinical Trials — Rexburg, Idaho, United States
• Qualmedica Research, LLC — Evansville, Indiana, United States
• Psychiatric Associates Purehealth Medical Center — Overland Park, Kansas, United States
• Midwest Research Group — Saint Charles, Missouri, United States
• Alivation Research, LLC — Lincoln, Nebraska, United States
• Center for Psychiatry and Behavioral Medicine — Las Vegas, Nevada, United States
• SP Research, PLLC — Oklahoma City, Oklahoma, United States
• Coastal Carolina Research Center — North Charleston, South Carolina, United States
• Gadolin Research, LLC — Beaumont, Texas, United States
• Family Psychiatry of The Woodlands — The Woodlands, Texas, United States
• Northwest Clinical Research Center — Bellevue, Washington, United States
• Barbara Diaz Hernandez MD Research, INC. — San Juan, Puerto Rico

Full record on ClinicalTrials.gov

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