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Evaluation of SPN-812 in Adults With Attention-Deficit/Hyperactivity Disorder

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ClinicalTrials.gov Identifier: NCT04016779
Recruitment Status : Not yet recruiting
First Posted : July 11, 2019
Last Update Posted : July 11, 2019
Sponsor:
Information provided by (Responsible Party):
Supernus Pharmaceuticals, Inc.

Brief Summary:
This study will evaluate the efficacy and safety of SPN-812, an extended-release formulation of viloxazine, in adults.

Condition or disease Intervention/treatment Phase
ADHD Drug: Placebo Drug: 200-600 mg SPN-812 Phase 3

Detailed Description:
This is a Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel-Group Flexible-Dose Study of the Efficacy and Safety of SPN-812 in Adults with ADHD.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 366 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel-Group Flexible-Dose Study of the Efficacy and Safety of SPN-812 in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)
Estimated Study Start Date : August 2019
Estimated Primary Completion Date : August 2020
Estimated Study Completion Date : November 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: Placebo
Placebo qd
Drug: Placebo
Placebo will be administered once daily
Other Name: PBO

Experimental: SPN-812
SPN-812 qd
Drug: 200-600 mg SPN-812
200-600 mg SPN-812 will be administered once daily and compared to Placebo
Other Name: SPN-812 Flexible Dose




Primary Outcome Measures :
  1. Efficacy of SPN-812 assessed by adult ADHD Investigator Symptom Rating Scale (AISRS) [ Time Frame: 6 weeks ]
    Change from Baseline to End of Study in the AISRS total score


Secondary Outcome Measures :
  1. Effect of SPN-812 assessed by Clinical Global Impression - Severity of Illness (CGI-S) Scale [ Time Frame: 6 weeks ]
    Change from Baseline to End of Study in the CGI-S total score

  2. Effect of SPN-812 assessed by the Adult ADHD Self-Report Scale (ASRS) [ Time Frame: 6 weeks ]
    Change from Baseline to End of Study in Self-reported ADHD symptoms

  3. Effect of SPN-812 assessed by Clinical Global Impression - Improvement scale (CGI-I) [ Time Frame: 6 weeks ]
    Change from Baseline to End of Study in CGI-I score

  4. Effect of SPN-812 assessed by categorical CGI-I Responder Rate [ Time Frame: 6 weeks ]
    Change from Baseline to End of Study in categorical CGI-I score

  5. Effect of SPN-812 assessed by the Generalized Anxiety Disorder 7 Item scale (GAD-7) [ Time Frame: 6 weeks ]
    Change from Baseline to End of Study in anxiety symptoms as measured by the GAD-7 score

  6. Effect of SPN-812 assessed by AISRS subscales of Inattention and Hyperactivity/Impulsivity [ Time Frame: 6 weeks ]
    Change from Baseline to End of Study in Inattention and Hyperactivity/Impulsivity scores

  7. Effect of SPN-812 assessed by 50% Responder Rate [ Time Frame: 6 weeks ]
    Percentage of subjects with at least 50% improvement in AISRS total score

  8. Effect of SPN-812 assessed by 30% Responder Rate [ Time Frame: 6 weeks ]
    Percentage of subjects with at least 30% improvement in AISRS total score

  9. Effect of SPN-812 assessed by ASRS [ Time Frame: 6 weeks ]
    Change from Baseline to End of Study in ASRS subscores for Inattention and Hyperactivity/Impulsivity

  10. Effect of SPN-812 assessed by the Brown Executive Function/Attention (EF/A) Scales [ Time Frame: 6 weeks ]
    Change from Baseline to End of Study on the Brown EF/A Total Composite scores

  11. Effect of SPN-812 assessed by Brown EF/A Scales cluster scale [ Time Frame: 6 weeks ]
    Change from Baseline to End of Study on domains of executive function by Brown EF/A Scales cluster scores



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Is male or female, aged 18 to ≤ 55 years at screening.
  2. Is able to read and understand the Informed Consent Form (ICF).
  3. Written informed consent obtained from the subject (a signed ICF).
  4. Weight within the normal or overweight ranges according to accepted values of the Body Mass Index Chart (18.0 to 35 kg/m2).
  5. Is able to swallow capsules whole, without crushing, chewing or cutting.
  6. Is willing and able to attend study appointments within the specified time windows.
  7. Has a primary diagnosis of ADHD according to the DSM-5 classification, with diagnosis made at least 6 months prior to screening and confirmed with Structured Clinical Interview for DSM-5 Clinical Trials version (SCID-5-CT).
  8. Has an AISRS total score of ≥ 26 at the Screening Visit and at the Baseline Visit (V2, Day 1).
  9. Has a CGI-S score of ≥ 4 (moderately ill or worse) at the Baseline Visit (V2, Day 1).
  10. Females of childbearing potential (FOCP) must be either sexually inactive (abstinent) or, if sexually active, must agree to use one of the following acceptable birth control methods beginning 30 days prior to the first dose of SM and throughout the study:

    1. Simultaneous use of male condom and intra-uterine contraceptive device placed at least 4 weeks prior to first SM administration
    2. Surgically sterile male partner
    3. Simultaneous use of male condom and diaphragm with spermicide
    4. Established hormonal contraceptive Females are considered not to be of childbearing potential if they are either post-menopausal (amenorrhea for at least 2 years and serum follicle stimulating hormone (FSH) level of >40 IU/L) or permanently sterilized (e.g., bilateral tubal ligation, hysterectomy, bilateral oophorectomy for 6 months minimum prior to screening).
  11. Males must:

    1. 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
    2. Have been surgically sterilized prior to the Screening Visit.

Exclusion Criteria:

  1. Has previously enrolled in a SPN-812 study.
  2. Is currently participating in another clinical trial or has participated in a clinical trial within 60 days prior to the first Screening Visit.
  3. 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.
  4. Female subjects who are pregnant, lactating and/or sexually active and not agreeing to use one of the acceptable birth control methods throughout the study.
  5. Has history of severe drug allergy or hypersensitivity, or known hypersensitivity, to the study medication or excipients.
  6. 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:

    1. A current diagnosis of a major neurological disorder; or
    2. Seizures, seizure disorder or seizure-like events; or a history of seizure disorder within the immediate family (siblings, parents); or
    3. Encephalopathy
  7. Has any history of schizophrenia, schizoaffective disorder, bipolar disorder, borderline personality disorder, antisocial personality disorder, narcissistic personality disorder, autism, post-traumatic stress disorder or obsessive-compulsive disorder.
  8. Has a major depressive disorder episode within the 6 months prior to screening.
  9. Has any current psychiatric disorder (per DSM-5 criteria) other than ADHD with the following exceptions: secondary diagnoses of nicotine dependence, social anxiety disorder, generalized anxiety disorder, and phobias.
  10. Has a Hamilton Anxiety Rating Scale (HAM-A) score of > 21 at screening.
  11. Has organic mental disorders, or mental disorders due to a general medical condition (per DSM-5 criteria).
  12. Has a current diagnosis or history of substance use disorder including alcohol use disorder (excluding nicotine and caffeine) (per DSM-5 criteria) within the 12 months prior to screening; or is assessed by the Investigator as having regularly consumed alcohol exceeding 21 units for males and 14 units for females per week (1 unit equals 340 mL of beer, 115 mL of wine, or 43 mL of spirits) within the 12 months prior to screening.
  13. Is currently using, or has a positive result on the urine drug screening at the Screening Visit for, drugs of abuse (opiates, methadone, cocaine, methamphetamine [including ecstasy], phencyclidine, propoxyphene, methylphenidate, barbiturates, and benzodiazepines).
  14. Is a (known or self-identified) current habitual/chronic cannabis user (medicinal or recreational); or

    • Has a positive urine drug screen for cannabis at the Screening Visit and is considered, per the Investigator's judgement, to be a habitual/chronic cannabis user; or
    • Has a positive urine drug screen for cannabis at both the screening and follow-up drug screen at the Baseline Visit, even though the subject is not considered, per the Investigator's judgement, to be a habitual/chronic cannabis user.

    Note: Subjects who have a positive urine drug screen at the Screening Visit but who are not considered to be a habitual/chronic cannabis user per the Investigator's judgement may, with Sponsor approval, undergo an additional urine drug screen at least 4 weeks after the original urine drug screen at Baseline Visit, prior to randomization. Subjects must agree to refrain from cannabis use throughout study.

  15. Has treatment-resistant ADHD based on a history of receipt of >2 approved ADHD medications that failed to adequately improve the subject's symptoms. A subject who is naive to ADHD treatment is not excluded from study participation.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04016779


Contacts
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Contact: Lily Makannah 240.403.5655 lmakannah@supernus.com
Contact: Christopher S Konkoy, PhD 317-619-5422 ckonkoy@supernus.com

Sponsors and Collaborators
Supernus Pharmaceuticals, Inc.
Investigators
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Study Director: Stefan Schwabe, MD Chief Medical Officer

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Responsible Party: Supernus Pharmaceuticals, Inc.
ClinicalTrials.gov Identifier: NCT04016779     History of Changes
Other Study ID Numbers: 812P306
First Posted: July 11, 2019    Key Record Dates
Last Update Posted: July 11, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders