Evaluation of Immediate-Release Viloxazine in Adults With ADHD

NCT01107496 | Completed Phase 1 Results

• 1 other identifier: 812P201
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 4

Brief Summary

This will be a randomized, double-blind, placebo-controlled, parallel group, safety and tolerability study in adults with ADHD. The target subjects are healthy male or female adults aged 18 to 64 years, inclusive, with a diagnosis of ADHD.

Conditions

Attention-Deficit/Hyperactivity Disorder (ADHD)

Keywords

ADHD; Adults

Outcome Measures

Primary Outcomes (1)

• Incidence of Adverse Events During 6 Weeks of Treatment

  The percent of subjects who took at least one dose of immediate-release viloxazine (Safety Population; N) and who reported at least one Adverse Event (n). The percent is calculated by dividing "the number of subjects who reported at least one Adverse Event (n)" by "the number of subjects in the Safety Population (N)" and multiplying the product by 100. The higher the percentage, the higher the incidence in the Safety Population

  Weeks 1-6

Secondary Outcomes (6)

• Change From Baseline in the Investigator-Rated Conners' Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Rating Scale (CAARS) Total Score at Week 6 (End of Study)

  Baseline and Week 6

• Change From Baseline in the Investigator-Rated Conners' Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Rating Scale (CAARS) Total Score at Week 1

  Baseline and Week 1

• Change in Global Clinical Impression-Improvement (CGI-I) Score From Baseline Global Clinical Impression-Severity of Illness (CGI-S) Score at Week 1, Week 2, Week 3, Week 4, Week 5, and Week 6

  Weeks 1, 2, 3, 4, 5, and 6

• Change From Baseline in the Investigator-Rated Conners' Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Rating Scale (CAARS) Total Score at Week 2, Week 3, Week 4, and Week 5

  Baseline and Weeks 2, 3, 4, and 5

• Change From Baseline in the Self-rated Conners' Adult Attention-Deficit/Hyperactivity Disorder (ADHD) Rating Scale (CAARS) Total Score at Week 6

  Baseline and Week 6

Study Arms (2)

IR Viloxazine

EXPERIMENTAL

Treatment A: immediate-release (IR) viloxazine capsules administered orally 3 times a day

Drug: IR Viloxazine

Placebo

PLACEBO COMPARATOR

Treatment B: Placebo capsules administered orally 3 times a day

Drug: Placebo

Interventions

IR Viloxazine DRUG

One 50mg immediate-release viloxazine capsule administered orally 3 times a day (150mg total daily dose) for Week 1. Two 50mg immediate-release viloxazine capsules administered orally 3 times a day (300mg total daily dose) for Weeks 2 to 6.

Also known as: immediate-release viloxazine, SPN-812V immediate-release

IR Viloxazine

Placebo DRUG

Placebo capsules administered orally 3 times a day

Also known as: PBO

Placebo

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Able to provide informed consent prior to any study procedure being conducted.
• Capable and willing to comply with study procedures.
• Male or female aged 18 to 64, inclusive.
• Subjects with a current diagnosis of ADHD as confirmed by the Conners' Adult ADHD Diagnostic Interview for DSM-IV (CAADID)
• Clinical Global Impression - Severity (CGI-S) score of 4 or higher.
• On no treatment for ADHD or willing to be withdrawn from an ongoing treatment after a washout of at least 10 days.
• Body Mass Index (BMI) between 18.0 and 34.0 inclusive.
• Subject must be in general good health as determined by medical history, ECG, and other analysis that, in the judgment of the Investigator, would confirm the Subject's good health.
• Females of childbearing potential (FOCP) who, if sexually active, agree to use acceptable forms of contraception (including oral, transdermal, or implanted contraceptives; intrauterine device; female condom with spermicide; diaphragm with spermicide; cervical cap; abstinence; use of condom with spermicide by sexual partner or sterile \[at least 6 months prior to SM administration\] sexual partner) at least 14 days prior to start of study drug administration, throughout the study, and for 30 days following the last dose of SM.
• Postmenopausal females with amenorrhea for at least 2 years or females who are permanently sterilized (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy).

You may not qualify if:

• Current or past history of psychotic disorder or major depressive disorder with psychotic features.
• Presence of another primary DSM-IV-TR disorder.
• Suicidality, defined as either active suicidal plan/intent or active suicidal thoughts, in the 6 months before the Screening Visit or more than 1 lifetime suicide attempt. (The Columbia-Suicide Severity Rating Scales \[C-SSRS\] will be administered at each visit.)
• Substance or alcohol abuse/dependence within previous 6 months, or a positive urine drug screen at screening or baseline prior to first dose of study medication (SM).
• Any known or suspected significant medical or psychiatric illnesses that, in the judgment of the Investigator, may impair interpretation of study results or constitute a significant safety concern in the context of the clinical trial
• ECG abnormalities (clinically significant according to Investigator's opinion) or vital sign abnormalities (systolic blood pressure \[SBP\] \<90 or \>140 millimeters of mercury \[mmHg\], diastolic blood pressure \[DBP\] \<40 or \>90mmHg, or heart rate \[HR\] \<40 or \>100 beats per minute \[BPM\]) at screening.
• Clinically significant laboratory abnormalities; including presence of potential hepatic function impairment as shown by, but not limited to alanine aminotransferase (ALT/SGPT) values \>2 times upper limit of normal (ULN), aspartate aminotransferase (AST/SGOT) \> 2 times ULN, gamma-glutamyl transpeptidase (GGT) \>3 times ULN, or total bilirubin \>1.5 ULN .
• Medications, including health food supplements judged by the Investigator to be likely to have central nervous system activity (for example, St John's Wort, gingko leaf, and melatonin), are not permitted during the study. If the subject is taking the medication prior to study entry, there must be a 7 day washout period prior to first dose of SM.
• Lifetime history of tic disorder, Tourette's Disease, or organic brain disorder; or family history of Tourette's Disease.
• Current or lifetime history of hyperthyroidism unless treated and stable for at least 6 months.
• Participation in or plan to begin behavioral therapy during the study.
• Subject has a prior history of allergy or any significant adverse reaction (including rash) to study medication, or any of the product components.
• Females who are pregnant or lactating or are unwilling to use an acceptable form of contraception throughout the study.
• Difficulty swallowing whole capsules.
• History of seizures or risk factors for seizures (e.g., head trauma), not including febrile seizures.

Sponsors & Collaborators

• Supernus Pharmaceuticals, Inc.: lead

Study Sites (4)

Unknown Facility

Bradenton, Florida, 34208, United States

Location

Unknown Facility

Libertyville, Illinois, 60048, United States

Location

Unknown Facility

Owensboro, Kentucky, 42301, United States

Location

Unknown Facility

Herndon, Virginia, 20170, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Jonathan Rubin, MD, Senior Vice President and Chief Medical Officer
• Organization: Supernus Pharmaceuticals, Inc.

jrubin@supernus.com

240-403-5710

Study Officials

• Jonathan Rubin, MD

  Supernus Pharmaceuticals, Inc.

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2010
• First Posted: April 21, 2010
• Study Start: June 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: October 15, 2024
• Results First Posted: October 15, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)