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IR Viloxazine

Phase 1

Attention-Deficit/Hyperactivity Disorder (ADHD) | Small molecule | Psychiatry |Supernus Pharmaceuticals, Inc.|Last Updated: Oct 15, 2024

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment52

FDA Designations

No designations recorded

Clinical trial landscape

IR Viloxazine · 1 trial · 1 indication

Phase 1 1
NCT01107496Evaluation of Immediate-Release Viloxazine in Adults With ADHDAttention-Deficit/Hyperactivity Disorder (ADHD)
COMPLETED52 Analytics
PHASE1COMPLETED
Evaluation of Immediate-Release Viloxazine in Adults With ADHD
Attention-Deficit/Hyperactivity Disorder (ADHD)Unlock trial analytics

Study Endpoints

Primary Endpoints

Incidence of Adverse Events During 6 Weeks of Treatment
Weeks 1-6

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

Secondary Endpoints

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
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeOTHER

Treatment Arms

ArmTypeDescription
IR ViloxazineEXPERIMENTALTreatment A: immediate-release (IR) viloxazine capsules administered orally 3 times a day
PlaceboPLACEBO_COMPARATORTreatment B: Placebo capsules administered orally 3 times a day

Interventions

NameTypeDescription
IR ViloxazineDRUGOne 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.
PlaceboDRUGPlacebo capsules administered orally 3 times a day
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Eligibility Criteria

Age Range18 Years to 64 Years
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion criteria: 1. Able to provide informed consent prior to any study procedure being conducted. 2. Capable and willing to comply with study procedures. 3. Male or female aged 18 to 64, inclusive. 4. Subjects with a current diagnosis of ADHD as confirmed by the Conners' Adult ADHD Diagnostic I...

Countries:United States
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Frequently asked questions about IR Viloxazine

What is IR Viloxazine used for?

IR Viloxazine is an investigational small molecule being studied for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD). It is in Phase 1 clinical development and has not been approved by the FDA. The drug is being evaluated in adult patients with ADHD.

Who makes IR Viloxazine?

IR Viloxazine is being developed by Supernus Pharmaceuticals, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol SUPN. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with ADHD.

What phase is IR Viloxazine in?

IR Viloxazine is currently in Phase 1 clinical development. It is an investigational drug and has not received FDA approval. The drug is being studied for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in adult patients.

What clinical trials is IR Viloxazine in?

IR Viloxazine has one completed clinical trial, NCT01107496, titled 'Evaluation of Immediate-Release Viloxazine in Adults With ADHD'. This Phase 1 study was a randomized, double-blind, placebo-controlled trial conducted in the United States with 52 adult participants.

How does IR Viloxazine work?

IR Viloxazine is a small molecule being developed for ADHD. Its specific molecular target has not been disclosed in available information. The drug is being evaluated in clinical trials to determine its safety and efficacy in treating ADHD symptoms.