Attention-Deficit/Hyperactivity Disorder (ADHD)Phase 1/2NCT01107496
Evaluation of Immediate-Release Viloxazine in Adults With ADHD
A Phase 1/2 study testing IR Viloxazine in people with Attention-Deficit/Hyperactivity Disorder (ADHD), run by Supernus Pharmaceuticals, Inc. at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Attention-Deficit/Hyperactivity Disorder (ADHD)
- What is being tested?
- IR Viloxazine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 4 sitesUnited States
- Study dates
- Jun 2010to Dec 2010
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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- On no treatment for ADHD or willing to be withdrawn from an ongoing treatment after a washout of at least 10 days.
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- 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).
Who cannot join
- 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.
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- 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.
- Use of an investigational drug or participation in an investigational study within 30 days prior to first dose of SM.
- Any reason which, in the opinion of the Investigator, would prevent the subject from participating in the study.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Study site
Bradenton, Florida, 34208
Study site
Herndon, Virginia, 20170
Study site
Libertyville, Illinois, 60048
Study site
Owensboro, Kentucky, 42301
About this study
Official title: A Phase I/IIa Randomized, Double-Blind, Multicenter, Placebo-Controlled, Parallel-Group Study of the Safety and Efficacy of Immediate-Release Viloxazine in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)
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.
Read the detailed description
This will be a randomized, double-blind, multicenter, 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 of age, inclusive, with a diagnosis of ADHD. Approximately 50 subjects will be enrolled at approximately 5 sites in the United States. Subjects will be randomized (1:1) to one of two treatment groups, immediate-release (IR) viloxazine or placebo. Primary objective is to determine the safety of IR viloxazine in adults with ADHD.
- Being tested
- IR Viloxazine, Placebo
- Keywords
- ADHD, Adults
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IR ViloxazineDrug
Also called immediate-release viloxazine, SPN-812V immediate-release
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.
PlaceboDrug
Also called PBO
Placebo capsules administered orally 3 times a day
| Study group | Role | What they receive |
|---|---|---|
| IR Viloxazine | Experimental | Treatment A: immediate-release (IR) viloxazine capsules administered orally 3 times a day Receives: Drug: IR Viloxazine |
| Placebo | Placebo comparator | Treatment B: Placebo capsules administered orally 3 times a day Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
The Conners' Adult ADHD Rating Scale (CAARS) is an ADHD-specific rating scale designed and validated to assess current ADHD symptomatology in adults. The CAARS consists of 30 items, including 18 items that correspond to the 18 ADHD symptoms per the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV). The 18 items are further subdivided into two subscales: Inattention (9 items) and Hyperactivity/Impulsivity (9 items). Each item is rated on a 4-point scale from 0 (not at all, never) to 3 (very much, very frequently). The sum of 18 items yields the raw Total score (range: 0 to 54; the higher the score, the more severe the ADHD symptoms). Raw score is converted to a change from baseline (CFB) score. A lower CFB score (<0) represents a better outcome.
Measured: 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
The Conners' Adult ADHD Rating Scale (CAARS) is an ADHD-specific rating scale designed and validated to assess current ADHD symptomatology in adults. The CAARS consists of 30 items, including 18 items that correspond to the 18 ADHD symptoms per the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV). The 18 items are further subdivided into two subscales: Inattention (9 items) and Hyperactivity/Impulsivity (9 items). Each item is rated on a 4-point scale from 0 (not at all, never) to 3 (very much, very frequently). The sum of 18 items yields the raw Total score (range: 0 to 54; the higher the score, the more severe the ADHD symptoms). Raw score is converted to a change from baseline (CFB) score. A lower CFB score (<0) represents a better outcome.
Measured: 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
The Global Clinical Impression-Improvement (CGI-I) scale is a single item clinician-rated assessment of how much the subject's condition (symptoms) has improved, worsened, or has not changed relative to his/her baseline state prior to the beginning of treatment; it is rated on a 7-point scale from 1 to 7, where 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, 7=very much worse. The Clinical Global Impression-Severity of Illness (CGI-S) score is a single item clinician-rated assessment of the severity of subject's condition (symptoms) in relation to the clinician's total experience with patients with ADHD; it is rated on a 7-point scale with 1=Normal, not at all ill, 2=Borderline Ill, 3=Mildly Ill, 4=Moderately Ill, 5=Markedly Ill, 6=Severely Ill, 7=Among the most extremely ill patients. CGI-I scores at post-baseline visits were subtracted from CGI-S score at baseline; a change from baseline score <0 represent better outcome.
Measured: 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
The Conners' Adult ADHD Rating Scale (CAARS) is an ADHD-specific rating scale designed and validated to assess current ADHD symptomatology in adults. The CAARS consists of 30 items, including 18 items that correspond to the 18 ADHD symptoms per the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV). The 18 items are further subdivided into two subscales: Inattention (9 items) and Hyperactivity/Impulsivity (9 items). Each item is rated on a 4-point scale from 0 (not at all, never) to 3 (very much, very frequently). The sum of 18 items yields the raw Total score (range: 0 to 54; the higher the score, the more severe the ADHD symptoms). Raw score is converted to a change from baseline (CFB) score. A lower CFB score (<0) represents a better outcome.
Measured: 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
The Conners' Adult ADHD Rating Scale (CAARS) is an ADHD-specific rating scale designed and validated to assess current ADHD symptomatology in adults. The CAARS consists of 30 items, including 18 items that correspond to the 18 ADHD symptoms per the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV). The 18 items are further subdivided into two subscales: Inattention (9 items) and Hyperactivity/Impulsivity (9 items). Each item is rated on a 4-point scale from 0 (not at all, never) to 3 (very much, very frequently). The sum of 18 items yields the raw Total score (range: 0 to 54; the higher the score, the more severe the ADHD symptoms). Raw score is converted to a change from baseline (CFB) score. A lower CFB score (<0) represents a better outcome.
Measured: Baseline and Week 6
Global Clinical Impression-Improvement (CGI-I) Score at Week 1, Week 2, Week 3, Week 4, Week 5, and Week 6
The Global Clinical Impression-Improvement (CGI-I) scale is a single item clinician-rated assessment of how much the subject's condition (symptoms) has improved, worsened, or has not changed relative to his/her baseline state prior to the beginning of treatment; it is rated on a 7-point scale from 1 to 7, where 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, 7=very much worse. A CGI-I score <4 represents a better outcome.
Measured: Weeks 1, 2, 3, 4, 5, and 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2010 (estimated)
- Study startJun 2010
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Attention-Deficit/Hyperactivity Disorder (ADHD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Supernus Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jonathan Rubin, MD, Study director, Supernus Pharmaceuticals, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01107496
- Sponsor's protocol ID
- 812P201
- Status last verified
- Sep 2024
- First submitted
- 19 Apr 2010
- Last updated
- 15 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/IIa Randomized, Double-Blind, Multicenter, Placebo-Controlled, Parallel-Group Study of the Safety and Efficacy of Immediate-Release Viloxazine in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)
- ClinicalTrials.gov ID
- NCT01107496
- Acronym / sponsor ID
- 812P201
- Keywords
- ADHD, Adults
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Supernus Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 21 Apr 2010 (estimated)
- Results
- Posted 15 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This will be a randomized, double-blind, multicenter, 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 of age, inclusive, with a diagnosis of ADHD. Approximately 50 subjects will be enrolled at approximately 5 sites in the United States. Subjects will be randomized (1:1) to one of two treatment groups, immediate-release (IR) viloxazine or placebo. Primary objective is to determine the safety of IR viloxazine in adults with ADHD.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IR Viloxazine | Experimental | Drug: IR ViloxazineTreatment A: immediate-release (IR) viloxazine capsules administered orally 3 times a day |
| Placebo | Placebo comparator | Drug: PlaceboTreatment B: Placebo capsules administered orally 3 times a day |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IR ViloxazineAlso: immediate-release viloxazine, SPN-812V immediate-releaseOne 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. | Drug | IR Viloxazine |
| PlaceboAlso: PBOPlacebo capsules administered orally 3 times a day | Drug | Placebo |
Primary outcome
Incidence of Adverse Events During 6 Weeks of Treatment
Time frame: 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
6 secondary outcomes
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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline and Week 6
Global Clinical Impression-Improvement (CGI-I) Score at Week 1, Week 2, Week 3, Week 4, Week 5, and Week 6
Time frame: Weeks 1, 2, 3, 4, 5, and 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan Rubin, MD study director
Supernus Pharmaceuticals, Inc.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing IR Viloxazine in people with Attention-Deficit/Hyperactivity Disorder (ADHD), run by Supernus Pharmaceuticals, Inc. at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Adverse Events During 6 Weeks of Treatment (time frame: Weeks 1-6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024.