ADHDPhase 1/2NCT02253745
Safety, Tolerability, PK & Efficacy of V81444 in Volunteers With Attention Deficit/ Hyperactivity Disorder (ADHD)
A Phase 1/2 study testing V81444 in people with ADHD, run by Vernalis (R&D) Ltd at 1 site in United States.
Trial summary
The purpose of this research study is to evaluate the safety, tolerability, effectiveness, and pharmacokinetics (PK) of twice daily oral doses of V81444 in adults with ADHD. Pharmacokinetics (PK) is the study of how a drug is absorbed, distributed, metabolized, and eventually eliminated by the body. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- ADHD
- What is being tested?
- V81444
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2013to Apr 2014
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Subjects must:
- Be male or female subjects aged 18 to 50 years inclusive
- Meet DSM-IV-TR criteria for a primary diagnosis of ADHD combined, hyperactive-impulsive or predominantly inattentive type; confirmed by a minimum score of 24 on the ADHD-RS with adult prompts:
- Have a body mass index (BMI) between 19 and 32 kg/m2 inclusive
- Be willing and able to comply with the requirements of the entire study
- Be able to read and understand English
- Give written informed consent
Who cannot join
- Have a significant medical condition or a history of such a condition that the Investigator considers should exclude the subject from the study
- Have any other significant psychiatric disorder, as determined by the Structured Clinical Interview for DSM-IV-TR Axis I Disorders (SCID-I)
- Have known mental impairment defined as an intelligence quotient (IQ) less than 75, or clinical evidence of mental impairment based on the opinion of the Investigator
- Have a history or evidence of clinically significant GI disease, including ulcers, gastro-esophageal reflux disease, hiatus hernia or gastritis
- Have had any previous gastric surgery and/or bariatric procedure
- Have any known malformations that would make EGD difficult or unsafe
Show all 22Show fewer
- Have taken any prohibited concomitant medication
- Have multiple drug allergies or be allergic to any of the components of V81444 study medication or its matching placebo (see Section 7.1) or lidocaine
- Have abused drugs in the 12 months before study drug administration
- In the 90 days before study drug administration, on average
- have smoked more than 5 cigarettes per day
- have consumed more than 28 units of alcohol per week
- have consumed more than 500 mg of caffeine per day
- In the 2 calendar months before study drug administration
- have donated blood or plasma in excess of 500 mL
- been exposed to any new investigational agent
- In the calendar month prior to screening
- used non-steroidal anti-inflammatory drugs regularly
- had a new tattoo or body piercing
- Have any clinically relevant abnormal findings at Screening and/or admission
- Plan to undergo elective procedures/surgery at any time during the study
- Have any other condition that might increase the risk to the individual or decrease the chance of obtaining satisfactory data, as assessed by the Investigator.
Trial locations and contacts
1 site in 1 country.
United States1 site
Vince and Associates Clinical Research
Kansas City, Kansas, 66212
About this study
Official title: A Double-blind, Randomized, Placebo-controlled Study of the Safety, Tolerability, Pharmacokinetics and Efficacy of Repeat Oral Doses of V81444 in Volunteers With Attention Deficit / Hyperactivity Disorder (ADHD)
The purpose of this research study is to evaluate the safety, tolerability, effectiveness, and pharmacokinetics (PK) of twice daily oral doses of V81444 in adults with ADHD. Pharmacokinetics (PK) is the study of how a drug is absorbed, distributed, metabolized, and eventually eliminated by the body. Pharmacokinetics is what the body does to the drug. Blood samples will be taken throughout the study for PK analysis.
- Conditions
- ADHD
- Being tested
- V81444, Placebo
- Keywords
- ADHD, Attention Deficit/ Hyperactivity Disorder
- 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.
V81444Drug
V81444 capsules for oral administration, 100 mg twice daily for 13 days and once on Day 14
PlaceboDrug
Capsules to match V81444 twice daily for 13 days and once on Day 14
| Study group | Role | What they receive |
|---|---|---|
| Placebo:V81444 | Experimental | Placebo followed by a 7 day washout then V81444 Receives: Drug: V81444; Drug: Placebo |
| V81444:placebo | Experimental | V81444 followed by a 7 day washout then Placebo Receives: Drug: V81444; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
ADHD-RS
The absolute and change from baseline in ADHD-RS scores, and percentage change from baseline in ADHD-RS score will be summarized appropriately
Measured: 5 weeks
Secondary outcomes (3)
PERM-P
The average of the on-treatment total post-dose PERM-P scores for each treatment assessment day during the randomized treatment period will be calculated for each individual.
Measured: 5 weeks
Clinical Global Impression (CGI)
The CGI scores will be summarised using frequency counts and percentages.
Measured: 5 weeks
Safety and Tolerability
Parameters for evaluation of safety and tolerability:
Adverse events, Clinical laboratory safety tests, Physical examination, Vital signs, 12-lead ECG, Telemetry, EGD findings, CSSRS, LSEQ
Measured: 11 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2014 (estimated)
- Study startJul 2013
- Primary completionMar 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ADHDStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vernalis (R&D) Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bradley Vince, MD, Principal investigator, VACR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02253745
- Sponsor's protocol ID
- V81444-1CNS-01
- Status last verified
- Dec 2015
- First submitted
- 26 Sep 2014
- Last updated
- 3 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Randomized, Placebo-controlled Study of the Safety, Tolerability, Pharmacokinetics and Efficacy of Repeat Oral Doses of V81444 in Volunteers With Attention Deficit / Hyperactivity Disorder (ADHD)
- ClinicalTrials.gov ID
- NCT02253745
- Acronym / sponsor ID
- V81444-1CNS-01
- Conditions
- ADHD
- Keywords
- ADHD, Attention Deficit/ Hyperactivity Disorder
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Vernalis (R&D) LtdIndustry (pharma, biotech, devices)
- Study start
- Jul 2013
- Primary completion
- Mar 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 1 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research study is to evaluate the safety, tolerability, effectiveness, and pharmacokinetics (PK) of twice daily oral doses of V81444 in adults with ADHD. Pharmacokinetics (PK) is the study of how a drug is absorbed, distributed, metabolized, and eventually eliminated by the body. Pharmacokinetics is what the body does to the drug. Blood samples will be taken throughout the study for PK analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo:V81444 | Experimental | Drug: V81444, Drug: PlaceboPlacebo followed by a 7 day washout then V81444 |
| V81444:placebo | Experimental | Drug: V81444, Drug: PlaceboV81444 followed by a 7 day washout then Placebo |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Subjects must:
Key exclusion criteria (22 listed)
- Have a significant medical condition or a history of such a condition that the Investigator considers should exclude the subject from the study
- Have any other significant psychiatric disorder, as determined by the Structured Clinical Interview for DSM-IV-TR Axis I Disorders (SCID-I)
- Have known mental impairment defined as an intelligence quotient (IQ) less than 75, or clinical evidence of mental impairment based on the opinion of the Investigator
- Have a history or evidence of clinically significant GI disease, including ulcers, gastro-esophageal reflux disease, hiatus hernia or gastritis
- Have had any previous gastric surgery and/or bariatric procedure
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 |
|---|---|---|
| V81444V81444 capsules for oral administration, 100 mg twice daily for 13 days and once on Day 14 | Drug | Placebo:V81444, V81444:placebo |
| PlaceboCapsules to match V81444 twice daily for 13 days and once on Day 14 | Drug | Placebo:V81444, V81444:placebo |
Primary outcome
ADHD-RS
Time frame: 5 weeks
The absolute and change from baseline in ADHD-RS scores, and percentage change from baseline in ADHD-RS score will be summarized appropriately
3 secondary outcomes
PERM-P
Time frame: 5 weeks
Clinical Global Impression (CGI)
Time frame: 5 weeks
Safety and Tolerability
Time frame: 11 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2016.
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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.
Bradley Vince, MD principal investigator
VACR
1 site 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 V81444 in people with ADHD, run by Vernalis (R&D) Ltd at 1 site 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 7 inclusion and 22 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 3 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
ADHD-RS (time frame: 5 weeks). 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 3 Jun 2016.