Attention Deficit Hyperactivity DisorderPhase 2NCT00566449
A Safety and Effectiveness Study of JNJ-31001074 in Adults With Attention-Deficit/Hyperactivity Disorder.
A Phase 2 study testing JNJ-31001074 in people with Attention Deficit Hyperactivity Disorder, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. at 21 sites in United States.
Trial summary
The purpose of this study is to evaluate the safety and effectiveness of JNJ-31001074 compared to placebo in adults with Attention Deficit Hyperactivity Disorder (ADHD). Read more about this study
- Who is it for?
- Ages 18 to 64 years, men only
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- JNJ-31001074
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 21 sitesUnited States
- Study dates
- Dec 2007to Jul 2008
- Phase
- Phase 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 64 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosis of attention deficit hyperactivity disorder with symptoms from age 7
- In good general health
- Willing to not take any other ADHD medication or start any behaviorial modification programs during the study
- Willing to use approved birth control throughout the study and for 3 months afterwards
Who cannot join
- Any psychiatric condition including acute mood disorder, bipolar disorder, acute obsessive-compulsive disorder (OCD), anti-social personality disorder or borderline personality disorder
- Autism, asperger's syndrome, mental retardation
- Presence of motor tics, history of Tourette's syndrome or family history of Tourette's syndrome
- History of substance use/abuse disorder or eating disorder
- History of myocardial infarction, stroke, glaucoma, seizures, hypertension, heart rhythm abnormalities or color blindness
- Use of prescription medication or herbal supplements
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
United States21 sites
Study site
Austin, Texas
Study site
Boston, Massachusetts
Study site
Bradenton, Florida
Study site
Chapel Hll, North Carolina
Study site
Dayton, Ohio
Study site
Eagle, Idaho
Study site
Farmington, Michigan
Study site
Fort Myers, Florida
Study site
Herndon, Virginia
Study site
Houston, Texas
Study site
Irvine, California
Study site
Lafayette, California
Study site
Libertyville, Illinois
Study site
Media, Pennsylvania
Study site
Orlando, Florida
Study site
Overland Park, Kansas
Study site
Portland, Oregon
Study site
Raleigh, North Carolina
Study site
San Francisco, California
Study site
Seattle, Washington
Study site
South Miami, Florida
About this study
Official title: A Multi-Center, Double-Blind, Placebo-Controlled, Randomized, Parallel-Group Study to Investigate the Safety and Efficacy of JNJ-31001074 in Adults With Attention-Deficit/Hyperactivity Disorder
The purpose of this study is to evaluate the safety and effectiveness of JNJ-31001074 compared to placebo in adults with Attention Deficit Hyperactivity Disorder (ADHD).
Read the detailed description
This study is being done to assess safety and tolerability and to explore the effectiveness of a new, experimental drug in the treatment of attention deficit hyperactivity disorder in adults. Approximately 144 adult patients with ADHD will be recruited for the study. Patients who meet study criteria will need to stop taking any ADHD medications they are currently using. They will be randomly assigned to one of 3 treatment arms; each patient has an equal chance of receiving 10 mg JNJ-31001017, 30 mg JNJ-31001074, or placebo. Placebo has no active drug. This is a blinded study, i.e. the patient, the study doctor and the study sponsor will not know what treatment the patient receives until all patients complete the study. Patients will be dispensed a bottle containing study drug for the upcoming week at 4 of the study visits. The study doctor and the sponsor will monitor the study for the occurrence of possible side effects. In addition to a screening visit, patients will return weekly for 6 additional study visits including an end of study visit and a follow-up visit. Patients will take study drug for a total of 4 weeks. After completing the study, patients may resume other ADHD medications. Medical and ADHD history, physical examination, blood pressure, heart rate, temperature, weight and ECGs will be checked periodically throughout the study. Blood samples will be taken for standard safety laboratory tests as well as for the measurement of the drug blood level. Questionnaires relating to ADHD and cognitive testing will be administered throughout the study. Each day for four weeks, patients will take orally, at least one hour before eating in the morning, 1 tablet containing either 10 mg JNJ-31001074, 30 mg JNJ-31001074 or placebo.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- Placebo, JNJ-31001074
- Keywords
- Attention Deficit Hyperactivity Disorder, ADHD, JNJ-31001074
- 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.
PlaceboDrug
one dose daily for 4 weeks
JNJ-31001074Drug
10 mg daily for 4 weeks
JNJ-31001074Drug
30 mg daily for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| 001 | Experimental | JNJ-31001074 10 mg daily for 4 weeks Receives: Drug: JNJ-31001074 |
| 003 | Placebo comparator | Placebo one dose daily for 4 weeks Receives: Drug: Placebo |
| 002 | Experimental | JNJ-31001074 30 mg daily for 4 weeks Receives: Drug: JNJ-31001074 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary study objective is to evaluate the safety and effectiveness of JNJ- 31001074 in adult patients with ADHD.
Measured: ADHD assessments, vital signs, laboratory tests and ECGs will be collected 7 times during the study; at screening, baseline and 5 weekly visit. Adverse events will be collected throughout the study.
Secondary outcomes (1)
The secondary study objective is to assess drug levels in adults with ADHD after taking JNJ-31001074.
Measured: Samples to measure drug levels in the blood will be collected three times at baseline and termination visits and once at visits done at Weeks 1, 2, and 3.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2007 (estimated)
- Study startDec 2007
- Primary completionJul 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Hyperactivity DisorderStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alza Corporation Clinical Trial, Study director, ALZAJohnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial, Study director, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00566449
- Sponsor's protocol ID
- CR014608
- Other IDs
- C-2007-008
- Status last verified
- Apr 2014
- First submitted
- 29 Nov 2007
- Last updated
- 13 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Double-Blind, Placebo-Controlled, Randomized, Parallel-Group Study to Investigate the Safety and Efficacy of JNJ-31001074 in Adults With Attention-Deficit/Hyperactivity Disorder
- ClinicalTrials.gov ID
- NCT00566449
- Acronym / sponsor ID
- CR014608
- Conditions
- Attention Deficit Hyperactivity Disorder
- Keywords
- Attention Deficit Hyperactivity Disorder, ADHD, JNJ-31001074
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.Industry (pharma, biotech, devices)
- Study start
- Dec 2007
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 3 Dec 2007 (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 study is to evaluate the safety and effectiveness of JNJ-31001074 compared to placebo in adults with Attention Deficit Hyperactivity Disorder (ADHD).
Detailed description
This study is being done to assess safety and tolerability and to explore the effectiveness of a new, experimental drug in the treatment of attention deficit hyperactivity disorder in adults. Approximately 144 adult patients with ADHD will be recruited for the study. Patients who meet study criteria will need to stop taking any ADHD medications they are currently using. They will be randomly assigned to one of 3 treatment arms; each patient has an equal chance of receiving 10 mg JNJ-31001017, 30 mg JNJ-31001074, or placebo. Placebo has no active drug. This is a blinded study, i.e. the patient, the study doctor and the study sponsor will not know what treatment the patient receives until all patients complete the study. Patients will be dispensed a bottle containing study drug for the upcoming week at 4 of the study visits. The study doctor and the sponsor will monitor the study for the occurrence of possible side effects. In addition to a screening visit, patients will return weekly for 6 additional study visits including an end of study visit and a follow-up visit. Patients will take study drug for a total of 4 weeks. After completing the study, patients may resume other ADHD medications. Medical and ADHD history, physical examination, blood pressure, heart rate, temperature, weight and ECGs will be checked periodically throughout the study. Blood samples will be taken for standard safety laboratory tests as well as for the measurement of the drug blood level. Questionnaires relating to ADHD and cognitive testing will be administered throughout the study. Each day for four weeks, patients will take orally, at least one hour before eating in the morning, 1 tablet containing either 10 mg JNJ-31001074, 30 mg JNJ-31001074 or placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 001 | Experimental | Drug: JNJ-31001074JNJ-31001074 10 mg daily for 4 weeks |
| 003 | Placebo comparator | Drug: PlaceboPlacebo one dose daily for 4 weeks |
| 002 | Experimental | Drug: JNJ-31001074JNJ-31001074 30 mg daily for 4 weeks |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Diagnosis of attention deficit hyperactivity disorder with symptoms from age 7
- In good general health
- Willing to not take any other ADHD medication or start any behaviorial modification programs during the study
- Willing to use approved birth control throughout the study and for 3 months afterwards
Key exclusion criteria (6 listed)
- Any psychiatric condition including acute mood disorder, bipolar disorder, acute obsessive-compulsive disorder (OCD), anti-social personality disorder or borderline personality disorder
- Autism, asperger's syndrome, mental retardation
- Presence of motor tics, history of Tourette's syndrome or family history of Tourette's syndrome
- History of substance use/abuse disorder or eating disorder
- History of myocardial infarction, stroke, glaucoma, seizures, hypertension, heart rhythm abnormalities or color blindness
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 |
|---|---|---|
| Placeboone dose daily for 4 weeks | Drug | 003 |
| JNJ-3100107410 mg daily for 4 weeks | Drug | 001 |
| JNJ-3100107430 mg daily for 4 weeks | Drug | 002 |
Primary outcome
The primary study objective is to evaluate the safety and effectiveness of JNJ- 31001074 in adult patients with ADHD.
Time frame: ADHD assessments, vital signs, laboratory tests and ECGs will be collected 7 times during the study; at screening, baseline and 5 weekly visit. Adverse events will be collected throughout the study.
1 secondary outcome
The secondary study objective is to assess drug levels in adults with ADHD after taking JNJ-31001074.
Time frame: Samples to measure drug levels in the blood will be collected three times at baseline and termination visits and once at visits done at Weeks 1, 2, and 3.
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 13 May 2014.
Related trials for Attention Deficit Hyperactivity Disorder
Enrolling by invitationPhase 3
An Open-Label Study to Assess the Long-Term Safety of Solriamfetol in Children and Adolescents With ADHD
ADHD
Not yet recruitingPhase 2
Lisdexamfetamine For the Treatment of Conduct Disorder in Children
Conduct Disorder
RecruitingObservational study
Augmenting Parent Management Training for Child Temper Outbursts Using a Digital Tool
Disruptive Behavior Disorders, Conduct Disorder
Recruiting
Micronutrient Supplementation and Chronotherapy in Children With ADHD
Attention Deficit Hyperactivity Disorder (ADHD)
RecruitingPhase 3
Forward Treatment of Attention Deficit and Hyperactivity Using Solriamfetol (FOCUS-2)
ADHD
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.
Alza Corporation Clinical Trial study director
ALZA
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial study director
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing JNJ-31001074 in people with Attention Deficit Hyperactivity Disorder, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. at 21 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 4 inclusion and 6 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 13 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 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 phase mean?
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?
The primary study objective is to evaluate the safety and effectiveness of JNJ- 31001074 in adult patients with ADHD. (time frame: ADHD assessments, vital signs, laboratory tests and ECGs will be collected 7 times during the study; at screening, baseline and 5 weekly visit. Adverse events will be collected throughout the study.). 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 13 May 2014.