Attention Deficit Hyperactivity DisorderPhase 2NCT01472991
Safety & Efficacy of TC-5619 in Adults With Inattentive-predominant Attention Deficit/Hyperactivity Disorder (ADHD)
A Phase 2 study testing TC-5619-238 5mg and TC-5619-238 25mg in people with Attention Deficit Hyperactivity Disorder, run by Targacept Inc. at 14 sites in United States.
Trial summary
Study is to assess if TC-5619 improves symptoms for adults diagnosed with the inattentive-predominant subtype of ADHD over a 4-week treatment period. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- TC-5619-238 5mg and TC-5619-238 25mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 250 participants
- Where
- 14 sitesUnited States
- Study dates
- Nov 2011to Jul 2012
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Diagnosis of Inattentive predominant ADHD per DSM-IV TR) criteria at Screening
- Score ≥ 2 on at least 6 of 9 items in the inattentive subscale of the CAARS-INV at Baseline (Day 1)
- Score of < 2 on at least 4 of 9 items in the hyperactive/impulsivity subscale of the CAARS-INV at Baseline (Day 1)
- Score ≥ 4 (at least moderate) on the CGI-S
- Tobacco non-users as indicated by lack of tobacco use within the last 6 months prior to Screening, and by negative urinary cotinine level of < 50 ng/mL after quantification
Who cannot join
- Current DSM-IV Axis I psychiatric disorder other than ADHD;
- Use of tobacco cessation agents within 4 weeks prior to Screening
- Known or suspected drug abuse within the last 6 months prior to Screening
- Urine drug screen positive for illegal or non-prescribed drugs at Screening
- Patients at imminent risk of suicide or of danger to themselves or others as judged by the investigator
- Use of drugs affecting cognitive function within 4 weeks prior to Day 1. This includes use of any concomitant medications for treatment of ADHD.
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- History of significant other major or unstable neurological, metabolic, hepatic, renal, hematological, pulmonary, cardiovascular (CV), gastrointestinal (GI), or urological disorder; or diagnosis of major depressive disorder
- Myocardial infarction within past year
- Seizure disorder within past year
- Type 1 diabetes mellitus (DM); type 2 DM that requires medication (diet-controlled allowed)
- HbA1C > 7.4 at Screening
- BMI < 15 or > 35; male weight < 100 lbs; female weight < 80 lbs.
- Current tuberculosis (TB) or known systemic infection [Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Human Immunodeficiency Virus (HIV)]
- Women of child-bearing potential and male participants unwilling or unable to use accepted methods of birth control
- Participation in another Central Nervous System (CNS)-related clinical trial in the last 3 months and any other clinical trial in last 30 days prior to Screening, or participation in a previous TC-5619 clinical trial
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
FutureSearch Clinical Trials, LP
Austin, Texas, 78731
Southwestern Research, Inc
Beverly Hills, California, 90210
Clinical Trials Network & Institute, Massachusetts General Hospital
Boston, Massachusetts, 02114
Florida Clinical Research Center, LLC
Bradenton, Florida, 34201
Neuro-Behavioral Clinical Reseach, Inc.
Canton, Ohio, 44718
MCB Clinical Research Centers, LLC
Colorado Springs, Colorado, 80910
Midwest Clinical Research Center
Dayton, Ohio, 45417
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, 32216
Florida Clinical Research Center, LLC
Maitland, Florida, 32751
CNS Healthcare
Memphis, Tennessee, 38119
Synergy Clinical Research Center
National City, California, 91920
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, 32806
Compass Research, Inc.
Orlando, Florida, 32806
Compass Research, LLC
Orlando, Florida, 32806
About this study
Official title: A Double-Blind, Randomized, Placebo-Controlled, Multicenter, Fixed Dose Study to Assess Efficacy, Safety, and Tolerability of TC-5619 in Adults With Inattentive-Predominant Attention Deficit/Hyperactivity Disorder (ADHD)
Study is to assess if TC-5619 improves symptoms for adults diagnosed with the inattentive-predominant subtype of ADHD over a 4-week treatment period.
Read the detailed description
A 3-arm, double-blind, randomized, placebo-controlled, multicenter, fixed dose study to assess efficacy and safety of TC-5619 in adults with inattentive-predominant attention deficit/hyperactivity disorder (ADHD) utilizing the Connor's Adult ADHD Rating Scale-Investigator Completed Version (CAARS-INV) inattentive subscale scores through 4 weeks of treatment.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- TC-5619-238 5mg, TC-5619-238 25mg, Placebo
- Keywords
- ADHD
- 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.
TC-5619-238 5mgDrug
TC-5619-238 5mg capsule taken once daily for 4 weeks
TC-5619-238 25mgDrug
TC-5619-238 25mg capsules taken once daily for 4 weeks
PlaceboDrug
Placebo capsules will be taken once daily for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| TC-5619-238 (25mg) | Experimental | TC-5619-238 25 mg will be provided as hard gelatin capsules Receives: Drug: TC-5619-238 25mg |
| Placebo | Placebo comparator | Placebo will be provided as hard gelatin capsules similar to TC-5619-238 Receives: Drug: Placebo |
| TC-5619-238 (5 mg) | Experimental | TC-5619-238 5 mg will be provided as hard gelatin capsules. Receives: Drug: TC-5619-238 5mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inattentive Subscale of the Conner's Adult ADHD-Investigator Version (CAARS-INV)
Scores on the inattentive subscale of the CAARS-INV obtained at Day 1 (baseline) and weeks 2, 4, and 6. Primary comparison will be difference between Day 1 and Week 4 (TC-5619 5mg and 25 mg vs. placebo).
Measured: 4 weeks
Secondary outcomes (2)
Conner's Adult ADHD-Investigator Version total score
Scores on the total CAARS-INV obtained at Day 1 (baseline) and weeks 2, 4, and 6. Primary comparison will be difference between Day 1 and Week 4 (TC-5619 5mg and 25 mg vs. placebo).
Measured: 4 weeks
Conner's Adult ADHD Rating Scale-Subject Self-Rating Version (CAARS-S)
Scores on the CAARS-S obtained at Day 1 (baseline) and weeks 2, 4, and 6. Primary comparison will be difference between Day 1 and Week 4 (TC-5619 5mg and 25 mg vs. placebo).
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2011 (estimated)
- Study startNov 2011
- Primary completionJul 2012
- Study completionJul 2012
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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Targacept Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Timothy Wilens, MD, Principal investigator, Clinical Trials Network & Institute, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01472991
- Sponsor's protocol ID
- TC-5619-238-CRD-004
- Status last verified
- Apr 2013
- First submitted
- 14 Nov 2011
- Last updated
- 30 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Randomized, Placebo-Controlled, Multicenter, Fixed Dose Study to Assess Efficacy, Safety, and Tolerability of TC-5619 in Adults With Inattentive-Predominant Attention Deficit/Hyperactivity Disorder (ADHD)
- ClinicalTrials.gov ID
- NCT01472991
- Acronym / sponsor ID
- TC-5619-238-CRD-004
- Conditions
- Attention Deficit Hyperactivity Disorder
- Keywords
- ADHD
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Targacept Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2011
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 17 Nov 2011 (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.
Study is to assess if TC-5619 improves symptoms for adults diagnosed with the inattentive-predominant subtype of ADHD over a 4-week treatment period.
Detailed description
A 3-arm, double-blind, randomized, placebo-controlled, multicenter, fixed dose study to assess efficacy and safety of TC-5619 in adults with inattentive-predominant attention deficit/hyperactivity disorder (ADHD) utilizing the Connor's Adult ADHD Rating Scale-Investigator Completed Version (CAARS-INV) inattentive subscale scores through 4 weeks of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TC-5619-238 (25mg) | Experimental | Drug: TC-5619-238 25mgTC-5619-238 25 mg will be provided as hard gelatin capsules |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo will be provided as hard gelatin capsules similar to TC-5619-238 |
| TC-5619-238 (5 mg) | Experimental | Drug: TC-5619-238 5mgTC-5619-238 5 mg will be provided as hard gelatin capsules. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of Inattentive predominant ADHD per DSM-IV TR) criteria at Screening
- Score ≥ 2 on at least 6 of 9 items in the inattentive subscale of the CAARS-INV at Baseline (Day 1)
- Score of < 2 on at least 4 of 9 items in the hyperactive/impulsivity subscale of the CAARS-INV at Baseline (Day 1)
- Score ≥ 4 (at least moderate) on the CGI-S
- Tobacco non-users as indicated by lack of tobacco use within the last 6 months prior to Screening, and by negative urinary cotinine level of < 50 ng/mL after quantification
Key exclusion criteria (15 listed)
- Current DSM-IV Axis I psychiatric disorder other than ADHD;
- Use of tobacco cessation agents within 4 weeks prior to Screening
- Known or suspected drug abuse within the last 6 months prior to Screening
- Urine drug screen positive for illegal or non-prescribed drugs at Screening
- Patients at imminent risk of suicide or of danger to themselves or others as judged by the investigator
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 |
|---|---|---|
| TC-5619-238 5mgTC-5619-238 5mg capsule taken once daily for 4 weeks | Drug | TC-5619-238 (5 mg) |
| TC-5619-238 25mgTC-5619-238 25mg capsules taken once daily for 4 weeks | Drug | TC-5619-238 (25mg) |
| PlaceboPlacebo capsules will be taken once daily for 4 weeks | Drug | Placebo |
Primary outcome
Inattentive Subscale of the Conner's Adult ADHD-Investigator Version (CAARS-INV)
Time frame: 4 weeks
Scores on the inattentive subscale of the CAARS-INV obtained at Day 1 (baseline) and weeks 2, 4, and 6. Primary comparison will be difference between Day 1 and Week 4 (TC-5619 5mg and 25 mg vs. placebo).
2 secondary outcomes
Conner's Adult ADHD-Investigator Version total score
Time frame: 4 weeks
Conner's Adult ADHD Rating Scale-Subject Self-Rating Version (CAARS-S)
Time frame: 4 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 30 Apr 2013.
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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.
Timothy Wilens, MD principal investigator
Clinical Trials Network & Institute, Massachusetts General Hospital
14 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 TC-5619-238 5mg and TC-5619-238 25mg in people with Attention Deficit Hyperactivity Disorder, run by Targacept Inc. at 14 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 5 inclusion and 15 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 30 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 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?
Inattentive Subscale of the Conner's Adult ADHD-Investigator Version (CAARS-INV) (time frame: 4 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 30 Apr 2013.