Attention-Deficit/Hyperactivity DisorderPhase 2NCT01458340
A Study of TD-9855 in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)
A Phase 2 study testing TD-9855 in people with Attention-Deficit/Hyperactivity Disorder and ADHD, run by Theravance Biopharma at 17 sites in United States.
Trial summary
The safety and efficacy of multiple dosages of TD-9855, administered once daily, will be evaluated in adult males with ADHD. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Attention-Deficit/Hyperactivity Disorder, ADHD
- What is being tested?
- TD-9855
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 295 participants
- Where
- 17 sitesUnited States
- Study dates
- Dec 2011to Nov 2013
- Phase
- Phase 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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Subjects must meet the following ADHD diagnostic and inclusion criteria:
- Subjects must meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for current ADHD subtypes (ADHD combined type, ADHD predominately inattentive type, ADHD predominately hyperactive-impulsive type) as assessed by the clinical interview and confirmed by Adult Attention-Deficit/Hyperactivity Disorder Clinical Diagnostic Scale (ACDS V1.2).
- Subjects must have a total score of 24 or greater on the AISRS at both the Screening and Baseline Visits AND the Baseline Visit AISRS scores must not vary by more than 20% from Screening.
- Subjects are required to have CGI-S score ≥4 (moderate) at both the Screening and Baseline Visits. Subjects should have at least moderate severity for ADHD symptoms.
- For women of childbearing potential, documentation of a negative serum pregnancy test at Screening and a negative urine pregnancy test on Day 0. All female subjects of childbearing potential must be using a highly effective method of birth control during the study and for at least 1 month after completion of study drug dosing.
- A highly effective method of birth control is defined as one that results in a low failure rate (i.e., <1% per year) when used consistently and correctly, such as condom + diaphragm, condom + spermicide, diaphragm + spermicide, or intrauterine device [IUD] with documented failure rate of <1% per year, or oral/injectable/implanted hormonal contraceptives used in combination with a barrier method.
- Women are considered to be not of childbearing potential if they have had a total hysterectomy or bilateral tubal ligation (documentation for either must be provided before enrollment) or are at least 2 years postmenopausal. Female subjects cannot be breast-feeding.
Who cannot join
- Any current psychiatric disorder other than ADHD as defined in DSM-IV-TR as assessed by Mini International Neuropsychiatric Interview (MINI). Subjects with dysthymia that does not require pharmacological treatment will not be excluded.
- MADRS total score >15.
- A diagnosis of ADHD NOS.
- Any diagnosis of lifetime bipolar disorder or psychotic disorder
- A current diagnosis of any severe comorbid Axis II disorder
- Any history of mental retardation, organic mental disorders due to general medical condition or pervasive developmental disorder as defined by DSM-IV-TR.-
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
FutureSearch Clinical Trials
Austin, Texas, 78731
Florida Clinical Research Center, LLC
Bradenton, Florida, 34201
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, 32256
Ctr. for Psychiatry & Behavioral Med.
Las Vegas, Nevada, 89128
Lincoln Research
Lincoln, Rhode Island, 02865
Florida Clinical Research Center
Maitland, Florida, 34201
CNS Healthcare of Memphis
Memphis, Tennessee, 38119
Adult ADHD Program
New York, New York, 10016
IPS Research
Oklahoma City, Oklahoma, 73103
Psychiatric Associates
Overland Park, Kansas, 66211
Janus Ctr. for Psychiatric Research
Palm Beach, Florida, 33407
Summit Research Network
Portland, Oregon, 97210
Midwest Research Group
Saint Charles, Missouri, 63304
Psychiatric & Behavioral Solutions
Salt Lake City, Utah, 84105
Lifetree Clinical Research, LC
Salt Lake City, Utah, 84106
Summit Research Network (Seattle), LLC
Seattle, Washington, 98104
Carman Research
Smyrna, Georgia, 30080
About this study
Official title: A Phase 2 Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Proof-of-Concept Study of TD-9855 in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)
The safety and efficacy of multiple dosages of TD-9855, administered once daily, will be evaluated in adult males with ADHD.
- Conditions
- Attention-Deficit/Hyperactivity Disorder, ADHD
- Being tested
- TD-9855, Placebo
- Keywords
- Adult 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.
TD-9855Drug
Once daily
TD-9855Drug
Once daily
PlaceboDrug
Once daily
| Study group | Role | What they receive |
|---|---|---|
| TD-9855 Dose 1 | Experimental | Not described Receives: Drug: TD-9855 |
| Placebo | Experimental | Not described Receives: Drug: Placebo |
| TD-9855 Dose 2 | Experimental | Not described Receives: Drug: TD-9855 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in AISRS Total Score at Day 42
The AISRS is a modified version of the ADHD Rating Scale that more accurately reflects the impact and severity of ADHD among adults. It is a clinician-administered scale that measures all 18 symptoms of adult ADHD using a Likert scale from 0 (not present) to 3 (severe). The total score ranges from 0 to 54 with a negative change from baseline indicating an improvement in severity/reduction in symptoms.
Measured: Baseline and Day 42
Secondary outcomes (12)
Change From Baseline in BDEFS-SF: Self Report Total Score at Day 42
The BDEFS-SF: Self-Report is an empirically based tool for evaluating dimensions of adult executive functioning in daily life. The BDEFS-SF is used to score how frequently the participants experience problems involved in time management; organization and problem solving; self restraint; self motivation; and self-regulation of emotions. The score for each item ranges from 1 (never) to 4 (very often). The total score on the BDEFS-SF ranges from 20 to 80 with a negative change from baseline indicating an improvement in functioning.
Measured: Baseline and Day 42
Change From Baseline in AISRS Inattentive Subscale at Day 42
The AISRS is a modified version of the ADHD Rating Scale that more accurately reflects the impact and severity of ADHD among adults. The AISRS inattentive subscale that measures all 9 inattentive symptoms of adult ADHD using a Likert scale from 0 (not present) to 3 (severe). The AISRS inattentive subscale score ranges from 0 to 27 with a negative change from baseline indicating an improvement in severity/reduction in symptoms.
Measured: Baseline and Day 42
Change From Baseline in AISRS Hyperactive-impulsive Subscale at Day 42
The AISRS is a modified version of the ADHD Rating Scale that more accurately reflects the impact and severity of ADHD among adults. The AISRS hyperactive-impulsive subscale measures all 9 hyperactive/impulsive symptoms of adult ADHD using a Likert scale from 0 (not present) to 3 (severe). The AISRS hyperactive-impulsive subscale score ranges from 0 to 27 with a negative change from baseline indicating an improvement in severity/reduction in symptoms.
Measured: Baseline and Day 42
Percentage of Participants With an AISRS Response at Day 42
The AISRS is a modified version of the ADHD Rating Scale that more accurately reflects the impact and severity of ADHD among adults. The AISRS total scale measures all 18 symptoms of adult ADHD using a Likert scale from 0 (not present) to 3 (severe). The total score ranges from 0 to 54. A responder is defined as a participant with >=30% reduction from baseline in AISRS total score.
Measured: Day 42
Change From Baseline in Clinical Global Impression - Severity of Illness (CGI-S) Score at Day 42
The CGI-S is a 7-point scale that requires the clinician to rate the severity of the participants' illness at the time of assessment, relative to the clinician's past experience with patients who have the same diagnosis. Considering total clinical experience, a participant is assessed on severity of mental illness at the time of rating 1=normal, not at all ill; 2, borderline mentally ill; 3, mildly ill; 4, moderately ill; 5, markedly ill; 6, severely ill; or 7,extremely ill. A negative change from baseline indicates a reduction in illness.
Measured: Baseline and Day 42
Change From Baseline in Adult ADHD Self-Report Scale (ASRS) Total Score at Day 42
The ASRS is a checklist consisting of the 18 Diagnostic and Statistical Manual of Mental Disorders 4th edition (DSM-IV-TR) criteria in which participants rank frequency of each criterion from never (0) to very often (4). The ASRS total score ranges from 0-72 with a negative change from baseline indicating a reduction in frequency of symptoms.
Measured: Baseline and Day 42
Change From Baseline in ASRS Inattentive Subscale at Day 42
The ASRS inattentive subscale is a checklist consisting of 9 DSM-IV-TR inattentive criteria in which participants rank frequency of each criterion from never (0) to very often (4). The ASRS inattentive subscale score ranges from 0-36 with a negative change from baseline indicating a reduction in frequency of symptoms.
Measured: Baseline and Day 42
Change From Baseline in ASRS Hyperactive-impulsive Subscale at Day 42
The ASRS hyperactive-impulsive subscale is a checklist consisting of 9 DSM-IV-TR hyperactive/impulsive criteria in which participants rank frequency of each criterion from never (0) to very often (4). The ASRS hyperactive-impulsive subscale score ranges from 0-36 with a negative change from baseline indicating a reduction in frequency of symptoms.
Measured: Baseline and Day 42
Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Day 42
MADRS is a 10-item investigator-rated scale that assesses the range of symptoms that are most frequently observed in patients with major depression. The 10 selected items are rated on a scale of 0 (no depression) to 6 (highest level of depression) with anchors at 2-point intervals. Total scores on the MADRS range from 0 to 60 with a negative change from baseline indicating an improvement in levels of depression.
Measured: Baseline and Day 42
Percentage of Participants With a Reliable Change on the BDEFS-SF at Day 42
The BDEFS-SF is used to score how frequently the participants experience problems involved in time management; organization and problem solving; self restraint; self motivation; and self-regulation of emotions. The score for each item ranges from 1 (never) to 4 (very often). The total score on the BDEFS-SF ranges from 20 to 80. A reliable change is defined as a decrease in total BDEFS-SF score of 12 or more relative to the baseline value.
Measured: Baseline and Day 42
Percentage of Participants With a Reliable Change and Normalized Score on the BDEFS-SF at Day 42
The BDEFS-SF is used to score how frequently the participants experience problems involved in time management; organization and problem solving; self restraint; self motivation; and self-regulation of emotions. The score for each item ranges from 1 (never) to 4 (very often). The total score on the BDEFS-SF ranges from 20 to 80. A reliable change is defined as a decrease in total BDEFS-SF score of 12 or more relative to the baseline value. Normalization is defined as a post-baseline BDEFS-SF total score <45.
Measured: Baseline and Day 42
Change From Baseline in BDEFS-SF Symptom Count at Day 42
The BDEFS-SF is used to score how frequently the participants experience problems involved in time management; organization and problem solving; self restraint; self motivation; and self-regulation of emotions. A negative change from baseline in symptom count indicates an improvement in functioning. Only symptoms rated as occurring often or very often on the BDEFS-SF are included in the symptom count. Mean change from baseline in symptom count is reported
Measured: Baseline and Day 42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2011 (estimated)
- Study startDec 2011
- Primary completionOct 2013
- Study completionNov 2013
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 295 participants (actual)
Sponsor and investigators
- Lead sponsor
- Theravance Biopharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Theravance Biopharma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01458340
- Sponsor's protocol ID
- 0085
- Status last verified
- Mar 2022
- First submitted
- 20 Oct 2011
- Last updated
- 4 Apr 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No: Theravance Biopharma, Inc. will not be sharing individual de-identified participant data or other relevant study documents.
Publications
Kanodia J, Lo A, Baldwin RM, Graham RA, Bourdet DL. Pharmacokinetics of Ampreloxetine, a Norepinephrine Reuptake Inhibitor, in Healthy Subjects and Adults with Attention-Deficit/Hyperactive Disorder or Fibromyalgia Pain. Clin Pharmacokinet. 2021 Jan;60(1):121-131. doi: 10.1007/s40262-020-00918-7.
PubMed 32856281
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Proof-of-Concept Study of TD-9855 in Adults With Attention-Deficit/Hyperactivity Disorder (ADHD)
- ClinicalTrials.gov ID
- NCT01458340
- Acronym / sponsor ID
- 0085
- Conditions
- Attention-Deficit/Hyperactivity Disorder, ADHD
- Keywords
- Adult ADHD, Attention-Deficit/Hyperactivity Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 295 participants (actual)
- Lead sponsor
- Theravance BiopharmaIndustry (pharma, biotech, devices)
- Study start
- Dec 2011 (actual)
- Primary completion
- Oct 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 24 Oct 2011 (estimated)
- Results
- Posted 14 Mar 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The safety and efficacy of multiple dosages of TD-9855, administered once daily, will be evaluated in adult males with ADHD.
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 |
|---|---|---|
| TD-9855 Dose 1 | Experimental | Drug: TD-9855 |
| Placebo | Experimental | Drug: Placebo |
| TD-9855 Dose 2 | Experimental | Drug: TD-9855 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Subjects must meet the following ADHD diagnostic and inclusion criteria:
- Subjects must meet Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) criteria for current ADHD subtypes (ADHD combined type, ADHD predominately inattentive type, ADHD predominately hyperactive-impulsive type) as assessed by the clinical interview and confirmed by Adult Attention-Deficit/Hyperactivity Disorder Clinical Diagnostic Scale (ACDS V1.2).
- Subjects must have a total score of 24 or greater on the AISRS at both the Screening and Baseline Visits AND the Baseline Visit AISRS scores must not vary by more than 20% from Screening.
- Subjects are required to have CGI-S score ≥4 (moderate) at both the Screening and Baseline Visits. Subjects should have at least moderate severity for ADHD symptoms.
- For women of childbearing potential, documentation of a negative serum pregnancy test at Screening and a negative urine pregnancy test on Day 0. All female subjects of childbearing potential must be using a highly effective method of birth control during the study and for at least 1 month after completion of study drug dosing.
Key exclusion criteria (6 listed)
- Any current psychiatric disorder other than ADHD as defined in DSM-IV-TR as assessed by Mini International Neuropsychiatric Interview (MINI). Subjects with dysthymia that does not require pharmacological treatment will not be excluded.
- MADRS total score >15.
- A diagnosis of ADHD NOS.
- Any diagnosis of lifetime bipolar disorder or psychotic disorder
- A current diagnosis of any severe comorbid Axis II disorder
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 |
|---|---|---|
| TD-9855Once daily | Drug | TD-9855 Dose 1 |
| TD-9855Once daily | Drug | TD-9855 Dose 2 |
| PlaceboOnce daily | Drug | Placebo |
Primary outcome
Change From Baseline in AISRS Total Score at Day 42
Time frame: Baseline and Day 42
The AISRS is a modified version of the ADHD Rating Scale that more accurately reflects the impact and severity of ADHD among adults. It is a clinician-administered scale that measures all 18 symptoms of adult ADHD using a Likert scale from 0 (not present) to 3 (severe). The total score ranges from 0 to 54 with a negative change from baseline indicating an improvement in severity/reduction in symptoms.
12 secondary outcomes
Change From Baseline in BDEFS-SF: Self Report Total Score at Day 42
Time frame: Baseline and Day 42
Change From Baseline in AISRS Inattentive Subscale at Day 42
Time frame: Baseline and Day 42
Change From Baseline in AISRS Hyperactive-impulsive Subscale at Day 42
Time frame: Baseline and Day 42
Percentage of Participants With an AISRS Response at Day 42
Time frame: Day 42
Change From Baseline in Clinical Global Impression - Severity of Illness (CGI-S) Score at Day 42
Time frame: Baseline and Day 42
Change From Baseline in Adult ADHD Self-Report Scale (ASRS) Total Score at Day 42
Time frame: Baseline and Day 42
Change From Baseline in ASRS Inattentive Subscale at Day 42
Time frame: Baseline and Day 42
Change From Baseline in ASRS Hyperactive-impulsive Subscale at Day 42
Time frame: Baseline and Day 42
Change From Baseline in Montgomery-Asberg Depression Rating Scale (MADRS) Total Score at Day 42
Time frame: Baseline and Day 42
Percentage of Participants With a Reliable Change on the BDEFS-SF at Day 42
Time frame: Baseline and Day 42
Percentage of Participants With a Reliable Change and Normalized Score on the BDEFS-SF at Day 42
Time frame: Baseline and Day 42
Change From Baseline in BDEFS-SF Symptom Count at Day 42
Time frame: Baseline and Day 42
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32856281Kanodia J, Lo A, Baldwin RM, Graham RA, Bourdet DL. Pharmacokinetics of Ampreloxetine, a Norepinephrine Reuptake Inhibitor, in Healthy Subjects and Adults with Attention-Deficit/Hyperactive Disorder or Fibromyalgia Pain. Clin Pharmacokinet. 2021 Jan;60(1):121-131. doi: 10.1007/s40262-020-00918-7.
- Individual participant dataSharing planned: No. Theravance Biopharma, Inc. will not be sharing individual de-identified participant data or other relevant study documents.
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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.
Medical Monitor study director
Theravance Biopharma
17 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 TD-9855 in people with Attention-Deficit/Hyperactivity Disorder and ADHD, run by Theravance Biopharma at 17 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 7 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 4 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 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. 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?
Yes. Results are posted in the registry (first posted 14 Mar 2022). 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?
Change From Baseline in AISRS Total Score at Day 42 (time frame: Baseline and Day 42). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01458340, which also lists 1 linked publication.
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 4 Apr 2022.