Attention Deficit Hyperactivity Disorder (ADHD)Phase 3NCT02477748
The MEASURE Study - A Phase 3 Study of MDX 1400 mg Daily Compared With Placebo in Adults With ADHD
A Phase 3 study testing MDX in people with Attention Deficit Hyperactivity Disorder (ADHD), run by Alcobra Ltd. at 38 sites in 2 countries.
Trial summary
This study is a multi-center, randomized, double-blind, placebo-controlled, phase 3 study of MDX (1400 mg daily) for 10 weeks compared with placebo in adults with ADHD. The study will be comprised of Screening, Washout (if required), Treatment (total of 10 weeks) and Follow-up periods. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder (ADHD)
- What is being tested?
- MDX
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 283 participants
- Where
- 38 sitesin 2 countries
- Study dates
- Jun 2015to Jan 2017
- Phase
- Phase 3
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Subject is a man or a non-pregnant, non-lactating woman 18 to 55 years of age, inclusive, at the Screening visit.
- Subject has a diagnosis of ADHD based on criteria in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM5) as assessed by the Adult ADHD Clinician Diagnostic Scale, (ACDS Version 1.2) modified for DSM-IV and DSM5 diagnoses; a diagnosis of ADHD not otherwise specified is unacceptable.
- Male and Female subjects of childbearing potential must agree to use an effective contraceptive throughout the study
- Subject is able to attend the clinic regularly and reliably.
- Subject is able to swallow tablets and capsules.
- Subject is able to understand, read, write, and speak the local language fluently to complete the study-related materials.
- Subject is able to understand and sign an informed consent form to participate in the study.
Who cannot join
- Subject has any current major psychiatric condition (e.g., schizophrenia, bipolar or personality disorder) or autism spectrum disorder.
- Subject has any clinically significant or unstable medical or surgical condition that may preclude safe and complete study participation.
- Subject has used an investigational medication/treatment or was enrolled in another clinical trial in the 30 days before the Screening visit.
- Subject has used any medication or food supplement that the investigator or the medical monitor consider unacceptable during the 14-day period before the Baseline visit.
- Subject's alcohol and caffeine intake will be assessed.
- Subject has current suicidality, defined as active ideation, intent or plan, or any significant lifetime suicidal behavior (actual attempt, aborted attempt, interrupted attempt, or act or preparation towards imminently making a suicide attempt). Subjects exhibiting history (within previous 12 months) of non-suicidal self-injurious behavior will be excluded.
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- Subject has taken any prescription or non-prescription medication for ADHD during the 14 days (or 21 days for atomoxetine) before the Baseline visit. Subjects will not be allowed to take any other medications for ADHD besides the study medication (when prescribed) after the washout period and for the duration of the study, up to and including the safety Follow-up visit. (Other ADHD medications should NOT be prescribed to subjects before completion of the Follow-up visit or Early Termination Visit).
- Subject is significantly visually impaired to an extent that is not able to be corrected by prescription glasses or contact lenses.
- Subject is closely related to the sponsor, investigator, or study staff. Eligibility of subjects with any relationship to the sponsor, investigator, or study staff will be discussed with the medical monitor before study entry, and the medical monitor will decide on the eligibility of these cases.
- Subject has previously been enrolled in an MDX clinical trial.
- Subject lives in the same household as another subject in this clinical trial or in another on-going trial with MDX. Subject lives in the same household as someone who has previously participated in a trial with MDX.
- Subject has any condition that, in the principal investigator's opinion, would place the subject at risk or influence the conduct of the study or interpretation of results, including (but not limited to) abnormally low intellectual capacity as judged by the investigator.
- Subject cannot fully comprehend the implications of the protocol, cannot comply with its requirements, or is incapable of following the study schedule for any reason.
- Subject is pregnant, lactating, or using an inadequate contraceptive method. Complete entry criteria will be reviewed and evaluated individually by a protocol trained delegate.
Trial locations and contacts
38 sites in 2 countries.
38 sites in 2 countries
United States36 sites
Institute for Advanced Medical Research
Alpharetta, Georgia, 30005
BioBehavioral Research of Austin at Specialty Clinic of Austin
Austin, Texas, 78759
Kennedy Krieger Institute
Baltimore, Maryland, 21205
Neuro-Behavioral Clinical Research, Inc.
Canton, Ohio, 44718
Carolina Clinical Research, Inc.
Charleston, South Carolina, 29405
Center for Emotional Fitness
Cherry Hill, New Jersey, 08002
MCB Clinical Research Centers
Colorado Springs, Colorado, 80910
Connecticut Clinical Research
Cromwell, Connecticut, 06416
Harmonex, Inc.
Dothan, Alabama, 36303
Sarkis Clinical Trials
Gainesville, Florida, 32607
NeuroScience, Inc. (NSI)
Herndon, Virginia, 20170
Bayou City Research
Houston, Texas, 77007
Goldpoint Clinical Research
Indianapolis, Indiana, 46260
Clinical Neuroscience Solutions
Jacksonville, Florida, 32256
Lake Charles Clinical Trials
Lake Charles, Louisiana, 70629
Premier Psychiatric Research Institute
Lincoln, Nebraska, 68526
Pharmacology Research Institute
Los Alamitos, California, 90720
Suburban Research Associates
Media, Pennsylvania, 19063
Clinical Neuroscience Solutions
Memphis, Tennessee, 38119
Dean Foundation - Middleton
Middleton, Wisconsin, 53562
Coastal Connecticut Research
New London, Connecticut, 06320
The Medical Research Network
New York, New York, 10128
Pharmacology Research Institute
Newport Beach, California, 92660
IPS Research Company
Oklahoma City, Oklahoma, 73103
Village Clinical Research Inc
Oklahoma City, Oklahoma, 73103
CNS Healthcare
Orlando, Florida, 32801
Summit Research Network
Portland, Oregon, 97210
Global Medical Institutes, LLC, Princeton Medical Institute
Princeton, New Jersey, 08540
Richard H Weisler, MD, PA
Raleigh, North Carolina, 27609
Rochester Center For Behavioral Medicine
Rochester Hills, Michigan, 48307
St. Charles Psychiatric Associates - Midwest Research Group
Saint Charles, Missouri, 63304
Psychiatric & Behavioral Solutions
Salt Lake City, Utah, 84105
Artemis Institute for Clinical Research
San Diego, California, 92103
University of California, San Francisco
San Francisco, California, 94143
Summit Research Network(Seattle)LLC
Seattle, Washington, 98104
Miami Research Associates
South Miami, Florida, 33143
Israel2 sites
Rambam Medical Center
Haifa, 31096
Geha Medical Centre
Petah Tikva
About this study
Official title: A 10-week Randomized, Multicenter, Double-blind, Parallel, Fixed-dose Study of MDX (Metadoxine Immediate-release/Slow-release, Bilayer Tablet) 1400 mg Compared With Placebo in Adults With Attention Deficit Hyperactivity Disorder (ADHD)
This study is a multi-center, randomized, double-blind, placebo-controlled, phase 3 study of MDX (1400 mg daily) for 10 weeks compared with placebo in adults with ADHD.
The study will be comprised of Screening, Washout (if required), Treatment (total of 10 weeks) and Follow-up periods. Approximately 750 patients will be enrolled and undergo initial eligibility assessments.
Read the detailed description
- A 10-week randomized, multi-center, double-blind, placebo-controlled, phase 3 study of MDX (1400 mg daily) for 10 weeks compared with placebo in adults with ADHD.
- The study will be comprised of Screening, Washout (if required), Treatment (total of 10 weeks) and Follow-up periods. Approximately 750 patients will be enrolled and undergo initial eligibility assessments.
- Subjects requiring a washout will undergo a Washout period where ADHD medication is discontinued (21 days for atomoxetine, 14 days for other ADHD medications). These subjects will have an Interim Visit (off drug) on or about Day -10 (Day -10 to Day -3) for CAARS-Inv assessment at the end of the Washout period.
- Subjects will be randomly assigned to placebo/MDX for a total treatment duration of up to ten weeks.
There will be a one week Follow-up period after the last dose of study treatment or early termination.
- Being tested
- MDX, Placebo
- 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.
MDXDrug
Also called MG01CI
Immediate-release/slow-release,bilayer tablet PO of 1400 mg, taken once daily for 10 weeks.
PlaceboDrug
Also called Inert tablet
Tablet PO, taken once daily for 10 weeks.
| Study group | Role | What they receive |
|---|---|---|
| MDX | Active comparator | Metadoxine Immediate-release/slow-release, bilayer tablet PO of 1400 mg, taken once daily for 10 weeks.; alternative name: MG01CI. Receives: Drug: MDX |
| Placebo | Placebo comparator | Inert tablets Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
18-item total ADHD symptom score of the Conners Adult ADHD Rating Scale:O-SV (with the investigator as observer) with adult ADHD prompts (CAARS investigator).
The scale will be analyzed by change from Baseline to Week 10.
Measured: 10 weeks
Secondary outcomes (19)
Questionnaires of Clinical Global Severity of Illness (CGI-S) and Clinical Global Improvement (CGI-I).
The questionnaires will be analyzed by change from Baseline to all visits as well as by response rates.
Measured: 10 weeks
Adult ADHD Self Report Scale (ASRS-Self) v1.1 Symptom Checklist - expanded version
The scale will be analyzed by change from Baseline to Week 10 in total score and sub- scales.
Measured: 10 weeks
Test of Variables of Attention (TOVA)
A continuous performance test performed on the computer. Change from Baseline and response rate of Attention Comparison Score (ACS) will be assessed.
Measured: 10 weeks
Test of Variables of Attention (TOVA)
A continuous performance test performed on the computer. Change from Baseline, as well as response rates, in variability of response time will be assessed.
Measured: 10 weeks
Test of Variables of Attention (TOVA)
A continuous performance test performed on the computer. Change from Baseline, as well as response rates, in response time will be assessed.
Measured: 10 weeks
Test of Variables of Attention (TOVA)
A continuous performance test performed on the computer. Change from Baseline, as well as response rates, in errors of commission will be assessed.
Measured: 10 weeks
Test of Variables of Attention (TOVA)
A continuous performance test performed on the computer. Change from Baseline, as well as response rates, in errors of omission will be assessed.
Measured: 10 weeks
Test of Variables of Attention (TOVA)
A continuous performance test performed on the computer. Change from Baseline, as well as response rates, in D-prime will be assessed.
Measured: 10 weeks
Safety as assessed by adverse events (AEs)
Any undesirable experience associated with the use of a medical product in a subject
Measured: 10 weeks
Safety as assessed by body temperature measurements
Body temperature measurements as part of vital signs measurements
Measured: 10 weeks
Safety as assessed by Columbia Suicide Severity Rating Scale (C-SSRS)
C-SSRS scale allows investigators to gather lifetime history of suicidality as well as any recent suicidal ideation and/or behavior
Measured: 10 weeks
Safety as assessed by laboratory tests; blood and urine
Laboratory test results (hematology, chemistry and urinalysis).
Measured: 10 weeks
Safety as assessed by neurological evaluation
Neurological evaluation done by investigator
Measured: 10 weeks
Safety as assessed by Electrocardiogram (ECG) test
Analysis and Interpretation of the Electrocardiogram
Measured: 10 weeks
Safety as assessed by physical examinations
Physical examination done by investigator
Measured: 10 weeks
Safety as assessed by discontinuations due to AEs
Discontinuations of subjects due to AEs
Measured: 10 weeks
Safety as assessed by heart rate measurements
Heart rate measurements as part of vital signs measurements
Measured: 10 weeks
Safety as assessed by respiratory rate measurements
Respiratory rate measurements as part of vital signs measurements
Measured: 10 weeks
Safety as assessed by supine blood pressure
Supine blood pressure as part of vital signs measurements
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2015 (estimated)
- Study startJun 2015
- Primary completionJan 2017
- Study completionJan 2017
Why it stopped: FDA Clinical hold
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 283 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alcobra Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jeffrey Newcorn, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02477748
- Sponsor's protocol ID
- AL016
- Status last verified
- Apr 2016
- First submitted
- 8 Jun 2015
- Last updated
- 19 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 10-week Randomized, Multicenter, Double-blind, Parallel, Fixed-dose Study of MDX (Metadoxine Immediate-release/Slow-release, Bilayer Tablet) 1400 mg Compared With Placebo in Adults With Attention Deficit Hyperactivity Disorder (ADHD)
- ClinicalTrials.gov ID
- NCT02477748
- Acronym / sponsor ID
- AL016
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: FDA Clinical hold
- Enrolment
- 283 participants (actual)
- Lead sponsor
- Alcobra Ltd.Industry (pharma, biotech, devices)
- Study start
- Jun 2015
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 23 Jun 2015 (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.
This study is a multi-center, randomized, double-blind, placebo-controlled, phase 3 study of MDX (1400 mg daily) for 10 weeks compared with placebo in adults with ADHD.
The study will be comprised of Screening, Washout (if required), Treatment (total of 10 weeks) and Follow-up periods. Approximately 750 patients will be enrolled and undergo initial eligibility assessments.
Detailed description
- A 10-week randomized, multi-center, double-blind, placebo-controlled, phase 3 study of MDX (1400 mg daily) for 10 weeks compared with placebo in adults with ADHD.
- The study will be comprised of Screening, Washout (if required), Treatment (total of 10 weeks) and Follow-up periods. Approximately 750 patients will be enrolled and undergo initial eligibility assessments.
- Subjects requiring a washout will undergo a Washout period where ADHD medication is discontinued (21 days for atomoxetine, 14 days for other ADHD medications). These subjects will have an Interim Visit (off drug) on or about Day -10 (Day -10 to Day -3) for CAARS-Inv assessment at the end of the Washout period.
- Subjects will be randomly assigned to placebo/MDX for a total treatment duration of up to ten weeks.
There will be a one week Follow-up period after the last dose of study treatment or early termination.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MDX | Active comparator | Drug: MDXMetadoxine Immediate-release/slow-release, bilayer tablet PO of 1400 mg, taken once daily for 10 weeks.; alternative name: MG01CI. |
| Placebo | Placebo comparator | Drug: PlaceboInert tablets |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Subject is a man or a non-pregnant, non-lactating woman 18 to 55 years of age, inclusive, at the Screening visit.
- Subject has a diagnosis of ADHD based on criteria in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM5) as assessed by the Adult ADHD Clinician Diagnostic Scale, (ACDS Version 1.2) modified for DSM-IV and DSM5 diagnoses; a diagnosis of ADHD not otherwise specified is unacceptable.
- Male and Female subjects of childbearing potential must agree to use an effective contraceptive throughout the study
- Subject is able to attend the clinic regularly and reliably.
- Subject is able to swallow tablets and capsules.
Key exclusion criteria (14 listed)
- Subject has any current major psychiatric condition (e.g., schizophrenia, bipolar or personality disorder) or autism spectrum disorder.
- Subject has any clinically significant or unstable medical or surgical condition that may preclude safe and complete study participation.
- Subject has used an investigational medication/treatment or was enrolled in another clinical trial in the 30 days before the Screening visit.
- Subject has used any medication or food supplement that the investigator or the medical monitor consider unacceptable during the 14-day period before the Baseline visit.
- Subject's alcohol and caffeine intake will be assessed.
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 |
|---|---|---|
| MDXAlso: MG01CIImmediate-release/slow-release,bilayer tablet PO of 1400 mg, taken once daily for 10 weeks. | Drug | MDX |
| PlaceboAlso: Inert tabletTablet PO, taken once daily for 10 weeks. | Drug | Placebo |
Primary outcome
18-item total ADHD symptom score of the Conners Adult ADHD Rating Scale:O-SV (with the investigator as observer) with adult ADHD prompts (CAARS investigator).
Time frame: 10 weeks
The scale will be analyzed by change from Baseline to Week 10.
19 secondary outcomes
Questionnaires of Clinical Global Severity of Illness (CGI-S) and Clinical Global Improvement (CGI-I).
Time frame: 10 weeks
Adult ADHD Self Report Scale (ASRS-Self) v1.1 Symptom Checklist - expanded version
Time frame: 10 weeks
Test of Variables of Attention (TOVA)
Time frame: 10 weeks
Test of Variables of Attention (TOVA)
Time frame: 10 weeks
Test of Variables of Attention (TOVA)
Time frame: 10 weeks
Test of Variables of Attention (TOVA)
Time frame: 10 weeks
Test of Variables of Attention (TOVA)
Time frame: 10 weeks
Test of Variables of Attention (TOVA)
Time frame: 10 weeks
Safety as assessed by adverse events (AEs)
Time frame: 10 weeks
Safety as assessed by body temperature measurements
Time frame: 10 weeks
Safety as assessed by Columbia Suicide Severity Rating Scale (C-SSRS)
Time frame: 10 weeks
Safety as assessed by laboratory tests; blood and urine
Time frame: 10 weeks
Safety as assessed by neurological evaluation
Time frame: 10 weeks
Safety as assessed by Electrocardiogram (ECG) test
Time frame: 10 weeks
Safety as assessed by physical examinations
Time frame: 10 weeks
Safety as assessed by discontinuations due to AEs
Time frame: 10 weeks
Safety as assessed by heart rate measurements
Time frame: 10 weeks
Safety as assessed by respiratory rate measurements
Time frame: 10 weeks
Safety as assessed by supine blood pressure
Time frame: 10 weeks
Results and safety
The study was stopped early (reason given: FDA Clinical hold). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2017.
- 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.
Jeffrey Newcorn, MD principal investigator
Icahn School of Medicine at Mount Sinai
38 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing MDX in people with Attention Deficit Hyperactivity Disorder (ADHD), run by Alcobra Ltd. at 38 sites in 2 countries.
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 14 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: stopped early, as of the sponsor's last update on 19 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 38 sites in United States, Israel. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 was stopped early (reason given: FDA Clinical hold). Results are not available in the source record.
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?
18-item total ADHD symptom score of the Conners Adult ADHD Rating Scale:O-SV (with the investigator as observer) with adult ADHD prompts (CAARS investigator). (time frame: 10 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 19 Jan 2017.