Attention Deficit Disorder With HyperactivityPhase 2NCT02808104
Mazindol Controlled Release in Adults With Attention Deficit Hyperactivity Disorder (ADHD)
A Phase 2 study testing mazindol in people with Attention Deficit Disorder With Hyperactivity, run by NLS Pharmaceutics at 7 sites in United States.
Trial summary
The purpose of this study is to determine whether a controlled release formulation of mazindol is more effective than a placebo in the treatment of Attention Hyperactivity Disorder (ADHD) in adults. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Attention Deficit Disorder With Hyperactivity
- What is being tested?
- mazindol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 7 sitesUnited States
- Study dates
- Aug 2016to 28 Mar 2017
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject has a primary diagnosis of ADHD established by a comprehensive psychiatric evaluation based on DSM-5 criteria.
- Subject is functioning at an appropriate level intellectually as judged by the investigator.
- Subject has a minimum baseline score of 28 at screen and at baseline using the ADHD-RS-DSM5
- Subject has a minimum score of 4 (moderate) on the CGI-S at screening.
- Women of child-bearing potential must be non-pregnant, non-lactating, and agree to be on an acceptable method of contraception. Acceptable methods of contraception include intrauterine devices (IUDs), hormonal contraceptives (oral, depot, patch or injectable), and double barrier methods such as condoms or diaphragms with spermicidal gel or foam.
- In good general physical health as determined by medical history, a baseline physical examination, vital signs, clinical laboratory tests and electrocardiogram (ECG) measurement.
- Subject is fluent in written and spoken English and is willing and able to sign written informed consent prior to receipt of any study medication or beginning study procedures.
- Subject is willing and able to follow instructions, comply with the protocol requirements and make all required study visits.
Who cannot join
- Any primary DSM-5 Axis I disorder other than ADHD or any comorbid DSM-5 disorder that currently requires treatment.
- Lifetime history of any DSM-5 bipolar disorder
- Treatment with medications for any psychiatric or neurologic condition (e.g., amphetamines, MPH products, antidepressants, antipsychotics, mood stabilizers, anti-epileptics) or pressor agents concurrently or within 14 days of randomization.
- Concurrent medical illness that would interfere with the conduct of the study in the opinion of the investigator.
- History of significant cardiovascular disease, structural cardiac abnormality, cardiomyopathy, heart failure, serious heart rhythm abnormalities, coronary heart disease, transient ischemic attack or stroke, or other serious cardiac problems.
- Family history of sudden cardiac death.
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- Clinically significant ECG abnormality or a QTc (Bazett correction) interval >450 msec.
- Resting sitting systolic blood pressure > 150 mm Hg or diastolic blood pressure > 90 mm Hg.
- BMI <18 or >40 kg/m2.
- Other medications that have CNS effects on cognition or attention (e.g., sedating antihistamines or decongestants).
- Positive drug screen (UDS) at screening (with the exception of current ADHD medication).
- Concomitant use of sensitive CYPA4/5 or CYP2D6 substrates with narrow therapeutic indices.
- Pregnant or lactating.
- Ongoing psychotherapeutic treatment for the treatment of ADHD begun less than three months before entry into this study.
- Recent or current DSM-5 Substance Use Disorder of moderate or greater severity (i.e., > 4 SUD symptoms), excluding nicotine.
- Suicidal ideation within past 3 months, suicidal behavior within the past year, or a C-SSRS score of 3, 4 or 5 on ideation item.
- Evidence of any out-of-range laboratory value at screening that has not been reviewed, approved and documented as not clinically significant by the Study Investigator.
- A history of significant drug allergy or systemic allergic disease (e.g., urticaria, atopic dermatitis), or any known/suspected hypersensitivity to any form of mazindol.
- Any other condition or clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening that, in the opinion of the Study Investigator, would make the subject unsuitable for the study or put them at additional risk.
- Treatment with an investigational drug within 30 days preceding the first dose of study medication.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Memorial Park Psychiatry / Bayou City Research
Houston, Texas, 77007
CNS Healthcare
Jacksonville, Florida, 32256
South Shore Psychiatric Services
Marshfield, Massachusetts, 02050
Clinical Neuroscience Solutions
Memphis, Tennessee, 38119
AVIDA Clinic
Newport Beach, California, 92660
Rochester Center for Behavorial Medicine
Rochester Hills, Michigan, 48307
Midwest Research Group / St. Charles Psychiatric Associates
Saint Charles, Missouri, 63304
About this study
Official title: A Double-Blind Placebo-Controlled Phase II Study to Determine the Efficacy, Safety, Tolerability and Pharmacokinetics of a Controlled Release (CR) Formulation of Mazindol in Adults With DSM-5 Attention Deficit Hyperactivity Disorder (ADHD)
The purpose of this study is to determine whether a controlled release formulation of mazindol is more effective than a placebo in the treatment of Attention Hyperactivity Disorder (ADHD) in adults.
Read the detailed description
This study is an outpatient, randomized, double-blind, placebo-controlled trial in which adult subjects with ADHD will be randomized to either oral mazindol controlled release or placebo once daily. Subjects will be treated with study medication or placebo for 6 weeks with visits occurring weekly to measure efficacy and any adverse events with adjustment of medication dosing as necessary.
- Being tested
- mazindol
- 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.
mazindolDrug
| Study group | Role | What they receive |
|---|---|---|
| Mazindol Controlled Release | Experimental | Mazindol controlled release taken once daily. Dosage starting at 1 mg increasing or decreasing in increments of 1 mg depending on efficacy and tolerability. Maximum dose during the study is 3 mg taken once daily. Receives: Drug: mazindol |
| Placebo | Placebo comparator | Matching placebo Receives: Drug: mazindol |
What is being measured
The primary outcome is the main question the study is designed to answer.
ADHD Rating Scale
Measured: weekly rating up to six weeks
Secondary outcomes (1)
Clinical Global Improvement Scale
Measured: weekly rating up to six weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2016 (estimated)
- Study startAug 2016
- Primary completion28 Mar 2017
- Study completion28 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit Disorder With HyperactivityStudies 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
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- NLS Pharmaceutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02808104
- Sponsor's protocol ID
- NLS-1001
- Status last verified
- Apr 2017
- First submitted
- 15 Jun 2016
- Last updated
- 6 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Wigal TL, Newcorn JH, Handal N, Wigal SB, Mulligan I, Schmith V, Konofal E. A Double-Blind, Placebo-Controlled, Phase II Study to Determine the Efficacy, Safety, Tolerability and Pharmacokinetics of a Controlled Release (CR) Formulation of Mazindol in Adults with DSM-5 Attention-Deficit/Hyperactivity Disorder (ADHD). CNS Drugs. 2018 Mar;32(3):289-301. doi: 10.1007/s40263-018-0503-y.
PubMed 29557078
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind Placebo-Controlled Phase II Study to Determine the Efficacy, Safety, Tolerability and Pharmacokinetics of a Controlled Release (CR) Formulation of Mazindol in Adults With DSM-5 Attention Deficit Hyperactivity Disorder (ADHD)
- ClinicalTrials.gov ID
- NCT02808104
- Acronym / sponsor ID
- NLS-1001
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- NLS PharmaceuticsIndustry (pharma, biotech, devices)
- Study start
- Aug 2016 (actual)
- Primary completion
- 28 Mar 2017 (actual)
- Study completion
- 28 Mar 2017 (actual)
- First posted
- 21 Jun 2016 (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 determine whether a controlled release formulation of mazindol is more effective than a placebo in the treatment of Attention Hyperactivity Disorder (ADHD) in adults.
Detailed description
This study is an outpatient, randomized, double-blind, placebo-controlled trial in which adult subjects with ADHD will be randomized to either oral mazindol controlled release or placebo once daily. Subjects will be treated with study medication or placebo for 6 weeks with visits occurring weekly to measure efficacy and any adverse events with adjustment of medication dosing as necessary.
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 |
|---|---|---|
| Mazindol Controlled Release | Experimental | Drug: mazindolMazindol controlled release taken once daily. Dosage starting at 1 mg increasing or decreasing in increments of 1 mg depending on efficacy and tolerability. Maximum dose during the study is 3 mg taken once daily. |
| Placebo | Placebo comparator | Drug: mazindolMatching placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subject has a primary diagnosis of ADHD established by a comprehensive psychiatric evaluation based on DSM-5 criteria.
- Subject is functioning at an appropriate level intellectually as judged by the investigator.
- Subject has a minimum baseline score of 28 at screen and at baseline using the ADHD-RS-DSM5
- Subject has a minimum score of 4 (moderate) on the CGI-S at screening.
- Women of child-bearing potential must be non-pregnant, non-lactating, and agree to be on an acceptable method of contraception. Acceptable methods of contraception include intrauterine devices (IUDs), hormonal contraceptives (oral, depot, patch or injectable), and double barrier methods such as condoms or diaphragms with spermicidal gel or foam.
Key exclusion criteria (20 listed)
- Any primary DSM-5 Axis I disorder other than ADHD or any comorbid DSM-5 disorder that currently requires treatment.
- Lifetime history of any DSM-5 bipolar disorder
- Treatment with medications for any psychiatric or neurologic condition (e.g., amphetamines, MPH products, antidepressants, antipsychotics, mood stabilizers, anti-epileptics) or pressor agents concurrently or within 14 days of randomization.
- Concurrent medical illness that would interfere with the conduct of the study in the opinion of the investigator.
- History of significant cardiovascular disease, structural cardiac abnormality, cardiomyopathy, heart failure, serious heart rhythm abnormalities, coronary heart disease, transient ischemic attack or stroke, or other serious cardiac problems.
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 |
|---|---|---|
| mazindol | Drug | Mazindol Controlled Release, Placebo |
Primary outcome
ADHD Rating Scale
Time frame: weekly rating up to six weeks
1 secondary outcome
Clinical Global Improvement Scale
Time frame: weekly rating up to six 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 6 Apr 2017.
- Derived from this study: PubMed 29557078Wigal TL, Newcorn JH, Handal N, Wigal SB, Mulligan I, Schmith V, Konofal E. A Double-Blind, Placebo-Controlled, Phase II Study to Determine the Efficacy, Safety, Tolerability and Pharmacokinetics of a Controlled Release (CR) Formulation of Mazindol in Adults with DSM-5 Attention-Deficit/Hyperactivity Disorder (ADHD). CNS Drugs. 2018 Mar;32(3):289-301. doi: 10.1007/s40263-018-0503-y.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
7 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 mazindol in people with Attention Deficit Disorder With Hyperactivity, run by NLS Pharmaceutics at 7 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 8 inclusion and 20 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 6 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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?
ADHD Rating Scale (time frame: weekly rating up to six weeks). 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 NCT02808104, 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 6 Apr 2017.