Mazindol Controlled Release in Adults With Attention Deficit Hyperactivity Disorder (ADHD)

NCT02808104 | Completed Phase 2

• 1 other identifier: NLS-1001
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 7

Brief 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.

Conditions

Attention Deficit Disorder With Hyperactivity

Outcome Measures

Primary Outcomes (1)

• ADHD Rating Scale

  weekly rating up to six weeks

Secondary Outcomes (1)

• Clinical Global Improvement Scale

  weekly rating up to six weeks

Study Arms (2)

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.

Drug: mazindol

Placebo

PLACEBO COMPARATOR

Matching placebo

Drug: mazindol

Interventions

mazindol DRUG

Mazindol Controlled Release; Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• NLS Pharmaceutics: lead

Study Sites (7)

AVIDA Clinic

Newport Beach, California, 92660, United States

Location

CNS Healthcare

Jacksonville, Florida, 32256, United States

Location

South Shore Psychiatric Services

Marshfield, Massachusetts, 02050, United States

Location

Rochester Center for Behavorial Medicine

Rochester Hills, Michigan, 48307, United States

Location

Midwest Research Group / St. Charles Psychiatric Associates

Saint Charles, Missouri, 63304, United States

Location

Clinical Neuroscience Solutions

Memphis, Tennessee, 38119, United States

Location

Memorial Park Psychiatry / Bayou City Research

Houston, Texas, 77007, United States

Location

Related Publications (1)

• 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.

  PMID: 29557078 DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Mazindol

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2016
• First Posted: June 21, 2016
• Study Start: August 1, 2016
• Primary Completion: March 28, 2017
• Study Completion: March 28, 2017
• Last Updated: April 6, 2017

Record last verified: 2017-04

Locations

US (7)