Safety and Tolerability Study of Metadoxine Extended Release (MDX) (Previously Known as MG01CI) i… (NCT02189772) | Clinical Trial Compass
CompletedPhase 2
Safety and Tolerability Study of Metadoxine Extended Release (MDX) (Previously Known as MG01CI) in PI-ADHD Adolescent Subjects
Israel83 participantsStarted 2014-08
Plain-language summary
The purpose of this study is to evaluate the safety and tolerability of a single administration of Metadoxine Extended Release (MDX) formulation for the treatment of adolescents diagnosed with ADHD that have predominantly inattentive symptoms. The study will also try to evaluate the efficacy of MDX and its level in the blood.
Who can participate
Age range13 Years – 17 Years
SexALL
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Inclusion criteria
✓. Adolescent males and females, 13-17 years old, inclusive, at screening visit, with visible axillary hair.
✓. Diagnosed with predominantly inattentive ADHD based on DSM V criteria for ADHD as assessed by the Adolescent ADHD Clinician Diagnostic Scale (Adol-CDS V1.2).
✓. Clinical severity of at least a moderate level (Clinical Global Impression-Severity score of 4 or above).
✓. STAI State score of \<52, STAI Trait score of \<52 and BDI score of \<19.
✓. Sexually active subjects of childbearing potential must agree to use an effective contraceptive throughout the study (e.g., oral contraceptives or Norplant®; a reliable double barrier method of birth control \[diaphragms with contraceptive jelly; cervical caps with contraceptive jelly; condoms with contraceptive foam\]; intrauterine devices; vasectomy; or abstinence) and for at least a month after the study, and must have a negative serum pregnancy test at the Screening Visit. Females of childbearing potential are defined as women who are between menarche and 2 years post-menopause and who are not surgically sterilized. Males and Female subjects who are not sexually active, and who agree to be abstinent throughout the study, will not be required to use birth control.
✓. Subject is able to attend the clinic regularly and reliably.
✓. Subject is able to swallow tablets and capsules.
✓. Able to understand, read, write and speak Hebrew fluently to complete study related materials.
Exclusion criteria
✕. Subject has any psychiatric condition (e.g., schizophrenia or personality disorder as diagnosed by DSM-V) or clinically significant or unstable medical or surgical condition that may preclude safe and complete study participation as determined by the investigator using medical history, physical examination, neurological examination, laboratory tests, and electrocardiograms. Common diseases such as mild hypertension, well-controlled type 2 diabetes mellitus (hemoglobin A1C \<6.5%), etc, are allowed per the investigator's judgment as long as they are stable and controlled by medical therapy that is constant for at least 8 weeks before randomization and subsequently throughout the study. If there are any concerns about the suitability of the subject's medical or surgical condition, the investigator should review the subject's history with the medical monitor.
✕. Subject has a known or suspected human immune deficiency virus positive status or has diseases such as acquired immunodeficiency disorder, hepatitis C, hepatitis B, or tuberculosis.
✕. Subject has a history of an allergy or sensitivity to B-complex vitamins.
✕. Subject has a history of intellectual disability or a history or suspicion of autism spectrum disorder.
✕. Subject has a current clinically significant Axis I diagnosis (other than ADHD) according to the K-SADS-PL or has a lifetime history of bipolar disorder or psychosis.
✕. Subject has used mega-dose vitamin B6/pyridoxine during the 28 days before the Randomization Visit. Subjects will be allowed to have a 28-day washout of mega-dose vitamin B6/pyridoxine after the Screening visit. Routine multivitamin supplements will be allowed.
✕. Subject has used high-dose supplements of omega-3 fatty acids ≥ 500 mg on at least 1 day (such as softgels, capsules, or fish oils; regular daily dietary consumption of fish is allowed) or folic acid supplements (other than routine multivitamin supplements) during the 2 weeks before the Randomization Visit.
✕. Subject has used an investigational medication/treatment in the 30 days before the Screening Visit