Safety and efficacy of low dose MM-120 in ADHD
- Conditions
- Attention-Deficit/Hyperactivity DisorderTherapeutic area: Psychiatry and Psychology [F] - Behaviours [F01]
- Registration Number
- EUCTR2020-001098-55-NL
- Lead Sponsor
- Mind Medicine, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 52
1. Ability and willingness to provide written, informed consent prior to initiation of any study-related procedures and to adhere to all study requirements.
NOTE: The subject (i.e., not a legally authorized representative) must be cognitively able to understand the requirements of the study and provide the informed consent
2. Age = 18 and = 65 years at Screening.
3. Subjects with the diagnosis of Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) ADHD, as determined by clinical evaluation and confirmed by structured interview (MINI).
4. AISRS total score of = 26 at screening.
5. CGI-S score of = 4 at screening.
6. Must be willing to receive IMP dose twice weekly. On day 1, the subject will come to the site clinic and must be willing to take a taxi or public transportation home or be accompanied by a caregiver and not drive a car, use heavy equipment, or participate in any other dangerous activity for the remainder of the day after receiving IMP
(NOTE: at any protocol visit after Day 1 dosing, dosing visits may occur at the subject’s home at the discretion of the PI, conducted by one of the study investigators or delegate and administered under supervision followed by the performance of the same procedures done at the clinic including safety monitoring. If early withdrawal is considered due to any safety issue identified, the Sponsor’s medical monitor should be notified. If a remote visit is conducted due to any reason related to the COVID-19 pandemic, notification must be sent to the Medical Monitor’s dedicated email address and Urgent Safety Measures as outlined in this protocol must be followed.)
7. Must be willing to refrain from more than 6 standard alcoholic drinks per week (1 standard drink corresponds to 0.1 L wine, 0.3 L beer, or 4 cL liquor), more than 10 cigarettes a day, and more than 2 cups of coffee a day throughout the study treatment period (6 weeks) and until the last study visit is complete (EoS or ET).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 52
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1. Past or present diagnosis of a primary psychotic disorder or first degree relative with a psychotic disorder.
2. Past or present bipolar disorder (DSM-5).
3. Other current psychiatric disorders that, in the opinion of the Investigator or medical supervisor, may confound the results of the study (e.g., obsessive-compulsive disorder, dysthymic disorder, panic disorder, dissociative disorder, anorexia nervosa or bulimia nervosa)
4. Subjects with past (> 1 month prior to the screening visit) or present history of substance use disorder (except nicotine, provided subject does not smoke more than 10 cigarettes a day).
5. Somatic disorders including Central Nervous System (CNS) involvement of cancer, severe cardiovascular disease, untreated hypertension, severe liver disease (liver enzyme increase by more than 3x the upper limit of normal except unconjugated hyperbilirubinemia due to Gilbert’s Disease, per Investigator), severely impaired renal function (estimated creatinine clearance < 50 mL/min by CKD-EPI formula), or anything else that, in the judgment of the Investigator or medical supervisor, poses too great a potential for side effects.
6. Any lifetime history of suicide attempt; or recent (within 6 months prior to the screening visit) active suicidal thoughts or ideation (defined as a suicidal ideation score of 2 or greater in the Columbia-Suicide Severity Rating Scale [C-SSRS]); or endorsement of any suicidal behavior on the C-SSRS within the past 6 months prior to the screening visit.
7. Likely to require psychiatric hospitalization during the course of the study.
8. Once consent is signed, subject not willing or safely able to stop any prescription or non-prescription ADHD medications during screening and prior to the baseline visit through final study visit, EoS or ET. A list of prohibited medications is provided in Appendix 1.
9. Plan to start, stop, or alter the use of any medications, supplements, or other therapeutics from Baseline until the EoS or ET (see Appendix 1 for list of prohibited medications).
10. Plan to start, stop or alter the use of psychotherapy, massage, meditation, acupuncture, hypnosis, yoga, or other similar therapy/activity from the time of providing informed consent until EoS or ET.
11. Use of potent CYP2D6 inhibitors; moderate CYP2D6 inhibitors by Investigator discretion (see Appendix 3).
12. Likely to need any psychiatric medications with the potential to confound interpretation of study results or impact safety, at the discretion of the Investigator, in the 10 weeks following Baseline up to EoS or ET.
13. Use of investigational medication/treatment in the past 30 days prior to the screening visit.
14. Subjects with a positive urine drug screen (with the exception of THC or metabolites) at Screening OR Baseline.
15. Clinically significant abnormal baseline laboratory, VSs, and ECG values which include the following:
o Have evidence of clinically significant hepatic disorder (e.g., alanine aminotransferase [ALT] or aspartate aminotransferase [AST] >3X ULN (except for Gilbert’s disease).
o Any clinically significant abnormal metabolic or hematologic screen, per Investigator or medical supervisor decision.
o Exclusionary blood pressure: > 140 mm Hg (systolic) or > 90 mm Hg (diastolic); heart rate <45 beats/minute or >90 beats/minute after an approximately 5-minute supine or semi-supine rest.
NOTE: If the first measurement of a subject’s heart rate is >90 beats/minute, a second recording is allowed after a
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method