Authorised Therapeutic confirmatory (Phase III) Generalized Anxiety Disorder (GAD)

A Phase 3, Double-blind, Placebo-controlled Study (Part A) with an Open-label Extension (Part B) Evaluating MM120 Compared to Placebo in Generalized Anxiety Disorder – Panorama

EU CTIS ID: 2024-513572-17-00

What this study is testing

Double-blind Period (Part A): To evaluate the efficacy of a single dose of 100 μg MM120 versus placebo on anxiety symptoms in adults with GAD

Therapeutic confirmatory (Phase III)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

1. Participant must be between 18 and 74 years of age inclusive, at the time of signing the informed consent.
10. Participant must have an adult support person/caregiver able to monitor them throughout the study, accompany them to and from visits where study drug is administered, and agree to be in personal contact with participant at least 3 days a week. This support person must be available throughout the clinical trial.
2. Diagnosis of DSM-5 GAD based upon clinical assessment and confirmed by the Mini-International Neuropsychiatric Interview (MINI).
3. HAM-A Total Score ≥20 at Screening (Visit 1) and Baseline (Visit 2).
4. MADRS Items 1, 7, and 8 are ≤3 at Screening (Visit 1) and Baseline (Visit 2). Note: participant must not currently meet criteria for a major depressive episode.
5. Participant meets independent assessment for eligibility.

You likely can't join if

1. A psychiatric disorder, other than GAD, that was the primary focus of treatment as defined by the DSM-5 and assessed by the MINI within 6 months before Screening.
10. Significant loss of hearing or vision that, in the opinion of the Investigator, may confound the results of the study or interfere with the ability of the site staff to provide adequate oversight of the participant during the study.
11. Major trauma or surgery in the 3 months prior to randomization, or has any surgery scheduled to occur during the study that would require an overnight hospital stay.
12. Positive for hepatitis B surface antigen (HBsAg) or anti-hepatitis C virus (HCV) antibodies at Screening, or are receiving treatment for Hepatitis B or C. Note: positive test results for participants who have previously recovered from or have been vaccinated for hepatitis are not exclusionary if participant is asymptomatic.
13. Unstable human immunodeficiency virus (HIV) infection. Note: To be eligible, antiviral medication must be stable for 3 months prior to Screening and viral load undetectable at most recent check-up, within 6 months.
14. History of malignancy or treatment of malignancy within 2 years prior to Screening, excluding resected basal cell or squamous cell carcinoma of the skin or carcinoma in situ (CIS) of the cervix that has been resolved without further treatment.

See the full eligibility criteria

Who can join

1. Participant must be between 18 and 74 years of age inclusive, at the time of signing the informed consent.
10. Participant must have an adult support person/caregiver able to monitor them throughout the study, accompany them to and from visits where study drug is administered, and agree to be in personal contact with participant at least 3 days a week. This support person must be available throughout the clinical trial.
2. Diagnosis of DSM-5 GAD based upon clinical assessment and confirmed by the Mini-International Neuropsychiatric Interview (MINI).
3. HAM-A Total Score ≥20 at Screening (Visit 1) and Baseline (Visit 2).
4. MADRS Items 1, 7, and 8 are ≤3 at Screening (Visit 1) and Baseline (Visit 2). Note: participant must not currently meet criteria for a major depressive episode.
5. Participant meets independent assessment for eligibility.
6. Body mass index (BMI) within the range ≥18 to ≤38 kg/m2 (inclusive) at Screening (Visit 1).
7. Male or female: Willingness to use medically acceptable forms of contraception, when applicable, for the duration of their participation.
8. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the protocol.
9. Must be in acceptable overall medical condition to participate in the study.

What rules you out

1. A psychiatric disorder, other than GAD, that was the primary focus of treatment as defined by the DSM-5 and assessed by the MINI within 6 months before Screening.
10. Significant loss of hearing or vision that, in the opinion of the Investigator, may confound the results of the study or interfere with the ability of the site staff to provide adequate oversight of the participant during the study.
11. Major trauma or surgery in the 3 months prior to randomization, or has any surgery scheduled to occur during the study that would require an overnight hospital stay.
12. Positive for hepatitis B surface antigen (HBsAg) or anti-hepatitis C virus (HCV) antibodies at Screening, or are receiving treatment for Hepatitis B or C. Note: positive test results for participants who have previously recovered from or have been vaccinated for hepatitis are not exclusionary if participant is asymptomatic.
13. Unstable human immunodeficiency virus (HIV) infection. Note: To be eligible, antiviral medication must be stable for 3 months prior to Screening and viral load undetectable at most recent check-up, within 6 months.
14. History of malignancy or treatment of malignancy within 2 years prior to Screening, excluding resected basal cell or squamous cell carcinoma of the skin or carcinoma in situ (CIS) of the cervix that has been resolved without further treatment.
15. Any of the following cardiovascular conditions: a. History of clinically significant arrhythmia (eg, long QT syndrome); valvular heart disease; pulmonary hypertension; treatment or hospitalization for a major cardiovascular event (eg, myocardial infarction, heart failure, stroke) within 1 year prior to Screening (Visit 1). b. Family history of significant arrhythmia or a first-degree relative with sudden, unexplained death under 40 years of age; history of unexplained syncopal episodes; uncontrolled hypokalemia or hypomagnesemia. c. Uncontrolled hypertension as determined by the Investigator, or blood pressure at the Screening visit above 140 mmHg systolic or 90 mmHg diastolic after approximately 5 minutes of rest. NOTE: This population may experience anxiety in medical settings. If the first measurement of a participant’s blood pressure is outside the allowable range, 2 additional recordings are allowed each after an additional approximately 5 minutes rest. d. Any abnormal ECG findings as determined by the central reader and confirmed as clinically significant by the Investigator in consultation with the contract research organization (CRO)’s Medical Monitor.
16. One or more laboratory values outside the normal range at Screening (that are considered by the Investigator to be clinically significant). Has any of the following values at Screening or Baseline: a. Serum creatinine value >1.5 x the upper limits of normal (ULN), b. Serum total bilirubin value >1.5 x ULN, c. Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) value >2 x ULN.
17. Has risk of (CCI) based upon medical history or has active (CCI) from 6 months prior to Screening and up to Randomization, as defined by a “Yes” response to (CCI).
18. Has either (CCI) or been hospitalized due to (CCI) within 5 years prior to Screening and up to Randomization as defined by medical history of (CCI) or a “Yes” response in the following (CCI).
19. Treatment with deep brain stimulation (DBS), vagus nerve stimulation (VNS), electroconvulsive therapy (ECT), or transcranial magnetic stimulation (TMS) within 6 months prior to Screening or plan to receive treatment with any of these from the time of providing informed consent through End of Study (EOS).
2. First-degree relative with or personal lifetime history of a psychotic disorder (eg, schizophrenia, schizoaffective disorder, etc) or bipolar disorder based on the MINI and/or the psychiatric evaluation.
20. History of ketamine/esketamine use within the past (CCI) before Screening (including as part of a clinical study); or use of ketamine for treatment of an excluded condition.
21. Initiated systematic psychotherapy within 4 weeks prior to Screening (Visit 1) or plans to initiate such therapy during the double-blind treatment period.
22. Unwillingness or inability to discontinue prohibited concomitant medications, supplements, or other therapeutics (prescription or over-the-counter) including (CCI). Note: See Section 9.8 of the protocol for details of prohibited concomitant medications, supplements and other therapeutics, and allowable conditions of use. Participants may not discontinue standard of care medication if the purpose of the change is solely to enroll in the study and not medically indicated.
23. (CCI) use of psychedelics, including use as part of a clinical study.
24. Any chronic medication that is not expected to remain stable throughout at least the end of the double-blind period or has not been stable for at least 4 weeks prior to Screening. Note: Adjustments to chronic medication may be allowed on a case-by-case basis during the OLE.
25. Previous or current participation in any MM120 study.
26. Previous participation in any clinical study for an investigational drug, device, or therapy within 6 months of Screening and throughout the duration of this study.
27. Positive urine drug screen (UDS) for substances of abuse at Screening, Baseline, or Randomization. Note: Participants with a positive urine drug screen for cannabis or benzodiazepines or other prescribed medications at Screening may be eligible if they discontinue use and washout during the Screening period, if applicable.
28. Women who are currently pregnant or breastfeeding or plan to become pregnant during the study.
29. Participants who plan to donate sperm or eggs during the study, or who plan to donate sperm within 90 days or eggs within 30 days, respectively, after their last MM120 dose..
3. Personal lifetime history of bipolar disorder I or II, post-traumatic stress disorder, or a personality disorder, based on the MINI and/or the psychiatric evaluation.
4. Current psychiatric disorder that, in the opinion of the Investigator, is symptomatic in a manner that may confound the results of the study (eg, MDD, obsessive-compulsive disorder, dysthymic disorder, panic disorder, dissociative disorder, anorexia nervosa, or bulimia nervosa).
5. Lifetime diagnosis of substance use disorder (excluding nicotine and caffeine), current diagnosis of alcohol use disorder, or treatment for alcohol or substance use disorder within (CCI) prior to Screening (Visit 1) as assessed by the MINI.
6. Current diagnosis or history of neurological disorders including seizures (except febrile resolved before age 5): neurodevelopmental disorders (eg, autism spectrum disorder [ASD]), neurodegenerative disorders; movement disorders, traumatic brain injury (long-term impairment, currently symptomatic or in treatment), or any central nervous system (CNS) vascular disorders (eg, cerebral ischemia, aneurysm, or arteriovenous malformation)..
7. Any clinically significant unstable illness. For example, hepatic impairment, renal insufficiency, gastrointestinal, cardiovascular, pulmonary, musculoskeletal, immunologic, endocrine, or metabolic disease that, in the opinion of the Investigator, may pose a risk to participation or confound the results of the study.
8. Current clinically significant untreated sleep disorder that, in the opinion of the Investigator, may confound the results of the study (eg, obstructive sleep apnea, narcolepsy).
9. Undiagnosed, untreated, or poorly controlled diabetes, defined as: glycosylated hemoglobin (HbA1C) ≥7% at Screening (Visit 1), without prior intervention. Note: participants with known stable diabetes with HbA1C ≥7% may be eligible if deemed not clinically significant by the Investigator.

The study team makes the final eligibility decision.

Where it's taking place

United States
United Kingdom

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include United States; United Kingdom. Enter your location above to see the nearest site and check your eligibility.

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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.