A Phase 2 interventional study of Ecopipam and Placebo in Childhood-Onset Fluency Disorder (Stuttering), sponsored by Emalex Biosciences Inc.. Completed at 9 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-23.
Sponsored by Emalex Biosciences Inc. · Phase 2, Interventional, and Treatment
This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group, Phase 2 exploratory study in adult subjects with childhood onset fluency disorder.
At the Baseline visit, eligible subjects will be randomized 1:1 to receive either a target steady-state dose of ecopipam HCl \~2 mg/kg/day or matching placebo for a 12-week Treatment Period consisting of a 4-week Titration Phase followed by an 8-week Maintenance Phase.
Subjects will return to the clinic at 4, 8, and 12 weeks after Randomization and Follow-up visits 7 and 14 days after completing the Treatment Period or Early Discontinuation. Efficacy assessments will be conducted at Weeks 4, 8, and 12 and safety assessments will be conducted at all visits. Subjects will have adverse events and other safety parameters assessed by phone or video conference at Weeks 2, 6 and 10 and 30 days after the last study drug administration. Signs or symptoms of withdrawal, abuse, and dependence will be monitored throughout the study.
At the end of the Treatment Period or Early Discontinuation, subjects will taper study drug by 25 mg/day until off study drug, for up to 1 week.
74 studies on the registry are indexed under Stuttering; 23 are open to participants now.
This study's enrollment of 68 is above the median of 44 across 57 interventional studies indexed under Stuttering.
Browse Stuttering studies →Emalex Biosciences Inc. is the lead sponsor of 17 studies on the registry; none are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 5 (42%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ecopipam HCl tablets of 12.5, 50, and 75 mg for daily, oral administration for 12 weeks
Drug: Ecopipam
Matching placebo tablets for daily, oral administration for 12 weeks
Drug: Placebo
Oral tablet
Oral tablet
Stuttering Severity Instrument, 4th Edition (SSI-4)
The SSI-4 is a reliable and valid norm-referenced stuttering assessment that can be used for both clinical and research purposes. It takes 15-20 minutes to complete. It measures stuttering severity in both children and adults in the 4 areas of speech behavior:1. frequency 2. duration 3. physical concomitants 4. naturalness of the individual's speech. Frequency is expressed in percent of syllables stuttered and is converted to scale scores of 2-18. Duration is timed to the nearest one tenth of a second and is converted to scale scores of 2-18. The 4 types of physical concomitants are converted to scale scores of 0-56.
Time frame: 12 weeks
Clinical Global Impression - Severity (CGI-S) Baseline to Week 12
The CGI consists of two reliable and valid 7-item Likert scales used to assess severity and change in clinical symptoms. The severity scale (CGI-S) ranges from 1 (Normal, not ill) to 7 (extremely ill). Pediatric and adult versions of the CGI-TS-S and CGI-TS-I scales are available and will be administered according to the age of the subject at the time of Informed Consent. The efforts of peers, teachers and parents to assist, accommodate, or support the subject should be considered in overall severity in the case of pediatric subjects.
Time frame: Baseline, Week 4, Week 8 and 12 weeks
Change From Baseline Subjective Screening of Stuttering (SSS)
The Subjective Screening of Stuttering (SSS) research edition is designed to quantify the selected self-reports of people who stutter prior to, during, and following their treatment. The three areas screened by the SSS are perceived stuttering severity (range 3-27), the locus of control subtest (range 6-54), and reported word or situation avoidance (range 6-54). Each of the areas has two or three items rated for three audiences on a 1 to 9, equal appearing scale in which 1 represents "normal" or target level and 9 is the most severe. The total score has a range of 15-135. Higher scores indicate greater severity.
Time frame: From baseline (enrollment) to Week 12.
Nine study centers located in the USA participated. The first participant screened 22-Oct-2020 and the last participant completed 2022-04-Apr.
| Milestone | Ecopipam HCl ~2mg/kg/Day | Matching Placebo |
|---|---|---|
| Started | 35 | 33 |
| Completed | 22 | 29 |
| Not completed | 13 | 4 |
| Withdrew: Withdrawal by subject | 6 | 1 |
| Withdrew: Lack of efficacy | 1 | 0 |
| Withdrew: Adverse event | 3 | 2 |
| Withdrew: Lost to follow-up | 1 | 1 |
| Withdrew: Pi decision to discontinue | 1 | 0 |
| Withdrew: Subject did not complete 12 weeks of study drug | 1 | 0 |
The SSI-4 is a reliable and valid norm-referenced stuttering assessment that can be used for both clinical and research purposes. It takes 15-20 minutes to complete. It measures stuttering severity in both children and adults in the 4 areas of speech behavior:1. frequency 2. duration 3. physical concomitants 4. naturalness of the individual's speech. Frequency is expressed in percent of syllables stuttered and is converted to scale scores of 2-18. Duration is timed to the nearest one tenth of a second and is converted to scale scores of 2-18. The 4 types of physical concomitants are converted to scale scores of 0-56.
| units on a scale | Ecopipam HCl ~2mg/kg/Day | Matching Placebo |
|---|---|---|
| Stuttering Severity Instrument, 4th Edition (SSI-4) | -1.5 ± 5.8 | -1.8 ± 3.04 |
The CGI consists of two reliable and valid 7-item Likert scales used to assess severity and change in clinical symptoms. The severity scale (CGI-S) ranges from 1 (Normal, not ill) to 7 (extremely ill). Pediatric and adult versions of the CGI-TS-S and CGI-TS-I scales are available and will be administered according to the age of the subject at the time of Informed Consent. The efforts of peers, teachers and parents to assist, accommodate, or support the subject should be considered in overall severity in the case of pediatric subjects.
| units on a scale | Ecopipam | Matching Placebo |
|---|---|---|
| Clinical Global Impression - Severity (CGI-S) Baseline to Week 12 | -0.8 ± 1.13 | -0.3 ± 0.70 |
The Subjective Screening of Stuttering (SSS) research edition is designed to quantify the selected self-reports of people who stutter prior to, during, and following their treatment. The three areas screened by the SSS are perceived stuttering severity (range 3-27), the locus of control subtest (range 6-54), and reported word or situation avoidance (range 6-54). Each of the areas has two or three items rated for three audiences on a 1 to 9, equal appearing scale in which 1 represents "normal" or target level and 9 is the most severe. The total score has a range of 15-135. Higher scores indicate greater severity.
| score on a scale | Ecopipam HCl ~2mg/kg/Day | Matching Placebo |
|---|---|---|
| Change From Baseline Subjective Screening of Stuttering (SSS) | -25.4 ± 27.46 | -18.6 ± 24.83 |
Collected over Adverse event (AE) data was collected from the time of signed informed consent to 30 days after last administration of study drug. Treatment-related AEs were collected from the time of first dose to 30 days after last administration of study drug.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Ecopipam HCl ~2mg/kg/Day | 0/34 (0%) | 0/34 (0%) | 23/34 (67.6%) |
| Matching Placebo | 0/33 (0%) | 0/33 (0%) | 8/33 (24.2%) |
| Event | Ecopipam HCl ~2mg/kg/Day | Matching Placebo |
|---|---|---|
| SomnolenceNervous system disorders | 8/34 | 1/33 |
| HypertensionVascular disorders | 0/34 | 3/33 |
| SedationNervous system disorders | 3/34 | 0/33 |
| FatigueGeneral disorders | 3/34 | 1/33 |
| HeadacheNervous system disorders | 1/34 | 2/33 |
| DizzinessNervous system disorders | 2/34 | 0/33 |
| Abnormal dreamsPsychiatric disorders | 2/34 | 1/33 |
| InsomniaPsychiatric disorders | 2/34 | 0/33 |
| COVID-19Infections and infestations | 2/34 | 0/33 |
1 Subject randomized to ecopipam took zero (0) study drug.
| Age, Categorical(Participants) | Ecopipam HCl ~2mg/kg/Day | Matching Placebo | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 34 | 33 | 67 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Ecopipam HCl ~2mg/kg/Day | Matching Placebo | Total |
|---|---|---|---|
| Mean | 33.5 ± 10.15 | 31.1 ± 9.74 | 32.3 ± 9.95 |
| Sex: Female, Male(Participants) | Ecopipam HCl ~2mg/kg/Day | Matching Placebo | Total |
|---|---|---|---|
| Female | 3 | 4 | 7 |
| Male | 31 | 29 | 60 |
| Race (NIH/OMB)(Participants) | Ecopipam HCl ~2mg/kg/Day | Matching Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 3 | 5 | 8 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 7 | 7 | 14 |
| White | 24 | 17 | 41 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 4 | 4 |
| Ethnicity (NIH/OMB)(Participants) | Ecopipam HCl ~2mg/kg/Day | Matching Placebo | Total |
|---|---|---|---|
| Hispanic or Latino | 2 | 9 | 11 |
| Not Hispanic or Latino | 30 | 24 | 54 |
| Unknown or Not Reported | 2 | 0 | 2 |
| Region of Enrollment(Participants) | Ecopipam HCl ~2mg/kg/Day | Matching Placebo | Total |
|---|---|---|---|
| United States | 34 | 33 | 67 |
| Stuttering Severity Instrument 4th Edition (SSI-4)(units on a scale) | Ecopipam HCl ~2mg/kg/Day | Matching Placebo | Total |
|---|---|---|---|
| Mean | 37.6 ± 6.49 | 36.4 ± 6.49 | 37 ± 6.47 |
| Subjective Screening of Stuttering (SSS)(units on a scale) | Ecopipam HCl ~2mg/kg/Day | Matching Placebo | Total |
|---|---|---|---|
| Mean | 84.4 ± 22.88 | 89.1 ± 23.79 | 86.7 ± 23.28 |
1 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
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Studies of the drug tested here: Ecopipam
Emalex Biosciences Inc.