- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05583955
A 10-week Efficacy Study of NOE-105 in Childhood Onset Fluency Disorder (Orpheus)
March 12, 2024 updated by: Noema Pharma AG
A Double-blind, Placebo-controlled, Phase IIb, Multi-center, Ten-week Prospective Study to Evaluate the Efficacy and Safety of NOE-105 in Adult Male Patients With Childhood Onset Fluency Disorder (Orpheus)
This study is designed to evaluate the effectiveness of NOE-105 on speech fluency without the known antipsychotic-induced side effects of commonly used treatments for childhood onset fluency disorder (COFD).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
NOE-105 is an investigational selective PDE10A inhibitor with a potential therapeutic effect for the treatment of COFD.
In this study adult male patients may be randomized to a double-blind, placebo-controlled, parallel group treatment with NOE-105 or placebo once daily.
The study is designed to find the maximum tolerated dose of NOE-105 and thereafter, to maintain the participants at this dose until they have completed a total of 10 weeks treatment period.
Following up to 10 weeks of treatment, participants will visit the study site for a follow-up visit within 28 (± 7) days of the date of the last dose of study treatment.
Study Type
Interventional
Enrollment (Actual)
75
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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New South Wales
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Brookvale, New South Wales, Australia, 2100
- Noema Investigator site
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Miranda, New South Wales, Australia, 2228
- Noema Investigator site
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Sydney, New South Wales, Australia, 2109
- Noema Investigator site
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California
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Bellflower, California, United States, 90706
- Noema Investigator site
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Florida
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Jacksonville, Florida, United States, 32256
- Noema Investigator site
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Orlando, Florida, United States, 32801
- Noema Investigator site
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Kansas
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Overland Park, Kansas, United States, 66210
- Noema Investigator site
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New Jersey
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Berlin, New Jersey, United States, 08009
- Noema Investigator site
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Tennessee
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Memphis, Tennessee, United States, 38119
- Noema Investigator site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Patients must be 18 to 55 years of age inclusive, at the time of signing the informed consent.
- Patients who satisfy DSM-5 criteria for childhood onset fluency disorder and are suitable for pharmacotherapy.
- Have a history of stuttering for more than or equal to ≥ 2 years with onset consistent to developmental in nature before age 8 years.
- Patient reported global stuttering experience as "moderate" at screening and baseline.
- Patients must discontinue all medications used to treat stuttering for at least 14 days prior to receiving study treatment. With the exception of antipsychotic therapies (see exclusion criterion #11), other psychotropic drugs will be allowed provided they have been stable for at least 14 days prior to receiving study treatment and are expected to remain stable for the duration of the study.
- BMI within the range 19 to 35 kg/m2 (inclusive).
Male Contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
Male patients must use a condom during the treatment period and until the end of relevant systemic exposure in the male participant, plus a further 90-day period. In addition, for a non-pregnant WOCBP partner.
- Capable of giving signed informed consent
- Able to read and write in English
Exclusion Criteria:
- Stuttering is related to a known neurological cause eg, stroke, etc.
- Low IQ in the opinion of the investigator.
- Patients with uncontrolled seizure disorders.
- A history of severe traumatic brain injury or stroke.
- Patients who are, in the investigator's opinion, at imminent risk of suicide.
- Known to have tested positive for human immunodeficiency virus.
- Known DSM-5 diagnosis of substance abuse or dependence.
- Unstable medical illness or clinically significant abnormalities on screening tests/exams.
- Any unstable medical conditions or are currently ill (eg, congenital heart disease, arrhythmia or cancer), which, in the investigator's judgment, will put them at a risk of major adverse event during this trial, are expected to progress during the study, or will interfere with safety and efficacy assessments.
- Initiation of new behavioral therapies for stuttering within 10 weeks prior to baseline.
- Use of antipsychotic drug therapy within 14 days prior to receiving treatment until the EoT visit.
- Participation in another clinical study with an IP administered in the last 30 days.
- Participants with a known hypersensitivity to NOE-105 or any of the excipients of the product.
- Patient must not intend to use cannabinoids, cocaine, or nonprescribed opiates.
- Involvement in the planning and/or conduct of the study (applies to both Noema staff and/or staff at the study site).
- Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions, and requirements.
- Previous randomization in the present study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Active
Escalating doses of NOE-105 capsules
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Escalating dose levels of NOE-105 will be given and maximum tolerated dose will be maintained
Other Names:
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Placebo Comparator: Placebo
Escalating doses of matching placebo
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Escalating dose levels of matching Placebo will be given
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline to end point in severity subset of the MLGSSS
Time Frame: Up to 71 days
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MLGSSS refers to Maguire-Leal-Garibaldi Self-rated Stuttering Scale
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Up to 71 days
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Number of participants with adverse events
Time Frame: Up to 71 days
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An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment
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Up to 71 days
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Severity of the adverse events
Time Frame: Up to 71 days
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Adverse events will be categorized as mild, moderate or severe by the investigator
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Up to 71 days
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Change in the hematological parameters
Time Frame: Up to 71 days
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Platelet count, RBC count, Hemoglobin, hematocrit and differential WBC count will be assessed
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Up to 71 days
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Change in clinical chemistry
Time Frame: Up to 71 days
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Urea, creatinine, potassium, SGOT, SGPT, glucose, sodium chloride, magnesium, phosphates, calcium, total and conjugated bilirubin, GGT, total protein albumin, phosphokinase, and plasma prolactin will be assessed
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Up to 71 days
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Change in the vital signs
Time Frame: Up to 71 days
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Temperature, weight, height, pulse rate and blood pressure will be assessed.
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Up to 71 days
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline to end point in SDS
Time Frame: Up to 71 days
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SDS refers to Sheehan disability scale
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Up to 71 days
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PGI-S rating at end point
Time Frame: Up to 71 days
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PGI-S refers to patient global impression of severity
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Up to 71 days
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CGI-C rating at end point
Time Frame: Up to 71 days
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Clinician global impression of change
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Up to 71 days
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Rating of the medication satisfaction questionnaire at end point
Time Frame: Up to 71 days
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To evaluate the patient's satisfaction in treatment with NOE-105
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Up to 71 days
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Change from baseline to end point in clinician-rated stuttering severity instrument-4
Time Frame: Up to 71 days
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To evaluate the effect of NOE-105 on the change in stuttering severity
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Up to 71 days
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PGI-C rating at end point
Time Frame: Up to 71 days
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PGI-C refers to patient global impression of change
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Up to 71 days
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Change in mood as rated by the patient through change from baseline to end point in Quick inventory of depressive symptomology (QIDS-16)
Time Frame: Up to 71 days
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Up to 71 days
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Gerald A Maguire, M.D., Clinical Innovations, Inc. dba CITrails (a CenExel company)
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 25, 2022
Primary Completion (Actual)
October 20, 2023
Study Completion (Actual)
November 24, 2023
Study Registration Dates
First Submitted
June 16, 2022
First Submitted That Met QC Criteria
October 13, 2022
First Posted (Actual)
October 18, 2022
Study Record Updates
Last Update Posted (Actual)
March 13, 2024
Last Update Submitted That Met QC Criteria
March 12, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NOE-CFD-201
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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