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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05583955




Registration number
NCT05583955
Ethics application status
Date submitted
16/06/2022
Date registered
18/10/2022

Titles & IDs
Public title
A 10-week Efficacy Study of NOE-105 in Childhood Onset Fluency Disorder (Orpheus)
Scientific title
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)
Secondary ID [1] 0 0
NOE-CFD-201
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Childhood-Onset Fluency Disorder 0 0
Condition category
Condition code
Mental Health 0 0 0 0
Other mental health disorders
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - NOE-105
Treatment: Drugs - Placebo

Experimental: Active - Escalating doses of NOE-105 capsules

Placebo comparator: Placebo - Escalating doses of matching placebo


Treatment: Drugs: NOE-105
Escalating dose levels of NOE-105 will be given and maximum tolerated dose will be maintained

Treatment: Drugs: Placebo
Escalating dose levels of matching Placebo will be given
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change from baseline to end point in severity subset of the MLGSSS
Timepoint [1] 0 0
Up to 71 days
Primary outcome [2] 0 0
Number of participants with adverse events
Timepoint [2] 0 0
Up to 71 days
Primary outcome [3] 0 0
Severity of the adverse events
Timepoint [3] 0 0
Up to 71 days
Primary outcome [4] 0 0
Change in the hematological parameters
Timepoint [4] 0 0
Up to 71 days
Primary outcome [5] 0 0
Change in clinical chemistry
Timepoint [5] 0 0
Up to 71 days
Primary outcome [6] 0 0
Change in the vital signs
Timepoint [6] 0 0
Up to 71 days
Secondary outcome [1] 0 0
Change from baseline to end point in SDS
Timepoint [1] 0 0
Up to 71 days
Secondary outcome [2] 0 0
PGI-S rating at end point
Timepoint [2] 0 0
Up to 71 days
Secondary outcome [3] 0 0
CGI-C rating at end point
Timepoint [3] 0 0
Up to 71 days
Secondary outcome [4] 0 0
Rating of the medication satisfaction questionnaire at end point
Timepoint [4] 0 0
Up to 71 days
Secondary outcome [5] 0 0
Change from baseline to end point in clinician-rated stuttering severity instrument-4
Timepoint [5] 0 0
Up to 71 days
Secondary outcome [6] 0 0
PGI-C rating at end point
Timepoint [6] 0 0
Up to 71 days
Secondary outcome [7] 0 0
Change in mood as rated by the patient through change from baseline to end point in Quick inventory of depressive symptomology (QIDS-16)
Timepoint [7] 0 0
Up to 71 days

Eligibility
Key inclusion criteria
1. Patients must be 18 to 55 years of age inclusive, at the time of signing the informed consent.
2. Patients who satisfy DSM-5 criteria for childhood onset fluency disorder and are suitable for pharmacotherapy.
3. Have a history of stuttering for more than or equal to = 2 years with onset consistent to developmental in nature before age 8 years.
4. Patient reported global stuttering experience as "moderate" at screening and baseline.
5. 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.
6. BMI within the range 19 to 35 kg/m2 (inclusive).
7. 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.
8. Capable of giving signed informed consent
9. Able to read and write in English
Minimum age
18 Years
Maximum age
55 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
1. Stuttering is related to a known neurological cause eg, stroke, etc.
2. Low IQ in the opinion of the investigator.
3. Patients with uncontrolled seizure disorders.
4. A history of severe traumatic brain injury or stroke.
5. Patients who are, in the investigator's opinion, at imminent risk of suicide.
6. Known to have tested positive for human immunodeficiency virus.
7. Known DSM-5 diagnosis of substance abuse or dependence.
8. Unstable medical illness or clinically significant abnormalities on screening tests/exams.
9. 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.
10. Initiation of new behavioral therapies for stuttering within 10 weeks prior to baseline.
11. Use of antipsychotic drug therapy within 14 days prior to receiving treatment until the EoT visit.
12. Participation in another clinical study with an IP administered in the last 30 days.
13. Participants with a known hypersensitivity to NOE-105 or any of the excipients of the product.
14. Patient must not intend to use cannabinoids, cocaine, or nonprescribed opiates.
15. Involvement in the planning and/or conduct of the study (applies to both Noema staff and/or staff at the study site).
16. 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.
17. Previous randomization in the present study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
25/07/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
24/11/2023
Sample size
Target
Accrual to date
Final
75
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Noema Investigator site - Brookvale
Recruitment hospital [2] 0 0
Noema Investigator site - Miranda
Recruitment hospital [3] 0 0
Noema Investigator site - Sydney
Recruitment postcode(s) [1] 0 0
2100 - Brookvale
Recruitment postcode(s) [2] 0 0
2228 - Miranda
Recruitment postcode(s) [3] 0 0
2109 - Sydney
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Kansas
Country [4] 0 0
United States of America
State/province [4] 0 0
New Jersey
Country [5] 0 0
United States of America
State/province [5] 0 0
Tennessee

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Noema Pharma AG
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Gerald A Maguire, M.D.
Address 0 0
Clinical Innovations, Inc. dba CITrails (a CenExel company)
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05583955