Persistent Developmental StutteringPhase 3NCT04173949
Explorative Study for Treating Persistent Developmental Stuttering With Ramipril
A Phase 3 study testing Ramipril 2.5 MG in people with Persistent Developmental Stuttering, run by HaEmek Medical Center, Israel at 2 sites in Israel.
Trial summary
Persistent developmental stuttering (PDS) is diagnosed when developmental stuttering persists beyond adolescence. Most stutterers experience vast improvement in stuttering during childhood and it generally disappears within five years. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Persistent Developmental Stuttering
- What is being tested?
- Ramipril 2.5 MG
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesIsrael
- Study dates
- 15 Mar 2020to 30 Dec 2025
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 or above
- Developmental stuttering of 10 points severity at least (SSI-4)
- Agree not to have any speech or emotional therapy during the trial.
Who cannot join
- Systolic blood pressure < 110mmHg
- Estimated creatinine clearance < 50ml/min
- Baseline potassium > 5meq/ml
- Any sign of psychopathology by the MINI international neuropsychiatric interview
- Any psychotropic medications or substances in the past month
- History of angioedema or cough with any ACE inhibitor
Show all 11Show fewer
- Aliskerin use in diabetes patients
- Current medication include ACE inhibitors or ARBS
- Pregnancy, or pregnancy plans during the study
- Less than 3% stuttered syllables
- Subjects with cluttering-stuttering when the cluttering is prominent
Trial locations and contacts
2 sites in 1 country.
About this study
Persistent developmental stuttering (PDS) is diagnosed when developmental stuttering persists beyond adolescence. Most stutterers experience vast improvement in stuttering during childhood and it generally disappears within five years. A minority of stutterers continue stuttering over age 18, often accompanied by social and personal difficulties.
Following a report of a 75 year old woman, with severe Persistent developmental stuttering , who experienced significant improvement in her stuttering since treated by Ramipril for hypertension, we scrutinized the literature, and discovered that there is a physiological basis for this surprising reaction. Ace inhibitors, such as Ramipril, might in fact be successful for treating Persistent developmental stuttering .
Read more
In theory, it seems that ACE inhibitors, such as Ramipril could improve stuttering by reducing striatum dopamine levels.
- Stuttering is associated with high striatum dopamine levels
- Angiotensin receptors are present in the striatum
- Angiotensin causes elevated striatum dopamine levels
- ACE inhibitors penetrate the blood brain barrier and reduce brain angiotensin II levels.
Methods The study will begin as a pilot study in which 10 stuttering patients will be recruited for 12 weeks on open label Ramipril 1.25mg/d.
If there is improvement in at least 2 of the stuttering patients, we will continue to the main study.
Efficacy Evaluation:
- The MINI Neuropsychiatric interview will be used to rule out major neuropsychiatric conditions
- Stuttering evaluation
- Stuttering Severity instrument Version 4 (SSI-4) (Riley 2009)
- SLD :Percentage of stuttered syllables (Yairi 2015)
- The Subjective Screening of Stuttering (SSS)
- Speech Situation Checklist (Brutten 1975,1981)
- Leibowitz Social Anxiety Scale (Leibowitz 1987)
The efficacy evaluation will be performed by speech therapists. All evaluations will be will be recorded on video
Safety evaluation:
- Blood pressure: The average of three consecutive measures. Blood pressure will be measure in both arms on the first meeting, and thereafter on the arm with the highest measurements.
- Orthostatic hypotension will be defined as a drop of 20mmHg systolic or 10mmHg diastolic, one and three minutes after standing from sitting position.
- Creatinine clearance will be calculated by the MDRD method (Levy 2006) GFR, in mL/min per 1.73 m2 = 186.3 x SCr (exp[-1.154]) x Age (exp[-0.203]) x (0.742 if female) x (1.21 if black)
- Conditions
- Persistent Developmental Stuttering
- Being tested
- Ramipril 2.5 MG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ramipril 2.5 MGDrug
3 month of treatment with daily Ramipril 2.5 MG
| Study group | Role | What they receive |
|---|---|---|
| Ramipril 2.5 MG | Experimental | Ramipril 2.5 MG orall, daily. Receives: Drug: Ramipril 2.5 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
changed in stuttered syllables
The difference in stuttering measures with and without treatment will be determined.
Measured: 4 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2019
- Study start15 Mar 2020
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Persistent Developmental StutteringStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The study will begin as a pilot study in which 10 stuttering patients will be recruited for 12 weeks on open label Ramipril 2.5mg.
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- HaEmek Medical Center, Israel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04173949
- Sponsor's protocol ID
- EMC169-15
- Status last verified
- Mar 2025
- First submitted
- 7 Nov 2019
- Last updated
- 13 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Explorative Study for Treating Persistent Developmental Stuttering With Ramipril
- ClinicalTrials.gov ID
- NCT04173949
- Acronym / sponsor ID
- EMC169-15
- Conditions
- Persistent Developmental Stuttering
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 10 participants (actual)
- Lead sponsor
- HaEmek Medical Center, IsraelUniversity, hospital or other
- Study start
- 15 Mar 2020 (actual)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 22 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Persistent developmental stuttering (PDS) is diagnosed when developmental stuttering persists beyond adolescence. Most stutterers experience vast improvement in stuttering during childhood and it generally disappears within five years. A minority of stutterers continue stuttering over age 18, often accompanied by social and personal difficulties.
Following a report of a 75 year old woman, with severe Persistent developmental stuttering , who experienced significant improvement in her stuttering since treated by Ramipril for hypertension, we scrutinized the literature, and discovered that there is a physiological basis for this surprising reaction. Ace inhibitors, such as Ramipril, might in fact be successful for treating Persistent developmental stuttering .
In theory, it seems that ACE inhibitors, such as Ramipril could improve stuttering by reducing striatum dopamine levels.
- Stuttering is associated with high striatum dopamine levels
- Angiotensin receptors are present in the striatum
- Angiotensin causes elevated striatum dopamine levels
- ACE inhibitors penetrate the blood brain barrier and reduce brain angiotensin II levels.
Methods The study will begin as a pilot study in which 10 stuttering patients will be recruited for 12 weeks on open label Ramipril 1.25mg/d.
If there is improvement in at least 2 of the stuttering patients, we will continue to the main study.
Efficacy Evaluation:
- The MINI Neuropsychiatric interview will be used to rule out major neuropsychiatric conditions
- Stuttering evaluation
- Stuttering Severity instrument Version 4 (SSI-4) (Riley 2009)
- SLD :Percentage of stuttered syllables (Yairi 2015)
- The Subjective Screening of Stuttering (SSS)
- Speech Situation Checklist (Brutten 1975,1981)
- Leibowitz Social Anxiety Scale (Leibowitz 1987)
The efficacy evaluation will be performed by speech therapists. All evaluations will be will be recorded on video
Safety evaluation:
- Blood pressure: The average of three consecutive measures. Blood pressure will be measure in both arms on the first meeting, and thereafter on the arm with the highest measurements.
- Orthostatic hypotension will be defined as a drop of 20mmHg systolic or 10mmHg diastolic, one and three minutes after standing from sitting position.
- Creatinine clearance will be calculated by the MDRD method (Levy 2006) GFR, in mL/min per 1.73 m2 = 186.3 x SCr (exp[-1.154]) x Age (exp[-0.203]) x (0.742 if female) x (1.21 if black)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The study will begin as a pilot study in which 10 stuttering patients will be recruited for 12 weeks on open label Ramipril 2.5mg.
| Arm | Type | Receives |
|---|---|---|
| Ramipril 2.5 MG | Experimental | Drug: Ramipril 2.5 MGRamipril 2.5 MG orall, daily. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18 or above
- Developmental stuttering of 10 points severity at least (SSI-4)
- Agree not to have any speech or emotional therapy during the trial.
Key exclusion criteria (11 listed)
- Systolic blood pressure < 110mmHg
- Estimated creatinine clearance < 50ml/min
- Baseline potassium > 5meq/ml
- Any sign of psychopathology by the MINI international neuropsychiatric interview
- Any psychotropic medications or substances in the past month
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ramipril 2.5 MG3 month of treatment with daily Ramipril 2.5 MG | Drug | Ramipril 2.5 MG |
Primary outcome
changed in stuttered syllables
Time frame: 4 month
The difference in stuttering measures with and without treatment will be determined.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2025.
- Individual participant dataSharing planned: No
Related trials for Persistent Developmental Stuttering
Recruiting
Noninvasive Thalamocortical Neuromodulation With Low-Intensity Focused Ultrasound for Persistent Developmental Stuttering
Stuttering, Developmental Stuttering
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ramipril 2.5 MG in people with Persistent Developmental Stuttering, run by HaEmek Medical Center, Israel at 2 sites in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changed in stuttered syllables (time frame: 4 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2025.