NCT04173949

Explorative Study for Treating Persistent Developmental Stuttering With Ramipril

Active, enrolled Phase 3 Last updated 13 March 2025

What this trial tests

Phase 3 trial testing Ramipril 2.5 MG in Persistent Developmental Stuttering in 10 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

15 March 2020

Primary endpoint
30 December 2025

30 December 2025

Quick facts

Lead sponsor	HaEmek Medical Center, Israel
Phase	Phase 3
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	10
Start date	15 March 2020
Primary completion	30 December 2025
Estimated completion	30 December 2025
Sites	2 locations across Israel

Drugs / interventions tested

• Ramipril 2.5 MG

Conditions studied

• Persistent Developmental Stuttering — all drugs for Persistent Developmental Stuttering →

Sponsor

HaEmek Medical Center, Israel

Who can join

18 and older, any sex, with Persistent Developmental Stuttering. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

1. Stuttering is associated with high striatum dopamine levels
2. Angiotensin receptors are present in the striatum
3. Angiotensin causes elevated striatum dopamine levels
4. 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:

1. The MINI Neuropsychiatric interview will be used to rule out major neuropsychiatric conditions
2. Stuttering evaluation

1. Stuttering Severity instrument Version 4 (SSI-4) (Riley 2009)
2. SLD :Percentage of stuttered syllables (Yairi 2015)
3. The Subjective Screening of Stuttering (SSS)
4. Speech Situation Checklist (Brutten 1975,1981)
3. 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:

1. 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.
2. Orthostatic hypotension will be defined as a drop of 20mmHg systolic or 10mmHg diastolic, one and three minutes after standing from sitting position.
3. 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)

Publications & conference data

No peer-reviewed publications indexed yet for this trial.