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Explorative Study for Treating Persistent Developmental Stuttering With Ramipril

StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated March 13, 2025 (before its estimated December 30, 2025 completion). Its status may not reflect the trial's current state.

Record History

  1. Notable Primary completion date: Jun 15, 2023 to Dec 30, 2025
    • Trial status: Recruiting to Active, Not Recruiting
    • Study completion date: Nov 15, 2023 to Dec 30, 2025
    • Site details revised at 2 of 2 sites
    v5
  2. Notable Primary completion date: Dec 15, 2021 to Jun 15, 2023
    • Study completion date: Feb 15, 2022 to Nov 15, 2023
    v4
  3. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 1 to 2
    v3
  4. Notable Start date: Dec 15, 2019 to Mar 15, 2020v2
  5. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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)
Trial Details
NCT Number NCT04173949
Lead Sponsor HaEmek Medical Center, Israel
Conditions
(from sponsor)
Persistent Developmental Stuttering
Enrollment 10 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov