רדאר קליני AI | ||
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הניסוי הקליני NCT07216001 עבור אפרקסיה של הדיבור בילדות, Verbal Apraxia, אוטיזם הוא טרם החל גיוס. לכל הפרטים, עיינו בתצוגת הכרטיסים של רדאר ניסויים קליניים ובכלי הגילוי של AI. אפשר גם לשאול כל דבר כאן. | ||
מחקר אחד תואם לקריטריוני המסנן
תצוגת כרטיסים
Role of Omega-DEK in Childhood Apraxia of Speech שלב II 34 אקראי מבוקר פלסבו תווית פתוחה
פרטי הניסויים הקליניים זמינים בעיקר באנגלית. רדאר קליני AI יכול לעזור! לחץ על 'הסבר את המחקר' כדי לצפות ולשוחח על מידע מהמחקר בשפה המועדפת עליך.
הניסוי הקליני NCT07216001 מתוכנן לבדוק את טיפול עבור אפרקסיה של הדיבור בילדות, Verbal Apraxia, אוטיזם. זהו מחקר שלב II מסוג התערבותי שנמצא במצב טרם החל גיוס. גיוס המשתתפים צפוי להתחיל ב-1 במאי 2026, במטרה לכלול 34 משתתפים. המחקר ינוהל על ידי Claudia R. Morris וצפוי להסתיים ב-1 בדצמבר 2027. מידע זה עודכן לאחרונה באתר ClinicalTrials.gov ב-27 בפברואר 2026.
סיכום קצר
This is a 20-week study for children between 3 and 6 years old with confirmed childhood apraxia of speech (CAS). The study includes a 12-week open-label pilot feasibility study of an investigational drug (Omega-DEK) plus L-carnitine (Carnitor®), which is followed by an 8-week randomized, placebo-controlled discontinuation period among the same study participants.
תיאור מפורט
Verbal apraxia (VA) is a severe neurological motor planning speech disorder of unknown etiology. It is a devastating disorder that is insufficiently recognized by general pediatricians and often goes unaddressed and improperly treated during critical years of speech and language development. The high prevalence of this disorder excludes it as an "orphan" disease, although like autism, it may have met the definition o...הצג עוד
כותרת רשמית
Role of Omega-DEK in Childhood Apraxia of Speech
מצבים רפואיים
אפרקסיה של הדיבור בילדותVerbal Apraxiaאוטיזםמזהי מחקר נוספים
- STUDY00007888
- 2025P010775 (מזהה אחר) (Emory IRB)
מספר NCT
תחילת המחקר (בפועל)
2026-05
עדכון אחרון שפורסם
2026-02-27
סיום המחקר (מוערך)
2027-12
משתתפים (מתוכנן)
34
סוג המחקר
התערבותי
שלב
שלב II
סטטוס
טרם החל גיוס
מטרה ראשית
טיפול
הקצאת טיפול
אקראי
דגם מתערב
קבוצות מקבילות
עיוורון
מרובע
זרועות / התערבויות
| קבוצת משתתפים/זרוע | התערבות/טיפול |
|---|---|
ניסיOmega-DEK and L-carnitine for 12 Weeks Followed by Omega-DEK for 8 Weeks Children aged 3 to 6 years old with confirmed childhood apraxia of speech (CAS) receiving Omega-DEK and L-carnitine for the 12-week open-label part of the trial, who are then randomized to continue to receive Omega-DEK for 8 additional weeks. L-carnitine is provided to participants only during the 12-week open-label portion of the trial. | Omega-DEK Participants take 2 capsules, twice daily (BID). L-carnitine Participants take 250 mg L-carnitine administered as a 2.5 mL oral solution twice daily (BID). |
ניסיOmega-DEK and L-carnitine for 12 Weeks Followed by Placebo for 8 Weeks Children aged 3 to 6 years old with confirmed childhood apraxia of speech (CAS) receiving Omega-DEK and L-carnitine for the 12-week open-label part of the trial, who are then randomized to receive a placebo to match Omega-DEK for 8 weeks. L-carnitine is provided to participants only during the 12-week open-label portion of the trial. | Omega-DEK Participants take 2 capsules, twice daily (BID). L-carnitine Participants take 250 mg L-carnitine administered as a 2.5 mL oral solution twice daily (BID). פלצבו A placebo of palm kernel oil to match Omega-DEK is provided. Participants take 2 capsules, twice daily (BID). |
ניסיExpanded Cohort Children aged 2 or older with a working diagnosis of CAS, intestinal lymphangiectasia, or a fat malabsorption syndrome (in isolation or associated with other medical conditions) receiving Omega-DEK and L-carnitine for 12 months. | Omega-DEK Participants take 2 capsules, twice daily (BID). L-carnitine Participants take 250 mg L-carnitine administered as a 2.5 mL oral solution twice daily (BID). |
מדדי תוצאה ראשיים
מדדי תוצאה משניים
| מדד תוצאה | תיאור המדידה | טווח זמן |
|---|---|---|
Percent of Participants Retained in Study | Feasibility of the intervention is assessed with the percentage of enrolled participants who complete the 20 week study. Successful retention is defined as \>85% of enrolled participants completing the study. | Up to Week 20 |
Percent of Expanded Cohort Recruited | Feasibility of conducting a 12-month, open-label trial is measured by successful recruitment, which is defined as \<20% refusal of eligible children. | Up to Month 12 |
Percent of Expanded Cohort Retained | Feasibility of conducting a 12-month, open-label trial is measured by successful retention, which is defined as \>85% of study participants completing the study. | Up to Month 12 |
Percent of Expanded Cohort Complying with Treatment Regimen | Feasibility of conducting a 12-month, open-label trial is measured by successful compliance, which is defined as \>75% of participants with compliance with the treatment regimen. | Up to Month 12 |
Percent of Expanded Cohort With Complete Data | Feasibility of conducting a 12-month, open-label trial is measured by collection of study data, which is defined as \>90% of participants providing outcome data. | Up to Month 12 |
| מדד תוצאה | תיאור המדידה | טווח זמן |
|---|---|---|
Percent of Participants With Complete Outcome Data | Feasibility of the intervention is assessed with the percentage of participants who complete all surveys and study visits. Successful collection of outcome data is defined as \>90% of participants completing study surveys and visits. | Up to Week 20 |
Change in Dynamic Evaluation of Motor Speech Skill (DEMSS) Score | The Dynamic Evaluation of Motor Speech Skill (DEMSS) is a validated tool specifically designed to identify the level of breakdown in a child's ability to speak so that treatment can be established, and improvement tracked. The DEMSS is comprised of 9 subtests with a total of 66 utterances which are associated with 171 items. Four subscores for overall articulatory accuracy of the word, vowel accuracy, prosodic accuracy, and consistency, are calculated. An overall score is calculated and ranges from 0 to 426, where lower scores suggest that CAS is present. Within a clinical setting, scores between 0 and 323 indicate CAS, scores between 323 and 373 indicate mild evidence of mild CAS, and scores of 373 to 426 indicate little or no evidence of CAS. Baseline scores are compared to scores at Week 12, for analysis of the open-label portion of the study, while Week 12 and Week 20 scores are compared for analysis of the randomized discontinuation portion of the study. | Baseline, Week 12, Week 20 |
Mean Length of Utterances (MLU) | Mean length of utterance (MLU) is an assessment of expressive language measures the average number of morphemes per utterance. Morphemes are smallest language elements that make up linguistic expression. A spontaneous speech sample will be obtained and MLU is calculated as the number of morphemes in each utterance divided by the total number of utterances. | Baseline, Week 12, Week 20 |
Clinical Global Impression for Improvement Scale (CGI-I) Score | The CGI-I is a 7-point scale designed to measure overall improvement from baseline. The CGI-I is rated by an independent evaluator who is blind to treatment assignment during the randomized discontinuation phase. Scores range from 1 (Very Much Improved) to 4 (Unchanged) to 7 (Very Much Worse). Positive response to treatment (an improvement from baseline) is defined by a rating of Much Improved or Very Much Improved. Scores of 3 (minimally improved), 4 (no change) and 5 (minimally worse) indicate no change. Scores of 6 or 7 are considered as a worsening of symptoms from baseline (a negative response). | Weeks 1, 4, 8, 12 (during the open-label portion of the study), weekly during Weeks 13-22 (during the randomized portion of the study) |
עוזר השתתפות
קריטריוני זכאות
גילאים מוערכים למחקר
ילד
גיל מינימלי למחקר
2 Years
מגדרים מוערכים למחקר
הכל
- Confirmed diagnosis of childhood apraxia of speech/verbal apraxia by a qualified professional (SLP) based on established guidelines
- Male and female, age 36 months - 6 years (inclusive)
- Ability to comprehend and use Standard American English
- Children unable to tolerate oral supplementation
- Known allergy to fish oil, palm kernel oil or other ingredients in investigational drug
- Medical or genetic condition that in the opinion of the PI/Co-Is may affect participation and compromise results (including significant receptive language delay, moderate-severe cognitive delay, complex medical history, hearing loss, cerebral palsy, history of traumatic brain injury or severe anoxic event, Down's syndrome)
- Known seizure disorder or history of febrile seizures
- History of cardiac dysrhythmia or abnormal ECG at baseline
- A prothrombin time test with an international normalised ratio (PT/INR) >1.2
- Use of blood thinners, including chronic aspirin, chronic NSAIDS, warfarin etc.
- A history of PUFA or vit E supplementation use within 3 months prior to enrollment in the study
- On an elimination diet for < 3 months (gluten, casein, yeast free etc.) prior to enrollment, or planning to initiate a special diet during the study
- Recent reintroduction of food items from elimination diet < 3 months
- On any additional nutritional interventions/supplements < 3 months (i.e. high dose vitamins/minerals that exceed what would be found in a children's multivitamin supplement etc., probiotics)
- Any new chronic medication < 3 months prior to enrollment (stable doses > 3 months allowed; medications for acute illness allowed including antipyretics, antibiotics, asthma medication)
- Anticipated initiation of new chronic medication during study timeline including new attention-deficit/hyperactivity disorder (ADHD) medications, other behavior medications
- Plans to try additional complementary interventions or diets during the study period
- Planned surgery during or within 4 weeks after conclusion of trial
Inclusion Criteria for Expanded Cohort:
- Working Diagnosis of CAS, or intestinal lymphangiectasia, or fat malabsorption syndrome (in isolation or associated with other medical conditions such as cystic fibrosis, celiac disease, etc.)
- Male and female, aged ≥2 years
- Ability to comprehend and use Standard American English
Exclusion Criteria for Expanded Cohort:
- Subjects unable to tolerate oral supplementation
- Known allergy to fish oil, palm kernel oil or other ingredients in investigational drug
- History of cardiac dysrhythmia or abnormal ECG at baseline
- PT-INR >1.2. A clinical lab performed within a month of enrollment will be accepted to meet this exclusion criteria
- Use of blood thinners, including chronic aspirin, chronic NSAIDS, warfarin etc. (Symptomatic use of NSAIDS for acute fever or pain permitted)
Claudia R. Morrisהגורם האחראי למחקר
Claudia R. Morris, חוקר נותן החסות, Professor, Emory University
איש קשר מרכזי למחקר
איש קשר: Claudia R Morris, MD, 470-656-2942, [email protected]
2 מיקומי המחקר ב-1 מדינות
Georgia
Children's Healthcare of Atlanta, Atlanta, Georgia, 30322, United States
Marcus Autism Center, Atlanta, Georgia, 30329, United States