Trial · NCT07430046
Registered outcomes25
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 25
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Primary Endpoint: Improvement in the rating scale Motor-Behavior Assessment Scale (MBAS). | From enrollment to the end of treatment at 24 weeks | The drug will be considered effective if the treatment decreases the Motor-Behavior Assessment Scale (MBAS) score (maximum score=68) by at least 8.5 points (12.5%) compared to the pre-treatment value. |
| Secondary | Secondary endpoint 1. Reduced mood and anxiety disorder symptoms | From enrollment to the end of treatment at 24 weeks | 1\. The drug will be considered effective if the treatment reduces the overall Anxiety, Depression, Mood Scale (ADAMS) score (maximum score=84) by at least 10.6 points (12.5%) compared to the pre-treatment value. |
| Secondary | Secondary Endpoint 1bis: Reduced mood and anxiety disorder symptoms | From enrollment to the end of treatment at 24 weeks | 1bis. The drug will be considered effective if is will reduce the overall Rett Syndrome Behaviour questionnaire (RSBQ) score by at least 11.25 points (12.5%) compared to the pre-treatment value. |
| Secondary | Secondary Endpoint 2-a. Improved Vital parameters | From enrollment to the end of treatment at 24 weeks | 2-a. The drug will be considered effective if the treatment improves the measurements of Respiratory Rate (RR), obtained from the medical devices for remote sensing (Youcare Smart T-shirt) by at least 20% compared to the pre-treatment value. |
| Secondary | Secondary Endpoint 2-b. Improved Vital parameters | From enrollment to the end of treatment at 24 weeks | 2-b. The drug will be considered effective if the treatment improves the measurements of Heart Rate (HR), obtained from the medical devices for remote sensing (Youcare Smart T-shirt) by at least 20% compared to the pre-treatment value. |
| Secondary | Secondary Endpoint 2-c. Improved Vital parameters | From enrollment to the end of treatment at 24 weeks | 2-c. The drug will be considered effective if the treatment improves the measurements of Variation of Heart Rate (VHR), obtained from the medical devices for remote sensing (Youcare Smart T-shirt) by at least 20% compared to the pre-treatment value. |
| Secondary | Secondary Endpoint 2-d. Improved Vital parameters | From enrollment to the end of treatment at 24 weeks | 2-d. The drug will be considered effective if the treatment improves the measurements of Skin Temperature (SkT) obtained from the medical devices for remote sensing (Youcare Smart T-shirt) by at least 20% compared to the pre-treatment value. |
| Secondary | Secondary Endpoint 3-a: Improved Sleep quality | From enrollment to the end of treatment at 24 weeks | 3-a. The drug will be considered efficacious if the Sleep Disturbances Scale for Children (SDSC) scores will be reduced by at least 20% compared to the pre-treatment value. |
| Secondary | Secondary Endpoint 3-b: Improved Sleep Quality | From enrollment to the end of treatment at 24 weeks. | 3-b: The drug will be considered efficacious if the estimated time in bed (eTIB) measured by wrist actigraphy will be increasing by 20% over the pre-treatment score. |
| Secondary | Secondary Endpoint 3-c: Improved Sleep Quality | From enrollment to the end of treatment at 24 week | Description: 3-c: The drug will be considered efficacious if the estimated total sleep time (eTST), measured by wrist actigraphy, will be increasing by 20% over the pre-treatment score. |
| Secondary | Secondary Endpoint 3-d: Improved Sleep Quality | From enrollment to the end of treatment at 24 week | Description: 3-d: The drug will be considered efficacious if the estimated sleep latency (eSOL), measured by wrist actigraphy, will be decreased by 20% over the pre-treatment score. |
| Secondary | Secondary Endpoint 3-e: Improved Sleep Quality | From enrollment to the end of treatment at 24 week | Description: 3-e: The drug will be considered efficacious if the estimated sleep efficiency (eSE), measured by wrist actigraphy, will be increasing by 20% over the pre-treatment score. |
| Secondary | Secondary Endpoint 3-f: Improved Sleep Quality | From enrollment to the end of treatment at 24 week | Description: 3-f: The drug will be considered efficacious if the estimated wake time after sleep onset (eWASO), measured by wrist actigraphy, will be decreasing by 20% over the pre-treatment score. |
| Secondary | Secondary Endpoint 3-g: Improved Sleep Quality | From enrollment to the end of treatment at 24 week | Description: 3-g: The drug will be considered efficacious if the number of estimated awakenings (eAwk), measured by wrist actigraphy, will be decreasing by 20% over the pre-treatment score. |
| Secondary | Secondary Endpoint 3-h: Improved Sleep Quality | From enrollment to the end of treatment at 24 week | Description: 3-h: The drug will be considered efficacious if the estimated sleep motor activity (eSMA), measured by wrist actigraphy, will be decreasing by 20% over the pre-treatment score. |
| Secondary | Secondary Endpoint 3-i: Improved Sleep Quality | From enrollment to the end of treatment at 24 week | Description: 3-i: The drug will be considered efficacious if the num. ber of estimated naps (eNaps), num. ber of estimated naps (eNaps), will be decreasing by 20% over the pre-treatment score. |
| Secondary | Secondary Endpoint 3-j: Improved Sleep Quality | From enrollment to the end of treatment at 24 week | Description: 3-j: The drug will be considered efficacious if the mean duration of the longest estimated nap (eNapD), measured by wrist actigraphy, will be increasing by 20% over the pre-treatment score. |
| Secondary | Secondary Endpoint 4. Regaining of hand control | From enrollment to the end of treatment at 24 weeks | 4\. The drug will be considered effective if the Purposeful Hand Function scale (PHF) score increases at least 2 points above the pre-treatment score |
| Secondary | Secondary Endpoint 5: Changes in Global severity | From enrollment to the end of treatment at 24 weeks | 5\. Drug efficacy will be determined using the Clinical Global Impression of Change (CGI-C) scale, which consists of a 7-point scale, ranging from 1 (very much improved) to 7 (very much worse), while 4 indicates no change. Decreased score of at least 1 point compared to the pre-treatment value is expected upon successful treatment. |
| Secondary | Secondary Endpoint 6: Reduced Rett-specific Severity | From enrollment to the end of treatment at 24 weeks | 6\. Drug efficacy will be determined using the Rett Syndrome Severity Scale (RCSS), which consists of 13 items providing a rating of core symptoms of RTT on a Likert scale of either 0 to 4 or 0 to 5 with a maximum total score of 58. Drug will be considered efficacious if RCSS scores will result decreased by at least 3%, i.e. 2 points compared to the pre-treatment value. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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GET https://conductscience.org/api/trials/v1/NCT07430046/registered