Trial · NCT03775096
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 123I-MIBG reuptake changes | At baseline and at 26 weeks of treatment. | 123I-MIBG reuptake will be measured by early and late Heart to Mediastinal ratio (H/M) and Washout ratio (WR) which will be calculated using the following formula: \[(early heart counts/pixel - early mediastinum counts/pixel) - (late heart counts/pixel decay-corrected - late mediastinum counts/pixel decay-corrected)\]/(early heart counts/pixel - early mediastinum counts/pixel). Care will be taken to exclude lung or liver from the myocardial and large vessels and lung from the mediastinum region of interest. MIBG abnormality cutoffs will be set for values of late H/M \<2.2 and WR \>30%. |
| Secondary | Adverse Events frequency | every 3 months up to 34 weeks | Safety will be monitored collecting the type and frequency of adverse events, including clinical symptoms, changes in vital signs, clinical laboratory measures and EKG abnormalities. |
| Secondary | Heart rate variability changes | At baseline and at 26 weeks of treatment. | Twenty-four-hour Holter monitoring of all patients will be conducted at two points during the study: 1) After MIBG and prior to the administration of the study drug and 2) within one week of the end of the six-month treatment trial. Two-channel Holter recordings will obtained and analyzed on a commercially available scanner in the cardiac laboratory at Cedars Sinai Medical Center, according to published guidelines. |
| Other | MDS-UPDRS part III changes | At baseline and at 26 weeks of treatment. | The Movement disorder society-unified Parkinson's disease rating scale (MDS-UPDRS) Part III will be administered at baseline and 26 weeks after study medication titration. Each item of the MDS-UPDRS has a possible rating from 0 to 4, where 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe.Clinical scales will be performed OFF medication in those subjects that might be receiving dopaminergic drugs |
| Other | Sleep changes as measured by REM Behavior Disorder questionnaire | At baseline and at 26 weeks of treatment. | RBD questionnaire (RBDSQ) changes from Screening at 26 weeks after study drug titration |
| Other | Smell changes as measured by University of Pennsylvania Smell Identification Test (UPSIT) | At baseline and at 26 weeks of treatment. | University of Pennsylvania Smell Identification Test (UPSIT) changes from screening at 26 weeks after study medication titration |
| Other | Constipation score changes using a questionnaire based on modified ROME III diagnostic criteria | At baseline and at 26 weeks of treatment. | Functional constipation will be assessed at screening and at 26 weeks after study medication titration using a questionnaire based on modified ROME III diagnostic criteria, which focuses on symptoms including straining, lumpy or hard stools, sensation of incomplete evacuation, sensation of anorectal obstruction or blockage, manual maneuvers to facilitate evacuation, and two or fewer bowel movements per week. This questionnaire is based on a six item self-report measures with a three point summated rating scale. The total score has a range of 0 to 12, with scores \> 4 identifying functional constipation. |
| Other | Color vision changes as measured by HRR Pseudochromatic Plates | At baseline and at 26 weeks of treatment. | Color vision changes will be assessed using HRR Pseudochromatic Plates from screening at 26 weeks after study medication titration |
| Other | DAT scan Changes | At baseline and at 26 weeks of treatment. | DaT/SPECT uptake at baseline will be quantified at baseline and 26 weeks after study medication titration |
| Other | Non-Motor Symptoms Scale (NMSS) changes | At baseline and at 26 weeks of treatment. | The NMSS measures non-motor symptoms over the previous month. Each symptom is scored with respect to: Severity: 0 = None, 1 = Mild; 2 = Moderate; 3 = Severe and Frequency: 1 = Rarely (\<1/wk); 2 = Often (1/wk); 3 = Frequent (several times per week); 4 = Very Frequent (daily or all the time). |
| Other | Scopa-AUT changes | At baseline and at 26 weeks of treatment. | The SCOPA-AUT scale consists of 25 items assessing autonomic symptoms in the following regions: gastrointestinal (7), urinary (6), cardiovascular (3), thermoregulatory (4), pupillomotor (1), and sexual (2 items for men and 2 items for women) dysfunction. |
| Other | Peripheral insulin resistance changes | At baseline and at 26 weeks of treatment. | Peripheral IR will be defined by testing for fasting plasma insulin (FPI), fasting plasma glucose (FPG) and glycated hemoglobin (HbA1c) from baseline at 26 weeks after study medication titration. HOMA index will be calculated by the formula: HOMA-IR = (FPI x FPG)/405. \[A cutoff HOMA index of 2.0, equivalent to \<50% sensitivity, will be used to define IR. Subjects were considered to have IR if they either had a HOMA≥2.0 and/or HbA1c≥5.7. |
| Other | Central insulin resistance changes | At baseline and at 26 weeks of treatment. | Measures of insulin sensitivity in neuronal-origin enriched plasma EVs (central IR) will be used to test the association of changes in such sensitivity to changes in MIBG uptake and clinical scores from baseline to 26 weeks after carvedilol titration. For that purpose, plasma samples will be collected and stored and -80oC to allow for isolation of neuronal origin EVs at the completion of the study. |
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.
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