Trial · NCT03948178
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 | Adverse Events Recording | From signing informed consent until 14-25 days after the last study treatment for all patients, an average of 23.5 weeks. | Adverse Events as subject counts and proportions (%) of subject per Adverse Event |
| Primary | Pulse/Heart Rate Assessment | Change in pulse and heart rate(from ECG recording) from Baseline, week 2, week 4, week 6 (pulse rate only), Month 3, Month 6, end of study (subject's last visit, 2-48 weeks after study entry) | Actual values and changes from baseline in supine pre-dose pulse/heart rate were summarised using descriptive statistics . |
| Primary | 12-lead Electrocardiogram Assessments | Baseline, week 2, week 4, month 3, month 6, end-of-study(subject's last visit, 2-48 weeks after study entry) | Summarisation of any abnormal 12-lead ECG findings using descriptive statistics. |
| Secondary | Disease Progression | From Baseline through study completion(subject's last visit, 2-48 weeks after study entry) | Count of study withdrawals due to disease progression |
| Secondary | Supine Slow Vital Capacity (SVC) | The change from Baseline, week 2, week 4, month 3, month 6, end-of-study (subject's last visit, 2-48 weeks after study entry) | Change from baseline in supine and sitting SVC (all devices) through to the end of the study, expressed as a % of predicted normal |
| Secondary | Revised ALS Functional Rating Scale (ALSFRS-R) | Change from Baseline in respiratory function of ALSFRS-R at study completion (subject's last visit, 2-48 weeks after study entry) | ALSFRS-R scale contains 3 parameters related to respiratory function: Severity of dyspnea, occurrence of orthopnea (shortness of breath when in supine position i.e. lying flat), and the use of mechanical ventilation for respiratory in sufficiency. These 3 parameters are combined to create the respiratory domain with a score of 0-12(where 12 is normal function). Although individual items and patients vary, ALSFRS-R typically declines at a relatively constant rate over time. Plotted over time the slope of the line obtained indicates the speed of progression and thus an effective treatment might be expected ro reduce the slope of decline. |
| Secondary | Need for Respiratory Support Device | Time to event at study completion (subject's last visit, 2-48 weeks after study entry) | Time to respiratory device support (non invasive) or death |
| Secondary | Borg Category Ratio 10 Scale (CR 10) | Baseline through study completion (week 2, week 4, month 3, month 6, end of study (subject's last visit, 2-48 weeks after study entry) | Patients rated their perception of the severity of their dyspnea using the Borg Category Ration 10 scale (CR 10). The scale ranges from 0(no dysponea) to 10 (maximal dyspnea). each category is numbered and most but not all have verbal cues. At each assessment the patient scored the category they felt best described their symptoms. The analysis measured change from baseline to the end of the study in both a supine and sitting position where a negative score indicates improvement and a positive score reflects worsening. |
| Secondary | Number of Subjects Requiring Health and Home Care Resource Use | Baseline through study completion (2- 48 weeks after study entry) | The number of study subjects requiring Health and home care resource use was aggregated over the course of the study for each subject and summarised using descriptive statistics. |
| Secondary | Subject's Status for Tracheostomy and Survival | Baseline to end of study (average 2-48 weeks after study entry | Number of patients with the need for tracheostomy or who died whilst on treatment from baseline to the end of the study was summarised using descriptive statistics. |
| Secondary | Health Care Service Use During the Study(Stays in Hospital) | From baseline to the end of the study(2-48 weeks after study entry) | The number of night stays in hospital were recorded throughout the study using a diary given to the study subjects |
| Secondary | Health Care Service Use During the Study(Visits to the Emergency Room) | From baseline to the end of the study(2-48 weeks after study entry) | The number of visits to the emergency room were recorded throughout the study using a diary given to the study subjects |
| Secondary | Health Care Service Use During the Study (Days Spent in an Institutional Facility) | From baseline to the end of the study(2-48 weeks after study entry) | The number of days spent in an institutional facility were recorded throughout the study using a diary given to the study subjects |
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/NCT03948178/registered