Trial · NCT03948178
Outcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| 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. | Analysis is reported for the safety population which included all subjects receiving any study treatment. Treatment emergent AEs are defined as any event arising or worsening after the start of study treatment until 25 days after the individual subject's last study treatment. | Participants | COUNT_OF_PARTICIPANTS |
| 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) | Analysis was performed on the safety population which included all patients who had received at least one dose of study treatment. The change from baseline in pulse and heart rate was measured at week 2, week 4, week 6 (pulse rate only) Month 3, Month 6 and the individual subject 's last visit in the study. The number of subjects analysed at each timepoint differs from the total number of subjects that entered the study as some study subjects did not undergo the assessment at all timepoints. | beats per minute (bpm) | MEAN |
| 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) | Analysis of patients in the safety population defined as all patients who had received at least one dose of study treatment | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Disease Progression | From Baseline through study completion(subject's last visit, 2-48 weeks after study entry) | Number of study withdrawals due to disease progression were collected for all subjects entered into the study. The study sponsor terminated the study. | Participants | COUNT_OF_PARTICIPANTS |
| 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) | Analysis was performed on the safety population which included all patients who had received at least one dose of study treatment. The change from baseline in pulse and heart rate was measured at week 2, week 4, week 6 (pulse rate only) Month 3, Month 6 and the individual subject 's last visit in the study. The number of subjects analysed at each timepoint differs from the total number of subjects that entered the study as some study subjects did not undergo the assessment at all timepoints. | % of predicted normal | MEAN |
| 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) | Analysis was performed on the safety population which included all patients who had received at least one dose of study treatment. The change from baseline in pulse and heart rate was measured at week 2, week 4, week 6 (pulse rate only) Month 3, Month 6 and the individual subject 's last visit in the study. The number of subjects analysed at each timepoint differs from the total number of subjects that entered the study as some study subjects did not undergo the assessment at all timepoints. | Score on a scale | MEAN |
| SECONDARY | Need for Respiratory Support Device | Time to event at study completion (subject's last visit, 2-48 weeks after study entry) | Analyses were performed in the safety population in which all subjects received at least one dose of study treatment | days | MEAN |
| 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) | Analysis was performed on the safety population which included all patients who had received at least one dose of study treatment. The change from baseline in pulse and heart rate was measured at week 2, week 4, week 6 (pulse rate only) Month 3, Month 6 and the individual subject 's last visit in the study. The number of subjects analysed at each timepoint differs from the total number of subjects that entered the study as some study subjects did not undergo the assessment at all timepoints. | units on a scale | MEAN |
| SECONDARY | Number of Subjects Requiring Health and Home Care Resource Use | Baseline through study completion (2- 48 weeks after study entry) | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Subject's Status for Tracheostomy and Survival | Baseline to end of study (average 2-48 weeks after study entry | Analysis was performed on the safety population which includes all subjects receiving at least one dose of study treatment | Participants | COUNT_OF_PARTICIPANTS |
| 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) | Analysis performed on the safety population defined as any subject receiving at least one dose of study treatment | Nights | MEAN |
| 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) | Analysis performed on the safety population defined as any subject receiving at least one dose of study treatment | visits | MEAN |
| 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) | Analysis performed on the safety population defined as any subject receiving at least one dose of study treatment | days | MEAN |
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
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT03948178/outcomes