Trial · NCT02462759
Outcomes21
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 20 of 21
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Part 1 and 2: From first dose/sham procedure to end of study (up to 1080 days) | The safety population included all participants who were randomized and received at least 1 dose of study treatment or sham procedure. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Change From Baseline in Clinical Laboratory Parameters | Part 1 and 2: From first dose/sham procedure to end of study (up to 1080 days) | The safety population included all participants who were randomized and received at least 1 dose of study treatment or sham procedure. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Change From Baseline in Electrocardiograms (ECGs) | Part 1: Day 2, 29 and 422; Part 2: Day 1 to 596 | The safety population included all participants who were randomized and received at least 1 dose of study treatment or sham procedure. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Change From Baseline in Vital Signs | Part 1: Day 2, 29 and 422; Part 2: Day 1 to 596 | The safety population included all participants who were randomized and received at least 1 dose of study treatment or sham procedure. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Change From Baseline in Head Circumference | Part 2: Baseline, Day 15, 29, 64, 183, 302, 422, 540, 659, 778, 898, 1018 and 1138 | Safety population: participants who were randomized and received at least 1 dose of study treatment or sham procedure. Number analyzed indicates participants who were evaluated for the specified time points. Due the early termination of Part 2, no participants in the ISIS 396443 Part 2(participants on sham in Part 1) were on study beyond Day 659. | centimeter (cm) | MEAN |
| PRIMARY | Change From Baseline in Chest Circumference | Part 2: Baseline, Day 15, 29, 64, 183, 302, 422, 540, 659, 778, 898, 1018 and 1138 | Safety population: participants who were randomized and received at least 1 dose of study treatment or sham procedure. Number analyzed indicates participants who were evaluated for the specified time points. Due the early termination of Part 2, no participants in the ISIS 396443 Part 2(participants on sham in Part 1) were on study beyond Day 659. | cm | MEAN |
| PRIMARY | Change From Baseline in Arm Circumference | Part 2: Baseline, Day 15, 29, 64, 183, 302, 422, 540, 659, 778, 898, 1018 and 1138 | Safety population: participants who were randomized and received at least 1 dose of study treatment or sham procedure. Number analyzed indicates participants who were evaluated for the specified time points. Due the early termination of Part 2, no participants in the ISIS 396443 Part 2(participants on sham in Part 1) were on study beyond Day 659. | cm | MEAN |
| PRIMARY | Change From Baseline in Weight for Age | Part 2: Baseline, Day 15, 29, 64, 183, 302, 422, 540, 659, 778, 898, 1018 and 1138 | Safety population: participants who were randomized and received at least 1 dose of study treatment or sham procedure. Number analyzed indicates participants who were evaluated for the specified time points. Due the early termination of Part 2, no participants in the ISIS 396443 Part 2(participants on sham in Part 1) were on study beyond Day 659. | kilogram (kg) | MEAN |
| PRIMARY | Change From Baseline in Weight | Part 2: Baseline, Day 15, 29, 64, 183, 302, 422, 540, 659, 778, 898, 1018 and 1138 | Safety population: participants who were randomized and received at least 1 dose of study treatment or sham procedure. Number analyzed indicates participants who were evaluated for the specified time points. Due the early termination of Part 2, no participants in the ISIS 396443 Part 2(participants on sham in Part 1) were on study beyond Day 659. | kg | MEAN |
| PRIMARY | Change From Baseline in Head to Chest Circumference (HCC) Ratio | Part 2: Baseline, Day 15, 29, 64, 183, 302, 422, 540, 659, 778, 898, 1018 and 1138 | Safety population: participants who were randomized and received at least 1 dose of study treatment or sham procedure. Number analyzed indicates participants who were evaluated for the specified time points. Due the early termination of Part 2, no participants in the ISIS 396443 Part 2(participants on sham in Part 1) were on study beyond Day 659. | ratio | MEAN |
| PRIMARY | Change From Baseline in Body Length | Part 2: Baseline, Day 15, 29, 64, 183, 302, 422, 540, 659, 778, 898, 1018 and 1138 | Safety population: participants who were randomized and received at least 1 dose of study treatment or sham procedure. Number analyzed indicates participants who were evaluated for the specified time points. Due the early termination of Part 2, no participants in the ISIS 396443 Part 2(participants on sham in Part 1) were on study beyond Day 659. | cm | MEAN |
| PRIMARY | Number of Participants With Change From Baseline in Neurological Examination Outcomes | Part 1: Baseline to Day 422; Part 2: Baseline to Day 596 | The safety population included all participants who were randomized and received at least 1 dose of study treatment or sham procedure. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Change From Baseline in Activated Partial Thromboplastin Time [aPTT] | Part 2: Up to 1080 days | The safety population included all participants who were randomized and received at least 1 dose of study treatment or sham procedure. Number analyzed indicates participants whose baseline value was not low (or high) and who had at least one post-baseline measurement. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Change From Baseline in Partial Thromboplastin Time [PTT] | Part 2: Up to 1080 days | The safety population included all participants who were randomized and received at least 1 dose of study treatment or sham procedure. Number analyzed indicates participants whose baseline value was not low (or high) and who had at least one post-baseline measurement. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Change From Baseline in International Normalized Ratio [INR]) | Part 2: Up to 1080 days | The safety population included all participants who were randomized and received at least 1 dose of study treatment or sham procedure. Number analyzed indicates participants whose baseline value was not low (or high) and who had at least one post-baseline measurement. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Presence of Urine Total Protein Post-baseline | Part 2: Up to 1080 days | The safety population included all participants who were randomized and received at least 1 dose of study treatment or sham procedure. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Plasma Concentration of ISIS 396443 in Part 2 of Study in Participants Who Received Sham Procedure in Part 1 of the Study | Pre-dose on Days 64, 183, 540 and 659 | The pharmacokinetic (PK) population included all participants who were randomized and have at least 1 evaluable post dose or post sham-procedure PK sample. | nanogram per milliliter (ng/mL) | MEAN |
| SECONDARY | Plasma Concentration of ISIS 396443 in Part 1 and 2 of Study in Participants Who Received ISIS 396443 in Part 1 of the Study | Pre-dose on Days 64, 183, 302, 422, 540, 659, 778, 898, 1018 and 1138 | The PK population included all participants who were randomized and have at least 1 evaluable post dose or post sham-procedure PK sample. Number analyzed indicates participants who were evaluated for the specified time points. | ng/mL | MEAN |
| SECONDARY | Cerebrospinal Fluid (CSF) Concentration of ISIS 396443 in Part 2 of Study in Participants Who Received Sham Procedure in Part 1 of the Study | Pre-dose on Days 15, 29, 64, 183, 302, 422 and 540 | The PK population included all participants who were randomized and have at least 1 evaluable post dose or post sham-procedure PK sample. Number analyzed indicates participants who were evaluated for the specified time points. | ng/mL | MEAN |
| SECONDARY | CSF Concentration of ISIS 396443 in Part 1 and 2 of Study in Participants Who Received ISIS 396443 in Part 1 of the Study | Pre-dose on Days 15, 29, 64, 183, 302, 422, 540, 659, 778, 898 and 1018 | The PK population included all participants who were randomized and have at least 1 evaluable post dose or post sham-procedure PK sample. Number analyzed indicates participants who were evaluated for the specified time points. | ng/mL | 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.
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