Trial · NCT01737398
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 19 of 19
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline In The Modified Neuropathy Impairment Score (mNIS) +7 Composite Score at Week 66 | Baseline and Week 66 | The mNIS+7 composite score is a measure of neurologic impairment that evaluates muscle weakness, sensation, reflexes, nerve conduction, and autonomic function. The mNIS+7 Composite Score has a range of -22.32 to 346.32 and a higher mNIS+7 composite score indicates lower function. |
| Primary | Change From Baseline In The Norfolk Quality Of Life Diabetic Neuropathy (QoL-DN) Questionnaire at Week 66 | Baseline and Week 66 | The Norfolk QoL-DN score is a measure of physical function/large fiber neuropathy, symptoms, activities of daily living, small fiber neuropathy, and autonomic neuropathy. The Norfolk QoL-DN total score has a range of -4 to 136, and a higher Norfolk QoL-DN score indicates poorer QoL. |
| Secondary | Change From Baseline In The Norfolk QoL-DN Questionnaire Symptoms Domain Score at Week 66 | Baseline and Week 66 | The Norfolk QoL-DN symptoms score is a sub-score of the total Norfolk QoL-DN Questionnaire. The Norfolk QoL-DN symptoms domain score has a range of 0-32, and a higher Norfolk QoL-DN score indicates poorer QoL. |
| Secondary | Change From Baseline In The Norfolk QoL-DN Questionnaire Physical Functioning/Large Fiber Neuropathy Domain Score at Week 66 | Baseline and Week 66 | The Norfolk QoL-DN physical functioning/large fiber neuropathy domain score is a sub-score of the total Norfolk QoL-DN Questionnaire. The Norfolk QoL-DN physical function/large fiber neuropathy domain score has a range of -4 to 56, and a higher Norfolk QoL-DN domain score indicates poorer QoL. |
| Secondary | Change From Baseline In Modified Body Mass Index (mBMI) at Week 65 | Baseline and Week 65 | The mBMI is the BMI multiplied by the serum albumin g/L |
| Secondary | Change From Baseline In Body Mass Index (BMI) at Week 65 | Baseline and Week 65 | |
| Secondary | Change From Baseline in Neuropathy Impairment Score (NIS) at Week 66 | Baseline and Week 66 | The NIS score is a measure of neurologic impairment. The NIS Score has a range of 0 to 244 and a higher NIS score indicates lower function. |
| Secondary | Change From Baseline in Modified +7 at Week 66 | Baseline and Week 66 | The Modified +7 score is a version of the NIS score that is a measure of neurologic impairment. The Modified +7 Score has a range of -22.32 to 102.32 and a higher NIS score indicates lower function. |
| Secondary | Change From Baseline in NIS+7 at Week 66 | Baseline and Week 66 | The NIS+7 score is a version of the NIS score that is a measure of neurologic impairment. The NIS+7 Score has a range of -26.04 to 270.04 and a higher NIS score indicates lower function. |
| Secondary | Change From Baseline in Global Longitudinal Strain (GLS) by Echocardiogram (ECHO) at Week 65 in the CM-ECHO Set | Baseline and Week 65 | GLS by ECHO is a measure of cardiac systolic function |
| Secondary | Change From Baseline in Global Longitudinal Strain (GLS) by Echocardiogram ECHO at Week 65 in the ECHO Subgroup | Baseline and Week 65 | GLS by ECHO is a measure of cardiac systolic function |
| Secondary | Change From Baseline in Transthyretin (TTR) Level at Week 65 | Baseline and Week 65 | |
| Secondary | Change From Baseline in Retinol Binding Protein 4 (RBP4) Level at Week 65 | Baseline and Week 65 | |
| Secondary | Maximum Measured Plasma Concentration (Cmax) Of Inotersen At Week 65 | Week 65 | |
| Secondary | Time To The Maximum Plasma Concentration (Tmax) Of Inotersen At Week 65 | Week 65 | |
| Secondary | Area Under The Plasma Concentration-time Curve From 0 To 24 Hours (AUC[0-24hr]) Of Inotersen At Week 65 | Week 65 | |
| Secondary | Area Under The Plasma Concentration-time Curve From 0 To 168 Hours (AUC[0-168hr]) Of Inotersen At Week 65 | Week 65 | |
| Secondary | Plasma Clearance From 0 To 24 Hours (CL[0-24hr]/F) Of Inotersen At Week 65 | Week 65 | |
| Secondary | Inotersen Plasma Clearance At Steady State (CLss/F) At Week 65 | Week 65 |
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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