Trial · NCT02579759
Outcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Neuropathy Limitation Scale (ONLS) Total Score | From Baseline to Month 15 | mFAS selection | Scores on the ONLS | MEAN |
| SECONDARY | Mean of Ten Meter Walking Test (10MWT) | From Baseline to Month 15 | mFAS selection | Seconds (s) | MEAN |
| SECONDARY | Mean of the CMTNS-v2 Sensory Score | From Baseline to Month 15 | mFAS selection | Scores on the CMTNS-v2 Sensory Score | MEAN |
| SECONDARY | Mean of the CMTNS-v2 Examination Score (CMTES-v2) | From Baseline to Month 15 | mFAS selection | Scores on the CMTES-v2 | MEAN |
| SECONDARY | Mean of the Results at the Nine-Hole Peg Test (9-HPT) | From Baseline to Month 15 | mFAS selection | Seconds (s) | MEAN |
| SECONDARY | Number of Subjects With at Least One TEAE | The period between the patient signing the informed consent and 30 days after the end of study (i.e. completion/early discontinuation/last contact as recorded on the 'Study Completion on Early Termination' form up to 15 months) | FAS selection | participants | NUMBER |
| SECONDARY | Incidence of AE Leading to Withdrawal of Study Drug | The period between the patient signing the informed consent and 30 days after the end of study (i.e. completion/early discontinuation/last contact as recorded on the 'Study Completion on Early Termination' form up to 15 months) | FAS selection | participants | NUMBER |
| SECONDARY | Incidence of SAEs | The period between the patient signing the informed consent and 30 days after the end of study (i.e. completion/early discontinuation/last contact as recorded on the 'Study Completion on Early Termination' form up to 15 months). | FAS selection | participants | NUMBER |
| OTHER_PRE_SPECIFIED | Mean of the CMTNS-v2 Sensory Symptoms | From Baseline to Month 15 | mFAS selection | Scores on the CMTNS-v2 Sensory Symptoms | MEAN |
| OTHER_PRE_SPECIFIED | Plasma Concentrations of Baclofen at Trough and at 90 Min After Drug Intake | At Month 12 and Month 15 | PP selection LLOQ = 30 pg/mL The placebo arm has not been described for this endpoint. | pg/mL | MEAN |
| OTHER_PRE_SPECIFIED | Plasma Concentrations of Naltrexone at Trough and at 90 Min After Drug Intake | At Month 12 and month 15 | PP selection LLOQ = 30 pg/mL The placebo arm has not been described for this endpoint. | pg/mL | MEAN |
| OTHER_PRE_SPECIFIED | Plasma Concentrations of 6β-naltrexol at Trough and at 90 Min After Drug Intake | At Month 12 and Month 15 | PP selection LLOQ = 50 pg/mL The placebo arm has not been described for this endpoint. | pg/mL | MEAN |
| OTHER_PRE_SPECIFIED | Number of Participants With ONLS Therapy Response 1 | From Baseline to Month 15 | Completers selection | Number of Participants | NUMBER |
| OTHER_PRE_SPECIFIED | Number of Participants With ONLS Therapy Response 2 | From Baseline to Month 15 | Completers selection | Number of Participants | NUMBER |
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.
Twenty rows a page, as JSON. No key.
GET https://conductscience.org/api/trials/v1/NCT02579759/outcomes