Trial · NCT03023540
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 15 of 15
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence of treatment-emergent adverse events (TEAEs) related to PXT3003 during the follow-up in patients with CMT1A | 9 or 24 months | Incidence of treatment-emergent adverse events (TEAEs) related to PXT3003 during the follow-up in patients with CMT1A |
| Secondary | Incidence of all TEAEs and their evaluation of type/nature, severity/intensity, seriousness, duration, relationship to study drug, and outcome | 9 or 24 months | Incidence of all TEAEs and their evaluation of type/nature, severity/intensity, seriousness, duration, relationship to study drug, and outcome |
| Secondary | Incidence of adverse events leading to withdrawal of study drug | 9 or 24 months | Incidence of adverse events leading to withdrawal of study drug |
| Secondary | Overall Neuropathy Limitation Scale (ONLS) score, and its arm and leg sub-items | 9 or 24 months | Overall Neuropathy Limitation Scale (ONLS) score, and its arm and leg sub-items |
| Secondary | Charcot-Marie-Tooth Neuropathy Score - version 2 (CMTNS-V2), and its sub-items | 9 or 24 months | Charcot-Marie-Tooth Neuropathy Score - version 2 (CMTNS-V2), and its sub-items |
| Secondary | Nine-hole Peg Test (9-HPT) | 9 or 24 months | Nine-hole Peg Test (9-HPT) |
| Secondary | Quantified Muscular Testing (QMT) by hand grip and foot dorsiflexion dynamometry (mean of both sides) | 9 or 24 months | Quantified Muscular Testing (QMT) by hand grip and foot dorsiflexion dynamometry (mean of both sides) |
| Secondary | Time to walk 10 meters | 9 or 24 months | Time to walk 10 meters |
| Secondary | Compound Muscle Action Potential (CMAP) on ulnar nerve | 9 or 24 months | Compound Muscle Action Potential (CMAP) on ulnar nerve |
| Secondary | Sensory Nerve Action Potential (SNAP) on radial nerve | 9 or 24 months | Sensory Nerve Action Potential (SNAP) on radial nerve |
| Secondary | Nerve conduction velocity (NCV) | 9 or 24 months | Nerve conduction velocity (NCV) |
| Secondary | Quality of Life (EQ-5D) | 9 or 24 months | Quality of Life (EQ-5D) |
| Secondary | Visual analog scale on self-assessment of individualized main impairment in daily activities (defined at baseline with the patient) | 9 or 24 months | Visual analog scale on self-assessment of individualized main impairment in daily activities (defined at baseline with the patient) |
| Other | Through plasma concentration of PXT3003 | at month 6 and 9 | Measurement of baclofen, naltrexone and 6-beta-naltrexone plasma concentration at the through |
| Other | Peak plasma concentration of PXT3003 | at month 6 and 9 | Measurement of baclofen, naltrexone and 6-beta-naltrexone plasma concentration at the through |
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/NCT03023540/registered