Trial · NCT04303416
Plasma Exchange With Albumin in AMN Patients
NCT04303416, Phase 2, Phase 3, Completed, Pujol, Aurora, M.D.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Plasma Exchange With Albumin in AMN Patients. Trials, record NCT04303416. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04303416
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Plasma Exchange With Albumin in AMN Patients
- NCT number
- NCT04303416
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 5 participants, actual
- Lead sponsor
- Pujol, Aurora, M.D.
- Conditions
- Adrenomyeloneuropathy, Adrenoleukodystrophy
- Interventions
- Albumin solution
- First posted
- 2020-03-11
- Last updated
- 2022-09-22
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Concentration of very long chain fatty acids | Change from baseline at 6 months | Concentration of C26:0, C24:0 fatty acids and C26:0/C22:0 ratio in plasma |
| Secondary | 2 Minute Walk Test | Months 0, 6 and 12 | It measures the distance an individual is able to walk over a total of two minutes on a hard, flat surface |
| Secondary | 6 Minute Walk Test | Months 0, 6 and 12 | It measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface |
| Secondary | Timed Up and Go (TUG) test | Months 0, 6 and 12 | It consists in standing up, walking 3 meters, turning around, walk back to the chair and sitting back down, at regular pace |
| Secondary | Time to walk 25 Feet (TW25) | Months 0, 6 and 12 | The patient should walk 7.62 meters (25 feet) as quickly, but safely, as possible without running |
| Secondary | Expanded disability status scale (EDSS) | Months 0, 6 and 12 | This scale measures motor function, ranging from 0 (normal neurological examination) to 10 (death) |
| Secondary | Ashworth scale | Months 0, 6 and 12 | The Modified Ashworth Scale measures spasticity in patients with lesions of the CNS or neurological disorders. It ranges from 0 (no increase in tone) to 4 (affected part(s) rigid in flexion or extension). |
| Secondary | SF-Qualiveen (Short-form Qualiveen) | Months 0, 6 and 12 | The Qualiveen is a specific patients' health-related quality of life developed to assess the impact of urinary disorders in patients with neurological conditions. Response options are framed as 5-point Likert-type scales, with 0 indicating no impact of urinary problems on health-related quality of life and 4 indicating a high adverse impact. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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 trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04303416
GET https://conductscience.org/api/trials/v1/NCT04303416/registered