At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 13 enrolled
Drug / intervention
Albuminbiological
Likely dose
Albumin 3000 mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Pilot Study on the Effects of Plasma Exchange on Motor Dysfunction and Cognitive Function in Patients With Amyotrophic Lateral Sclerosis
In Brief
A Phase 2 clinical trial evaluating Albumin for Amyotrophic Lateral Sclerosis. Completed, enrolled 13 participants across 1 site.
Detailed Summary
Pilot, phase II, prospective, open-label, uncontrolled study of plasma exchange with 5% albumin in 10 subjects having a definite, possible, or probable diagnosis of Amyotrophic Lateral Sclerosis (ALS).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAmyotrophic Lateral Sclerosis
CountriesSpain
Collaborators--
Timeline
Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
Enrollment StartNov 2014
First PostedJun 2015
Primary CompletionJun 2016
TodayJul 2026
First PostedJun 24, 2015
Enrollment StartNov 1, 2014
Primary CompletionJun 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 11.0 years ago
Interventions
Albuminbiological
27 plasma exchange procedures using Albumin 5% (estimated 3000 mL per plasma exchange) as replacement solution: * three weeks of intensive treatment with two plasma exchanges per week * twenty-one weeks of maintenance treatment with one weekly plasma exchange