Trials / Completed
CompletedNCT02479802
Efficacy and Safety of Plasma Exchange With Albumin in Patients With Amyotrophic Lateral Sclerosis
Pilot Study on the Effects of Plasma Exchange on Motor Dysfunction and Cognitive Function in Patients With Amyotrophic Lateral Sclerosis
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 13 (actual)
- Sponsor
- Instituto Grifols, S.A. · Industry
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Albumin | 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 |
Timeline
- Start date
- 2014-11-01
- Primary completion
- 2016-06-01
- Completion
- 2016-06-01
- First posted
- 2015-06-24
- Last updated
- 2020-06-16
- Results posted
- 2020-06-16
Locations
1 site across 1 country: Spain
Source: ClinicalTrials.gov record NCT02479802. Inclusion in this directory is not an endorsement.