Pilot study to evaluate the effect of plasma exchange with albumin in patients with amyotrophic lateral sclerosis

Phase 1

• Conditions: Amytrophic Lateral Sclerosis (ALS); MedDRA version: 16.1Level: PTClassification code 10002026Term: Amyotrophic lateral sclerosisSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2013-004842-40-ES
• Lead Sponsor: Instituto Grifols S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03-07
• Last Update Posted: 4 July 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

In order to be eligible for participation in the trial, the patients must meet the following requirements:
- Must give written informed consent.
- Age ?18 and <70 years.
- Subjects with diagnosis of definitive, posible and probable ALS according El Escorial-Arlie criteria.
- Subjects with ALS symptom onset < 18 months from recruitment.
- FVC > 70%.
- Be medically able to undergo study procedures and to comply with the visits schedule at the time of inclusion in the study.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients meeting any of the following criteria will not be able to participate in the trial:
- Subjects with a clinically significant preexisting lung disease not attributable to ALS.
- Subjects with a diagnosis of other neurodegenerative diseases or diseases associated with dysfunction of the motor neurons that can confuse the diagnosis of ALS.
- Participation in other clinical trials, or the reception of any other investigational drug in the six months prior to the start of the study.
- Female subjects who are pregnant, currently breastfeeding, or attempting to conceive during the study.
- Difficult peripheral venous access precluding plasma exchange and inability to implement a viable alternative catheter to make continued performing plasma exchange visits according to protocol
- Any contraindication for plasma exchange or abnormal coagulation parameters according clinical criteria from apheresis team (Banc de Sang i Teixits, BST Bellvitge).
- A history of frequent adverse reactions (serious or otherwise) to blood products.
- Hypersensitivity to albumin or allergies to any of the components of Albutein®.
- Subjects that can not interrupt treatment with acetylsalicylic acid or oral anticoaguants
- Plasma creatinine > 2mg/dl.
- Present a history of heart disease including ischemic heart disease or congestive heart failure.
- Presence of prior conduct disorders requiring pharmacologic intervention, with less than 3 months of stable treatment
- Any condition that complicates adherence to study protocol (illness with less than one year of expected survival , drug or alcohol abuse, etc.)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Evaluate the progress of the disease through functional scale (ALSFRS-R) and forced vital capacity (FVC) of patients with ALS treated with plasma exchange.;Secondary Objective: Evaluate the effect of plasma exchange in ALS-related:<br>- Cognitive dysfunction<br>- Systemic inflammatory response<br>- Oxidative Stress<br>- Non-directed metabolome profile<br>- Safety and tolerability;Primary end point(s): Change from baseline in the functional scale ALSFRS-R (ALS functional rating scale-revised)<br>Change from baseline in Forced Vital Capacity (FVC);Timepoint(s) of evaluation of this end point: ALSFRS-R (6 measurements: week 0, 4, 12, 25, 36 y 48). <br>FVC (6 measurements: week 0, 4, 12, 25 36 y 48).