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Efficacy and Safety of Plasma Exchange With Albumin in Patients With Amyotrophic Lateral Sclerosis

Information source: Grifols Biologicals Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Amyotrophic Lateral Sclerosis

Intervention: Albumin (Biological)

Phase: Phase 2

Status: Recruiting

Sponsored by: Instituto Grifols, S.A.

Overall contact:
Miquel Barcelo, PhD, Email: miquel.barcelo@grifols.com

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).

Clinical Details

Official title: Pilot Study on the Effects of Plasma Exchange on Motor Dysfunction and Cognitive Function in Patients With Amyotrophic Lateral Sclerosis

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

Evaluate disease progression by changes from baseline in the ALS Functional Rating Scale Revised (ALSFRS-R)

Evaluate disease progression by changes from baseline in Forced Vital Capacity (FVC)

Secondary outcome:

Changes from baseline in ALS cognitive function determined by the ALS-Cognitive Behavioral Screen (ALS-CBS) test

Changes from baseline in electromyography profile by assessing the motor evoked potential in thenar and hypothenar eminence, and anterior tibialis muscle

Evaluation of quality of life using the changes from baseline in ALS assessment questionnaire 40 (ALSAQ40).

Changes from baseline in albumin functional capacity in plasma samples

Changes from baseline in plasma cytokine panel

Changes from baseline in cerebrospinal fluid cytokine panel

Changes from baseline in plasma oxidative stress parameters such as hydroxynonenal, neuroketal, malondialdehyde-lysine and nitrotyrosine

Changes from baseline in cerebrospinal fluid oxidative stress parameters such as glutamic semialdehyde, carboxymethyl lysine, carboxymethyl lysine and malondialdehyde-lysine

Changes from baseline in non-directed metabolome profile in plasma samples

Changes from baseline in non-directed metabolome profile in cerebrospinal fluid samples

Percentage of plasma exchange sessions associated with one adverse event or adverse reaction, including clinically significant changes in vital signs or lab parameters

Eligibility

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Signed written-informed consent.

- Subjects over 18 years of age, and less than 70 years old.

- Subjects with a definite, possible, or probable diagnosis of ALS, according to the

revised El Escorial criteria.

- Subjects having experienced their first ALS symptoms within 18 months before

recruitment/consent.

- FVC > 70%

- Subjects must be medically suitable for study participation and of complying with

all planned aspects of the protocol including blood sampling at the time of inclusion in the study. Exclusion Criteria:

- 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

- 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

anticoagulants

- 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.)

Locations and Contacts

Miquel Barcelo, PhD, Email: miquel.barcelo@grifols.com

Hospital Universitari Bellvitge, Hospitalet de Llobregat, Barcelona 08907, Spain; Recruiting
Monica Povedano, MD, Principal Investigator
Additional Information

Starting date: November 2014
Last updated: June 19, 2015

Page last updated: August 23, 2015

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