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Trial record 78 of 677 for:    amyotrophic lateral sclerosis

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02479802
Recruitment Status : Completed
First Posted : June 24, 2015
Last Update Posted : February 14, 2018
Information provided by (Responsible Party):
Grifols Biologicals, LLC ( Instituto Grifols, S.A. )

Brief 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).

Condition or disease Intervention/treatment Phase
Amyotrophic Lateral Sclerosis Biological: Albumin Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study on the Effects of Plasma Exchange on Motor Dysfunction and Cognitive Function in Patients With Amyotrophic Lateral Sclerosis
Study Start Date : November 2014
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Arm Intervention/treatment
Experimental: Albumin
Plasma exchange with Albumin
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
Other Names:
  • Human Albumin 5%
  • Albutein 5%

Primary Outcome Measures :
  1. Evaluate disease progression by changes from baseline in the ALS Functional Rating Scale Revised (ALSFRS-R) [ Time Frame: 1 year ]
  2. Evaluate disease progression by changes from baseline in Forced Vital Capacity (FVC) [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Changes from baseline in ALS cognitive function determined by the ALS-Cognitive Behavioral Screen (ALS-CBS) test [ Time Frame: 1 year ]
  2. Changes from baseline in electromyography profile by assessing the motor evoked potential in thenar and hypothenar eminence, and anterior tibialis muscle [ Time Frame: 1 year ]
  3. Evaluation of quality of life using the changes from baseline in ALS assessment questionnaire 40 (ALSAQ40). [ Time Frame: 1 year ]
  4. Changes from baseline in albumin functional capacity in plasma samples [ Time Frame: 1 year ]
  5. Changes from baseline in plasma cytokine panel [ Time Frame: 1 year ]
  6. Changes from baseline in cerebrospinal fluid cytokine panel [ Time Frame: 1 year ]
  7. Changes from baseline in plasma oxidative stress parameters such as hydroxynonenal, neuroketal, malondialdehyde-lysine and nitrotyrosine [ Time Frame: 1 year ]
  8. Changes from baseline in cerebrospinal fluid oxidative stress parameters such as glutamic semialdehyde, carboxymethyl lysine, carboxymethyl lysine and malondialdehyde-lysine [ Time Frame: 1 year ]
  9. Changes from baseline in non-directed metabolome profile in plasma samples [ Time Frame: 1 year ]
  10. Changes from baseline in non-directed metabolome profile in cerebrospinal fluid samples [ Time Frame: 1 year ]
  11. Percentage of plasma exchange sessions associated with one adverse event or adverse reaction, including clinically significant changes in vital signs or lab parameters [ Time Frame: 1 year ]

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02479802

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Hospital Universitari Bellvitge
Hospitalet de Llobregat, Barcelona, Spain, 08907
Sponsors and Collaborators
Instituto Grifols, S.A.

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Responsible Party: Instituto Grifols, S.A. Identifier: NCT02479802     History of Changes
Other Study ID Numbers: IG1309
First Posted: June 24, 2015    Key Record Dates
Last Update Posted: February 14, 2018
Last Verified: February 2018
Keywords provided by Grifols Biologicals, LLC ( Instituto Grifols, S.A. ):
plasma exchange
Additional relevant MeSH terms:
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Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases