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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02479802
• Date of registration: 10/06/2015
• Prospective Registration: No
• Primary sponsor: Instituto Grifols, S.A.
• Public title: Efficacy and Safety of Plasma Exchange With Albumin in Patients With Amyotrophic Lateral Sclerosis
• Scientific title: Pilot Study on the Effects of Plasma Exchange on Motor Dysfunction and Cognitive Function in Patients With Amyotrophic Lateral Sclerosis
• Date of first enrolment: November 2014
• Target sample size: 13
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02479802
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

Spain

Key inclusion & exclusion 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.)



Age minimum: 18 Years
Age maximum: 70 Years
Gender: All

Health Condition(s) or Problem(s) studied

Amyotrophic Lateral Sclerosis

Intervention(s)

Biological: Albumin

Primary Outcome(s)

Changes From Baseline in the Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R) [Time Frame: Baseline, Weeks 4, 12, 25, 36, and 48]

Changes From Baseline in Percent Predicted Forced Vital Capacity (FVC) [Time Frame: Baseline, Weeks 4, 12, 25, 36, and 48]

Secondary Outcome(s)

Changes From Baseline in ALS Cognitive Function Determined by the ALS-Cognitive Behavioral Screen (ALS-CBS) Test [Time Frame: Baseline, Weeks 25 and 48]

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: During the Treatment Phase (24 weeks)]

Changes From Baseline in Amyotrophic Lateral Sclerosis Assessment Questionnaire 40 (ALSA-Q40). [Time Frame: Baseline, Weeks 25 and 48]

Motor Evoked Potential in Thenar and Hypothenar Eminence, and Anterior Tibialis Muscle [Time Frame: Baseline, Weeks 4, 12, 25, 36, and 48]

Secondary ID(s)

IG1309

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 16/06/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02479802