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Albumin

Phase 2

Amyotrophic Lateral Sclerosis | Monoclonal antibody | Neurology |Grifols, S.A.|Last Updated: Jun 16, 2020

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment13
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02479802Efficacy and Safety of Plasma Exchange With Albumin in Patients With Amyotrophic Lateral SclerosisPHASE2 COMPLETED 13 — — Nov 1, 2014Jun 1, 2016Jun 16, 20201 Spain
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Study Endpoints
Primary Endpoints
Changes From Baseline in the Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R)
Baseline, Weeks 4, 12, 25, 36, and 48

Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R) includes 12 questions classified into 3 subdomains: bulbar function (3 questions), fine and gross motor skills (6 questions), and respiratory function (3 questions) to assess the level self sufficiency. Each task was graded according to a 5-point scale from 0 (incapable) to 4 (normal ability) with a total score from 0 (worst) to 48 (best).

Changes From Baseline in Percent Predicted Forced Vital Capacity (FVC)
Baseline, Weeks 4, 12, 25, 36, and 48
Secondary Endpoints
Changes From Baseline in ALS Cognitive Function Determined by the ALS-Cognitive Behavioral Screen (ALS-CBS) Test
Baseline, Weeks 25 and 48
Motor Evoked Potential in Thenar and Hypothenar Eminence, and Anterior Tibialis Muscle
Baseline, Weeks 4, 12, 25, 36, and 48
Changes From Baseline in Amyotrophic Lateral Sclerosis Assessment Questionnaire 40 (ALSA-Q40).
Baseline, Weeks 25 and 48
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
AlbuminEXPERIMENTALPlasma exchange with Albumin
Interventions
NameTypeDescription
AlbuminBIOLOGICAL27 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
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Eligibility Criteria
Age Range18 Years — 70 Years
SexALL
Healthy VolunteersNo
Study Sites1

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 mon...

Countries:Spain
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