Clinical study to assess treatment effects of Cerebrolysin in amyotrophic lateral sclerosis

Add-on treatment with Cerebrolysin improves clinical symptoms in amyotrophic lateral sclerosis patients: results of a prospective, single-center, placebo-controlled, randomized, double-blind, Phase II study

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN38393880

Enrollment

Registered

2024-01-08

Start date

2021-07-29

Completion date

Unknown

Last updated

2024-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amyotrophic lateral sclerosis Nervous System Diseases Motor neuron disease

Interventions

Patients were randomized 1:1 to Cerebrolysin or placebo (0.9% NaCl). An Excel-generated randomization list was used with blocks of 10 patients to account for balancing the sample size. Patients recei

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Either sex and at least 18 years of age 2. Clinically definite diagnosis of ALS according to the El Escorial and revised Airlie House diagnostic criteria 3. Limb onset and/or bulbar onset with pyramidal signs 4. Modified Ashworth Spasticity Scale score of 3 5. Informed consent

Exclusion criteria

Exclusion criteria: 1. Co-morbidities such as hepatic disease, renal failure or severe renal impairment, coronary disease, epilepsy, Parkinson’s disease, or dementia 2. Any condition that might interfere with compliance with study procedures or influence outcome assessment 3. Pregnant or breastfeeding 4. Participation in another interventional study within the previous 2 months 5. Contraindication to Cerebrolysin 6. Concomitant use of ginkgo biloba, erythropoietin, citicoline, and amantadine

Design outcomes

Primary

Measure	Time frame
Functional impairment is measured using the Amyotrophic Lateral Sclerosis Functional Rating Scale – revised (ALSFRS-R) at baseline and month 1	—

Secondary

Measure	Time frame
1. Functional impairment is measured using the Amyotrophic Lateral Sclerosis Functional Rating Scale – revised (ALSFRS-R) at baseline to months 2 and 3 2. Depressive symptoms are measured using the Beck’s Depression Inventory-II (BDI-II) at baseline to months 1, 2, and 3 3. Spasticity is measured by the Modified Ashworth Scale (MAS) at baseline to months 1, 2, and 3 4. Gross motor skills are measured by the time taken to walk four meters, the walked distance in 120 seconds, and the number of knee bends to the opposite arm at baseline to months 1, 2, and 3 5. Hand strength is measured by an handheld dynamometer at baseline to months 1, 2, and 3	—

Measure

Time frame

1. Functional impairment is measured using the Amyotrophic Lateral Sclerosis Functional Rating Scale – revised (ALSFRS-R) at baseline to months 2 and 3 2. Depressive symptoms are measured using the Beck’s Depression Inventory-II (BDI-II) at baseline to months 1, 2, and 3 3. Spasticity is measured by the Modified Ashworth Scale (MAS) at baseline to months 1, 2, and 3 4. Gross motor skills are measured by the time taken to walk four meters, the walked distance in 120 seconds, and the number of knee bends to the opposite arm at baseline to months 1, 2, and 3 5. Hand strength is measured by an handheld dynamometer at baseline to months 1, 2, and 3

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Countries

Argentina

Contacts

Public ContactAlfredo José Firstenfeld

alfredo.firstenfeld@gmail.com+54 (0)11 4202-5925

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026