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

Phase 2

Completed

• Conditions: Amyotrophic lateral sclerosis; Nervous System Diseases; Motor neuron disease

• Registration Number: ISRCTN38393880
• Lead Sponsor: Instituto Cardiológico Banfield

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2022-06-02
• Study Start: 2024-01-08
• Last Update Posted: 22 January 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 20

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
1. Functional impairment is measured using the Amyotrophic Lateral Sclerosis Functional Rating Scale – revised (ALSFRS-R) at baseline to months 2 and 3<br>2. Depressive symptoms are measured using the Beck’s Depression Inventory-II (BDI-II) at baseline to months 1, 2, and 3<br>3. Spasticity is measured by the Modified Ashworth Scale (MAS) at baseline to months 1, 2, and 3<br>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<br>5. Hand strength is measured by an handheld dynamometer at baseline to months 1, 2, and 3