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Pridopidine in Amyotrophic Lateral Sclerosis (EAP 2) - Trial NCT06069934

Access comprehensive clinical trial information for NCT06069934 through Pure Global AI's free database. This phase not specified trial is sponsored by Prilenia and is currently Available. The study focuses on Amyotrophic Lateral Sclerosis.

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NCT06069934
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Trial Details
ClinicalTrials.gov โ€ข NCT06069934
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Pridopidine in Amyotrophic Lateral Sclerosis (EAP 2)
A Second Intermediate-Size Expanded Access Protocol (EAP) for Pridopidine in People With Amyotrophic Lateral Sclerosis (Pridopidine EAP 2)

Study Focus

Pridopidine

drug

Sponsor & Location

Prilenia

Timeline & Enrollment

N/A

N/A

N/A

Summary

This EAP will provide access to pridopidine for up to 200 patients with ALS who are
 ineligible for clinical trials. Pridopidine will be given at a dose of 45 mg twice daily p.o.
 (or via feeding tube).
 
 Each patient will be followed for 2 years with regularly scheduled visits. The screening and
 baseline visits will be performed in person; subsequent visits may occur in person or
 remotely. Recommended in-person visits will occur at Weeks 4, 12, 28, 52, 78, and end of
 treatment (Week 104 or early termination). If the patient is unable to complete the visits in
 person, these visits may also be completed remotely.

ICD-10 Classifications

Neuralgic amyotrophy
Motor neuron disease
Other degenerative diseases of the nervous system
Other degenerative disorders of nervous system in diseases classified elsewhere
Multiple sclerosis

Data Source

ClinicalTrials.gov

NCT06069934

Non-Device Trial