Pridopidine in Amyotrophic Lateral Sclerosis (EAP 2)

Amyotrophic Lateral Sclerosis Clinical Trial

Official title:

A Second Intermediate-Size Expanded Access Protocol (EAP) for Pridopidine in People With Amyotrophic Lateral Sclerosis (Pridopidine EAP 2)

Clinical Trial Details — Status: Available

Administrative data

• NCT number: NCT06069934
• Other study ID #: PL101-ALS501
• Status: Available

Study information

• Verified date: November 2023
• Source: Prilenia
• Contact: Victoria Wang
• Phone: +1-857-282
• Email: vjwang[@]mgh.harvard.edu
• Is FDA regulated: No
• Study type: Expanded Access

Clinical Trial 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.

Recruitment information / eligibility

• Status: Available
• Enrollment: 0
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Sporadic or familial ALS.
• Patient does not qualify for clinical trials of pridopidine or other clinical trials for the treatment of ALS at the enrolling site
• Capable of providing informed consent and complying with study procedures
• Patient has established care with a physician at the specialized ALS center involved in the study and will maintain this clinical care throughout the duration of the EAP
• Life expectancy of at least 6 months.

Exclusion Criteria:

• Confirmed prolonged Fridericia-corrected QT (QTcF) interval (>450 ms for men; >470 ms for women).
• Clinically significant heart disease, clinically significant history of arrhythmia, symptomatic or uncontrolled atrial fibrillation despite treatment, asymptomatic sustained ventricular tachycardia, or left bundle branch block.
• Known history of long QT syndrome or a first degree relative with long QT syndrome.
• Use of Nuedexta (>20 mg dextromethorphan and >10 mg quinidine twice daily); citalopram >20 mg/day; escitalopram >10 mg/day.
• Known allergy to pridopidine or any of the exipients (silicified microcrystalline cellulose, magnesium stearate).
• History of any clinically significant or unstable medical condition or laboratory abnormality that may interfere with assessment of the study objectives.
• Female who is pregnant or nursing or who plans to get pregnant during the course of the EAP
• Female of child-bearing potential or male unwilling or unable to use accepted methods of birth control.
• Use of investigational treatments for ALS (as part of participation in a clinical trial or another EAP) within 5 half-lives (if known) or 30 days (whichever is longer) prior to screening (other than pridopidine).
• Patient receives or has received any gene therapy
• Active cancer or history of cancer, except for basal cell carcinoma or successfully treated squamous cell carcinoma of the skin, cervical carcinoma in situ, prostatic carcinoma in situ, or other malignancies curatively treated and with no evidence of disease recurrence for at least 3 years
• Patients who chose to take experimental medications and/or supplements, and for whom this is the only reason they are not eligible for trials.

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Motor Neuron Disease
• Sclerosis

Intervention

Drug:
• Pridopidine
Pridopidine 45 mg once daily p.o. (or via feeding tube) over a 2-week up-titration period; followed by pridopidine 45 mg twice daily p.o. (or via feeding tube) for the remainder of the treatment period (through Week 104)

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
Prilenia	Massachusetts General Hospital, National Institute of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH)