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A Clinical Trial of Pimozide in Patients With Amyotrophic Lateral Sclerosis (ALS)

NCT03272503 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2020-05-28

No results posted yet for this study

Summary

This study will look at whether Pimozide may help to slow the progression of Amyotrophic Lateral Sclerosis.

100 people from several Canadian centres with ALS who have provided their consent will be randomly assigned into one of 2 groups. The first group will receive a dose of up to 2mg of Pimozide per day and the second group will receive placebo (lactose tablets). Subjects will be assigned randomly (like by a flip of a coin) to receive either Pimozide 2 mg per day or placebo tablets. There will be a fifty-fifty chance of receiving Pimozide or placebo.

Participants will be on study medication up to 22 weeks, and on study up to 26 weeks. There are 8 clinic visits and 1 phone visit over the course of the Treatment Phase of the study. The second phase which is Observational, is optional with follow-up for up to 5 years from the end of the Treatment Phase.

Conditions

Interventions

DRUG

Pimozide 2mg/day (current) or 4 mg/day (study initiation)

Pimozide 2mg tablets will be taken once daily.

DRUG

Placebo Oral Tablet

Identical matching placebo lactose tablets

Sponsors & Collaborators

  • ALS Canada

    collaborator UNKNOWN

  • Brain Canada

    collaborator OTHER

  • University of Calgary

    lead OTHER

Principal Investigators

  • Lawrence Korngut, M.D. · University of Calgary and Alberta Health Services

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-27
Primary Completion
2020-12-31
Completion
2020-12-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03272503 on ClinicalTrials.gov