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Antipsychotic

Group 1 Pimozide 2 mg (current) or 4 mg/day (study initiation) for Amyotrophic Lateral Sclerosis (Pimozide2 Trial)

Phase 2
Waitlist Available
Led By Lawrence Korngut, M.D.
Research Sponsored by University of Calgary
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline (week 2), at each of weeks 4,8,12,16,20, week 24 final study visit, and week 26 follow-up phone call. will also be done for a study drug withdrawal visit or if applicable, an edaravone initiation visit.
Awards & highlights

Pimozide2 Trial 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.

Eligible Conditions
  • Amyotrophic Lateral Sclerosis
  • Lou Gehrig's Disease

Pimozide2 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline (week 2), at each of weeks 4,8,12,16,20, week 24 final study visit, and week 26 follow-up phone call. will also be done for a study drug withdrawal visit or if applicable, an edaravone initiation visit.
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline (week 2), at each of weeks 4,8,12,16,20, week 24 final study visit, and week 26 follow-up phone call. will also be done for a study drug withdrawal visit or if applicable, an edaravone initiation visit. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in ALS Functional Rating Scale-Revised (ALSFRS-R)
Secondary outcome measures
Antilymphocyte Serum
Change in Common Terminology Criteria for Adverse Events (CTCAE) will be entered for each visit for adverse effect profile analysis
Change in Cramp Frequency and Severity
+3 more

Side effects data

From 2009 Phase 4 trial • 76 Patients • NCT00158223
4%
Severe EPS
4%
bleeding
4%
delirium
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Pimozide

Pimozide2 Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Group 1 Pimozide 2 mg (current) or 4 mg/day (study initiation)Experimental Treatment1 Intervention
Pimozide will be initiated at 2 mg once daily. The maximum dose will then be administered for a target period of 22 weeks.
Group II: Group 2 PlaceboPlacebo Group1 Intervention
Placebo tablets will be utilized and administered in an identical manner for subjects in Group 1

Find a Location

Who is running the clinical trial?

Brain CanadaOTHER
18 Previous Clinical Trials
5,938 Total Patients Enrolled
University of CalgaryLead Sponsor
792 Previous Clinical Trials
869,054 Total Patients Enrolled
3 Trials studying Amyotrophic Lateral Sclerosis
870 Patients Enrolled for Amyotrophic Lateral Sclerosis
ALS CanadaUNKNOWN

Frequently Asked Questions

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~13 spots leftby May 2025