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Mesdopetam for Parkinson's Disease

Phase 2
Waitlist Available
Research Sponsored by Integrative Research Laboratories AB
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 baseline to end of treatment (week 12)
Awards & highlights

Summary

This trial is testing mesdopetam, a medication, to help people with Parkinson's disease. The goal is to see if it can increase the time patients feel well without experiencing troublesome movements. Patients will take the medication for a few months, and their symptoms will be closely monitored. Mesdopetam is a new treatment developed for managing complications of Parkinson's disease therapy, such as involuntary movements and psychosis.

Eligible Conditions
  • Parkinson's Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to end of treatment (week 12)
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to end of treatment (week 12) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Average Daily Hours of ON-time Without Troublesome Dyskinesia With Mesdopetam Compared to Placebo as Assessed With 24-hour Patient Home Diaries From Baseline to End of Treatment.
Secondary study objectives
Change From Baseline in Average Daily Hours of OFF-time (With Mesdopetam Compared to Placebo).
Change From Baseline in Mean Score of Disability Associated With ON-phase Dyskinesia Assessed With the Sum Score of Parts 1b and 4 of the Unified Dyskinesia Rating Scale (UDysRS), With Mesdopetam Compared to Placebo.
Change From Baseline in Mean Score of Motor Symptoms of PD Assessed With MDS-UPDRS Total Score of Part 2 (M-EDL) (With Mesdopetam Compared to Placebo)
+1 more

Side effects data

From 2022 Phase 2 trial • 155 Patients • NCT04435431
11%
Mobility decreased
5%
Parkinsonism
3%
Fall
3%
Dyskinesia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Mesdopetam 5 mg
Mesdopetam 7.5 mg
Mesdopetam 2.5 mg
Placebo

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: Mesdopetam dose 3Experimental Treatment1 Intervention
Mesdopetam capsule (mg), dose 3, 1 capsule b.i.d. for 84 days.
Group II: Mesdopetam dose 2Experimental Treatment1 Intervention
Mesdopetam capsule (mg), dose 2, 1 capsule b.i.d. for 84 days.
Group III: Mesdopetam dose 1Experimental Treatment1 Intervention
Mesdopetam capsule (mg), dose 1, 1 capsule b.i.d. for 84 days.
Group IV: PlaceboPlacebo Group1 Intervention
Placebo capsule, 1 capsule b.i.d. for 84 days
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mesdopetam
2020
Completed Phase 2
~160

Find a Location

Who is running the clinical trial?

Integrative Research Laboratories ABLead Sponsor
4 Previous Clinical Trials
337 Total Patients Enrolled
Joakim TedroffStudy DirectorIntegrative Research Laboratories AB (IRLAB)
1 Previous Clinical Trials
165 Total Patients Enrolled
~32 spots leftby Sep 2025