← Back to Search

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

Study Summary

This trial is testing a new medication to see if it can help people with Parkinson's disease by reducing their symptoms without causing troublesome side effects.

Eligible Conditions

Parkinson's Disease

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to end of treatment (week 12)

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

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

Parkinsonism

Fall

Dyskinesia

100%

80%

60%

40%

20%

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Integrative Research Laboratories ABLead Sponsor

3 Previous Clinical Trials

255 Total Patients Enrolled

Joakim TedroffStudy DirectorIntegrative Research Laboratories AB (IRLAB)

1 Previous Clinical Trials

165 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are researchers still signing up patients for this clinical trial?

"At the moment, this clinical trial is not looking for new participants. The first posting was on October 29th 2020 and there have been no updates as of September 12th 2022. However, if you are still interested in participating in research, 539 trials for patients with parkinson disease and 1 study concerning Mesdopetam are currently enrolling individuals."

Answered by AI

Which patients would be a good match for this clinical research?

"The requirements for potential candidates are that they currently suffer from parkinson disease, and are between the ages of 30-79. So far, the study has recruited 156 individuals."

Answered by AI

Does the age limit for this experiment extend below 75 years old?

"The target patient population for this trial are individuals that are between the ages of 30 to 79."

Answered by AI

Has this sort of medical experiment been conducted before?

"Mesdopetam has been under clinical observation since 2020. The first trial, sponsored by Integrative Research Laboratories AB, involved 156 patients. After successful completion of Phase 2 drug approval stage in 2020, there is only one active trial for Mesdopetam today."

Answered by AI

Has Mesdopetam completed the approval process with the United States Federal Drug Administration?

"Since there is only some data supporting safety, and no efficacy data available, Mesdopetam was given a score of 2."

Answered by AI

Could you please compare and contrast other scientific research projects that have used Mesdopetam?

"Mesdopetam was first trialled in 2020 at Centrum Medyczne NeuroProtect. To date, there have been 18291 completed studies. right now, 1 live trial is underway with several others being conducted in Miami, Florida."

Answered by AI

Are there any participating institutions in North America for this clinical trial?

"There are a total of 14 clinical trial sites currently up and running, with locations in Miami, Boca Raton, Tulsa, and 11 other cities."

Answered by AI

How many people are receiving care through this experiment?

"At this time, patients can no longer join this trial as it is not recruiting. The study was first made public on October 29th 2020 and updated September 12th 2022. 539 clinical trials for parkinson disease and 1 trial for Mesdopetam are still currently enrolling participants."

Answered by AI

Recent research and studies

Journal of Pharmacology and Experimental TherapeuticsJournal

Preclinical Pharmacology of [2-(3-fluoro-5-methanesulfonyl-phenoxy)ethyl](propyl)amine (IRL790), a Novel Dopamine Transmission Modulator for the Treatment of Motor and Psychiatric Complications in Parkinson Disease

Waters, Susanna, Clas Sonesson, Peder Svensson, Joakim Tedroff, Manolo Carta, Elisabeth Ljung, Jenny Gunnergren, et al.. 2020. “Preclinical Pharmacology of [2-(3-fluoro-5-methanesulfonyl-phenoxy)ethyl](propyl)amine (IRL790), a Novel Dopamine Transmission Modulator for the Treatment of Motor and Psychiatric Complications in Parkinson Disease”. Journal of Pharmacology and Experimental Therapeutics. American Society for Pharmacology & Experimental Therapeutics (ASPET). doi:10.1124/jpet.119.264226.

npj Parkinson's DiseaseJournal

Safety and Tolerability of IRL790 in Parkinson’s Disease with Levodopa-induced Dyskinesia—a Phase 1b Trial

Svenningsson, Per, Anders Johansson, Dag Nyholm, Panagiota Tsitsi, Fredrik Hansson, Clas Sonesson, and Joakim Tedroff. 2018. “Safety and Tolerability of IRL790 in Parkinson’s Disease with Levodopa-induced Dyskinesia—a Phase 1b Trial”. Npj Parkinson's Disease. Springer Science and Business Media LLC. doi:10.1038/s41531-018-0071-3.

Journal of Pharmacology and Experimental TherapeuticsJournal

Effects of a Novel Psychomotor Stabilizer, IRL790, on Biochemical Measures of Synaptic Markers and Neurotransmission

Becanovic, Kristina, Maria Vittoria de Donno, Vasco C. Sousa, Joakim Tedroff, and Per Svenningsson. 2020. “Effects of a Novel Psychomotor Stabilizer, IRL790, on Biochemical Measures of Synaptic Markers and Neurotransmission”. Journal of Pharmacology and Experimental Therapeutics. American Society for Pharmacology & Experimental Therapeutics (ASPET). doi:10.1124/jpet.119.264754.

clinicaltrials.govStudy