Parkinson DiseasePhase 2NCT04435431
A Clinical Study of Mesdopetam in Patients With Parkinson's Disease Experiencing Levodopa Induced Dyskinesia
A Phase 2 study testing Mesdopetam in people with Parkinson Disease, run by Integrative Research Laboratories AB at 44 sites in 6 countries.
Trial summary
This is a Phase 2b study investigating the efficacy and safety of mesdopetam as adjunct therapy on daily ON-time without troublesome dyskinesia in patients with Parkinson disease. Mesdopetam is taken for 84 days. Read more about this study
- Who is it for?
- Ages 30 to 79 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Mesdopetam
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 155 participants
- Where
- 44 sitesin 6 countries
- Study dates
- 29 Oct 2020to 9 Dec 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female ≥30 and ≤79 years of age at the time of screening.
- Signed a current Ethics Committee approved informed consent form (ICF).
- PD, per UK Parkinson's Disease Society (UKPDS) Brain Bank Clinical Diagnostic Criteria.
- Minimal amount of 2 hours of levodopa-induced daily "ON-time with troublesome dyskinesia" during waking hours
- Functional impact of dyskinesias determined as a score of ≥2 as per Question 4.2 of the MDS-UPDRS.
- On a stable regimen of antiparkinson medications for at least 30 days prior to first home diary completion which must include a levodopa preparation administered 3-8 times/day (excluding nighttime levodopa) and willing to continue the same doses and regimens during study participation. Rescue medications such as Madopar dispersable and Apomorphine injections are allowed if prescribed PRN prior to study entry.
- Any other current and allowed prescription/non-prescription medications and/or nutritional supplements taken regularly must have been at a stable dose and regimen for at least 30 days prior to first home diary completion and the patient must be willing to continue the same doses and regimens during study participation (this criterion does not apply to medications that are being taken pre-study only on an as-needed basis).
- Able to complete 24-hour patient home diaries of which two valid diaries must be presented at visit 1.
Who cannot join
- History of neurosurgical intervention related to PD (e.g. deep brain stimulation).
- Treatment with pump delivered antiparkinsonian therapy (i.e. subcutaneous apomorphine or levodopa/carbidopa intestinal infusion).
- History of seizures within two years prior to screening.
- History of stroke or transient ischemic attack (TIA) within two years prior to screening.
- History of cancer within five years prior to screening, with the following exceptions: adequately treated non-melanomatous skin cancers, localized bladder cancer, non metastatic prostate cancer or in situ cervical cancer.
- Presence of cognitive impairment, as evidenced by a Mini-Mental State Examination (MMSE) score of less than 24 during screening.
Show all 19Show fewer
- A Hoehn and Yahr stage of 5.
- Ongoing treatment with amantadine at time of screening or within 6 weeks prior first home diary completion.
- Treatment with Inbrija (levodopa inhalation powder) at time of screening or within 4 weeks prior first home diary completion.
- Any history of a significant heart condition or cardiac arrhythmias within the past 5 years, any repolarisation deficits or any other clinically significant abnormal ECG as judged by the Investigator.
- Severe or ongoing unstable medical condition including a history of poorly controlled diabetes; obesity associated with metabolic syndrome; uncontrolled hypertension; cerebrovascular disease, or any form of clinically significant cardiac disease, clinically significant symptomatic orthostatic hypotension (a fall and/or a discomfort); clinically significant hepatic disease, severe renal impairment, i.e. creatinine clearance <30 mL/min (stage IV or V).
- Any history of a neurological disorder other than PD or a psychiatric disorder, including history of Diagnostic and Statistical Manual of Mental Disorders (DSM) IV diagnosed major depression or psychosis. Patients with illusions or hallucinations with no loss of insight will be eligible. Patients with mild depression who are well controlled on a stable dose of an antidepressant medication for at least 4 weeks before screening will be eligible.
- Enrolment in any other clinical study involving medication, medical devices or surgical procedures, current or within three months prior to screening visit, or previous participation in the present study. Patients enrolled in non-interventional clinical trials will be eligible.
- Drug and/or alcohol abuse.
- History of severe drug allergy or hypersensitivity.
- If female, is pregnant or lactating, or has a positive pregnancy test result pre-dose.
- Patients unwilling to use two forms of contraception (one of which being a barrier method (see Section 8.1) during the treatment period and 90 days for men and 30 days for women after last IMP dose.
- Any planned major surgery within the duration of the study.
- Any other condition or symptoms preventing the patient from entering the study, according to the Investigator's judgement.
Trial locations and contacts
44 sites in 6 countries.
44 sites in 6 countries
United States14 sites
Parkinson's Disease and Movement Disorders Center of Boca Raton
Boca Raton, Florida, 33486
Colorado Springs Neurological Associates
Colorado Springs, Colorado, 80907
University of Texas Southwestern Medical Center
Dallas, Texas, 75390
NeuroStudies.net, LLC
Decatur, Georgia, 30030
University of Kentucky, Department of Neurology
Lexington, Kentucky, 40536
Collaborative Neuroscience Research (CNS Research)
Long Beach, California, 90806
Avantis Clinical Research
Miami, Florida, 33155
Elias Research Associates (Allied Biomedical Research Institute)
Miami, Florida, 33155
Pharmax Research of South Florida, Inc.
Miami, Florida, 33175
Life Medical Research Group Corp
Miami Gardens, Florida, 33014
Parkinson's Disease and Movement Disorders Center of Silicon Valley
Palo Alto, California, 94301
Movement Disorders Center of Arizona
Scottsdale, Arizona, 85258
Inland Northwest Research
Spokane, Washington, 99202
The Movement Disorder Clinic of Oklahoma
Tulsa, Oklahoma, 74136
Poland10 sites
Centrum Medyczne Neuromed
Bydgoszcz, 85-163
Specjalistyczna Praktyka Lekarska
Katowice, 40-097
Centrum Medyczne PLEJADY
Krakow, 30-363
Specjalistyczne Gabinety Sp z o.o.
Krakow, 30-539
Krakowska Akademia Neurologii
Krakow, 31-505
Instytut Zdrowia
Oświęcim, 32-600
Neuro-Care
Siemianowice Śląskie, 41-100
Centrum Medyczne NeuroProtect
Warsaw, 01-684
Next Stage sp.z o.o.
Warsaw, 02-042
ClinHouse Centrum Medyczne
Zabrze, 41-807
France6 sites
Centre Hospitalier Regional Universitaire de Lille
Lille, 59037
CHU Dupuytren 1 - Neurologie
Limoges, 87042
CHU Carémeau
Nîmes, 30029
CHU de Poitiers
Poitiers, 86021
CHU Rennes-Pontchaillou
Rennes, 35033
CHU Charles Nicolle; Service de Neurologie
Rouen, 76031
Israel5 sites
Rambam Health Care Campus, Department of Neurology
Haifa, 3109601
Hadassah University Hospital-Ein Kerem, Department of Neurology
Jerusalem, 9112001
Rabin Medical Centre - Beilinson Hospital, Department of Neurology
Petah Tikva, 4941492
The Chaim Sheba Medical Centre, Department of Neurology
Ramat Gan, 5265601
Tel Aviv Sourasky Medical Centre; Movement Disorders Unit
Tel Aviv, 6423906
Italy5 sites
IRCCS - Ospedale "San Martino"
Genova, 16132
Azienda Ospedaliera di Padova
Padova, 35128
IRCCS San Raffaele Pisana
Roma, 00163
Fondazione Policlinico Gemelli IRCCS
Roma, 00168
AOU San Giovanni di Dio e Ruggi d'Aragona, Clinica Neurologica
Salerno, 84131
Serbia4 sites
Clinical Hospital Center Zvezdara, Clinical department of Neurology
Belgrade, 11000
University Clinical Center of Serbia, Clinic for Neurology
Belgrade, 11000
University Clinical Center Kragujevac, Clinic for Neurology (Site 601)
Kragujevac, 34000
University Clinical Center Kragujevac, Clinic for Neurology (Site 602)
Kragujevac, 34000
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Phase IIB Study Evaluating the Efficacy of Mesdopetam on Daily ON-time Without Troublesome Dyskinesia in Patients With Parkinson's Disease
This is a Phase 2b study investigating the efficacy and safety of mesdopetam as adjunct therapy on daily ON-time without troublesome dyskinesia in patients with Parkinson disease. Mesdopetam is taken for 84 days.
Read the detailed description
At the screening visit consenting patients will be screened for eligibility according to study specific inclusion/exclusion criteria within 8 weeks before start of Investigational Medicinal Product (IMP) administration. A diary concordance training will be performed and following the screening visit the patient will be asked to self-administer three 24-hour home diaries and to bring the completed diaries to the baseline visit for assessment prior randomization.
At the baseline visit, patients will be randomized to receive one of three doses of mesdopetam (dose 1, dose 2 and dose 3) or placebo b.i.d.
During the first week a dose run-in phase will take place, where all patients allocated to mesdopetam will receive a run-in dose of mesdopetam twice daily and patients allocated to placebo will receive placebo twice daily. At Visit 2, patients will receive mesdopetam dose 1, dose 2 or dose 3 or placebo b.i.d., as randomized and continue the same dose for the rest of the treatment period until end of treatment (EOT). Dose reductions are restricted and the dose can only be reduced once. Dose reductions are permitted from visit 2 (day 9) until visit 3 (day 28), where after the dose should be kept stable until EOT.
The treatment allocation will be double-blind, i.e. it will not be disclosed to the patients, the site staff or the Sponsor.
During the treatment period, changes in disease state and ON phase dyskinesia will be assessed using the Movement Disorder Society revised Unified Parkinson's Disease Rating Scale (MDS-UPDRS), the modified Unified Dyskinesia Rating Scale (UDysRS), i.e. parts 1, 3 and 4, and Clinician's Global Impression of Severity (CGI-S). Furthermore, patients will self-administer three 24-hour home diaries prior to visit 3 (week 4), visit 4 (week 8) and visit 5 (week 12) to assess daily motor function.
Blood samples for pharmacokinetic (PK) analysis will be collected at visit 4 (week 8) and visit 5 (week 12).
Visit 6 (follow-up) will be performed for all patients, including any patients that discontinue the IMP early, 5-8 days after last administration of IMP.
- Conditions
- Parkinson Disease
- Being tested
- Mesdopetam, Placebo
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MesdopetamDrug
Also called IRL790
Oral use
PlaceboDrug
Oral use
| Study group | Role | What they receive |
|---|---|---|
| Mesdopetam dose 1 | Experimental | Mesdopetam capsule (mg), dose 1, 1 capsule b.i.d. for 84 days. Receives: Drug: Mesdopetam |
| Mesdopetam dose 2 | Experimental | Mesdopetam capsule (mg), dose 2, 1 capsule b.i.d. for 84 days. Receives: Drug: Mesdopetam |
| Mesdopetam dose 3 | Experimental | Mesdopetam capsule (mg), dose 3, 1 capsule b.i.d. for 84 days. Receives: Drug: Mesdopetam |
| Placebo | Placebo comparator | Placebo capsule, 1 capsule b.i.d. for 84 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
This is a self-administered diary where patients assess their motor state every half hour during 24 hours. ON time without troublesome dyskinesia measures time when the medication is working without causing troublesome dyskinesia.
Measured: Baseline to end of treatment (week 12)
Secondary outcomes (4)
Change From Baseline in Mean Score of ON-phase Dyskinesia Assessed With the Sum Score of the Modified Unified Dyskinesia Rating Scale (UDysRS), Parts 1, 3 and 4, With Mesdopetam Compared to Placebo.
The scoring range is 0-88, where higher score means more dyskinesia.
Measured: Baseline to end of treatment (week 12)
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.
The scoring range is 0-60, where higher score means more disability associated with dyskinesia.
Measured: Baseline to end of treatment (week 12)
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)
This scale is a patient reported outcome measure assessing motor aspects of experiences of daily living. Minimum score is 0 and maximum score is 52. A higher score means more Parkinson's disease motor symptoms.
Measured: Baseline to end of treatment (week 12)
Change From Baseline in Average Daily Hours of OFF-time (With Mesdopetam Compared to Placebo).
This is a self-administered diary where patients assess their motor state every half hour during 24 hours. OFF time means time means daily time spent when the medication is not working.
Measured: Baseline to end of treatment (week 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2020
- Study start29 Oct 2020
- Primary completion2 Dec 2022
- Study completion9 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 155 participants (actual)
Sponsor and investigators
- Lead sponsor
- Integrative Research Laboratories AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joakim Tedroff, Study director, Integrative Research Laboratories AB (IRLAB)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04435431
- Sponsor's protocol ID
- IRL790C005
- Status last verified
- Feb 2024
- First submitted
- 15 Jun 2020
- Last updated
- 6 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Becanovic K, Vittoria de Donno M, Sousa VC, Tedroff J, Svenningsson P. Effects of a Novel Psychomotor Stabilizer, IRL790, on Biochemical Measures of Synaptic Markers and Neurotransmission. J Pharmacol Exp Ther. 2020 Jul;374(1):126-133. doi: 10.1124/jpet.119.264754. Epub 2020 May 1.
PubMed 32358047Waters S, Sonesson C, Svensson P, Tedroff J, Carta M, Ljung E, Gunnergren J, Edling M, Svanberg B, Fagerberg A, Kullingsjo J, Hjorth S, Waters N. 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. J Pharmacol Exp Ther. 2020 Jul;374(1):113-125. doi: 10.1124/jpet.119.264226. Epub 2020 May 1.
PubMed 32358046Svenningsson P, Johansson A, Nyholm D, Tsitsi P, Hansson F, Sonesson C, Tedroff J. Safety and tolerability of IRL790 in Parkinson's disease with levodopa-induced dyskinesia-a phase 1b trial. NPJ Parkinsons Dis. 2018 Dec 6;4:35. doi: 10.1038/s41531-018-0071-3. eCollection 2018.
PubMed 30534585
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Phase IIB Study Evaluating the Efficacy of Mesdopetam on Daily ON-time Without Troublesome Dyskinesia in Patients With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT04435431
- Acronym / sponsor ID
- IRL790C005
- Conditions
- Parkinson Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- Integrative Research Laboratories ABIndustry (pharma, biotech, devices)
- Study start
- 29 Oct 2020 (actual)
- Primary completion
- 2 Dec 2022 (actual)
- Study completion
- 9 Dec 2022 (actual)
- First posted
- 17 Jun 2020 (actual)
- Results
- Posted 6 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase 2b study investigating the efficacy and safety of mesdopetam as adjunct therapy on daily ON-time without troublesome dyskinesia in patients with Parkinson disease. Mesdopetam is taken for 84 days.
Detailed description
At the screening visit consenting patients will be screened for eligibility according to study specific inclusion/exclusion criteria within 8 weeks before start of Investigational Medicinal Product (IMP) administration. A diary concordance training will be performed and following the screening visit the patient will be asked to self-administer three 24-hour home diaries and to bring the completed diaries to the baseline visit for assessment prior randomization.
At the baseline visit, patients will be randomized to receive one of three doses of mesdopetam (dose 1, dose 2 and dose 3) or placebo b.i.d.
During the first week a dose run-in phase will take place, where all patients allocated to mesdopetam will receive a run-in dose of mesdopetam twice daily and patients allocated to placebo will receive placebo twice daily. At Visit 2, patients will receive mesdopetam dose 1, dose 2 or dose 3 or placebo b.i.d., as randomized and continue the same dose for the rest of the treatment period until end of treatment (EOT). Dose reductions are restricted and the dose can only be reduced once. Dose reductions are permitted from visit 2 (day 9) until visit 3 (day 28), where after the dose should be kept stable until EOT.
The treatment allocation will be double-blind, i.e. it will not be disclosed to the patients, the site staff or the Sponsor.
During the treatment period, changes in disease state and ON phase dyskinesia will be assessed using the Movement Disorder Society revised Unified Parkinson's Disease Rating Scale (MDS-UPDRS), the modified Unified Dyskinesia Rating Scale (UDysRS), i.e. parts 1, 3 and 4, and Clinician's Global Impression of Severity (CGI-S). Furthermore, patients will self-administer three 24-hour home diaries prior to visit 3 (week 4), visit 4 (week 8) and visit 5 (week 12) to assess daily motor function.
Blood samples for pharmacokinetic (PK) analysis will be collected at visit 4 (week 8) and visit 5 (week 12).
Visit 6 (follow-up) will be performed for all patients, including any patients that discontinue the IMP early, 5-8 days after last administration of IMP.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Mesdopetam dose 1 | Experimental | Drug: MesdopetamMesdopetam capsule (mg), dose 1, 1 capsule b.i.d. for 84 days. |
| Mesdopetam dose 2 | Experimental | Drug: MesdopetamMesdopetam capsule (mg), dose 2, 1 capsule b.i.d. for 84 days. |
| Mesdopetam dose 3 | Experimental | Drug: MesdopetamMesdopetam capsule (mg), dose 3, 1 capsule b.i.d. for 84 days. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo capsule, 1 capsule b.i.d. for 84 days |
Who may qualify
- Ages
- 30 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female ≥30 and ≤79 years of age at the time of screening.
- Signed a current Ethics Committee approved informed consent form (ICF).
- PD, per UK Parkinson's Disease Society (UKPDS) Brain Bank Clinical Diagnostic Criteria.
- Minimal amount of 2 hours of levodopa-induced daily "ON-time with troublesome dyskinesia" during waking hours
- Functional impact of dyskinesias determined as a score of ≥2 as per Question 4.2 of the MDS-UPDRS.
Key exclusion criteria (19 listed)
- History of neurosurgical intervention related to PD (e.g. deep brain stimulation).
- Treatment with pump delivered antiparkinsonian therapy (i.e. subcutaneous apomorphine or levodopa/carbidopa intestinal infusion).
- History of seizures within two years prior to screening.
- History of stroke or transient ischemic attack (TIA) within two years prior to screening.
- History of cancer within five years prior to screening, with the following exceptions: adequately treated non-melanomatous skin cancers, localized bladder cancer, non metastatic prostate cancer or in situ cervical cancer.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MesdopetamAlso: IRL790Oral use | Drug | Mesdopetam dose 1, Mesdopetam dose 2, Mesdopetam dose 3 |
| PlaceboOral use | Drug | Placebo |
Primary outcome
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.
Time frame: Baseline to end of treatment (week 12)
This is a self-administered diary where patients assess their motor state every half hour during 24 hours. ON time without troublesome dyskinesia measures time when the medication is working without causing troublesome dyskinesia.
4 secondary outcomes
Change From Baseline in Mean Score of ON-phase Dyskinesia Assessed With the Sum Score of the Modified Unified Dyskinesia Rating Scale (UDysRS), Parts 1, 3 and 4, With Mesdopetam Compared to Placebo.
Time frame: Baseline to end of treatment (week 12)
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.
Time frame: Baseline to end of treatment (week 12)
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)
Time frame: Baseline to end of treatment (week 12)
Change From Baseline in Average Daily Hours of OFF-time (With Mesdopetam Compared to Placebo).
Time frame: Baseline to end of treatment (week 12)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 32358047Becanovic K, Vittoria de Donno M, Sousa VC, Tedroff J, Svenningsson P. Effects of a Novel Psychomotor Stabilizer, IRL790, on Biochemical Measures of Synaptic Markers and Neurotransmission. J Pharmacol Exp Ther. 2020 Jul;374(1):126-133. doi: 10.1124/jpet.119.264754. Epub 2020 May 1.
- Background: PubMed 32358046Waters S, Sonesson C, Svensson P, Tedroff J, Carta M, Ljung E, Gunnergren J, Edling M, Svanberg B, Fagerberg A, Kullingsjo J, Hjorth S, Waters N. 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. J Pharmacol Exp Ther. 2020 Jul;374(1):113-125. doi: 10.1124/jpet.119.264226. Epub 2020 May 1.
- Background: PubMed 30534585Svenningsson P, Johansson A, Nyholm D, Tsitsi P, Hansson F, Sonesson C, Tedroff J. Safety and tolerability of IRL790 in Parkinson's disease with levodopa-induced dyskinesia-a phase 1b trial. NPJ Parkinsons Dis. 2018 Dec 6;4:35. doi: 10.1038/s41531-018-0071-3. eCollection 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joakim Tedroff study director
Integrative Research Laboratories AB (IRLAB)
44 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Mesdopetam in people with Parkinson Disease, run by Integrative Research Laboratories AB at 44 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 44 sites in United States, Poland, France, Israel, Italy and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Mar 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: Baseline to end of treatment (week 12)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04435431, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2024.