Parkinson DiseasePhase 2NCT03368170
Efficacy and Tolerability of IRL790 in Parkinson's Disease Dyskinesia
A Phase 2 study testing Mesdopetam (IRL790) in people with Parkinson Disease, run by Integrative Research Laboratories AB at 20 sites in 2 countries.
Trial summary
Mesdopetam (IRL790) is an experimental small molecule compound with psychomotor stabilizing properties. The primary target is the dopamine D3 receptor, a target implicated in the generation of levodopa-induced dyskinesia, a side-effect frequently occurring with long-term levodopa treatment in patients with Parkinson's… Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Mesdopetam (IRL790)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 20 sitesin 2 countries
- Study dates
- 12 Apr 2018to 12 Jun 2019
- 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 18 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female ≥18 and ≤79 years of age.
- Signed a current Ethics Committee approved informed consent form.
- Parkinson's disease, per UK Parkinson's Disease Society (UKPDS) Brain Bank Clinical Diagnostic Criteria.
- Waking day dyskinesia of ≥25% determined as a score of ≥2 as per Question 4.1 of the MDS-UPDRS.
- On a stable regimen of antiparkinson medications for at least 30 days prior to screening, including a levodopa preparation administered not less than three times daily and willing to continue the same doses and regimens during study participation. Rescue medication such as Madopar dispersable and Apomorphine injections are allowed.
- Taking a maximum of eight regular levodopa intakes per day, excluding bedtime and night time levodopa.
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- 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 screening 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).
- Patient must be willing and able to avoid direct exposure to sunlight from day 1 to day 28.
- Able to complete at least one valid 24-hour patient diary at Visit 1.
Who cannot join
- History of neurosurgical intervention related to Parkinson's disease (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, localised bladder cancer, non-metastatic prostate cancer or in situ cervical cancer.
- Presence of cognitive impairment, as evidenced by a Mini-Mental Status Examination (MMSE) score of less than 24 during screening.
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- A Hoehn and Yahr score of five when "off" as per Question 3.18 of the MDS-UPDRS, assessed during screening.
- 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; clinically significant hepatic disease, renal failure or abnormal renal function.
- Any history of a neurological other than Parkinson's disease or a psychiatric disorder, including history of 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 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
20 sites in 2 countries.
20 sites in 2 countries
United Kingdom16 sites
Bristol Brain Centre, Southmead Hospital
Bristol
Fairfield General Hospital (Pennine Acute NHS Trust)
Bury
Ninewells Hospital
Dundee
Lincoln County Hospital
Lincoln
Charing Cross Hospital, Imperial College Healthcare NHS Trust
London
The National Hospital of Neurology and Neurosurgery (UCL)
London
Luton and Dunstable University Hospital NHS Foundation Trust
Luton
North Tyneside General Hospital
North Shields
Qeens' Medical Centre
Nottingham
John Radcliffe Hospital
Oxford
Peterborough City Hospital
Peterborough
Plymouth Hospitals NHS Trust - Derriford Hospital
Plymouth, PL6 8DH
Queens's Hospital
Romford
Royal Stoke University Hospital
Stoke-on-Trent
Torbay hospital
Torquay
Royal Cornwall Hospital
Truro
Sweden4 sites
Sahlgrenska University hospital
Gothenburg
University hospital
Linköping
University hospital
Lund
Karolinska University hospital
Stockholm
About this study
Official title: A Randomized, Placebo-controlled, Phase IIa Study Evaluating the Efficacy and Tolerability of IRL790 in Parkinson's Disease Dyskinesia
Mesdopetam (IRL790) is an experimental small molecule compound with psychomotor stabilizing properties. The primary target is the dopamine D3 receptor, a target implicated in the generation of levodopa-induced dyskinesia, a side-effect frequently occurring with long-term levodopa treatment in patients with Parkinson's disease. In experimental animals mesdopetam potently reduced levodopa-induced involuntary movement without impairing the antiparkinsonian effect of levodopa.
The primary purpose of the trial is to investigate whether mesdopetam given as adjunctive treatment can reduce levodopa induced dyskinesia in patients with Parkinson's disease. The trial will also help to establish the most optimal dosing of the compound.
Read the detailed description
METHODOLOGY:
This is a multicentre study where 74 patients with Parkinson's disease exhibiting levodopa induced dyskinesia will be randomised to receive study drug or placebo. Thirty seven patients will be randomised to mesdopetam and 37 patients to placebo (1:1 randomisation).
Patients will be screened for eligibility according to inclusion/exclusion criteria within four weeks of initiation of study treatment (Screening visit).
An outpatient study with the patients taking the study drug for four weeks at home. Mesdopetam will be taken twice daily (b.i.d.) as adjunctive treatment to the patients' regular and stable antiparkinsonian medication.
The first two weeks of treatment will allow for per patient titration of study medication to the highest tolerated predefined dose, after which patients will continue on this highest tolerated dose for an additional two weeks.
Changes in disease state and dyskinesia will be measured using the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) and Unified Dyskinesia Rating Scale (UDysRS); furthermore, patients will administer two 24-hour diaries on run-in and on the fourth week of dosing to assess daily movements.
Pharmacokinetic (PK) samples will be collected for the determination of concentrations of mesdopetam and its metabolites IRL902 and IRL872 in plasma. They will be collected before and after IMP administration at two visits.
A Follow-up Visit will be performed for all patients five to eight days after last administration of IMP.
- Conditions
- Parkinson Disease
- Being tested
- Mesdopetam (IRL790)
- Keywords
- Levodopa induced dyskinesia
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mesdopetam (IRL790)Drug
Also called IRL790
Mesdopetam (IRL790) capsule
| Study group | Role | What they receive |
|---|---|---|
| Mesdopetam (IRL790) | Experimental | Capsule 2.5 mg, oral administration Receives: Drug: Mesdopetam (IRL790) |
| Placebo | Placebo comparator | Identical capsule, oral administration Receives: Drug: Mesdopetam (IRL790) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Unified Dyskinesia Rating Scale (UDysRS)
The change from baseline to day 28 of treatment (Visit 4) in the sum of the items comprising the Unified Dyskinesia Rating Scale (UDysRS). The Unified Dyskinesia Rating Scale (UDysRS) is administered to assess dyskinesia. The scoring range is 0-104, where higher score means more dyskinesia.
Measured: Baseline and 4 weeks
Secondary outcomes (2)
Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part IV, Question 4.1 and 4.2
Change in MDS-UPDRS sum score of questions 4.1 (Time spent with dyskinesias) and 4.2 (Functional impact of dyskinesias) in part IV from baseline to visit 4. Minimum score is 0 and maximum score is 8. A higher score means more dyskinesia.
Measured: Baseline and 4 weeks
Unified Parkinson's Disease Rating Scale (MDS-UPDRS), Part II and III
Change in MDS-UPDRS sum score of parts II+III (Motor aspects of Experiences of Daily living + Motor Examination) from baseline to visit 4. Minimum value is 0 and maximum value is 124. Higher score mean a worse outcome.
Measured: Baseline and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2017
- Study start12 Apr 2018
- Primary completion12 Jun 2019
- Study completion12 Jun 2019
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 (1)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
- Model description
- Double blind, placebo controlled
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Integrative Research Laboratories AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The Clinical Trial Company
- Responsible party
- Sponsor
- Investigators
- Camille Carroll, MD, Principal investigator, Plymouth University Peninsula Schools of Medicine and Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03368170
- Sponsor's protocol ID
- IRL790C003
- Status last verified
- Mar 2022
- First submitted
- 5 Dec 2017
- Last updated
- 31 Mar 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
McFarthing K, Prakash N, Simuni T. CLINICAL TRIAL HIGHLIGHTS - DYSKINESIA. J Parkinsons Dis. 2019;9(3):449-465. doi: 10.3233/JPD-199002. No abstract available.
PubMed 31356217
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-controlled, Phase IIa Study Evaluating the Efficacy and Tolerability of IRL790 in Parkinson's Disease Dyskinesia
- ClinicalTrials.gov ID
- NCT03368170
- Acronym / sponsor ID
- IRL790C003
- Conditions
- Parkinson Disease
- Keywords
- Levodopa induced dyskinesia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Integrative Research Laboratories ABIndustry (pharma, biotech, devices)
- Collaborators
- The Clinical Trial Company
- Study start
- 12 Apr 2018 (actual)
- Primary completion
- 12 Jun 2019 (actual)
- Study completion
- 12 Jun 2019 (actual)
- First posted
- 11 Dec 2017 (actual)
- Results
- Posted 24 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Mesdopetam (IRL790) is an experimental small molecule compound with psychomotor stabilizing properties. The primary target is the dopamine D3 receptor, a target implicated in the generation of levodopa-induced dyskinesia, a side-effect frequently occurring with long-term levodopa treatment in patients with Parkinson's disease. In experimental animals mesdopetam potently reduced levodopa-induced involuntary movement without impairing the antiparkinsonian effect of levodopa.
The primary purpose of the trial is to investigate whether mesdopetam given as adjunctive treatment can reduce levodopa induced dyskinesia in patients with Parkinson's disease. The trial will also help to establish the most optimal dosing of the compound.
Detailed description
METHODOLOGY:
This is a multicentre study where 74 patients with Parkinson's disease exhibiting levodopa induced dyskinesia will be randomised to receive study drug or placebo. Thirty seven patients will be randomised to mesdopetam and 37 patients to placebo (1:1 randomisation).
Patients will be screened for eligibility according to inclusion/exclusion criteria within four weeks of initiation of study treatment (Screening visit).
An outpatient study with the patients taking the study drug for four weeks at home. Mesdopetam will be taken twice daily (b.i.d.) as adjunctive treatment to the patients' regular and stable antiparkinsonian medication.
The first two weeks of treatment will allow for per patient titration of study medication to the highest tolerated predefined dose, after which patients will continue on this highest tolerated dose for an additional two weeks.
Changes in disease state and dyskinesia will be measured using the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) and Unified Dyskinesia Rating Scale (UDysRS); furthermore, patients will administer two 24-hour diaries on run-in and on the fourth week of dosing to assess daily movements.
Pharmacokinetic (PK) samples will be collected for the determination of concentrations of mesdopetam and its metabolites IRL902 and IRL872 in plasma. They will be collected before and after IMP administration at two visits.
A Follow-up Visit will be performed for all patients five to eight 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
- 2
- Model description
- Double blind, placebo controlled
| Arm | Type | Receives |
|---|---|---|
| Mesdopetam (IRL790) | Experimental | Drug: Mesdopetam (IRL790)Capsule 2.5 mg, oral administration |
| Placebo | Placebo comparator | Drug: Mesdopetam (IRL790)Identical capsule, oral administration |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male or female ≥18 and ≤79 years of age.
- Signed a current Ethics Committee approved informed consent form.
- Parkinson's disease, per UK Parkinson's Disease Society (UKPDS) Brain Bank Clinical Diagnostic Criteria.
- Waking day dyskinesia of ≥25% determined as a score of ≥2 as per Question 4.1 of the MDS-UPDRS.
- On a stable regimen of antiparkinson medications for at least 30 days prior to screening, including a levodopa preparation administered not less than three times daily and willing to continue the same doses and regimens during study participation. Rescue medication such as Madopar dispersable and Apomorphine injections are allowed.
Key exclusion criteria (17 listed)
- History of neurosurgical intervention related to Parkinson's disease (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, localised 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 |
|---|---|---|
| Mesdopetam (IRL790)Also: IRL790Mesdopetam (IRL790) capsule | Drug | Mesdopetam (IRL790), Placebo |
Primary outcome
Unified Dyskinesia Rating Scale (UDysRS)
Time frame: Baseline and 4 weeks
The change from baseline to day 28 of treatment (Visit 4) in the sum of the items comprising the Unified Dyskinesia Rating Scale (UDysRS). The Unified Dyskinesia Rating Scale (UDysRS) is administered to assess dyskinesia. The scoring range is 0-104, where higher score means more dyskinesia.
2 secondary outcomes
Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part IV, Question 4.1 and 4.2
Time frame: Baseline and 4 weeks
Unified Parkinson's Disease Rating Scale (MDS-UPDRS), Part II and III
Time frame: Baseline and 4 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31356217McFarthing K, Prakash N, Simuni T. CLINICAL TRIAL HIGHLIGHTS - DYSKINESIA. J Parkinsons Dis. 2019;9(3):449-465. doi: 10.3233/JPD-199002. No abstract available.
- 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.
Camille Carroll, MD principal investigator
Plymouth University Peninsula Schools of Medicine and Dentistry
20 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Mesdopetam (IRL790) in people with Parkinson Disease, run by Integrative Research Laboratories AB at 20 sites in 2 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 9 inclusion and 17 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 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in United Kingdom, Sweden. 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 24 Mar 2020). 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?
Unified Dyskinesia Rating Scale (UDysRS) (time frame: Baseline and 4 weeks). 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 NCT03368170, which also lists 1 linked publication.
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 31 Mar 2022.