Parkinson DiseasePhase 1/2NCT03531060
A Clinical Study of IRL790 in Patients With Parkinson's Disease Experiencing Levodopa Induced Dyskinesia
A Phase 1/2 study testing IRL790 in people with Parkinson Disease, run by Integrative Research Laboratories AB.
Trial summary
This is a Phase 1b study investigating the safety and tolerability of IRl790 as adjunct therapy in patients with Parkinson disease. IRL790/placebo is taken for 28 days. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- IRL790
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- 8 Nov 2016to 12 Apr 2017
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female aged 50-85 years inclusive.
- Female patients had to be of non-childbearing potential (defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or post-menopausal females defined as 12 months of amenorrhoea [in questionable cases a blood sample with simultaneous follicle stimulation hormone (FSH) 25-140 IE/L and estradiol <200 pmol/L was confirmatory]).
- Male patients had to be willing to use condom and contraceptive methods with a failure rate of < 1% to prevent pregnancy7 and drug exposure of a partner and refrain from donating sperm from the date of dosing until three months after dosing of the IMP.
- A diagnosis of idiopathic PD according to the United Kingdom Parkinson's Disease Society brain bank diagnostic criteria.
- Showing a clear peak-dose dyskinetic response to regular L-Dopa medication. Patients with additional complex dyskinesia patterns including, but not limited to, diphasic dyskinesias or end of dose dyskinesias could be included if peak dose dyskinesias were also present.
- On stable doses of anti-parkinson treatment for at least one month prior to inclusion and expected to remain stable on the same doses throughout the study.
- Clinical laboratory tests within normal limits or clinically acceptable to the Investigator/Sponsor.
- Able to understand study specific procedures and willing and able to give written informed consent for participation in the study.
Who cannot join
- History of any clinically significant disease or disorder which, in the opinion of the Investigator, could either put the patient at risk because of participation in the study, or influence the results or the patient's ability to participate in the study.
- History of or present clinically significant psychiatric diagnosis, at discretion of the Investigator.
- History of seizures, including febrile seizure in childhood.
- History or presence of hepatic or renal disease or other condition known to interfere with the absorption, distribution, metabolism or excretion of drugs.
- Any clinically significant illness, medical/surgical procedure or trauma within four weeks of the first administration of IMP.
- Any planned major surgery within the duration of the study.
Show all 9Show fewer
- Previous surgery for PD. . A Hoehn and Yahr score of 5 when "off".
- 9. Prolonged QTcF (>450 ms), cardiac arrhythmias or any clinically significant abnormalities in the resting ECG at the time of screening, as judged by the Investigator.
- 10. History of severe allergy/hypersensitivity or on-going allergy/hypersensitivity, as judged by the Investigator, or history of hypersensitivity to drugs with a similar chemical structure or class to IRL790. 11. Administration of another new chemical entity (defined as a compound which has not been approved for marketing) or participation in any other clinical study that included drug treatment with less than three months between administration of last dose and first dose of IMP in this study. 12. History of alcohol abuse and/or use of drugs of abuse. 13. Investigator considered the patient unlikely to comply with study procedures, restrictions and requirements.
About this study
Official title: A Randomised, Double-blind, Placebo-controlled, Phase Ib Study Evaluating the Safety and Tolerability of IRL790 in Patients With Parkinson's Disease (PD) Experiencing Levodopa (L-Dopa) Induced Dyskinesia (LID).
This is a Phase 1b study investigating the safety and tolerability of IRl790 as adjunct therapy in patients with Parkinson disease. IRL790/placebo is taken for 28 days.
Read the detailed description
Consenting patients were screened for eligibility as per study-specific inclusion/exclusion criteria within 8-28 days before start of Investigational Medicinal Product (IMP) administration (Visit 1; Screening Visit). At Visit 2 (Day -7) a kinetigraph device (the Parkinson's KinetiGraph™, Global Kinetics Corporation, Melbourne, Victoria, Australia) was attached to the right or left wrist (the parkinsonian dominant side) and baseline patient movement data were recorded during a run-in period of seven consecutive days.
Following baseline assessments at Visit 3 (Day 1) patients were randomized to receive IRL790 or placebo (3:1). The treatment allocation was double-blinded, i.e. it was not disclosed to the patients, the site staff or the Sponsor. During the treatment period, Visits 4-8 were performed on Days 4, 7, 10, 14 and 28 (end of treatment) and a follow-up phone call was performed on Day 21. Dose adjustments of IRL790 could be made until Day 14, following pre-defined criteria. A follow-up visit (Visit 9) was performed 7-10 days after the last IMP dose.
- Conditions
- Parkinson Disease
- Being tested
- IRL790, 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.
IRL790Drug
IRL790 capsule 10 mg
PlaceboDrug
Placebo capsule
| Study group | Role | What they receive |
|---|---|---|
| IRL790 | Experimental | IRL790 Capsule 10 mg, oral administration Receives: Drug: IRL790 |
| Placebo | Placebo comparator | Placebo capsule, identical appearance, oral administration Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
Medical Dictionary for Regulatory Activities Preferred Term
Measured: 4 weeks
Physical examination
Number of participants with clinically significant abnormal physical examination findings
Measured: 4 weeks
Electrocardiogram (ECG) recordings
Number of participants with clinically significant abnormal electrocardiogram readings
Measured: 4 weeks
Heart rate
Beats per minute
Measured: 4 weeks
Blood pressure
mm Hg
Measured: 4 weeks
Safety laboratory measurements
Number of participants with clinically significant abnormal laboratory values
Measured: 4 weeks
Secondary outcomes (6)
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 UDysRS is administered to assess dyskinesia. The scoring range is 0-104, where higher score means more dyskinesia.
Measured: 4 weeks
Unified Parkinson's Disease Rating Scale (UPDRS)
The UPDRS assess symptoms of Parkinson's disease. The scoring range from 0-199, where higher score means more severe disease.
Measured: 4 weeks
Parkinson Kinetigraph (PKG)
Wrist worn kinetigraph capturing electronic readings of movement activity.
Measured: Change from run-in to week 4 of treatment
Clinical Global impression of change (CGI-C)
Global impression of change
Measured: 4 weeks
Pharmacokinetic assessment
Plasma concentration at Cmax
Measured: 4 weeks
Pharmacokinetic assessment
Trough level plasma concentration
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2018
- Study start8 Nov 2016
- Primary completion12 Apr 2017
- Study completion12 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Integrative Research Laboratories AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Per Svenningsson, MD, PhD, Principal investigator, Karolinska Institutet, Stockholm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03531060
- Sponsor's protocol ID
- IRL790C002
- Status last verified
- Apr 2018
- First submitted
- 10 Apr 2018
- Last updated
- 21 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-blind, Placebo-controlled, Phase Ib Study Evaluating the Safety and Tolerability of IRL790 in Patients With Parkinson's Disease (PD) Experiencing Levodopa (L-Dopa) Induced Dyskinesia (LID).
- ClinicalTrials.gov ID
- NCT03531060
- Acronym / sponsor ID
- IRL790C002
- Conditions
- Parkinson Disease
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Integrative Research Laboratories ABIndustry (pharma, biotech, devices)
- Study start
- 8 Nov 2016 (actual)
- Primary completion
- 12 Apr 2017 (actual)
- Study completion
- 12 Apr 2017 (actual)
- First posted
- 21 May 2018 (actual)
- Results
- Not posted in the source record
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 1b study investigating the safety and tolerability of IRl790 as adjunct therapy in patients with Parkinson disease. IRL790/placebo is taken for 28 days.
Detailed description
Consenting patients were screened for eligibility as per study-specific inclusion/exclusion criteria within 8-28 days before start of Investigational Medicinal Product (IMP) administration (Visit 1; Screening Visit). At Visit 2 (Day -7) a kinetigraph device (the Parkinson's KinetiGraph™, Global Kinetics Corporation, Melbourne, Victoria, Australia) was attached to the right or left wrist (the parkinsonian dominant side) and baseline patient movement data were recorded during a run-in period of seven consecutive days.
Following baseline assessments at Visit 3 (Day 1) patients were randomized to receive IRL790 or placebo (3:1). The treatment allocation was double-blinded, i.e. it was not disclosed to the patients, the site staff or the Sponsor. During the treatment period, Visits 4-8 were performed on Days 4, 7, 10, 14 and 28 (end of treatment) and a follow-up phone call was performed on Day 21. Dose adjustments of IRL790 could be made until Day 14, following pre-defined criteria. A follow-up visit (Visit 9) was performed 7-10 days after the last IMP dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IRL790 | Experimental | Drug: IRL790IRL790 Capsule 10 mg, oral administration |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo capsule, identical appearance, oral administration |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female aged 50-85 years inclusive.
- Female patients had to be of non-childbearing potential (defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or post-menopausal females defined as 12 months of amenorrhoea [in questionable cases a blood sample with simultaneous follicle stimulation hormone (FSH) 25-140 IE/L and estradiol <200 pmol/L was confirmatory]).
- Male patients had to be willing to use condom and contraceptive methods with a failure rate of < 1% to prevent pregnancy7 and drug exposure of a partner and refrain from donating sperm from the date of dosing until three months after dosing of the IMP.
- A diagnosis of idiopathic PD according to the United Kingdom Parkinson's Disease Society brain bank diagnostic criteria.
- Showing a clear peak-dose dyskinetic response to regular L-Dopa medication. Patients with additional complex dyskinesia patterns including, but not limited to, diphasic dyskinesias or end of dose dyskinesias could be included if peak dose dyskinesias were also present.
Key exclusion criteria (9 listed)
- History of any clinically significant disease or disorder which, in the opinion of the Investigator, could either put the patient at risk because of participation in the study, or influence the results or the patient's ability to participate in the study.
- History of or present clinically significant psychiatric diagnosis, at discretion of the Investigator.
- History of seizures, including febrile seizure in childhood.
- History or presence of hepatic or renal disease or other condition known to interfere with the absorption, distribution, metabolism or excretion of drugs.
- Any clinically significant illness, medical/surgical procedure or trauma within four weeks of the first administration of IMP.
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 |
|---|---|---|
| IRL790IRL790 capsule 10 mg | Drug | IRL790 |
| PlaceboPlacebo capsule | Drug | Placebo |
Primary outcome
Adverse Events
Time frame: 4 weeks
Medical Dictionary for Regulatory Activities Preferred Term
Physical examination
Time frame: 4 weeks
Number of participants with clinically significant abnormal physical examination findings
Electrocardiogram (ECG) recordings
Time frame: 4 weeks
Number of participants with clinically significant abnormal electrocardiogram readings
Heart rate
Time frame: 4 weeks
Beats per minute
Blood pressure
Time frame: 4 weeks
mm Hg
Safety laboratory measurements
Time frame: 4 weeks
Number of participants with clinically significant abnormal laboratory values
6 secondary outcomes
Unified Dyskinesia Rating Scale (UDysRS)
Time frame: 4 weeks
Unified Parkinson's Disease Rating Scale (UPDRS)
Time frame: 4 weeks
Parkinson Kinetigraph (PKG)
Time frame: Change from run-in to week 4 of treatment
Clinical Global impression of change (CGI-C)
Time frame: 4 weeks
Pharmacokinetic assessment
Time frame: 4 weeks
Pharmacokinetic assessment
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 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.
Per Svenningsson, MD, PhD principal investigator
Karolinska Institutet, Stockholm
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing IRL790 in people with Parkinson Disease, run by Integrative Research Laboratories AB.
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 9 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 21 May 2018. Status can change between updates, so confirm with the study contact before making plans.
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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Adverse Events (time frame: 4 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 May 2018.