Parkinson's disease dyskinesia MedDRA version: 20.0 Level: PT Classification code 10061536 Term: Parkinson's disease System Organ Class: 10029205 - Nervous system disorders
Conditions
Sponsors
Integrative Research Laboratories AB (IRLAB)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female =18 and =79 years of age. 2. Signed a current Ethics Committee approved informed consent form. 3. Parkinson's disease, per UK Parkinson's Disease Society (UKPDS) Brain Bank Clinical Diagnostic Criteria. 4. Waking day dyskinesia of =25% determined as a score of =2 as per Question 4.1 of the MDS-UPDRS. 5. 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. 6. Taking a maximum of eight regular levodopa intakes per day, excluding bedtime and night time levodopa. 7. 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). 8. Patients must be willing and able to avoid direct exposure to sunlight from day 1 to day 28. 9. Able to complete at least one valid 24-hour patient diary at Visit 1. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 37 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 37
Exclusion criteria
Exclusion criteria: 1. History of neurosurgical intervention related to Parkinson's disease (e.g. deep brain stimulation). 2. Treatment with pump delivered antiparkinsonian therapy (i.e. subcutaneous apomorphine or levodopa/carbidopa intestinal infusion). 3. History of seizures within two years prior to screening. 4. History of stroke or transient ischemic attack (TIA) within two years prior to screening. 5. 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. 6. Presence of cognitive impairment, as evidenced by a Mini-Mental Status Examination (MMSE) score of less than 24 during screening. 7. A Hoehn and Yahr stage of five. 8. 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. 9. 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 a abnormal renal function (definition of abnormal renal function is creatinine clearance <45 ml/min (calculated according to the Cockcroft-Gault formula). 10. Any history of a neurological or 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. 11. 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. 12. Drug and/or alcohol abuse 13. History of severe drug allergy or hypersensitivity 14. If female, is pregnant or lactating, or has a positive pregnancy test result pre-dose 15. Patients unwilling to use two forms of contraception (one of which being a barrier method see Section 7.3) 90 days for men and 30 days for women after last IMP dose 16. Any planned major surgery within the duration of the study 17. Any other condition or symptoms preventing the patient from entering the study, according to the Investigator’s judgement
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of IRL790 in Parkinson's disease dyskinesia; Secondary Objective: To evaluate the effects of IRL790 on core symptoms of Parkinson's disease. To evaluate the pharmacokinetics, safety and tolerability of IRL790 in patients with Parkinson's disease dyskinesia ;Primary end point(s): Change in the Unified Dyskinesia Rating Scale (UDysRS) total score ;Timepoint(s) of evaluation of this end point: UDysRS measured at Baseline (Day 1) and week 4 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary Endpoints Change in Total Objective Score (III, IV) of the UDysRS Change in daily "OFF" time as assessed with patient diaries from run-in to Visit 4. Change in Unified Parkinson's Disease Rating Scale (MDS-UPDRS) total score of part III (motor), and sum score of Questions 4.1 and 4.2 in part IV Exploratory Endpoints Unified Parkinson's Disease Rating Scale (MDS-UPDRS), part I (total score), part II (total score) and part IV (total score) Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Question 1.2 (Hallucinations and Psychosis) Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Question 1.6 (Features of dopamine dysregulation syndrome) Clinician's Global Impression of Change in overall PD symptoms Daily "ON" time with troublesome dyskinesia as assessed with patient diaries from run-in to Visit 4. Change in “ON” time as assessed by patient completed 24-hour diaries, from run-in to Visit 4 (Day 28). ; Timepoint(s) of evaluation of this end point: Secondary Endpoints Change in Total Objective Score (III, IV) of UDysRS from Day 1 to Week 4 Change in daily "OFF" time as assessed with patient diaries from 28 to 7 days prior to Day 1 and Week 4. Change in MDS-UPDRS total score of part III and sum of score of Questions 4.1 and 4.2 in part IV from Day 1 to Week 4 Exploratory Endpoints MDS-UPDRS Part I, part II and Part IV total scores from Day 1 to Week 4 MDS-UPDRS Question 1.2 from Day 1 to Week 4 MDS-UPDRS Question 1.6 from Day 1 to Week 4 Clinician's Global Impression of Change in overall PD symptoms from Day 1 to Week 4. Daily "ON" time assessed by patient diaries from 28-7 days prior to D | — |
Countries
Sweden, United Kingdom
Contacts
Public ContactClinical Trials Information
Integrative Research Laboratories AB (IRLAB)
Outcome results
None listed