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Efficacy and Tolerability of IRL790 in Parkinson's Disease Dyskinesia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03368170
Recruitment Status : Recruiting
First Posted : December 11, 2017
Last Update Posted : March 28, 2019
The Clinical Trial Company
Information provided by (Responsible Party):
Integrative Research Laboratories AB

Brief Summary:

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 IRL790 potently reduced levodopa-induced involuntary movement without impairing the antiparkinsonian effect of levodopa.

The primary purpose of the trial is to investigate whether IRL790 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.

Condition or disease Intervention/treatment Phase
Parkinson Disease Drug: IRL790 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 74 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Double blind, placebo controlled
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Placebo-controlled, Phase IIa Study Evaluating the Efficacy and Tolerability of IRL790 in Parkinson's Disease Dyskinesia
Actual Study Start Date : February 27, 2018
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: IRL790
Capsule 2.5 mg, oral administration
Drug: IRL790
IRL790 capsule

Placebo Comparator: Placebo
Identical capsule, oral administration
Drug: IRL790
IRL790 capsule

Primary Outcome Measures :
  1. Unified Dyskinesia Rating Scale (UDysRS) [ Time Frame: 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 UDysRS is administered to assess dyskinesia. The scoring range is 0-104, where higher score means more dyskinesia.

Secondary Outcome Measures :
  1. Unified Dyskinesia Rating Scale (UDysRS) [ Time Frame: 4 weeks ]
    Change in Total Objective Score (III, IV) of the UDysRS from Baseline (Day 1) to Visit 4. Therse parts of the UDysRS assess objective impairment and disability of dyskinesia. The objective score ranges from 0-44, where a higher score means more impairment and disability associated with dyskinesia.

  2. Patient diaries [ Time Frame: 4 weeks ]
    Change in daily "OFF"-time as assessed with patient diaries from run-in to Visit 4. This is a self administerd diary where patients assess their motor state every half hour during 24 hours.

  3. Unified Parkinson's Disease Rating Scale (MDS-UPDRS) [ Time Frame: 4 weeks ]
    Change in Unified Parkinson's Disease Rating Scale (MDS-UPDRS) total score of part III from Baseline (Day 1) to Visit 4. The part III of the MDS-UPDRS assess motor function in best on phase. The score range is 0-132, where a higher score means more severe motor impariment.

  4. Unified Parkinson's Disease Rating Scale (MDS-UPDR [ Time Frame: 4 weeks ]
    The sum score of Questions 4.1 and 4.2 in part IV of the MDS-UPDRS assess dyskinesia (maximum score 8).

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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. Patient 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.

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 score of five when "off" as per Question 3.18 of the MDS-UPDRS, assessed during screening.
  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 abnormal renal function.
  10. 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.
  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 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03368170

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Contact: Joakim Tedroff, MD +46 707601691
Contact: Clas Sonesson, PhD +46 730757700

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Sahlgrenska University hospital Recruiting
Göteborg, Sweden
Principal Investigator: Filip Bergquist, Dr         
University hospital Recruiting
Linköping, Sweden
Principal Investigator: Nil Dizdar, Dr         
University hospital Recruiting
Lund, Sweden
Principal Investigator: Per Odin, Prof.         
Karolinska University hospital Recruiting
Stockholm, Sweden
Principal Investigator: Anders Johansson, Dr         
United Kingdom
Bristol Brain Centre, Southmead Hospital Recruiting
Bristol, United Kingdom
Principal Investigator: Alan Whone, Dr         
Fairfield General Hospital (Pennine Acute NHS Trust) Recruiting
Bury, United Kingdom
Principal Investigator: Jason Raw, Dr         
Ninewells Hospital Completed
Dundee, United Kingdom
Lincoln County Hospital Recruiting
Lincoln, United Kingdom
Principal Investigator: Jagdish Sharma, Prof.         
Charing Cross Hospital, Imperial College Healthcare NHS Trust Not yet recruiting
London, United Kingdom
Principal Investigator: Sophie Molloy, Dr         
The National Hospital of Neurology and Neurosurgery (UCL) Recruiting
London, United Kingdom
Principal Investigator: Thomas Warner, Prof.         
Luton and Dunstable University Hospital NHS Foundation Trust Recruiting
Luton, United Kingdom
Principal Investigator: Anettte Schrag, Prof.         
North Tyneside General Hospital Recruiting
North Shields, United Kingdom
Principal Investigator: Richard Walker, Prof.         
Qeens' Medical Centre Recruiting
Nottingham, United Kingdom
Principal Investigator: Jonathan Evans, Dr         
John Radcliffe Hospital Recruiting
Oxford, United Kingdom
Principal Investigator: Michele Hu, Dr         
Peterborough City Hospital Recruiting
Peterborough, United Kingdom
Principal Investigator: Sunku Guptha, Dr         
Plymouth Hospitals NHS Trust - Derriford Hospital Recruiting
Plymouth, United Kingdom, PL6 8DH
Contact: Camille Carroll, MD         
Queens's Hospital Recruiting
Romford, United Kingdom
Principal Investigator: Anjum Misbahuddin, Dr         
Royal Stoke University Hospital Recruiting
Stoke-on-Trent, United Kingdom
Principal Investigator: J Ellis, Dr         
Torbay hospital Completed
Torquay, United Kingdom
Royal Cornwall Hospital Recruiting
Truro, United Kingdom
Principal Investigator: Aaron de Souza, Dr         
Sponsors and Collaborators
Integrative Research Laboratories AB
The Clinical Trial Company
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Principal Investigator: Camille Carroll, MD Plymouth University Peninsula Schools of Medicine and Dentistry

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Responsible Party: Integrative Research Laboratories AB Identifier: NCT03368170     History of Changes
Other Study ID Numbers: IRL790C003
First Posted: December 11, 2017    Key Record Dates
Last Update Posted: March 28, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Integrative Research Laboratories AB:
Levodopa induced dyskinesia

Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Neurologic Manifestations
Signs and Symptoms