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Trial record 1 of 1 for:    NCT03368170
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Efficacy and Tolerability of IRL790 in Parkinson's Disease Dyskinesia

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ClinicalTrials.gov Identifier: NCT03368170
Recruitment Status : Recruiting
First Posted : December 11, 2017
Last Update Posted : March 28, 2019
Sponsor:
Collaborator:
The Clinical Trial Company
Information provided by (Responsible Party):
Integrative Research Laboratories AB

Tracking Information
First Submitted Date  ICMJE December 5, 2017
First Posted Date  ICMJE December 11, 2017
Last Update Posted Date March 28, 2019
Actual Study Start Date  ICMJE February 27, 2018
Estimated Primary Completion Date April 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 9, 2017)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: December 5, 2017)
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)
Change History Complete list of historical versions of study NCT03368170 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 9, 2017)
  • 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.
  • 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.
  • 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.
  • 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).
Original Secondary Outcome Measures  ICMJE
 (submitted: December 5, 2017)
  • 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
  • Patient diaries [ Time Frame: 4 weeks ]
    Change in daily "OFF"-time as assessed with patient diaries from run-in to Visit 4
  • 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 (motor), and sum score of Questions 4.1 and 4.2 in part IV from Baseline (Day 1) to Visit 4
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Tolerability of IRL790 in Parkinson's Disease Dyskinesia
Official Title  ICMJE A Randomized, Placebo-controlled, Phase IIa Study Evaluating the Efficacy and Tolerability of IRL790 in Parkinson's Disease Dyskinesia
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Double blind, placebo controlled
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Parkinson Disease
Intervention  ICMJE Drug: IRL790
IRL790 capsule
Study Arms  ICMJE
  • Experimental: IRL790
    Capsule 2.5 mg, oral administration
    Intervention: Drug: IRL790
  • Placebo Comparator: Placebo
    Identical capsule, oral administration
    Intervention: Drug: IRL790
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 5, 2017)
74
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2019
Estimated Primary Completion Date April 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 79 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Joakim Tedroff, MD +46 707601691 joakim.tedroff@irlab.se
Contact: Clas Sonesson, PhD +46 730757700 clas.sonesson@irlab.se
Listed Location Countries  ICMJE Sweden,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03368170
Other Study ID Numbers  ICMJE IRL790C003
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Integrative Research Laboratories AB
Study Sponsor  ICMJE Integrative Research Laboratories AB
Collaborators  ICMJE The Clinical Trial Company
Investigators  ICMJE
Principal Investigator: Camille Carroll, MD Plymouth University Peninsula Schools of Medicine and Dentistry
PRS Account Integrative Research Laboratories AB
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP