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A Clinical Study of IRL790 in Patients With Parkinson's Disease Experiencing Levodopa Induced 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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03531060
Recruitment Status : Completed
First Posted : May 21, 2018
Last Update Posted : May 21, 2018
Sponsor:
Information provided by (Responsible Party):
Integrative Research Laboratories AB

Tracking Information
First Submitted Date  ICMJE April 10, 2018
First Posted Date  ICMJE May 21, 2018
Last Update Posted Date May 21, 2018
Actual Study Start Date  ICMJE November 8, 2016
Actual Primary Completion Date April 12, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 9, 2018)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: May 9, 2018)
  • 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.
  • Unified Parkinson's Disease Rating Scale (UPDRS) [ Time Frame: 4 weeks ]
    The UPDRS assess symptoms of Parkinson's disease. The scoring range from 0-199, where higher score means more severe disease.
  • Parkinson Kinetigraph (PKG) [ Time Frame: Change from run-in to week 4 of treatment ]
    Wrist worn kinetigraph capturing electronic readings of movement activity.
  • Clinical Global impression of change (CGI-C) [ Time Frame: 4 weeks ]
    Global impression of change
  • Pharmacokinetic assessment [ Time Frame: 4 weeks ]
    Plasma concentration at Cmax
  • Pharmacokinetic assessment [ Time Frame: 4 weeks ]
    Trough level plasma concentration
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Clinical Study of IRL790 in Patients With Parkinson's Disease Experiencing Levodopa Induced Dyskinesia
Official Title  ICMJE 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).
Brief 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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Parkinson Disease
Intervention  ICMJE
  • Drug: IRL790
    IRL790 capsule 10 mg
  • Drug: Placebo
    Placebo capsule
Study Arms  ICMJE
  • Experimental: IRL790
    IRL790 Capsule 10 mg, oral administration
    Intervention: Drug: IRL790
  • Placebo Comparator: Placebo
    Placebo capsule, identical appearance, oral administration
    Intervention: Drug: Placebo
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 Completed
Actual Enrollment  ICMJE
 (submitted: May 9, 2018)
15
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 12, 2017
Actual Primary Completion Date April 12, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Male or female aged 50-85 years inclusive.
  2. 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]).
  3. 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.
  4. A diagnosis of idiopathic PD according to the United Kingdom Parkinson's Disease Society brain bank diagnostic criteria.
  5. 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.
  6. 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.
  7. Clinical laboratory tests within normal limits or clinically acceptable to the Investigator/Sponsor.
  8. Able to understand study specific procedures and willing and able to give written informed consent for participation in the study.

Exclusion Criteria:

  1. 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.
  2. History of or present clinically significant psychiatric diagnosis, at discretion of the Investigator.
  3. History of seizures, including febrile seizure in childhood.
  4. History or presence of hepatic or renal disease or other condition known to interfere with the absorption, distribution, metabolism or excretion of drugs.
  5. Any clinically significant illness, medical/surgical procedure or trauma within four weeks of the first administration of IMP.
  6. Any planned major surgery within the duration of the study.
  7. 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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03531060
Other Study ID Numbers  ICMJE IRL790C002
Has Data Monitoring Committee No
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: No
Current Responsible Party Integrative Research Laboratories AB
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Integrative Research Laboratories AB
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Per Svenningsson, MD, PhD Karolinska Institutet, Stockholm
PRS Account Integrative Research Laboratories AB
Verification Date April 2018

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