A Clinical Study of IRL790 in Patients With Parkinson's Disease Experiencing Levodopa Induced Dyskinesia

NCT03531060 | Completed Phase 1

• 1 other identifier: IRL790C002
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (6)

• Adverse Events

  Medical Dictionary for Regulatory Activities Preferred Term

  4 weeks

• Physical examination

  Number of participants with clinically significant abnormal physical examination findings

  4 weeks

• Electrocardiogram (ECG) recordings

  Number of participants with clinically significant abnormal electrocardiogram readings

  4 weeks

• Heart rate

  Beats per minute

  4 weeks

• Blood pressure

  mm Hg

  4 weeks

• Safety laboratory measurements

  Number of participants with clinically significant abnormal laboratory values

  4 weeks

Secondary Outcomes (6)

• Unified Dyskinesia Rating Scale (UDysRS)

  4 weeks

• Unified Parkinson's Disease Rating Scale (UPDRS)

  4 weeks

• Parkinson Kinetigraph (PKG)

  Change from run-in to week 4 of treatment

• Clinical Global impression of change (CGI-C)

  4 weeks

• Pharmacokinetic assessment

  4 weeks

Study Arms (2)

IRL790

EXPERIMENTAL

IRL790 Capsule 10 mg, oral administration

Drug: IRL790

Placebo

PLACEBO COMPARATOR

Placebo capsule, identical appearance, oral administration

Drug: Placebo

Interventions

IRL790 DRUG

IRL790 capsule 10 mg

IRL790

Placebo DRUG

Placebo capsule

Placebo

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.
• Previous surgery for PD. . A Hoehn and Yahr score of 5 when "off".
• \. 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.
• \. 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.

Sponsors & Collaborators

• Integrative Research Laboratories AB: lead

MeSH Terms

Conditions

Parkinson Disease

Interventions

mesdopetam

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Per Svenningsson, MD, PhD

  Karolinska Institutet, Stockholm

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2018
• First Posted: May 21, 2018
• Study Start: November 8, 2016
• Primary Completion: April 12, 2017
• Study Completion: April 12, 2017
• Last Updated: May 21, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share