Clinical trial NCT03531060 (phase 1/phase 2, status: completed)
Conditions: parkinson disease
ICD codes: G20
Drugs: irl790, placebo
SMILES: CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Eligibility criteria:

        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.