Efficacy, Safety and Pharmacokinetic Study of CPL500036 in Patients with Levodopa Induced Dyskinesia

Korábbi kezelés

• Patient has a history of substance abuse or alcohol abuse within 12 months prior to Screening.

Más betegség

• The patient has (suspected) atypical Parkinson's disease.
• The patient has a history of neurosurgical intervention because of Parkinson's disease.
• Patient has a history of psychotic event induced by anti-PD treatments or impulse control disorder.
• The patient has any moderate or severe neuromuscular, locomotor disease, that interfere with the study scoring.
• The Patient has a history of severe head injury, stroke or any diagnosis of significant nervous system disease.
• Patient has a history of neuroleptic malignant syndrome, or known personality disorder, or other psychiatric disorder that, in the opinion of the Investigator, would interfere with participation in the study.
• Patient with the presence of cognitive impairment evidenced by a Mini-Mental State Exam (MMSE) of less than 19.
• Patients has any existing or previous history of cancer or has newly diagnosed diabetes.

Laborértékek

• Patient has abnormal QT interval, history of unexplained syncope or known family history of sudden death due to QT abnormality.
• The patient has any laboratory values outside the normal range that are considered by Investigator to be clinically significant at Screening.

Egyéb

• Patient has unstable medical status which may impact the ability of the patients to participate or potentially confound the study result.
• The patient is pregnant or lactating or intending to become pregnant or intending to donate ova.
• Patients is considered by the Investigator to be at imminent risk of suicide or injury to self or others.
• Patient has abnormal ECG that, in the opinion of the Investigator, increases the risks associated with participating in the study.
• Patient participated in another interventional clinical study with an IMP

• Signed and dated written informed consent.
• Male or female patient aged between 50 and 80, diagnosed of idiopathic Parkinson's disease according to the United Kingdom Parkinson's Disease Society Brain Bank Clinical Diagnosis Criteria.
• The patient is on stable dose of Levodopa.
• Other anti-PD medications are allowed if dosing is optimized and stably used.
• The patient is has been treated with Levodopa and is suffering from temporally predictable peak-dose LID.
• Patient declare that dyskinesia is problematic or disabling.
• Score of dyskinesia is at least 2 on part IV, item 4.2 (of the MDS-UPDRS at Screening and on Day -1).
• Patient with Hoehn-Yahr stages 2 to 4 (in OFF stage).
• Female patient is not pregnant (at Screening and Day -1), not breastfeeding and at least 1 of the following conditions applies: (i) woman of non-childbearing potential; (ii) woman of childbearing potential, using contraceptive methods during the Treatment Period and for at least 28 days after the last dose of the study drug.
  • The following are acceptable contraceptive methods: bilateral tubal occlusion, male sterilization, established proper use of hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices and copper intrauterine devices, male or female condom with spermicide; and cap, diaphragm or sponge with spermicide.
• Male patient must agree to use a barrier method of contraceptive for at least 90 days after the last dose of the study drug.
• Patient agrees to blood sample collection for DNA analysis.