A study investigating the effect and safety of a new potential drug for Parkinson's disease patients.

Phase 1

• Conditions: Parkinson's Disease; MedDRA version: 20.0Level: PTClassification code 10061536Term: Parkinson's diseaseSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2019-003315-60-NL
• Lead Sponsor: Criceto IKM B.V.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-10-08
• Last Update Posted: 7 June 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 46

Inclusion Criteria

Part A
1) Male or female, 30-85 years of age, inclusive at screening.
4) Clinical diagnosis (confirmed by a neurologist) of Parkinson’s disease and classified by the investigator as Hoehn and Yahr stage I to IV in the ON state.
5) Having clear, self-described motor fluctuations as assessed by the 9-symptom Wearing-off Questionnaire (WOQ-9): at least one motor symptom (Question 1, 2, 4, 6, 9) indicated to improve after the subject’s next anti-Parkinson medication dose.
6)Mini-Mental State Examination (MMSE) score = 20 and assessed by the investigator or qualified designee as able to provide informed consent.

Part B and C
1) Male or female, 30-85 years of age, inclusive at screening.
4) Clinical diagnosis (confirmed by a neurologist) of Parkinson’s disease and classified by the investigator as Hoehn and Yahr stage I to III in the ON state.
5)Mini-Mental State Examination (MMSE) score = 20 and assessed by the investigator or qualified designee as able to provide informed consent.
8) On a stable dose of 1 to 4 mg subcutaneous apomorphine (APO-GO PEN) for the management of OFF episodes for at least 4 weeks prior to first study drug administration.
9) Subject’s at-home subcutaneous apomorphine injection location is the abdomen.
11) Subjects who experience motor fluctuations (as assessed by the 9-symptom Wearing-off Questionnaire (WOQ-9): at least one motor symptom (Question 1, 2, 4, 6, 9) indicated to improve after the subject’s next anti-Parkinson medication dose) with recognizable OFF periods at least once per day.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 23
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 23

Exclusion Criteria

Part A:
1) Atypical or secondary parkinsonism e.g., multiple-system atrophy or progressive supranuclear palsy, or evidence of drug-induced parkinsonism.
2) Subjects with a borderline QT interval corrected for heart rate according to Fridericia's formula (QTcF) of >450 ms for male and >470 ms for female, PR interval > 220 msec or QRS duration > 120 msec at screening or history of long QT syndrome.
6) Currently taking medication that can influence the efficacy of apomorphine in the opinion of the investigator, such as dopamine antagonists and dopamine depleting drugs, with the exception of domperidone.

Part B and C:
1) Atypical or secondary parkinsonism e.g., multiple-system atrophy or progressive supranuclear palsy, or evidence of drug-induced parkinsonism.
2) Subjects with a borderline QT interval corrected for heart rate according to Fridericia’s formula (QTcF) of >450 ms for male and >470 ms for female, PR interval > 220 msec or QRS duration > 120 msec at screening or history of long QT syndrome.
4) Use of apomorphine formulations other than subcutaneous injections in the 4 weeks prior to first dosing.
7) Currently taking medication that can influence the efficacy of apomorphine in the opinion of the investigator, such as dopamine antagonists and dopamine depleting drugs, with the exception of domperidone.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified