A phase 1/2 study investigating the pharmacokinetics, safety and efficacy of a highly concentrated buccal formulation of apomorphine (APORON®) in subjects with Parkinson's Disease
- Conditions
- Parkinson's Disease10028037
- Registration Number
- NL-OMON52414
- Lead Sponsor
- Criceto
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 40
Part A and B
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.
6) Mini-Mental State Examination (MMSE) score >= 20 and assessed by the
investigator or qualified designee as able to provide informed consent.
Part 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 with recognizable OFF periods at
least once per day.
Part A and B:
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
As in part A, but with the following differences:
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 prior to first
dose, or history of long QT syndrome.
3) Contraindications to the excipients of the buccal or sublingual apomorphine
formulation, or contraindications to domperidone.
12) Elevated hepatic panel, defined as serum levels of ALT, AST, GGT, ALP or
TBL higher than 2 times the upper limit of normal.
19) Use of any apomorphine formulation in the 4 weeks prior to first dosing.
20) Use of 5HT3 antagonists.
Part 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
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method