A Study That Compares the Extent to Which Apomorphine Becomes Available in the Body After Taking Either an Investigational Drug Containing Apomorphine or Apomorphine That is Injected Under the Skin in People With PD Complicated by "OFF" Episodes

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03292016
• Date of registration: 11/09/2017
• Prospective Registration: No
• Primary sponsor: Sunovion
• Public title: A Study That Compares the Extent to Which Apomorphine Becomes Available in the Body After Taking Either an Investigational Drug Containing Apomorphine or Apomorphine That is Injected Under the Skin in People With PD Complicated by "OFF" Episodes
• Scientific title: A Comparative Bioavailability Study to Evaluate the Single Dose Pharmacokinetic Properties of APL-130277 With Two Different Formulations of Subcutaneous Apomorphine in a Randomized, 3-Period Crossover Design in Subjects With Parkinson's Disease Complicated by Motor Fluctuations ("OFF" Episodes)
• Date of first enrolment: August 22, 2017
• Target sample size: 8
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03292016
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: CNS Mecdical Director
• Affiliation: Sunovion Pharmacetuicals Inc.

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Male or female = 18 years of age.

2. Clinical diagnosis of Idiopathic PD, consistent with UK Brain Bank Criteria (excluding
the "more than one affected relative" criterion).

3. Clinically meaningful response to Levodopa (L-Dopa) with well-defined "OFF" episodes,
as determined by the Investigator.

4. Receiving APOKYN® of = 5 mg per dose for at least 4 weeks before the Screening Visit.

5. Receiving stable doses of L-Dopa/carbidopa (immediate or sustained release)
administered at least 4 times per day OR Rytary™ administered 3 times per day, for at
least 4 weeks before the Screening Visit. Adjunctive PD medication regimens must be
maintained at a stable dose for at least 4 weeks prior to the Screening Visit with the
exception that MAOB inhibitors must be maintained at a stable level for at least 8
weeks prior to the Screening Visit.

6. No planned medication change(s) or surgical intervention anticipated during the course
of study.

7. Patients must experience a well-defined "OFF" episode in the morning if they do not
take their morning PD medications on schedule, and must be willing to delay morning
doses on the 3 study dosing days

8. Stage III or less on the modified Hoehn and Yahr scale in the "ON" state.

9. Mini-Mental State Examination (MMSE) score > 23.

10. If female and of childbearing potential, must agree to use one of the following
methods of birth control:

- Oral contraceptive;

- Contraceptive patch;

- Barrier (diaphragm, sponge or condom) plus spermicidal preparations;

- Intrauterine contraceptive system;

- Levonorgestrel implant;

- Medroxyprogesterone acetate contraceptive injection;

- Complete abstinence from sexual intercourse;

- Hormonal vaginal contraceptive ring; or

- Surgical sterilization or partner sterile (must have documented proof).

11. Male patients must be either surgically sterile, agree to be sexually abstinent or use
a barrier method of birth control (e.g., condom) or maintain a monogamous relationship
with a person who is not of child-bearing potential from first study drug
administration until 30days after final drug administration.

12. Willing and able to comply with scheduled visits, treatment plan, laboratory tests,
and other study-related procedures to complete the study.

13. Able to understand the consent form, and to provide written informed consent

Exclusion Criteria:

1. Atypical or secondary parkinsonism.

2. Previous treatment with any of the following: continuous subcutaneous (s.c.)
apomorphine infusion; or Duodopa/Duopa.

3. Contraindications to APO-go® or APOKYN® or hypersensitivity to apomorphine
hydrochloride or any marcrolide antibiotic or any of the ingredients APO-go® or
APOKYN® (notably sodium metabisulfite).

4. Female who is pregnant or lactating.

5. Participation in a clinical trial within 30 days prior to the Screening Visit.

6. Receipt of any investigational (ie, unapproved) medication within 30 days prior to the
Screening Visit.

7. Any selective 5HT3 antagonists (ie, ondansetron, granisetron, dolasetron,
palonosetron, alosetron), dopamine antagonists (excluding quetiapine and clozapine) or
dopamine depleting agents within 30 days prior to the Screening Visit.

8. Drug or alcohol dependency in the past 12 months.

9. History of malignant melanoma.

10. Clinically significant medical, surgical, or laboratory abnormality in the opinion of
the Investigator.

11. Major psychiatric disorder including, but not limited to, dementia, bipolar disorder,
psychosis, or any disorder that, in the opinion of the Investigator, requires ongoing
treatment that would make study participation unsafe or make treatment compliance
difficult.

12. History of clinically significant hallucinations during the past 6 months.

13. History of clinically significant impulse control disorder(s).

14. Dementia that precludes providing informed consent or would interfere with
participation in the study.

15. Current suicidal ideation within one year prior to the Screening Visit as evidenced by
answering "yes" to Questions 4 or 5 on the suicidal ideation portion of the
Columbia-Suicide Severity Rating Scale (C-SSRS) or attempted suicide within the last 5
years.

16. Donation of blood plasma in the 30 days prior to first dosing.

17. Cankers or mouth sores within 30 days prior to the Screening Visit, or other
clinically significant oral pathology in the opinion of the Investigator. The
Investigator should follow-up with an appropriate specialist on any finding, if
indicated, before enrolling a patient into the study.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Parkinson Disease

Intervention(s)

Drug: APL-130277

Drug: APO-go

Drug: Apokyn

Primary Outcome(s)

Apparent Volume of Distribution After Non-intravenous Administration (V/F) [Time Frame: Day 1]

Area Under the Concentration- Time Curve (AUC Inf) [Time Frame: Day 1]

Mean Residence Time (MRT) [Time Frame: Day 1]

Metabolite/Parent (M/P) Drug Concentration Ratio -Cmax [Time Frame: Day 1]

Observed Time of the Maximum Concentration (Tmax) [Time Frame: Day 1]

Area Under the Concentration- Time Curve (AUC Last) [Time Frame: Day 1]

Maximum Observed Plasma Concentration (Cmax) [Time Frame: Day 1]

Metabolite/Parent (M/P) Drug Concentration Ratio -AUC Last [Time Frame: Day 1]

Apparent Total Clearance of the Drug From Plasma After Oral Administration (CL/F) [Time Frame: Day 1]

Terminal-phase Rate Constant ( ?z) [Time Frame: Day 1]

Terminal-phase Half-life (t½) [Time Frame: Day 1]

Secondary ID(s)

CTH-203

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 13/08/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT03292016