AzTrials
AzTrials

Parkinson DiseasePhase 2NCT03292016

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

A Phase 2 study testing APL-130277, APO-go and Apokyn in people with Parkinson Disease, run by Sumitomo Pharma America, Inc. at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Parkinson Disease
What is being tested?
APL-130277, APO-go and Apokyn
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
3 sitesUnited States
Study dates
22 Aug 2017to 5 Mar 2019
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female ≥ 18 years of age.
  • Clinical diagnosis of Idiopathic PD, consistent with UK Brain Bank Criteria (excluding the "more than one affected relative" criterion).
  • Clinically meaningful response to Levodopa (L-Dopa) with well-defined "OFF" episodes, as determined by the Investigator.
  • Receiving APOKYN® of ≤ 5 mg per dose for at least 4 weeks before the Screening Visit.
  • 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.
  • No planned medication change(s) or surgical intervention anticipated during the course of study.
Show all 22Show fewer
  • 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
  • Stage III or less on the modified Hoehn and Yahr scale in the "ON" state.
  • Mini-Mental State Examination (MMSE) score > 23.
  • 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).
  • 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.
  • Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study-related procedures to complete the study.
  • Able to understand the consent form, and to provide written informed consent

Who cannot join

  • Atypical or secondary parkinsonism.
  • Previous treatment with any of the following: continuous subcutaneous (s.c.) apomorphine infusion; or Duodopa/Duopa.
  • 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).
  • Female who is pregnant or lactating.
  • Participation in a clinical trial within 30 days prior to the Screening Visit.
  • Receipt of any investigational (ie, unapproved) medication within 30 days prior to the Screening Visit.
Show all 17Show fewer
  • 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.
  • Drug or alcohol dependency in the past 12 months.
  • History of malignant melanoma.
  • Clinically significant medical, surgical, or laboratory abnormality in the opinion of the Investigator.
  • 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.
  • History of clinically significant hallucinations during the past 6 months.
  • History of clinically significant impulse control disorder(s).
  • Dementia that precludes providing informed consent or would interfere with participation in the study.
  • 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.
  • Donation of blood plasma in the 30 days prior to first dosing.
  • 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.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Parkinson's Disease and Movement Disorders Center of Boca Raton

    Boca Raton, Florida, 33486

  • QUEST Research Institute

    Farmington Hills, Michigan, 48334

  • Parkinson's Disese Treatment Center of SW Florida

    Port Charlotte, Florida, 33980

Other trials in United States

About this study

Official 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)

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.

Read the detailed description

This multi-center study will aim to evaluate the pharmacokinetics (PK) and comparative bioavailability of a single dose of APL-130277 sublingual thin film with subcutaneous (s.c.) APO-go® and s.c. APOKYN® in subjects with Parkinson's disease (PD). The dose of APOKYN® (≤ 5 mg) will be based on the subjects' current prescribed dose. The study is designed as an open-label, randomized, three-way crossover. Subjects will receive all three treatment arms with a minimum 1-day wash-out between each visit (excluding the screening visit) and will be randomly assigned to one of the six sequences

Being tested
APL-130277, APO-go, Apokyn
Keywords
Off Episodes, Parkinson Disease
Medical subject headings
Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • APL-130277Drug

    Also called amomorphine

    APL-130277 sublingual thin film

  • APO-goDrug

    Also called amomorphine

    Subcutaneous APO-go

  • ApokynDrug

    Also called amomorphine

    Subcutaneous APOKYN

Study groups in NCT03292016
Study groupRoleWhat they receive
APL-130277, sublingual thin filmExperimentalAPL-130277, sublingual thin film, once daily
Receives: Drug: APL-130277
Subcutaneous APO-goActive comparatorSubcutaneous APO-go, once daily
Receives: Drug: APO-go
Subcutaneous APOKYNActive comparatorSubcutaneous APOKYN, once daily
Receives: Drug: Apokyn

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximum Observed Plasma Concentration (Cmax)

    Dose normalized maximum observed plasma concentration (Cmax)

    Measured: Day 1

  2. Observed Time of the Maximum Concentration (Tmax)

    Time from dosing to Cmax, observed by inspection of individual subject plots of plasma concentration versus time.

    Measured: Day 1

  3. Area Under the Concentration- Time Curve (AUC Last)

    area under the concentration-time curve from time zero to the last measurable plasma concentration-time curve using the linear up log down trapezoidal rule.

    Measured: Day 1

  4. Area Under the Concentration- Time Curve (AUC Inf)

    area under the concentration-time curve from time zero extrapolated to infinity using the linear up log down trapezoidal rule.

    Measured: Day 1

  5. Mean Residence Time (MRT)

    Mean residence time during one dosing interval calculated using the following equation: MRT = AUMCinf/AUC inf. AUMCinf is the area under the first moment (time.plasma concentration vs. time) curve.

    Measured: Day 1

  6. Metabolite/Parent (M/P) Drug Concentration Ratio -Cmax

    Metabolite (apomorphine sulfate) to Parent exposure ratio, Cmax, corrected for molecular weight differences.

    Measured: Day 1

  7. Apparent Total Clearance of the Drug From Plasma After Oral Administration (CL/F)

    Apparent total clearance of the drug from plasma extravascular administration, calculated as Dose/AUCinf.

    Measured: Day 1

  8. Apparent Volume of Distribution After Non-intravenous Administration (V/F)

    Apparent volume of distribution after extravascular administration, calculated as Dose/(AUCinf * λz).

    Measured: Day 1

  9. Terminal-phase Half-life (t½)

    Terminal phase half-life, as calculated by the following equation: t½ = ln(2)/λz.

    Measured: Day 1

  10. Terminal-phase Rate Constant ( λz)

    Apparent terminal elimination rate constant, determined by log linear regression of the plasma concentration versus time data that was judged to be in the log-linear elimination phase. At least 3 data points in the terminal phase will be used in the determination of the rate constant.

    Measured: Day 1

  11. Metabolite/Parent (M/P) Drug Concentration Ratio -AUC Last

    Metabolite (apomorphine sulfate) to Parent exposure ratio, AUClast, corrected for molecular weight differences.

    Measured: Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Sep 2017
  2. Study start22 Aug 2017
  3. Primary completion5 Mar 2019
  4. Study completion5 Mar 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03292016
Sponsor's protocol ID
CTH-203
Status last verified
Aug 2020
First submitted
11 Sep 2017
Last updated
13 Aug 2020
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Agbo F, Isaacson SH, Gil R, Chiu YY, Brantley SJ, Bhargava P, Navia B. Pharmacokinetics and Comparative Bioavailability of Apomorphine Sublingual Film and Subcutaneous Apomorphine Formulations in Patients with Parkinson's Disease and "OFF" Episodes: Results of a Randomized, Three-Way Crossover, Open-Label Study. Neurol Ther. 2021 Dec;10(2):693-709. doi: 10.1007/s40120-021-00251-6. Epub 2021 May 15.

    PubMed 33991326

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing APL-130277, APO-go and Apokyn in people with Parkinson Disease, run by Sumitomo Pharma America, Inc. at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 22 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Observed Plasma Concentration (Cmax) (time frame: Day 1). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03292016, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2020; AzTrials last refreshed its copy on 27 Oct 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in