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Completed

NCT Number: NCT02228590

A Study to Examine APL-130277 in Patients With Parkinson's Disease

The primary objective of this study is to evaluate the efficacy, tolerability and safety of single treatments of APL-130277 in 16 patients with Parkinson's Disease (PD)

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Key information

Conditions

Parkinson's Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Synucleinopathies

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Banner Sun Health Research Institute, Sun City, Arizona, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female ≥18 years of age.
  • Clinical diagnosis of Idiopathic PD
  • Receiving stable doses of L-dopa +/- other adjunctive PD therapy for at least 4 weeks before study participation.
  • At least one OFF episode per day and a total daily OFF time of > 2 hours duration.
  • Experience predictable OFF episodes in the morning on awakening prior to receiving morning dose of levodopa.
  • Stage I to III on the Hoehn and Yahr scale in the "ON" state.
  • If female and of childbearing potential, must agree to use one of the following methods of birth control:
  • 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.

Exclusion criteria

  • Atypical or secondary parkinsonism
  • Changes in L-dopa or other PD drug dosing regimens 4 weeks before the screening visit.
  • Past treatment with any form of apomorphine within 30 days of Dosing Day 1 (patients who stopped apomorphine for reasons other than lack of efficacy OR tolerability issues may be considered for the trial).
  • Female who is pregnant or lactating.
  • Contraindications to APOKYN or hypersensitive to apomorphine hydrochloride or any of the ingredients of APOKYN (notably sodium metabisulfite), or Tigan®.
  • Participation in any other clinical trial within 14 days of the screening visit.
  • Receipt of any investigational (i.e., unapproved) medication within 30 days of the screening visit.
  • Currently taking, or likely to need to take at any time during the course of the study
  • Currently taking dopamine antagonists or depleting drugs excluding anticholinergics and/or antihistamines with anticholinergic effects.
  • Drug or alcohol dependency in the past 6 months.
  • Clinically significant orthostatic hypotension.
  • Malignant melanoma or a history of previously treated malignant melanoma within 5 years.
  • Clinically significant medical surgical or laboratory abnormality in the judgment of the investigator.
  • Psychiatric disorder, including but not limited to dementia or any disorder that, in the opinion of the Investigator requires ongoing treatment that would make study participation unsafe or make treatment compliance difficult.
  • Dementia that precludes providing informed consent.
  • Potential for lack of compliance and follow-up in the judgment of the investigator.
  • Any other condition, current therapy, or prior therapy (within 30 days of the screening visit), which, in the opinion of the Investigator, would make the subject unsuitable for the study.
  • Previous neurosurgery for PD.
  • Donation of blood or plasma in the 30 days prior to dosing.
  • Presence of cankers or mouth sores.

Treatment and study plan

APL-130277

Drug

Apomorphine Hydrochloride, Sublingual Thin Film

Other names: Apomorphine Hydrochloride, Sublingual Thin Film

Primary outcomes

  1. The Percentage of Patients With Resolution of an 'OFF' Episode to an 'ON' State Following Administration of APL-130277

    Time frame: At 15, 30, 45, 60 and 90 minutes after dosing at Visits 3 - 5.

    Clinical confirmation of an 'OFF' state was assessed prior to dosing and confirmation of 'OFF' or 'ON' was assessed after dosing at Visits 3 - 5 by the Investigator. The first full 'ON' dose was defined as the earliest dose in which a patient achieved a full 'ON' state as assessed by the Investigator. The percentage of patients who achieved their first full 'ON' is presented for each timepoint, regardless of the dose received, and for the study overall (i.e. all post-dose timepoints).

  2. Time to 'ON' State From Time of Dosing of APL-130277

    Time frame: At 15, 30, 45, 60 and 90 minutes after dosing at Visits 3 - 5.

    Clinical confirmation of 'OFF' or 'ON' was assessed after dosing at Visits 3 - 5 by the Investigator. The time to the full 'ON' state from the time of dosing in minutes was calculated from timings noted by the Investigator and recorded in the electronic case report form (eCRF). The mean time taken for a patient to reach their first full 'ON' state following administration of APL-130277 is presented for patients who turned 'ON' for the study overall.

  3. Duration of 'ON' Response From Time of Dosing of APL-130277

    Time frame: At 15, 30, 45, 60 and 90 minutes after dosing at Visits 3 - 5.

    Clinical confirmation of 'OFF' or 'ON' was assessed after dosing at Visits 3 - 5 by the Investigator. The duration of the 'ON' response was defined as the length of time in which a patient was confirmed 'ON' within a dose, and was calculated from the time noted by the Investigator and recorded in the eCRF. The mean duration of the first full 'ON' response following administration of APL-130277 is presented for patients who turned 'ON' for the study overall.

  4. Percentage of Patients Who Completed the Trial and Experienced an 'ON' Episode

    Time frame: At 15, 30, 45, 60 and 90 minutes after dosing at Visits 3 - 5.

    Clinical confirmation of 'OFF' or 'ON' was assessed after dosing at Visits 3 - 5 by the Investigator. For the overall study, the percentage of patients who completed the trial, and who experienced an 'ON' episode is presented.

  5. Pharmacokinetic (PK) Evaluation: Maximum Observed Plasma Concentration (Cmax)

    Time frame: Just prior to dosing and at 10, 20, 30, 45, 60 and 90 minutes after each dose at Visits 3 - 5.

    The mean Cmax values are presented for each dosage administered at Visits 3, 4, and 5 for which data was available.

    Plasma concentrations of the active substance of APL-130277, apomorphine, were analysed using a validated liquid chromatography-tandem mass spectrometry (LC-MS/MS) assay, with a lower limit of quantification of 0.020 nanograms per millilitre (ng/mL).

  6. PK Evaluation: Time of Maximum Observed Plasma Concentration (Tmax)

    Time frame: Just prior to dosing and at 10, 20, 30, 45, 60 and 90 minutes after each dose at Visits 3 - 5.

    The median Tmax values are presented for each dosage administered at Visits 3, 4, and 5 for which data was available.

    Plasma concentrations of the active substance of APL-130277, apomorphine, were analysed using a validated LC-MS/MS assay, with a lower limit of quantification of 0.020 ng/mL.

  7. PK Evaluation: Time to Last Analytically Quantifiable Concentration (Tlast)

    Time frame: Just prior to dosing and at 10, 20, 30, 45, 60 and 90 minutes after each dose at Visits 3 - 5.

    The mean Tlast values are presented for each dosage administered at Visits 3, 4, and 5 for which data was available.

    Plasma concentrations of the active substance of APL-130277, apomorphine, were analysed using a validated LC-MS/MS assay, with a lower limit of quantification of 0.020 ng/mL.

  8. PK Evaluation: Area Under the Plasma Concentration Time Curve, From Time 0 to 90 Minutes (AUC0-90)

    Time frame: Just prior to dosing and at 10, 20, 30, 45, 60 and 90 minutes after each dose at Visits 3 - 5.

    The mean AUC0-90 values are presented for each dosage administered at Visits 3, 4, and 5 for which data was available.

    Plasma concentrations of the active substance of APL-130277, apomorphine, were analysed using a validated LC-MS/MS assay, with a lower limit of quantification of 0.020 ng/mL.

  9. PK Evaluation: Area Under the Plasma Concentration Time Curve, From Time 0 to the Last Measurable Non-zero Concentration (AUClast)

    Time frame: Just prior to dosing and at 10, 20, 30, 45, 60 and 90 minutes after each dose at Visits 3 - 5.

    The mean AUClast values are presented for each dosage administered at Visits 3, 4, and 5 for which data was available.

    Plasma concentrations of the active substance of APL-130277, apomorphine, were analysed using a validated LC-MS/MS assay, with a lower limit of quantification of 0.020 ng/mL. The AUClast was calculated by a combination of linear and logarithmic trapezoidal methods (linear up/log down method).

Secondary outcomes

  1. Percentage Change in MDS-UPDRS Section III Score From Pre-dose Assessment

    Time frame: At 15, 30, 45, 60 and 90 minutes after dosing at Visits 3 - 5.

    The Motor Function section (Section III) of the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) included 33 scores based on 18-items, each anchored with 5 responses: 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe. The scale range was from 0 to 132, with a lower score indicating better motor function and a higher score indicating more severe motor symptoms. The percent change in the MDS-UPDRS Section III score from pre-dose to the first full ON dose or last dose for non-responders is presented. A negative change from baseline indicates an improvement.

Sponsors and collaborators

Lead sponsor

Sumitomo Pharma America, Inc.

Industry

Registry information

Official study title

A Phase 2 Study to Examine the Safety, Tolerability and Efficacy of APL-130277 in Patients With Parkinson's Disease

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Aug 29, 2014
Registry last updated
Jul 30, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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