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Parkinson DiseasePhase 2NCT06212089

Phase II Clinical Study of TR-012001 in Japanese Patients With Parkinson's Disease

A Phase 2 study testing TR-012001 in people with Parkinson Disease, run by SNLD, Ltd. at 1 site in Japan.

Completed

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

Official record
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Trial summary

The purpose of this study to evaluate the safety and pharmacokinetics of TR-012001 in patients with Parkinson's disease when TR-012001 or placebo is administered. Read more about this study

Who is it for?
Ages 30 years and older
Conditions the study is for
Parkinson Disease
What is being tested?
TR-012001
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
12 participants
Where
1 siteJapan
Study dates
28 Sep 2023to 30 May 2024
Phase
Phase 2
Are there results?
None posted in the registry

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

Who may be able to join

  • Japanese males and females aged 30 years or older at the time of informed consent.
  • Patients diagnosed with idiopathic Parkinson's disease according to the UKPDS Brain Bank Parkinson's disease diagnostic criteria.
  • Patients with Parkinson's disease stage 2-4 on the modified Hoehn \& Yahr Scale in the "ON state".
  • Patients who are taking levodopa-containing drugs* three times or more per day, with a daily dosage of 300 mg or more of levodopa.
  • Levodopa-containing drugs: Levodopa/dopa decarboxylase inhibitor (DCI) combination drugs; DCI can be either carbidopa or benserazide.
  • Patients who can maintain a fixed dosage and administration of levodopa-containing drugs and other antiparkinsonian drugs (only for patients taking medication) after obtaining informed consent until the end of the study.
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  • Patients who are found to be OFF in their daily life by patient evaluation.
  • Females of childbearing potential or males with female partners of childbearing potential who agree to practice adequate contraception on a daily basis from the time consent is obtained until the end of the study.
  • Female (partners) of childbearing potential: Women who have not confirmed menopause (no menstruation for 52 weeks or more counting from the start of the last menstrual period).
  • Patients who are fully informed about the purpose and contents of this study before the start of screening, who understand the contents of the informed consent form, and who can sign their own will.

Who cannot join

  • Patients with non-idiopathic Parkinson's disease [atypical Parkinson's disease, secondary (acquired or symptomatic) Parkinson's disease, Parkinson's plus syndrome, etc.].
  • Patients with hypersensitivity or allergy to the active pharmaceutical ingredient (API) or other ingredients used in the investigational drug, or patients with a history of severe allergy to other drugs (anaphylaxis, etc.).
  • Patients with angle-closure glaucoma.
  • Patients with disease or findings that are judged to affect this study from the viewpoint of safety and/or evaluation.
  • Patients who received Levodopa-carbidopa continuous infusion gel therapy (LCIG therapy) or patients who plan to receive it during the study period.
  • Patients who have used apomorphine subcutaneous injection 30 mg within 1 month prior to obtaining informed consent or patients who plan to use apomorphine during the study period.
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  • Patients who have undergone brain surgery for Parkinson's disease (pallidotomy, deep brain stimulation, etc.) or patients who plan to undergo such surgery during the study period.
  • Patients who received or plan to receive transcranial magnetic stimulation therapy within 6 months prior to consent.
  • Patients with a history or comorbidities of drug abuse or alcoholism.
  • Patients with a history or comorbidities of mental illness (schizophrenia, psychotic depression, etc.). However, psychiatric symptoms associated with Parkinson's disease are excluded.
  • Patients with overt dementia or Mini-Mental State Examination (MMSE) score less than 24 points.
  • Patients with a history of suicidal ideation or attempted suicide within the past year or a history of present illness.
  • Patients with a history of malignant syndrome caused by antiparkinsonian drugs.
  • Patients with clinically problematic brain, cardiovascular, hematological, autoimmune, endocrine, cardiovascular, renal, gastrointestinal, or respiratory diseases (including infectious diseases) that are judged by the investigator to have the potential to affect the conduct of this study from the perspective of safety and other factors.
  • Patients with any of the following laboratory test results from screening tests:
  • A creatinine level greater than or equal to 2 times the laboratory upper limit
  • Total bilirubin level greater than or equal to 3 times the laboratory upper limit
  • ALT or AST greater than or equal to 3 times the laboratory upper limit
  • ALP greater than or equal to 3 times the laboratory upper limit
  • Patients who have clinically significant abnormalities in "other tests (including clinical tests)" in the screening test and are judged by the investigator to be inappropriate for participation in this study.
  • Patients with acquired immunodeficiency syndrome (AIDS) (including patients who are either HIV antigen or antibody positive) or hepatitis (including patients who are HBs antigen positive or HCV antibody positive).
  • Patients who required treatment for malignant tumors within 5 years before consent was obtained (excluding treated cervical intraepithelial neoplasia, cured nonmetastatic squamous or basal cell tumors of the skin).
  • Patients who are scheduled for surgery requiring hospitalization during the study period or who are in a condition requiring surgery.
  • Patients who are pregnant, breastfeeding, may be pregnant, or wish to become pregnant during the study period.
  • Patients who have received all other unapproved drugs (including investigational drugs, drugs administered through clinical research, unapproved combination drugs, and new formulations) within 3 months prior to obtaining consent or within 5 times the half-life, whichever is longer.
  • Patients who have received TR-012001 in the past.
  • Patients who are deemed inappropriate for participation in this study by the investigator for any reason, including patients who have difficulty communicating or cooperating.

Trial locations and contacts

1 site in 1 country.

Japan1 site

  • Saiseikai Imabari Hospital

    Imabari, Ehime, 799-1592

Other trials in Japan

About this study

The purpose of this study to evaluate the safety and pharmacokinetics of TR-012001 in patients with Parkinson's disease when TR-012001 or placebo is administered.

Being tested
TR-012001, Placebo
Medical subject headings
Parkinson Disease

What participants receive

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

  • TR-012001Drug

    A single dose of TR-012001 will be administered.

  • PlaceboOther

    A single dose of placebo will be administered.

Study groups in NCT06212089
Study groupRoleWhat they receive
TR-012001ExperimentalSingle dose of TR-012001
Receives: Drug: TR-012001
PlaceboOtherSingle dose of placebo
Receives: Other: Placebo

What is being measured

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

  1. Safety evaluation of TR-012001: Incidents of Treatment-Emergent Adverse Events

    Name of adverse event, date and time of onset, severity, seriousness, outcome, date and time of outcome, and relationship to TR-012001 of all adverse events (including serious adverse events) are evaluated.

    Measured: Day of administration of TR-012001/placebo (Day3) to the day of leaving the facility (Day4). If any adverse event(s) continue or occur on Day4, follow-up will be conducted until recovery or until the investigator decides no longer follow-up is necessary.

  2. Safety evaluation of TR-012001: Incidents of physical findings

    The examination will include general findings and evaluation of the skin, eyes, ears/nose/throat, heart, chest, and abdomen. Record anything that is not normal, including those due to the subject's illness.

    Measured: 4 days and 3 nights

  3. Safety evaluation of TR-012001: Vital sign (body temperature)

    The results of vital signs will be used by the investigator to determine whether there are any safety issues continuing to participate in this study.

    Measured: 4 days and 3 nights

  4. Safety evaluation of TR-012001: Vital sign (blood pressure)

    The results of vital signs will be used by the investigator to determine whether there are any safety issues continuing to participate in this study. Blood pressure is measured in sitting state.

    Measured: 4 days and 3 nights

  5. Safety evaluation of TR-012001: Vital sign (pulse rate)

    The results of vital signs will be used by the investigator to determine whether there are any safety issues continuing to participate in this study. Pulse rate is measured in sitting state.

    Measured: 4 days and 3 nights

  6. Safety evaluation of TR-012001: Columbia Suicide Severity Rating Scale (C-SSRS)

    To evaluate the safety and tolerability of TR-012001, Columbia-Suicide Severity Rating Scale (C-SSRS) (Japanese version) is used to evaluates suicidal ideation and behavior.

    Scale range: Yes or No response to 11 questions, with minimum to maximum range of 0 to 5. Lower score represents better outcomes. Subscales not applicable.

    Measured: Day 1 and Day 4

  7. Safety evaluation of TR-012001: Incidents of participants with laboratory abnormality

    The results of laboratory test values (hematological, blood biochemical, and urinary tests) will be used by the investigator to determine whether there are any safety issues continuing to participate in this study.

    Measured: Day 1 and Day 4

  8. Pharmacokinetics of TR-012001: Maximum plasma concentration (Cmax)

    Maximum observed plasma concentration of TR-012001.

    Measured: Pre-dose (baseline) and specified time points of post-dose

  9. Pharmacokinetics of TR-012001: Time to reach maximum plasma concentration (Tmax)

    Time to maximum observed plasma concentration of TR-012001.

    Measured: Pre-dose (baseline) and specified time points of post-dose

  10. Pharmacokinetics of TR-012001: Elimination half-life (t1/2)

    Elimination half-life.

    Measured: Pre-dose (baseline) and specified time points of post-dose

  11. Pharmacokinetics of TR-012001: Area under the plasma concentration-time curve (AUC0-inf)

    Area under the plasma concentration-time curve.

    Measured: Pre-dose (baseline) and specified time points of post-dose

  12. Pharmacokinetics of TR-012001: Mean residence time (MRT)

    Mean residence time.

    Measured: Pre-dose (baseline) and specified time points of post-dose

  13. Pharmacokinetics of TR-012001: Apparent whole body clearance (CL/f)

    Apparent whole body clearance.

    Measured: Pre-dose (baseline) and specified time points of post-dose

  14. Pharmacokinetics of TR-012001: Volume of distribution (Vd/f )

    Volume of distribution.

    Measured: Pre-dose (baseline) and specified time points of post-dose

Timeline

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

  1. First posted18 Jan 2024
  2. Study start28 Sep 2023
  3. Primary completion26 Apr 2024
  4. Study completion30 May 2024

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
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06212089
Sponsor's protocol ID
TR-012001-PD201
Status last verified
Jun 2024
First submitted
21 Dec 2023
Last updated
6 Jun 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing TR-012001 in people with Parkinson Disease, run by SNLD, Ltd. at 1 site in Japan.

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 10 inclusion and 27 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 6 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Japan. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Safety evaluation of TR-012001: Incidents of Treatment-Emergent Adverse Events (time frame: Day of administration of TR-012001/placebo (Day3) to the day of leaving the facility (Day4). If any adverse event(s) continue or occur on Day4, follow-up will be conducted until recovery or until the investigator decides no longer follow-up is necessary.). The study lists 14 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 NCT06212089.

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 6 Jun 2024.

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