A Long-term, Phase 3 Study of TVP-1012 (1 mg) in Levodopa Treated Parkinson's Disease Participants

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02337764
• Date of registration: 09/01/2015
• Prospective Registration: Yes
• Primary sponsor: Takeda
• Public title: A Long-term, Phase 3 Study of TVP-1012 (1 mg) in Levodopa Treated Parkinson's Disease Participants
• Scientific title: A Multicenter, Open-label, Long-term, Phase 3 Study to Evaluate the Safety and Efficacy of TVP-1012 at 1 mg in Levodopa Treated Parkinson's Disease Patients
• Date of first enrolment: February 3, 2015
• Target sample size: 222
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02337764
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Japan

Contacts

• Name: Study Director
• Affiliation: Takeda

Key inclusion & exclusion criteria

Inclusion Criteria:

- In the opinion of the investigator or sub-investigator, the participant is capable of
understanding and complying with protocol requirements.

- The participant signs and dates a written, informed consent form and any required
privacy authorization prior to the initiation of any study procedures.

- The participant has a diagnosis of Parkinson's disease according to the diagnostic
criteria of the UK Parkinson's Disease Society Brain Bank.

- The participant has received a levodopa combination drug for >= 1 month at the start
of the run-in period and has either of the following.

- Wearing off phenomenon

- Decreased response to levodopa combination drugs

- The participant has been receiving a levodopa combination drug a stable dose regimen
since the start of the run-in period.

- The participant is an outpatient of either sex aged >= 30 and < 80 years at the time
of consent.

- A female participant of childbearing potential who is sexually active with a
nonsterilized male partner agrees to use routinely adequate contraception from signing
of informed consent to 1 month after the last dose of the investigational drug.

Exclusion Criteria:

- The participant has received any investigational medication within 90 days prior to
the start of the run-in period.

- The participant has received TVP-1012 in the past.

- The participant is a study site employee, an immediate family member, or in a
dependent relationship with a study site employee who is involved in the conduct of
this study (e.g., spouse, parent, child, sibling) or may consent under duress.

- Participant has donated 400 mL or more of his or her blood volume within 90 days prior
to the start of the run-in period.

- The participant has Modified Hoehn & Yahr stage 5 (or stage 5 at eather on-time or
off-time for the participant with wearing off phenomenon) at the start of the run-in
period.

- The participant has severe dyskinesia.

- The participant has unstable systemic disease.

- The participant has a Mini-Mental State Examinations (MMSE) score of <= 24 at the
start of the run-in period..

- The participant has known or a history of schizophrenia, major or severe depression,
or any other clinically significant psychiatric disease.

- The participant has a history of hypersensitivity or allergies to TVP-1012 (including
any associated excipients) or selegiline.

- The participant has a history of clinically significant hypertension or other
reactions associated with ingestion of tyramine-rich food (e.g., cheese, lever,
herring, yeast, horsebean, banana, beer or wine).

- The participant has a history or concurrent of drug abuse or alcohol dependence.

- The participant has received neurosurgical intervention for Parkinson's disease (e.g.,
pallidotomy, thalamotomy, deep brain stimulation).

- The participant has received transcranial magnetic stimulation within 6 months prior
to the start of the run-in period.

- The participant has received selegiline, pethidine, tramadol, reserpine or methyldopa
within 90 days prior to the start of the run-in period.

- The participant has received single agent of levodopa, any psychoneurotic agent or
antiemetic medication of dopamine agonist within 14 days prior to the start of the
run-in period. However, the participant has been receiving quetiapine or domperidone
with a stable dose regimen for >= 14 days prior to the start of the run-in period may
be included in the study.

- The participant is required to take any of the prohibited concomitant medications or
treatments.

- If female, the participant is pregnant or lactating or intending to become pregnant
during, or within 1 month after the last administration of study medication in this
study; or intending to donate ova during such time period.

- The participant has clinically significant neurologic, cardiovascular, pulmonary,
hepatic (including mild cirrhosis), renal, metabolic, gastrointestinal, urological,
endocrine, or hematological disease.

- The participant has clinically significant or unstable brain or cardiovascular
disease, such as:

- clinically significant arrhythmia or cardiac valvulopathy,

- heart failure of NYHA Class II or higher,

- concurrent or a history of ischemic cardiac disease within 6 months prior to the
start of the run-in period,

- concurrent or a history of clinically significant cerebrovascular disease within
6 months prior to the stat of the run-in period,

- severe hypertension (systolic blood pressure of 180 mmHg or higher, or diastolic
blood pressure of 110 mmHg or higher),

- clinically significant orthostatic hypotension (including those with diastolic
pressure decrease of 30 mmHg or more following postural change from
supine/sitting position to standing position), or

- a history of syncope due to hypotension within 2 years prior to the stat of the
run-in period.

- The participant is required surgery or hospitalization for surgery during the study
period.

- Participant has a history of cancer within 5 years prior to the start of the run-in
period, except cervix carcinoma in situ which has completely cured.

- The participant has acquired immunodeficiency syndrome (AIDS) [including human
immunodeficiency virus (HIV) carrier], or hepatitis [including viral hepatitis carrier
such as hepatitis B surface (HBs) antigen or hepatitis C antibody (HCV) positive].
However, the participant who has a negative result for HCV antigen or HCV-RNA can be
included in the study.

- The participant with laboratory data meeting any of the following at the start of the
run-in period:

- Creatinine >= 2 x upper limit of normal (ULN)

- Total bilirubin >= 2 x ULN

- ALT or AST >= 1.5 x ULN

- ALP >= 3 x ULN

- The participant has received any of the prohibited concomitant medications or
treatments during the run-in period

- The participant who, in the opinion of the investigator or sub-investigator, is
unsuitable for any other reason.



Age minimum: 30 Years
Age maximum: 79 Years
Gender: All

Health Condition(s) or Problem(s) studied

Parkinson's Disease

Intervention(s)

Drug: TVP-1012 1mg

Primary Outcome(s)

Number of Participants Who Experience at Least One Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) [Time Frame: Up to Week 52]

Secondary Outcome(s)

Change From Baseline in MDS-UPDRS Part III Total Score [Time Frame: Baseline and Week 52 (LOCF)]

Number of Participants With TEAE Related to Clinical Laboratory Tests [Time Frame: Up to Week 52]

Change From Baseline in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II Total Score [Time Frame: Baseline and Week 52 (LOCF)]

Number of Participants With Markedly Abnormal Vital Signs Values [Time Frame: Up to Week 52]

Change From Baseline to Week 52 (LOCF) in Mean Daily OFF-time [Time Frame: Baseline and Week 52 (LOCF)]

Number of Participants With TEAE Related to Body Weight (Weight Decreased) [Time Frame: Up to Week 52]

Number of Participants With TEAE Related to Electrocardiograms (ECG) [Time Frame: Up to Week 52]

Secondary ID(s)

U1111-1165-1500

JapicCTI-152762

TVP-1012/OCT-002

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 19/04/2019
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02337764