A Phase 3 Study of TVP-1012 (1 mg) in Early Parkinson's Disease Patients

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02337725
• Date of registration: 09/01/2015
• Prospective Registration: Yes
• Primary sponsor: Takeda
• Public title: A Phase 3 Study of TVP-1012 (1 mg) in Early Parkinson's Disease Patients
• Scientific title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Phase 3 Study to Evaluate the Efficacy and Safety of TVP-1012 at 1 mg in Early Parkinson's Disease Patients Not Treated With Levodopa
• Date of first enrolment: February 7, 2015
• Target sample size: 244
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02337725
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Japan

Contacts

• Name: Study Director
• Affiliation: Takeda

Key inclusion & exclusion criteria

Inclusion Criteria:

Run-in period

- 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 with at least two of the
following signs: resting tremor, akinesia/bradykinesia, and muscle rigidity.

- The participant has a Movement Disorder Society-Unified Parkinson's Disease Rating
Scale (MDS-UPDRS) Part II + Part III total score of >=14 at the start of the run-in
period.

- The participant has Modified Hoehn & Yahr stage 1 to 3 at the start of the run-in
period.

- The participant has the Parkinson's disease diagnosed within 5 years prior to the
start of the run-in period.

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

- 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.

Treatment period

- The participant has a MDS-UPDRS Part II + Part III total score of >= 14 at baseline.

Exclusion Criteria:

Run-in period

- 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 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 unstable systemic disease.

- The participant has Mini-Mental State Examination (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 amantadine or anticholinergic medication for >= 180 days.

- The participant has received selegiline, a levodopa-containing product or dopamine
agonist for >= 90 days.

- 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 a levodopa-containing product, dopamine agonist,
amantadine or anticholinergic drug within 30 days prior to the start of the run-in
period.

- The participant has received any psychoneurotic agent or antiemetic medication of
dopamine antagonist 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 has previously received a catechol-O-methyltransferase (COMT)
inhibitor, droxidopa, zonisamide or istradefylline.

- 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 this study, or within 1 month after the last dose of the investigational drug;
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,

- cardiac arrest 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 start of the run-in period,

- sever 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 systolic
pressure decrease of 30 mmHg or more following postural change from
supine/sitting position to standing position),

- a history of syncope due to hypotension within 2 years prior to the start 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 who, in the opinion of the investigator or sub-investigator, is
unsuitable for any other reason.

Treatment period

- The participant whose diagonosis of Parkinson's disease is ruled out by dopamine
transporter scintigraphy performed during the run-in period if conducted.




Age minimum: 30 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Parkinson's Disease

Intervention(s)

Drug: TVP-1012

Drug: Placebo

Primary Outcome(s)

Change From Baseline in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II + Part III Total Score [Time Frame: From Baseline to Week 26 (LOCF)]

Secondary Outcome(s)

Change From Baseline in MDS-UPDRS Part I Total Score [Time Frame: Baseline and Week 26 (LOCF)]

Number of Participants With TEAE Related to Clinical Laboratory Tests [Time Frame: Up to Week 26]

Change From Baseline in MDS-UPDRS Part III Total Score [Time Frame: Baseline and Week 26 (LOCF)]

Change From Baseline in MDS-UPDRS Part II Total Score [Time Frame: Baseline and Week 26 (LOCF)]

Number of Participants With Markedly Abnormal Vital Signs Values [Time Frame: Up to Week 26]

Number of Participants Who Experience at Least One Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) [Time Frame: Up to Week 26]

Number of Participants With TEAE Related to Electrocardiograms (ECG) [Time Frame: Up to Week 26]

Number of Participants With TEAE Related to Body Weight [Time Frame: Up to Week 26]

Secondary ID(s)

TVP-1012/CCT-001

U1111-1165-1302

JapicCTI-152760

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 31/12/2018
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02337725