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

NCT02337764 | Completed Phase 3 Results

• 3 other identifiers: TVP-1012/OCT-002U1111-1165-1500JapicCTI-152762
• Study Type: interventional
• Target: 222
• Locations: 1 country
• Sites: 24

Brief Summary

The purpose of this study is to evaluate long-term safety of TVP-1012 (1 mg/day) with levodopa in Japanese participants with Parkinson's disease.

Conditions

Parkinson's Disease

Outcome Measures

Primary Outcomes (1)

• Number of Participants Who Experience at Least One Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

  Up to Week 52

Secondary Outcomes (7)

• Number of Participants With TEAE Related to Clinical Laboratory Tests

  Up to Week 52

• Number of Participants With Markedly Abnormal Vital Signs Values

  Up to Week 52

• Number of Participants With TEAE Related to Electrocardiograms (ECG)

  Up to Week 52

• Number of Participants With TEAE Related to Body Weight (Weight Decreased)

  Up to Week 52

• Change From Baseline in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II Total Score

  Baseline and Week 52 (LOCF)

Study Arms (1)

TVP-1012 1mg

EXPERIMENTAL

TVP-1012 1 mg once daily orally, either before or after breakfast, concomitantly with levodopa tablet for 52 weeks as treatment period after 2 weeks of run-in period.

Drug: TVP-1012 1mg

Interventions

TVP-1012 1mg DRUG

TVP-1012 1mg Tablets

TVP-1012 1mg

Eligibility Criteria

• Age: 30 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Takeda: lead

Study Sites (24)

Unknown Facility

Nagoya, Aichi-ken, Japan

Location

Unknown Facility

Matsuyama, Ehime, Japan

Location

Unknown Facility

Fukuoka, Fukouka, Japan

Location

Unknown Facility

Kōriyama, Fukushima, Japan

Location

Unknown Facility

Sapporo, Hokkaido, Japan

Location

Unknown Facility

Himeji, Hyōgo, Japan

Location

Unknown Facility

Kobe, Hyōgo, Japan

Location

Unknown Facility

Sanda, Hyōgo, Japan

Location

Unknown Facility

Tsuchiura, Ibaragi, Japan

Location

Unknown Facility

Ichinoseki, Iwate, Japan

Location

Unknown Facility

Kawasaki, Kanagawa, Japan

Location

Unknown Facility

Sagamihara, Kanagawa, Japan

Location

Unknown Facility

Yokohama, Kanagawa, Japan

Location

Unknown Facility

Tenri, Nara, Japan

Location

Unknown Facility

Shimajiri-gun, Okinawa, Japan

Location

Unknown Facility

Chuo-ku, Tokyo, Japan

Location

Unknown Facility

Meguro-ku, Tokyo, Japan

Location

Unknown Facility

Shinjuku-ku, Tokyo, Japan

Location

Unknown Facility

Fukuoka, Japan

Location

Unknown Facility

Kochi, Japan

Location

Unknown Facility

Kyoto, Japan

Location

Unknown Facility

Miyazaki, Japan

Location

Unknown Facility

Osaka, Japan

Location

Unknown Facility

Yamagata, Japan

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Results Point of Contact

• Title: Medical Director
• Organization: Takeda

trialdisclosures@takeda.com

+1-877-825-3327

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2015
• First Posted: January 14, 2015
• Study Start: February 3, 2015
• Primary Completion: September 29, 2016
• Study Completion: September 29, 2016
• Last Updated: March 2, 2022
• Results First Posted: April 19, 2019

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Access Criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.

Locations

JP (24)