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

NCT02337725 | Completed Phase 3 Results

• 3 other identifiers: TVP-1012/CCT-001U1111-1165-1302JapicCTI-152760
• Study Type: interventional
• Target: 244
• Locations: 1 country
• Sites: 55

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of TVP-1012 (1 mg/day) administered to Japanese patients with early Parkinson's disease.

Conditions

Parkinson's Disease

Outcome Measures

Primary Outcomes (1)

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

  Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) retains the four-scale structure with a reorganization of the various subscale; (Part I; 13 items) non-motor experiences of daily living, (Part II; 13) motor experiences of daily living, (Part III; 34) motor examination, and (Part IV; 6) motor complications. Each items had 0-4 ratings, where 0 (normal) to 4 (severe) and score for each was summed to calculate the total scores. The scale range for Part II+III Total Score was 0-188, with higher scores reflecting greater severity.

  From Baseline to Week 26 (LOCF)

Secondary Outcomes (8)

• Change From Baseline in MDS-UPDRS Part I Total Score

  Baseline and Week 26 (LOCF)

• Change From Baseline in MDS-UPDRS Part II Total Score

  Baseline and Week 26 (LOCF)

• Change From Baseline in MDS-UPDRS Part III Total Score

  Baseline and Week 26 (LOCF)

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

  Up to Week 26

• Number of Participants With Markedly Abnormal Vital Signs Values

  Up to Week 26

Study Arms (2)

TVP-1012 1 mg

EXPERIMENTAL

For 2 weeks during the run-in period, one tablet of placebo orally, once daily before or after breakfast, followed by 26 weeks during the treatment period, one tablet of TVP-1012 1 mg orally, once daily before or after breakfast.

Drug: TVP-1012

Placebo

PLACEBO COMPARATOR

For 2 weeks during the run-in period, one tablet of placebo orally, once daily before or after breakfast, followed by 26 weeks during the treatment period, one tablet of placebo orally, once daily before or after breakfast.

Drug: Placebo

Interventions

TVP-1012 DRUG

TVP-1012 1mg Tablets

TVP-1012 1 mg

Placebo DRUG

Placebo tablets

Placebo

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Takeda: lead

Study Sites (55)

Unknown Facility

Nagoya, Aichi-ken, Japan

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Matsuyama, Ehime, Japan

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Touon, Ehime, Japan

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Kitakyushu, Fukuoka, Japan

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Onoshiro, Fukuoka, Japan

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Asahikawa, Hokkaido, Japan

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Iwamizawa, Hokkaido, Japan

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Akashi, Hyōgo, Japan

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Kobe, Hyōgo, Japan

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Tsuchiura, Ibaragi, Japan

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Tsukuba, Ibaragi, Japan

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Morioka, Iwate, Japan

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Takamatsu, Kagawa-ken, Japan

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Fujisawa, Kanagawa, Japan

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Sagamihara, Kanagawa, Japan

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Yokohama, Kanagawa, Japan

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Gōshi, Kumamoto, Japan

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Sendai, Miyagi, Japan

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Matsumoto, Nagano, Japan

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Higashisonogi-gun, Nagasaki, Japan

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Nishisonogi-gun, Nagasaki, Japan

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Tenri, Nara, Japan

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Jouetsu, Niigata, Japan

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Higashiosaka, Osaka, Japan

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Suita, Osaka, Japan

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Takatsuki, Osaka, Japan

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Toyonaka, Osaka, Japan

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Irima-gun, Saitama, Japan

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Fuji, Shizuoka, Japan

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Hamamatsu, Shizuoka, Japan

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Izunokuni, Shizuoka, Japan

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Shimono, Tochigi, Japan

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Yoshinogawa, Tokushima, Japan

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Bunkyo-ku, Tokyo, Japan

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Fuchū, Tokyo, Japan

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Kodaira, Tokyo, Japan

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Meguro-ku, Tokyo, Japan

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Nerima-ku, Tokyo, Japan

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Ōta-ku, Tokyo, Japan

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Setagaya-ku, Tokyo, Japan

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Shibuya-ku, Tokyo, Japan

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Akita, Japan

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Aomori, Japan

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Fukuoka, Japan

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Fukushima, Japan

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Hiroshima, Japan

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Kochi, Japan

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Kyoto, Japan

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Niigata, Japan

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Okayama, Japan

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Osaka, Japan

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Tokushima, Japan

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Toyama, Japan

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Wakayama, Japan

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Yamagata, Japan

Location

Related Publications (1)

• Hattori N, Takeda A, Takeda S, Nishimura A, Kitagawa T, Mochizuki H, Nagai M, Takahashi R. Rasagiline monotherapy in early Parkinson's disease: A phase 3, randomized study in Japan. Parkinsonism Relat Disord. 2019 Mar;60:146-152. doi: 10.1016/j.parkreldis.2018.08.024. Epub 2018 Sep 1.

  PMID: 30205936 DERIVED

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: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2015
• First Posted: January 14, 2015
• Study Start: February 7, 2015
• Primary Completion: September 15, 2016
• Study Completion: September 15, 2016
• Last Updated: March 2, 2022
• Results First Posted: December 31, 2018

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 (55)