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CompletedNCT02337751Updated Mar 2, 2022Results posted

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

A Phase 3 interventional study of TVP-1012 1mg in Parkinson's Disease, sponsored by Takeda. Completed at 56 sites in Japan. Open to participants aged 30 Years to 79 Years. Per ClinicalTrials.gov, last updated 2022-03-02.

Sponsored by Takeda · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
198
Allocation
Not applicable
Ages
30 Years to 79 Years
Sex
All
01

Study summary

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

Read the detailed description

This is a multicenter, open-label, long-term, extension, phase 3 study to evaluate the safety and efficacy of long-term administration of TVP-1012 at 1 mg for another 26 weeks in participants with early Parkinson's disease who have completed the preceding TVP-1012/CCT-001 (NCT02337725) study.

Among participants of the TVP-1012/CCT-001 study, those consenting to participate in this study prior to complete the preceding study and fulfilling the eligibility criteria will be enrolled in this study. From the day after the Visit 8 of the preceding study, participants will receive 1 mg of TVP-1012 once daily for 26 weeks in an unblinded manner.

02

Conditions studied

  • Parkinson's Disease

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03

In context

Parkinson Disease

4,583 studies on the registry are indexed under Parkinson Disease; 1,097 are open to participants now.

This study's enrollment of 198 is above the median of 40 across 3,365 interventional studies indexed under Parkinson Disease.

Browse Parkinson Disease studies →

Lead sponsor

Takeda is the lead sponsor of 1,025 studies on the registry; 92 are open to participants now.

Of its 177 completed or terminated interventional studies of FDA-regulated products, 153 (86%) have results posted.

Browse Takeda studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 79 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • The participant has completed the preceding study.
  • The participant has shown no safety issues during the study treatment in the preceding study, in the opinion of the investigator or subinvestigator.

Exclusion criteria

Exclusion Criteria:

  • The participant has undergone blood collection of >= 400 mL within 90 days prior to the start of treatment in this study.
  • The participant is required to take any of the excluded medications or treatments.
  • The participant is required surgery or hospitalization for surgery during the study period.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
198 participants (actual)

Study arms

  • Experimental
    TVP-1012 1mg Group

    TVP-1012 (1 mg/day) once daily, either before or after breakfast.

    Drug: TVP-1012 1mg

Interventions

06

What researchers measure

Primary outcomes

  1. Number of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE)

    Reported data was the number collected from the first dose of TVP-1012 to the end of study (up to 52 weeks). Timeframe was 52 weeks that was total duration of both this study (26 weeks) and the preceding study (TVP-1012/CCT-001: NCT02337725; 26 weeks).

    Time frame: Up to 52 weeks

Secondary outcomes

  1. Number of Participants With TEAE Related to Clinical Laboratory Tests

    Reported data was the number collected from the first dose of TVP-1012 to the end of study (up to 52 weeks). Timeframe was 52 weeks that was total duration of both this study (26 weeks) and the preceding study (TVP-1012/CCT-001: NCT02337725; 26 weeks).

    Time frame: Up to 52 weeks

  2. Number of Participants With Markedly Abnormal Vital Signs Values

    Reported data was the number collected from the first dose of TVP-1012 to the end of study (up to 52 weeks). Here "mmHg" is Millimeter of mercury. Timeframe was 52 weeks that was total duration of both this study (26 weeks) and the preceding study (TVP-1012/CCT-001: NCT02337725; 26 weeks).

    Time frame: Up to 52 weeks

  3. Number of Participants With TEAE Related to Electrocardiograms (ECG) (ECG QT Prolonged)

    Reported data was the number collected from the first dose of TVP-1012 to the end of study (up to 52 weeks). Timeframe was 52 weeks that was total duration of both this study (26 weeks) and the preceding study (TVP-1012/CCT-001: NCT02337725; 26 weeks).

    Time frame: Up to 52 weeks

  4. Number of Participants With TEAE Related to Body Weight (Weight Loss)

    Reported data was the number collected from the first dose of TVP-1012 to the end of study (up to 52 weeks). Timeframe was 52 weeks that was total duration of both this study (26 weeks) and the preceding study (TVP-1012/CCT-001: NCT02337725; 26 weeks).

    Time frame: Up to 52 weeks

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

    MDS-UPDRS retains the four-scale structure with a reorganization of the various subscales. The scales are now titled; (Part I) non-motor experiences of daily living (13 items), (Part II) motor experiences of daily living (13 items), (Part III) motor examination (18 items), and (Part IV) motor complications (six items). Each subscale now has 0-4 ratings, where 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe. The scale range for Part II+III Total Score was 0-188, with the higher score reflecting the greater severity. Timeframe was 52 weeks that was total duration of both this study (26 weeks) and the preceding study (TVP-1012/CCT-001: NCT02337725; 26 weeks).

    Time frame: Baseline to End of treatment (Week 52)

07

Results

Posted Feb 28, 2019

Participant flow

Participants took part in the study at 68 investigative sites in Japan, from 10 July 2015 to 14 March 2017.

Participant flow — Overall Study
MilestonePlacebo + TVP-1012 GroupTVP-1012 + TVP-1012 Group
Started95103
Completed8487
Not completed1116
Withdrew: Pretreatment event/adverse event23
Withdrew: Voluntary withdrawal68
Withdrew: Lack of efficacy25
Withdrew: Investigator's judgement10

Outcome measures

PrimaryNumber of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE)

Reported data was the number collected from the first dose of TVP-1012 to the end of study (up to 52 weeks). Timeframe was 52 weeks that was total duration of both this study (26 weeks) and the preceding study (TVP-1012/CCT-001: NCT02337725; 26 weeks).

Time frame:
Up to 52 weeks
Reported as:
Count of participants · Participants
Number of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE)
ParticipantsPlacebo + TVP-1012 GroupTVP-1012 + TVP-1012 Group
Number of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE)5191
SecondaryNumber of Participants With TEAE Related to Clinical Laboratory Tests

Reported data was the number collected from the first dose of TVP-1012 to the end of study (up to 52 weeks). Timeframe was 52 weeks that was total duration of both this study (26 weeks) and the preceding study (TVP-1012/CCT-001: NCT02337725; 26 weeks).

Time frame:
Up to 52 weeks
Reported as:
Count of participants · Participants
Number of Participants With TEAE Related to Clinical Laboratory Tests
ParticipantsPlacebo + TVP-1012 GroupTVP-1012 + TVP-1012 Group
Blood Creatine Phosphokinase Increased01
Blood Triglycerides Increased10
Blood Urine Present10
C-Reactive Protein Increased01
Glycosylated Haemoglobin Increased01
Liver Function Test Abnormal01
Liver Function Test Increased01
White Blood Cell Count Increased10
SecondaryNumber of Participants With Markedly Abnormal Vital Signs Values

Reported data was the number collected from the first dose of TVP-1012 to the end of study (up to 52 weeks). Here "mmHg" is Millimeter of mercury. Timeframe was 52 weeks that was total duration of both this study (26 weeks) and the preceding study (TVP-1012/CCT-001: NCT02337725; 26 weeks).

Time frame:
Up to 52 weeks
Reported as:
Count of participants · Participants
Number of Participants With Markedly Abnormal Vital Signs Values
ParticipantsPlacebo + TVP-1012 GroupTVP-1012 + TVP-1012 Group
Temperature <35.6 Celsius (ºC)1330
Temperature >37.7 ºC01
Systolic Blood Pressure <90 mmHg33
Diastolic Blood Pressure <50 mmHg40
Diastolic Blood Pressure >100 mmHg613
Pulse <45 Beats per Minute (bpm)01
SecondaryNumber of Participants With TEAE Related to Electrocardiograms (ECG) (ECG QT Prolonged)

Reported data was the number collected from the first dose of TVP-1012 to the end of study (up to 52 weeks). Timeframe was 52 weeks that was total duration of both this study (26 weeks) and the preceding study (TVP-1012/CCT-001: NCT02337725; 26 weeks).

Time frame:
Up to 52 weeks
Reported as:
Count of participants · Participants
Number of Participants With TEAE Related to Electrocardiograms (ECG) (ECG QT Prolonged)
ParticipantsPlacebo + TVP-1012 GroupTVP-1012 + TVP-1012 Group
Number of Participants With TEAE Related to Electrocardiograms (ECG) (ECG QT Prolonged)11
SecondaryNumber of Participants With TEAE Related to Body Weight (Weight Loss)

Reported data was the number collected from the first dose of TVP-1012 to the end of study (up to 52 weeks). Timeframe was 52 weeks that was total duration of both this study (26 weeks) and the preceding study (TVP-1012/CCT-001: NCT02337725; 26 weeks).

Time frame:
Up to 52 weeks
Reported as:
Count of participants · Participants
Number of Participants With TEAE Related to Body Weight (Weight Loss)
ParticipantsPlacebo + TVP-1012 GroupTVP-1012 + TVP-1012 Group
Number of Participants With TEAE Related to Body Weight (Weight Loss)10
SecondaryChange From Baseline in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II + Part III Total Score

MDS-UPDRS retains the four-scale structure with a reorganization of the various subscales. The scales are now titled; (Part I) non-motor experiences of daily living (13 items), (Part II) motor experiences of daily living (13 items), (Part III) motor examination (18 items), and (Part IV) motor complications (six items). Each subscale now has 0-4 ratings, where 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe. The scale range for Part II+III Total Score was 0-188, with the higher score reflecting the greater severity. Timeframe was 52 weeks that was total duration of both this study (26 weeks) and the preceding study (TVP-1012/CCT-001: NCT02337725; 26 weeks).

Time frame:
Baseline to End of treatment (Week 52)
Reported as:
Mean · Units on a Scale
Change From Baseline in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II + Part III Total Score
Units on a ScalePlacebo + TVP-1012 GroupTVP-1012 +TVP-1012 Group
Change From Baseline in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II + Part III Total Score-2.8 ± 6.01-2.8 ± 9.62

Adverse events

Collected over Up to 52 weeks. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Placebo + TVP-1012 Group0/95 (0%)4/95 (4.2%)23/95 (24.2%)
TVP-1012 + TVP-1012 Group0/117 (0%)6/117 (5.1%)49/117 (41.9%)
Most frequent serious events
Most frequent serious events
EventPlacebo + TVP-1012 GroupTVP-1012 + TVP-1012 Group
Mechanical ileusGastrointestinal disorders1/950/117
OsteoarthritisMusculoskeletal and connective tissue disorders1/950/117
Prostate cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps)1/950/117
Microscopic polyangiitisVascular disorders1/950/117
Inguinal herniaGastrointestinal disorders0/951/117
Leukoplakia oralGastrointestinal disorders0/951/117
Hepatic function abnormalHepatobiliary disorders0/951/117
Femoral neck fractureInjury, poisoning and procedural complications0/951/117
Spinal compression fractureInjury, poisoning and procedural complications0/951/117
Intracranial aneurysmNervous system disorders0/951/117
Most frequent other events
Most frequent other events
EventPlacebo + TVP-1012 GroupTVP-1012 + TVP-1012 Group
NasopharyngitisInfections and infestations17/9531/117
FallInjury, poisoning and procedural complications6/9511/117
EczemaSkin and subcutaneous tissue disorders2/959/117
HeadacheNervous system disorders1/957/117
ContusionInjury, poisoning and procedural complications5/955/117

Baseline characteristics

Safety Analysis Set; All participants who received at least one dose of TVP-1012 during this study and/or the preceding study (TVP-1012/CCT-001: NCT02337725). The analysis set included 103 participants who enrolled in this study and 14 participants who enrolled only in TVP-1012/CCT-001 and received TVP-1012 (totally 117 participants).

Age, Continuous
Age, Continuous(Years)Placebo + TVP-1012 GroupTVP-1012 + TVP-1012 GroupTotal
Mean65.4 ± 9.1367.4 ± 8.9966.5 ± 9.09
Sex: Female, Male
Sex: Female, Male(Participants)Placebo + TVP-1012 GroupTVP-1012 + TVP-1012 GroupTotal
Female5364117
Male425395
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)Placebo + TVP-1012 GroupTVP-1012 + TVP-1012 GroupTotal
Count of participants——0
Region of Enrollment
Region of Enrollment(Participants)Placebo + TVP-1012 GroupTVP-1012 + TVP-1012 GroupTotal
Japan95117212
Height
Height(Centimeters (cm))Placebo + TVP-1012 GroupTVP-1012 + TVP-1012 GroupTotal
Mean159.2 ± 9.28158.9 ± 8.87159.0 ± 9.04
Weight
Weight(Kilograms (kg))Placebo + TVP-1012 GroupTVP-1012 + TVP-1012 GroupTotal
Mean56.68 ± 9.77357.91 ± 11.80357.36 ± 10.932
BMI
BMI(kg/meter (m)^2)Placebo + TVP-1012 GroupTVP-1012 + TVP-1012 GroupTotal
Mean22.28 ± 2.79822.78 ± 3.30322.56 ± 3.090
Smoking Classification
Smoking Classification(Participants)Placebo + TVP-1012 GroupTVP-1012 + TVP-1012 GroupTotal
Never Smoked5663119
Current Smoker7512
Ex-Smoker324981

4 further baseline measures are reported on the registry.

08

Study locations

56 sites
  • Nagoya, Aichi-ken, Japan
  • Matsuyama, Ehime, Japan
  • Tōon, Ehime, Japan
  • Kitakyushu, Fukuoka, Japan
  • Ōnojō, Fukuoka, Japan
  • Asahikawa, Hokkaido, Japan
  • Iwamizawa, Hokkaido, Japan
  • Akashi, Hyōgo, Japan
  • Kobe, Hyōgo, Japan
  • Tsuchiura, Ibaraki, Japan
  • Tsukuba, Ibaraki, Japan
  • Ichinoseki, Iwate, Japan
  • Morioka, Iwate, Japan
  • Takamatsu, Kagawa-ken, Japan
  • Fujisawa, Kanagawa, Japan
  • Sagamihara, Kanagawa, Japan
  • Yokohama, Kanagawa, Japan
  • Gōshi, Kumamoto, Japan
  • Sendai, Miyagi, Japan
  • Matsumoto, Nagano, Japan
  • Nishisonogi, Nagasaki, Japan
  • Sonogishukugō, Nagasaki, Japan
  • Tenri, Nara, Japan
  • Jōetsu, Niigata, Japan
  • Higashiosaka, Osaka, Japan
  • Suita, Osaka, Japan
  • Takatsuki, Osaka, Japan
  • Toyonaka, Osaka, Japan
  • Irima, Saitama, Japan
  • Fuji, Shizuoka, Japan
  • Hamamatsu, Shizuoka, Japan
  • Izunokuni, Shizuoka, Japan
  • Shimono, Tochigi, Japan
  • Yoshinogawa, Tokushima, Japan
  • Bunkyo-ku, Tokyo, Japan
  • Fuchū, Tokyo, Japan
  • Kodaira, Tokyo, Japan
  • Meguro-ku, Tokyo, Japan
  • Nerima-ku, Tokyo, Japan
  • Ōta-ku, Tokyo, Japan
  • Setagaya-ku, Tokyo, Japan
  • Shibuya-ku, Tokyo, Japan
  • Akita, Japan
  • Aomori, Japan
  • Fukuoka, Japan
  • Fukushima, Japan
  • Hiroshima, Japan
  • Kochi, Japan
  • Kyoto, Japan
  • Niigata, Japan
  • Okayama, Japan
  • Osaka, Japan
  • Tokushima, Japan
  • Toyama, Japan
  • Wakayama, Japan
  • Yamagata, Japan
09

References and documents

Publications

  • Hattori N, Takeda A, Takeda S, Nishimura A, Kitagawa T, Mochizuki H, Nagai M, Takahashi R. Long-term, open-label, phase 3 study of rasagiline in Japanese patients with early Parkinson's disease. J Neural Transm (Vienna). 2019 Mar;126(3):299-308. doi: 10.1007/s00702-018-1964-3. Epub 2019 Jan 28. PubMed 30689042 ↗

Study documents

  • Study protocol · Mar 24, 2016
  • Statistical analysis plan · Apr 11, 2017

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.

Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report

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.

Data sharing details ↗ · vivli.org

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jul 2015 to primary completion in Mar 2017, 20 months.

Results were first posted in Feb 2019, 1 year 11 months after primary completion.

Of 38 industry-sponsored phase 3 interventional studies under Parkinson Disease, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 54. This study's 20 months is below that.

Counting every sponsor, half of 65 studies reached it within 36 months; a quarter within 20 and three quarters within 57.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 9, 2015
First posted
Jan 14, 2015
StartActual
Jul 10, 2015
Primary completionActual
Mar 14, 2017
CompletionActual
Mar 14, 2017
Results first posted
Feb 28, 2019
Last update
Mar 2, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 2, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02337751
Lead sponsor
Takeda
Responsible party
Sponsor
First posted
Jan 14, 2015
Start date
Jul 10, 2015
Primary completion
Mar 14, 2017
Completion
Mar 14, 2017
Results posted
Feb 28, 2019
Last update
Mar 2, 2022

Study contacts

Study Director
study director · Takeda

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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