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| ID | Type | Description | Link |
|---|---|---|---|
| U1111-1165-1437 | Registry Identifier | WHO | |
| JapicCTI-152761 | Registry Identifier | JapicCTI |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TVP-1012 1mg Group | Experimental | TVP-1012 (1 mg/day) once daily, either before or after breakfast. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TVP-1012 1mg | Drug | TVP-1012 1mg Tablets |
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| Measure | Description | Time Frame |
|---|---|---|
| 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). | Up to 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Up to 52 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Study Director | Takeda | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nagoya | Aichi-ken | Japan | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30689042 | Derived | 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. |
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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.
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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.
All participants with Parkinson's disease who completed the 26-week treatment period in preceding study (TVP-1012/CCT-001: NCT02337725) were enrolled in this study. Participants in TVP-1012 group and in Placebo group in preceding study were assigned to TVP-1012+TVP-1012 Group and Placebo+TVP-1012 Group in this study, respectively.
Participants took part in the study at 68 investigative sites in Japan, from 10 July 2015 to 14 March 2017.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo + TVP-1012 Group | TVP-1012 (1 mg/day) once daily, either before or after breakfast for up to 26 weeks. Reported data on Participants Flow was all participants who enrolled in this study and had assigned to Placebo group in preceding study. |
| FG001 | TVP-1012 + TVP-1012 Group |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 24, 2016 | Feb 25, 2018 |
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| 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). |
| Up to 52 weeks |
| 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). | Up to 52 weeks |
| 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). | Up to 52 weeks |
| 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). | Baseline to End of treatment (Week 52) |
| 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 |
TVP-1012 (1 mg/day) once daily, either before or after breakfast for up to 26 weeks. Reported data on Participants Flow was all participants who enrolled in this study and had assigned to TVP-1012 group in preceding study. |
| COMPLETED |
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| NOT COMPLETED |
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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).
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo + TVP-1012 Group | Placebo, once daily, either before or after breakfast in preceding study for 26 weeks, followed by in this study, TVP-1012 (1 mg/day) once daily, either before or after breakfast for 26 weeks. |
| BG001 | TVP-1012 + TVP-1012 Group | TVP-1012 1 mg, once daily, either before or after breakfast in preceding study for 26 weeks, followed by in this study, TVP-1012 (1 mg/day) once daily, either before or after breakfast for 26 weeks. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | All participants were enrolled in Japan. | Number | Participants |
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| Height | Mean | Standard Deviation | Centimeters (cm) |
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| Weight | Mean | Standard Deviation | Kilograms (kg) |
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| BMI | Body Mass Index = weight (kg)/[height (m)^2] | Mean | Standard Deviation | kg/meter (m)^2 |
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| Smoking Classification | Count of Participants | Participants |
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| Timing of Study Drug Dose | Count of Participants | Participants |
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| Duration of Parkinson's Disease | Mean | Standard Deviation | Years |
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| Modified Hoehn & Yahr Stage | Modified Hoehn & Yahr Stage represented severity for symptoms of Parkinson's disease progress. The Stage of Modified Hoehn & Yahr were assigned from Stage 0 (Asymptomatic) to Stage 5 (Wheelchair bound or bedridden unless aided (unable to walk even if aided)). | Mean | Standard Deviation | Units on a scale |
| ||||||||||||||
| MDS-UPDRS Part II + Part III Total Score (Pre-Dose) | Movement Disorder Society-sponsored revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS) retained the four-scale structure with a reorganization of the various subscales: (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 (6 items). Each subscale had 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. | Mean | Standard Deviation | Scores on a scale |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Safety Analysis Set: All participants who received at least 1 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). | Posted | Count of Participants | Participants | Up to 52 weeks |
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| Secondary | 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). | Safety Analysis Set: All participants who received at least 1 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). | Posted | Count of Participants | Participants | Up to 52 weeks |
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| Secondary | 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). | Safety Analysis Set: All participants who received at least 1 dose of TVP-1012 during this study, 103 participants, and only in the preceding study (TVP-1012/CCT-001: NCT02337725), 14 participants, totally 117 participants. The number of participants analyzed for each items are participants evaluable for each item within the safety analysis set. | Posted | Count of Participants | Participants | Up to 52 weeks |
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| Secondary | 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). | Safety Analysis Set: All participants who received at least 1 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). | Posted | Count of Participants | Participants | Up to 52 weeks |
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| Secondary | 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). | Safety Analysis Set: All participants who received at least 1 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). | Posted | Count of Participants | Participants | Up to 52 weeks |
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| Secondary | 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). | Full Analysis Set (FAS); All randomized participants who received at least one dose of TVP-1012 during this study, 103 participants, and only in the preceding study (TVP-1012/CCT-001: NCT02337725), 14 participants, totally 117 participants. The analyzed numbers for each arm were participants who were evaluable for this outcome measure. | Posted | Mean | Standard Deviation | Units on a Scale | Baseline to End of treatment (Week 52) |
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Up to 52 weeks
At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of the relation to study treatment. On adverse events table, only events that occurred after at least one dose of TVP-1012 during this study, 103 participants, and only in the preceding study (TVP-1012/CCT-001: NCT02337725), 14 participants, totally 117 participants, were reported.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo + TVP-1012 Group | Placebo, once daily, either before or after breakfast in preceding study for 26 weeks, followed by in this study, TVP-1012 (1 mg/day) once daily, either before or after breakfast for up to 26 weeks. | 0 | 95 | 4 | 95 | 23 | 95 |
| EG001 | TVP-1012 + TVP-1012 Group | TVP-1012 1 mg, once daily, either before or after breakfast in preceding study for 26 weeks, followed by in this study, TVP-1012 (1 mg/day) once daily, either before or after breakfast for up to 26 weeks. | 0 | 117 | 6 | 117 | 49 | 117 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Inguinal hernia | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
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| Leukoplakia oral | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
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| Mechanical ileus | Gastrointestinal disorders | MedDRA 19.0 | Systematic Assessment |
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| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 19.0 | Systematic Assessment |
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| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
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| Spinal compression fracture | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
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| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 19.0 | Systematic Assessment |
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| Prostate cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.0 | Systematic Assessment |
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| Intracranial aneurysm | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
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| Microscopic polyangiitis | Vascular disorders | MedDRA 19.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA 19.0 | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
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| Contusion | Injury, poisoning and procedural complications | MedDRA 19.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 19.0 | Systematic Assessment |
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| Eczema | Skin and subcutaneous tissue disorders | MedDRA 19.0 | Systematic Assessment |
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The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Director | Takeda | +1-877-825-3327 | trialdisclosures@takeda.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 11, 2017 | Feb 25, 2018 | SAP_001.pdf |
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
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TVP-1012 1 mg, once daily, either before or after breakfast in preceding study for 26 weeks, followed by in this study, TVP-1012 (1 mg/day) once daily, either before or after breakfast for up to 26 weeks. |
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