- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02337725
A Phase 3 Study of TVP-1012 (1 mg) in Early Parkinson's Disease Patients
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
연구 개요
상세 설명
This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group, phase 3 study to evaluate the efficacy and safety of TVP-1012 in Japanese participants with early Parkinson's disease.
The study period consisted of a 28-week trial period. The participants who fulfill the inclusion criteria and not meeting any of the exclusion criteria were enrolled, and randomized in a 1:1 ratio to either the 1 mg of TVP-1012 or the placebo group. In each treatment group, participants received either 1 mg of TVP-1012 or placebo once daily in a double-blinded manner.
연구 유형
등록 (실제)
단계
- 3단계
연락처 및 위치
연구 장소
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Akita, 일본
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Aomori, 일본
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Fukuoka, 일본
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Fukushima, 일본
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Hiroshima, 일본
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Kochi, 일본
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Kyoto, 일본
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Niigata, 일본
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Okayama, 일본
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Osaka, 일본
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Tokushima, 일본
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Toyama, 일본
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Wakayama, 일본
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Yamagata, 일본
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Aichi
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Nagoya, Aichi, 일본
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Ehime
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Matsuyama, Ehime, 일본
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Touon, Ehime, 일본
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Fukuoka
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Kitakyushu, Fukuoka, 일본
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Onoshiro, Fukuoka, 일본
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Hokkaido
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Asahikawa, Hokkaido, 일본
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Iwamizawa, Hokkaido, 일본
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Hyogo
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Akashi, Hyogo, 일본
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Kobe, Hyogo, 일본
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Ibaragi
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Tsuchiura, Ibaragi, 일본
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Tsukuba, Ibaragi, 일본
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Iwate
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Morioka, Iwate, 일본
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Kagawa
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Takamatsu, Kagawa, 일본
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Kanagawa
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Fujisawa, Kanagawa, 일본
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Sagamihara, Kanagawa, 일본
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Yokohama, Kanagawa, 일본
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Kumamoto
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Goushi, Kumamoto, 일본
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Miyagi
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Sendai, Miyagi, 일본
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Nagano
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Matsumoto, Nagano, 일본
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Nagasaki
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Higashisonogi-gun, Nagasaki, 일본
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Nishisonogi-gun, Nagasaki, 일본
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Nara
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Tenri, Nara, 일본
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Niigata
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Jouetsu, Niigata, 일본
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Osaka
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Higashiosaka, Osaka, 일본
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Suita, Osaka, 일본
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Takatsuki, Osaka, 일본
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Toyonaka, Osaka, 일본
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Saitama
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Irima-gun, Saitama, 일본
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Shizuoka
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Fuji, Shizuoka, 일본
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Hamamatsu, Shizuoka, 일본
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Izunokuni, Shizuoka, 일본
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Tochigi
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Shimono, Tochigi, 일본
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Tokushima
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Yoshinogawa, Tokushima, 일본
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Tokyo
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Bunkyo-ku, Tokyo, 일본
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Fuchu, Tokyo, 일본
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Kodaira, Tokyo, 일본
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Meguro-ku, Tokyo, 일본
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Nerima-ku, Tokyo, 일본
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Ota-ku, Tokyo, 일본
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Setagaya-ku, Tokyo, 일본
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Shibuya-ku, Tokyo, 일본
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
The participant has laboratory data meeting any of the following at the start of the run-in period:
- Creatinine >= 2 x upper limit of normal (ULN)
- Total bilirubin >= 2 x ULN
- ALT or AST >= 1.5 x ULN
- ALP >= 3 x ULN
- The participant has received any of the prohibited concomitant medications or treatments during the run-in period.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: TVP-1012 1 mg
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.
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TVP-1012 1mg Tablets
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위약 비교기: Placebo
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.
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위약 정제
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change From Baseline in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II + Part III Total Score
기간: From Baseline to Week 26 (LOCF)
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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.
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From Baseline to Week 26 (LOCF)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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적어도 하나의 치료 응급 부작용(TEAE) 및 심각한 부작용(SAE)을 경험한 참가자 수
기간: 26주까지
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26주까지
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현저하게 비정상적인 활력 징후 값을 가진 참가자 수
기간: 26주까지
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26주까지
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임상 실험실 테스트와 관련된 TEAE 참가자 수
기간: 26주까지
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26주까지
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Change From Baseline in MDS-UPDRS Part I Total Score
기간: Baseline and Week 26 (LOCF)
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For MDS-UPDRS Part I (non-motor experiences of daily living) scores, the scale range for Part I Total Score was 0-52, with higher scores reflecting greater severity.
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Baseline and Week 26 (LOCF)
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Change From Baseline in MDS-UPDRS Part II Total Score
기간: Baseline and Week 26 (LOCF)
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For MDS-UPDRS Part II (motor experiences of daily living) scores, the scale range for Part II Total Score was 0-52, with higher scores reflecting greater severity.
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Baseline and Week 26 (LOCF)
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Change From Baseline in MDS-UPDRS Part III Total Score
기간: Baseline and Week 26 (LOCF)
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For MDS-UPDRS Part III (motor examination) scores, the scale range for Part III Total Score was 0-132, with higher scores reflecting greater severity.
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Baseline and Week 26 (LOCF)
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Number of Participants With TEAE Related to Body Weight
기간: Up to Week 26
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Up to Week 26
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Number of Participants With TEAE Related to Electrocardiograms (ECG)
기간: Up to Week 26
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Up to Week 26
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공동 작업자 및 조사자
스폰서
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- TVP-1012/CCT-001
- U1111-1165-1302 (레지스트리 식별자: WHO)
- JapicCTI-152760 (레지스트리 식별자: JapicCTI)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
IPD 공유 액세스 기준
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- ICF
- CSR
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
위약에 대한 임상 시험
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Assistance Publique - Hôpitaux de Paris아직 모집하지 않음
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University Hospital, Strasbourg, France모집하지 않고 적극적으로
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AJU Pharm Co., Ltd.OM Pharma SA모병