A Phase 3, Long-term, Extension Study of TVP-1012 (1 mg) in Early Parkinson's Disease Participants
NCT ID: NCT02337751
Last Updated: 2022-03-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
198 participants
INTERVENTIONAL
2015-07-10
2017-03-14
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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TVP-1012 1mg Group
TVP-1012 (1 mg/day) once daily, either before or after breakfast.
TVP-1012 1mg
TVP-1012 1mg Tablets
Interventions
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TVP-1012 1mg
TVP-1012 1mg Tablets
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
30 Years
79 Years
ALL
No
Sponsors
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Takeda
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Takeda
Locations
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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
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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U1111-1165-1437
Identifier Type: REGISTRY
Identifier Source: secondary_id
JapicCTI-152761
Identifier Type: REGISTRY
Identifier Source: secondary_id
TVP-1012/OCT-001
Identifier Type: -
Identifier Source: org_study_id
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