Clinical trial NCT02337751: A Phase 3, Long-term, Extension Study of TVP-1012 (1 mg) in Early Parkinson's Disease Participants
Official title: A Multicenter, Open-label, Long-term, Extension, Phase 3 Study to Evaluate the Safety and Efficacy of TVP-1012 at 1 mg in Early Parkinson's Disease Patients Not Treated With Levodopa
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Parkinson's Disease
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2015-01-14
Enrollment: 198
Sex: ALL
Minimum age (years): 30
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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:

* 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.

Primary outcomes:
measure: Number of Participants Who Experience at Least One Treatment Emergent Adverse Event (TEAE)
timeFrame: Up to 52 weeks
Secondary outcomes:
measure: Number of Participants With TEAE Related to Clinical Laboratory Tests
timeFrame: Up to 52 weeks
measure: Number of Participants With Markedly Abnormal Vital Signs Values
timeFrame: Up to 52 weeks
measure: Number of Participants With TEAE Related to Electrocardiograms (ECG) (ECG QT Prolonged)
timeFrame: Up to 52 weeks
measure: Number of Participants With TEAE Related to Body Weight (Weight Loss)
timeFrame: Up to 52 weeks
measure: Change From Baseline in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part II + Part III Total Score
timeFrame: Baseline to End of treatment (Week 52)
Other outcomes:
Locations:
city: Nagoya
country: Japan
state: Aichi
city: Matsuyama
country: Japan
state: Ehime
city: Toon
country: Japan
state: Ehime
city: Kitakyushu
country: Japan
state: Fukuoka
city: Onojo
country: Japan
state: Fukuoka
city: Asahikawa
country: Japan
state: Hokkaido
city: Iwamizawa
country: Japan
state: Hokkaido
city: Akashi
country: Japan
state: Hyogo
city: Kobe
country: Japan
state: Hyogo
city: Tsuchiura
country: Japan
state: Ibaraki
city: Tsukuba
country: Japan
state: Ibaraki
city: Ichinoseki
country: Japan
state: Iwate
city: Morioka
country: Japan
state: Iwate
city: Takamatsu
country: Japan
state: Kagawa
city: Fujisawa
country: Japan
state: Kanagawa
city: Sagamihara
country: Japan
state: Kanagawa
city: Yokohama
country: Japan
state: Kanagawa
city: Goshi
country: Japan
state: Kumamoto
city: Sendai
country: Japan
state: Miyagi
city: Matsumoto
country: Japan
state: Nagano
city: Higashisonogi
country: Japan
state: Nagasaki
city: Nishisonogi
country: Japan
state: Nagasaki
city: Tenri
country: Japan
state: Nara
city: Joetsu
country: Japan
state: Niigata
city: Higashiosaka
country: Japan
state: Osaka
city: Suita
country: Japan
state: Osaka
city: Takatsuki
country: Japan
state: Osaka
city: Toyonaka
country: Japan
state: Osaka
city: Irima
country: Japan
state: Saitama
city: Fuji
country: Japan
state: Shizuoka
city: Hamamatsu
country: Japan
state: Shizuoka
city: Izunokuni
country: Japan
state: Shizuoka
city: Shimono
country: Japan
state: Tochigi
city: Yoshinogawa
country: Japan
state: Tokushima
city: Bunkyo-ku
country: Japan
state: Tokyo
city: Fuchu
country: Japan
state: Tokyo
city: Kodaira
country: Japan
state: Tokyo
city: Meguro-ku
country: Japan
state: Tokyo
city: Nerima-ku
country: Japan
state: Tokyo
city: Ota-ku
country: Japan
state: Tokyo
city: Setagaya-ku
country: Japan
state: Tokyo
city: Shibuya-ku
country: Japan
state: Tokyo
city: Akita
country: Japan
city: Aomori
country: Japan
city: Fukuoka
country: Japan
city: Fukushima
country: Japan
city: Hiroshima
country: Japan
city: Kochi
country: Japan
city: Kyoto
country: Japan
city: Niigata
country: Japan
city: Okayama
country: Japan
city: Osaka
country: Japan
city: Tokushima
country: Japan
city: Toyama
country: Japan
city: Wakayama
country: Japan
city: Yamagata
country: Japan
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References:
citation: 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.