Parkinson Disease Clinical Trial
Official title:
BI_Sifrol Tablets Special Drug Use Surveillance(Survey on the Safety and Efficacy in Parkinson's Disease Patients With Depressive Symptoms)
| NCT number | NCT00614575 |
| Other study ID # | 248.635 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | January 31, 2008 |
| Last updated | August 1, 2014 |
| Start date | January 2007 |
| Verified date | August 2014 |
| Source | Boehringer Ingelheim |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Japan: Ministry of Health, Labor and Welfare |
| Study type | Observational |
The primary objective of this investigation is to conduct a 12-week prospective survey in PD
patients with depressive symptoms treated with BI Sifrol Tablets (hereinafter referred to as
this drug) in the routine clinical settings to determine the following items related to the
safety and efficacy.
i. Adverse drug reaction symptoms, incidence, and severity ii. Motor capacity during the
investigation iii. Depressive symptoms during the investigation
| Status | Completed |
| Enrollment | 1089 |
| Est. completion date | |
| Est. primary completion date | August 2009 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 20 Years and older |
| Eligibility |
Inclusion criteria: **PD patients with depressive symptoms Patients who have not received pramipexole hydrochloride hydrate preparations within 1 month before survey entrance. Exclusion criteria: - PD patients with the past history of suicidal attempt, suicidal ideation or tendency - PD patients with suicidal ideation - PD patients with the past history of suicidal tendency |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| Japan | Boehringer Ingelheim Investigational Site | Akashi | |
| Japan | Boehringer Ingelheim Investigational Site 1 | Akita | |
| Japan | Boehringer Ingelheim Investigational Site 2 | Akita | |
| Japan | Boehringer Ingelheim Investigational Site | Asahikawa | |
| Japan | Boehringer Ingelheim Investigational Site | Ashikaga | |
| Japan | Boehringer Ingelheim Investigational Site | Awaji | |
| Japan | Boehringer Ingelheim Investigational Site | Chitose | |
| Japan | Boehringer Ingelheim Investigational Site | Chuo | |
| Japan | Boehringer Ingelheim Investigational Site 1 | Fuchu | |
| Japan | Boehringer Ingelheim Investigational Site 2 | Fuchu | |
| Japan | Boehringer Ingelheim Investigational Site | Fuefuki | |
| Japan | Boehringer Ingelheim Investigational Site | Fuehuki | |
| Japan | Boehringer Ingelheim Investigational Site | Fujioka | |
| Japan | Boehringer Ingelheim Investigational Site | Fujisaki | |
| Japan | Boehringer Ingelheim Investigational Site | Fujisawa | |
| Japan | Boehringer Ingelheim Investigational Site | Fukaya | |
| Japan | Boehringer Ingelheim Investigational Site 1 | Fukuoka | |
| Japan | Boehringer Ingelheim Investigational Site 2 | Fukuoka | |
| Japan | Boehringer Ingelheim Investigational Site 3 | Fukuoka | |
| Japan | Boehringer Ingelheim Investigational Site 4 | Fukuoka | |
| Japan | Boehringer Ingelheim Investigational Site 5 | Fukuoka | |
| Japan | Boehringer Ingelheim Investigational Site 1 | Fukushima | |
| Japan | Boehringer Ingelheim Investigational Site 2 | Fukushima | |
| Japan | Boehringer Ingelheim Investigational Site | Funabashi | |
| Japan | Boehringer Ingelheim Investigational Site 1 | Gifu | |
| Japan | Boehringer Ingelheim Investigational Site 2 | Gifu | |
| Japan | Boehringer Ingelheim Investigational Site | Habikino | |
| Japan | Boehringer Ingelheim Investigational Site | Hachioji | |
| Japan | Boehringer Ingelheim Investigational Site 1 | Hamamatsu | |
| Japan | Boehringer Ingelheim Investigational Site 2 | Hamamatsu | |
| Japan | Boehringer Ingelheim Investigational Site 3 | Hamamatsu | |
| Japan | Boehringer Ingelheim Investigational Site 4 | Hamamatsu | |
| Japan | Boehringer Ingelheim Investigational Site 5 | Hamamatsu | |
| Japan | Boehringer Ingelheim Investigational Site | Hanamaki | |
| Japan | Boehringer Ingelheim Investigational Site | Hayashima | |
| Japan | Boehringer Ingelheim Investigational Site 1 | Higashiosaka | |
| Japan | Boehringer Ingelheim Investigational Site 2 | Higashiosaka | |
| Japan | Boehringer Ingelheim Investigational Site | Himeji | |
| Japan | Boehringer Ingelheim Investigational Site | Hirakata | |
| Japan | Boehringer Ingelheim Investigational Site | Hirishima | |
| Japan | Boehringer Ingelheim Investigational Site | Hirosaki | |
| Japan | Boehringer Ingelheim Investigational Site | Ibaragi | |
| Japan | Boehringer Ingelheim Investigational Site | Iizuka | |
| Japan | Boehringer Ingelheim Investigational Site | Inag | |
| Japan | Boehringer Ingelheim Investigational Site | Irima | |
| Japan | Boehringer Ingelheim Investigational Site | Isahaya | |
| Japan | Boehringer Ingelheim Investigational Site | Iwaki | |
| Japan | Boehringer Ingelheim Investigational Site | Iwamizawa | |
| Japan | Boehringer Ingelheim Investigational Site | Iwata | |
| Japan | Boehringer Ingelheim Investigational Site 1 | Jyoetsu | |
| Japan | Boehringer Ingelheim Investigational Site 2 | Jyoetsu | |
| Japan | Boehringer Ingelheim Investigational Site | Jyoyo | |
| Japan | Boehringer Ingelheim Investigational Site 1 | Kagoshima | |
| Japan | Boehringer Ingelheim Investigational Site 2 | Kagoshima | |
| Japan | Boehringer Ingelheim Investigational Site 3 | Kagoshima | |
| Japan | Boehringer Ingelheim Investigational Site | Kahoku | |
| Japan | Boehringer Ingelheim Investigational Site | Kamakura | |
| Japan | Boehringer Ingelheim Investigational Site 1 | Kanazawa | |
| Japan | Boehringer Ingelheim Investigational Site 2 | Kanazawa | |
| Japan | Boehringer Ingelheim Investigational Site 1 | Kanoya | |
| Japan | Boehringer Ingelheim Investigational Site 2 | Kanoya | |
| Japan | Boehringer Ingelheim Investigational Site 1 | Kashihara | |
| Japan | Boehringer Ingelheim Investigational Site 2 | Kashihara | |
| Japan | Boehringer Ingelheim Investigational Site | Kasuga | |
| Japan | Boehringer Ingelheim Investigational Site | Kawagchi | |
| Japan | Boehringer Ingelheim Investigational Site | Kawaguchi | |
| Japan | Boehringer Ingelheim Investigational Site 1 | Kawasaki | |
| Japan | Boehringer Ingelheim Investigational Site 2 | Kawasaki | |
| Japan | Boehringer Ingelheim Investigational Site | Kitakami | |
| Japan | Boehringer Ingelheim Investigational Site 1 | Kiyose | |
| Japan | Boehringer Ingelheim Investigational Site 2 | Kiyose | |
| Japan | Boehringer Ingelheim Investigational Site | Kodaira | |
| Japan | Boehringer Ingelheim Investigational Site | Kofu | |
| Japan | Boehringer Ingelheim Investigational Site | Koga | |
| Japan | Boehringer Ingelheim Investigational Site | Komae | |
| Japan | Boehringer Ingelheim Investigational Site | Komatsu | |
| Japan | Boehringer Ingelheim Investigational Site | Komatsushima | |
| Japan | Boehringer Ingelheim Investigational Site 1 | Koriyama | |
| Japan | Boehringer Ingelheim Investigational Site 2 | Koriyama | |
| Japan | Boehringer Ingelheim Investigational Site | Koshigaya | |
| Japan | Boehringer Ingelheim Investigational Site 1 | Kumamoto | |
| Japan | Boehringer Ingelheim Investigational Site 2 | Kumamoto | |
| Japan | Boehringer Ingelheim Investigational Site 3 | Kumamoto | |
| Japan | Boehringer Ingelheim Investigational Site | Kure | |
| Japan | Boehringer Ingelheim Investigational Site | Kusatsu | |
| Japan | Boehringer Ingelheim Investigational Site 1 | Kyoto | |
| Japan | Boehringer Ingelheim Investigational Site 2 | Kyoto | |
| Japan | Boehringer Ingelheim Investigational Site 3 | Kyoto | |
| Japan | Boehringer Ingelheim Investigational Site 4 | Kyoto | |
| Japan | Boehringer Ingelheim Investigational Site | Maebashi | |
| Japan | Boehringer Ingelheim Investigational Site | Matsudo | |
| Japan | Boehringer Ingelheim Investigational Site | Matsumoto | |
| Japan | Boehringer Ingelheim Investigational Site | Mibu | |
| Japan | Boehringer Ingelheim Investigational Site | Mihara | |
| Japan | Boehringer Ingelheim Investigational Site | Mihoro | |
| Japan | Boehringer Ingelheim Investigational Site | Miriyama | |
| Japan | Boehringer Ingelheim Investigational Site | Misato | |
| Japan | Boehringer Ingelheim Investigational Site | Miyako | |
| Japan | Boehringer Ingelheim Investigational Site 1 | Miyazaki | |
| Japan | Boehringer Ingelheim Investigational Site 2 | Miyazaki | |
| Japan | Boehringer Ingelheim Investigational Site | Moriguchi | |
| Japan | Boehringer Ingelheim Investigational Site 1 | Morioka | |
| Japan | Boehringer Ingelheim Investigational Site 2 | Morioka | |
| Japan | Boehringer Ingelheim Investigational Site | Moriya | |
| Japan | Boehringer Ingelheim Investigational Site | Musashino | |
| Japan | Boehringer Ingelheim Investigational Site | Nagano | |
| Japan | Boehringer Ingelheim Investigational Site | Nagaoka | |
| Japan | Boehringer Ingelheim Investigational Site | Nagaokakyo | |
| Japan | Boehringer Ingelheim Investigational Site 1 | Nagoya | |
| Japan | Boehringer Ingelheim Investigational Site 2 | Nagoya | |
| Japan | Boehringer Ingelheim Investigational Site 3 | Nagoya | |
| Japan | Boehringer Ingelheim Investigational Site 4 | Nagoya | |
| Japan | Boehringer Ingelheim Investigational Site 1 | Nara | |
| Japan | Boehringer Ingelheim Investigational Site 2 | Nara | |
| Japan | Boehringer Ingelheim Investigational Site | Narashino | |
| Japan | Boehringer Ingelheim Investigational Site | Narita | |
| Japan | Boehringer Ingelheim Investigational Site | Naruto | |
| Japan | Boehringer Ingelheim Investigational Site | Nasushiobara | |
| Japan | Boehringer Ingelheim Investigational Site | Nichinan | |
| Japan | Boehringer Ingelheim Investigational Site | Ninohe | |
| Japan | Boehringer Ingelheim Investigational Site | Nishinomiya | |
| Japan | Boehringer Ingelheim Investigational Site | Nishitokyo | |
| Japan | Boehringer Ingelheim Investigational Site | Ogaki | |
| Japan | Boehringer Ingelheim Investigational Site | Oiso | |
| Japan | Boehringer Ingelheim Investigational Site 1 | Oita | |
| Japan | Boehringer Ingelheim Investigational Site 2 | Oita | |
| Japan | Boehringer Ingelheim Investigational Site 3 | Oita | |
| Japan | Boehringer Ingelheim Investigational Site | Okaya | |
| Japan | Boehringer Ingelheim Investigational Site 1 | Okayama | |
| Japan | Boehringer Ingelheim Investigational Site 2 | Okayama | |
| Japan | Boehringer Ingelheim Investigational Site | Okazaki | |
| Japan | Boehringer Ingelheim Investigational Site | Okinawa | |
| Japan | Boehringer Ingelheim Investigational Site | Omura | |
| Japan | Boehringer Ingelheim Investigational Site | Omuta | |
| Japan | Boehringer Ingelheim Investigational Site | Onojyo | |
| Japan | Boehringer Ingelheim Investigational Site 1 | Osaka | |
| Japan | Boehringer Ingelheim Investigational Site 2 | Osaka | |
| Japan | Boehringer Ingelheim Investigational Site 3 | Osaka | |
| Japan | Boehringer Ingelheim Investigational Site 4 | Osaka | |
| Japan | Boehringer Ingelheim Investigational Site 5 | Osaka | |
| Japan | Boehringer Ingelheim Investigational Site 6 | Osaka | |
| Japan | Boehringer Ingelheim Investigational Site | Ota | |
| Japan | Boehringer Ingelheim Investigational Site | Otake | |
| Japan | Boehringer Ingelheim Investigational Site | Otsu | |
| Japan | Boehringer Ingelheim Investigational Site | Ryugasaki | |
| Japan | Boehringer Ingelheim Investigational Site | Saeki | |
| Japan | Boehringer Ingelheim Investigational Site | Saga | |
| Japan | Boehringer Ingelheim Investigational Site 1 | Sagamihara | |
| Japan | Boehringer Ingelheim Investigational Site 2 | Sagamihara | |
| Japan | Boehringer Ingelheim Investigational Site 3 | Sagamihara | |
| Japan | Boehringer Ingelheim Investigational Site | Saijyo | |
| Japan | Boehringer Ingelheim Investigational Site | Saitama | |
| Japan | Boehringer Ingelheim Investigational Site 1 | Sakai | |
| Japan | Boehringer Ingelheim Investigational Site 2 | Sakai | |
| Japan | Boehringer Ingelheim Investigational Site 1 | Sapporo | |
| Japan | Boehringer Ingelheim Investigational Site 2 | Sapporo | |
| Japan | Boehringer Ingelheim Investigational Site 3 | Sapporo | |
| Japan | Boehringer Ingelheim Investigational Site 4 | Sapporo | |
| Japan | Boehringer Ingelheim Investigational Site 5 | Sapporo | |
| Japan | Boehringer Ingelheim Investigational Site 6 | Sapporo | |
| Japan | Boehringer Ingelheim Investigational Site 7 | Sapporo | |
| Japan | Boehringer Ingelheim Investigational Site 8 | Sapporo | |
| Japan | Boehringer Ingelheim Investigational Site 9 | Sapporo | |
| Japan | Boehringer Ingelheim Investigational Site | Sekigahara | |
| Japan | Boehringer Ingelheim Investigational Site 1 | Sendai | |
| Japan | Boehringer Ingelheim Investigational Site 2 | Sendai | |
| Japan | Boehringer Ingelheim Investigational Site | Shimoda | |
| Japan | Boehringer Ingelheim Investigational Site 1 | Shimotsuke | |
| Japan | Boehringer Ingelheim Investigational Site 2 | Shimotsuke | |
| Japan | Boehringer Ingelheim Investigational Site | Shinngu | |
| Japan | Boehringer Ingelheim Investigational Site | Shiroishi | |
| Japan | Boehringer Ingelheim Investigational Site 1 | Shizuoka | |
| Japan | Boehringer Ingelheim Investigational Site 2 | Shizuoka | |
| Japan | Boehringer Ingelheim Investigational Site | Showajima | |
| Japan | Boehringer Ingelheim Investigational Site 1 | Suita | |
| Japan | Boehringer Ingelheim Investigational Site 2 | Suita | |
| Japan | Boehringer Ingelheim Investigational Site | Susono | |
| Japan | Boehringer Ingelheim Investigational Site | Suzuka | |
| Japan | Boehringer Ingelheim Investigational Site 1 | Takaoka | |
| Japan | Boehringer Ingelheim Investigational Site 2 | Takaoka | |
| Japan | Boehringer Ingelheim Investigational Site | Takatsuki | |
| Japan | Boehringer Ingelheim Investigational Site | Tarimizu | |
| Japan | Boehringer Ingelheim Investigational Site | Togitsu | |
| Japan | Boehringer Ingelheim Investigational Site | Tokoname | |
| Japan | Boehringer Ingelheim Investigational Site | Tokushima | |
| Japan | Boehringer Ingelheim Investigational Site | Tokyo Arakawa-ku | |
| Japan | Boehringer Ingelheim Investigational Site | Tokyo Bunkyo-ku | |
| Japan | Boehringer Ingelheim Investigational Site 1 | Tokyo Chuo-ku | |
| Japan | Boehringer Ingelheim Investigational Site 2 | Tokyo Chuo-ku | |
| Japan | Boehringer Ingelheim Investigational Site | Tokyo Daito-ku | |
| Japan | Boehringer Ingelheim Investigational Site | Tokyo Koto-ku | |
| Japan | Boehringer Ingelheim Investigational Site 1 | Tokyo Meguro-ku | |
| Japan | Boehringer Ingelheim Investigational Site 2 | Tokyo Meguro-ku | |
| Japan | Boehringer Ingelheim Investigational Site 1 | Tokyo Minato-ku | |
| Japan | Boehringer Ingelheim Investigational Site 2 | Tokyo Minato-ku | |
| Japan | Boehringer Ingelheim Investigational Site 3 | Tokyo Minato-ku | |
| Japan | Boehringer Ingelheim Investigational Site | Tokyo Nakano-ku | |
| Japan | Boehringer Ingelheim Investigational Site | Tokyo Nerima-ku | |
| Japan | Boehringer Ingelheim Investigational Site 1 | Tokyo Ota-ku | |
| Japan | Boehringer Ingelheim Investigational Site 2 | Tokyo Ota-ku | |
| Japan | Boehringer Ingelheim Investigational Site | Tokyo Setagaya | |
| Japan | Boehringer Ingelheim Investigational Site | Tokyo Setagaya-ku | |
| Japan | Boehringer Ingelheim Investigational Site | Tokyo Shibuya-ku | |
| Japan | Boehringer Ingelheim Investigational Site | Tokyo Shinagawa-ku | |
| Japan | Boehringer Ingelheim Investigational Site 1 | Tokyo Shinjyuku-ku | |
| Japan | Boehringer Ingelheim Investigational Site 2 | Tokyo Shinjyuku-ku | |
| Japan | Boehringer Ingelheim Investigational Site 3 | Tokyo Shinjyuku-ku | |
| Japan | Boehringer Ingelheim Investigational Site | Tokyo Sibuya-ku | |
| Japan | Boehringer Ingelheim Investigational Site | Tokyo Toshima-ku | |
| Japan | Boehringer Ingelheim Investigational Site | Tokyo-Edogawa-ku | |
| Japan | Boehringer Ingelheim Investigational Site | Tokyo-Itabashi-ku | |
| Japan | Boehringer Ingelheim Investigational Site | Toride | |
| Japan | Boehringer Ingelheim Investigational Site | Tosu | |
| Japan | Boehringer Ingelheim Investigational Site 1 | Toyama | |
| Japan | Boehringer Ingelheim Investigational Site 2 | Toyama | |
| Japan | Boehringer Ingelheim Investigational Site 3 | Toyama | |
| Japan | Boehringer Ingelheim Investigational Site | Toyohashi | |
| Japan | Boehringer Ingelheim Investigational Site | Toyokawa | |
| Japan | Boehringer Ingelheim Investigational Site | Toyonaka | |
| Japan | Boehringer Ingelheim Investigational Site | Ube | |
| Japan | Boehringer Ingelheim Investigational Site | Uchinada | |
| Japan | Boehringer Ingelheim Investigational Site | Ueda | |
| Japan | Boehringer Ingelheim Investigational Site | Ushiku | |
| Japan | Boehringer Ingelheim Investigational Site 1 | Utsunomiya | |
| Japan | Boehringer Ingelheim Investigational Site 2 | Utsunomiya | |
| Japan | Boehringer Ingelheim Investigational Site | Wakayama | |
| Japan | Boehringer Ingelheim Investigational Site 1 | Yachiyo | |
| Japan | Boehringer Ingelheim Investigational Site 2 | Yachiyo | |
| Japan | Boehringer Ingelheim Investigational Site 3 | Yachiyo | |
| Japan | Boehringer Ingelheim Investigational Site | Yamanashi | |
| Japan | Boehringer Ingelheim Investigational Site | Yanago | |
| Japan | Boehringer Ingelheim Investigational Site | Yoichi | |
| Japan | Boehringer Ingelheim Investigational Site 1 | Yokohama | |
| Japan | Boehringer Ingelheim Investigational Site 2 | Yokohama | |
| Japan | Boehringer Ingelheim Investigational Site 3 | Yokohama | |
| Japan | Boehringer Ingelheim Investigational Site 4 | Yokohama | |
| Japan | Boehringer Ingelheim Investigational Site | Yokosuka | |
| Japan | Boehringer Ingelheim Investigational Site | Yoshinogawa |
| Lead Sponsor | Collaborator |
|---|---|
| Boehringer Ingelheim |
Japan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Percentage of Participants With Adverse Events, Adverse Drug Reactions, and Serious Adverse Events | The aim of this Post Marketing Surveillance (PMS) was to obtain safety data with treatment of pramipexole in Parkinson's disease patients with depressive symptoms. The percentage of participants with adverse events, adverse drug reactions, and serious adverse events are presented. | for 12 weeks | No |
| Secondary | Clinical Global Impression of Improvement | Investigators evaluation of the Parkinson's disease (PD) symptoms on the Clinical Global Impression (CGI) with 5 categories (very much improved, much improved, minimally improved, no effect, and unassessable). | for 12 weeks after initiation of the treatment | No |
| Secondary | Mean Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Total Score | Part III of the UPDRS contains the clinician-scored motor evaluation, and includes 14 individual items each scored from 0 (Normal) to 4 (Extreme dysfunction). The total score ranged from 0 to 56. A negative change in the Part III total score indicates improvement. | Baseline and after 12 weeks (or at the time of discontinuation) | No |
| Secondary | Mean Change From Baseline in Beck's Depression Inventory (BDI) Total Score | The degree of severity in depressive state are scored between 0-63 in BDI. A decrease in the score means improvement. | Baseline and after 12 weeks (or at the time of discontinuation) | No |
| Secondary | Mean Change From Baseline in UPDRS (Unified Parkinson's Disease Rating Scale) Part I Item 3 Score | Unified Parkinson's Disease Rating Scale Part I Item 3 assesses the participant for symptoms of depression. Item 3 scores range from 0 (None) to 4 (Sustained depression with suicidal thoughts or intent). A higher score indicates more severe depression symptoms. A negative change in the item 3 score indicates improvement. | Baseline and after 12 weeks (or at the time of discontinuation) | No |
| Secondary | Mean Change From Baseline in Modified Hoehn & Yahr Rating Scale | This scale is an investigator-completed assessment of the degree of complications arising from Parkinson's disease. The scale ranges from 0 (No signs) to 5 (Bedridden). A negative change in the Yahr rating scale indicates improvement. | After 12 weeks or at the time of discontinuation | No |
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