NCT00615914

Brief Summary

The survey is conducted to collect safety and effectiveness information on the use of Pramipexole for long time of period in daily clinical settings in Japan.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,645

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

273 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2004

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

January 31, 2008

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 14, 2008

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

November 23, 2010

Completed
Last Updated

July 11, 2014

Status Verified

June 1, 2014

Enrollment Period

5.1 years

First QC Date

January 31, 2008

Results QC Date

September 8, 2010

Last Update Submit

June 10, 2014

Conditions

Outcome Measures

Primary Outcomes (1)

  • Proportion of Adverse Events, Adverse Drug Reactions, Serious Adverse Events

    The aim of this Post Marketing Surveillance (PMS) was to obtain long-term safety data with treatment of pramipexole in Parkinson's disease (PD) patients. Therefore these items were considered as a safety evaluation.

    during 18 months

Secondary Outcomes (3)

  • Clinical Global Impression of Improvement

    18 months

  • Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Total Score

    Baseline and at 18 months (or at the time of discontinuation)

  • Change From Baseline in Modified Hoehn & Yahr Rating Scale

    Baseline and at 18 months (or at the time of discontinuation)

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Parkinson's disease patients in daily clinical settings

You may qualify if:

  • Patients with Parkinson's disease

You may not qualify if:

  • Patients should have been treated according to the Japanese insert slip

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (273)

Boehringer Ingelheim Investigational Site

Agano, Japan

Location

Boehringer Ingelheim Investigational Site

Aizu-Wakamatsu, Japan

Location

Boehringer Ingelheim Investigational Site

Akashi, Japan

Location

Boehringer Ingelheim Investigational Site

Akita, Japan

Location

Boehringer Ingelheim Investigational Site

Asahikawa, Japan

Location

Boehringer Ingelheim Investigational Site

Asakura, Japan

Location

Boehringer Ingelheim Investigational Site

Azumino, Japan

Location

Boehringer Ingelheim Investigational Site

Bandō, Japan

Location

Boehringer Ingelheim Investigational Site

Beppu, Japan

Location

Boehringer Ingelheim Investigational Site

Bihoro, Japan

Location

Boehringer Ingelheim Investigational Site

Chiba, Japan

Location

Boehringer Ingelheim Investigational Site

Chikusei, Japan

Location

Boehringer Ingelheim Investigational Site

Chūō, Japan

Location

Boehringer Ingelheim Investigational Site

Date, Japan

Location

Boehringer Ingelheim Investigational Site

Ebetsu, Japan

Location

Boehringer Ingelheim Investigational Site

Ebina, Japan

Location

Boehringer Ingelheim Investigational Site

Fuchū, Japan

Location

Boehringer Ingelheim Investigational Site

Fuji, Japan

Location

Boehringer Ingelheim Investigational Site

Fujieda, Japan

Location

Boehringer Ingelheim Investigational Site

Fujinomiya, Japan

Location

Boehringer Ingelheim Investigational Site

Fujioka, Japan

Location

Boehringer Ingelheim Investigational Site

Fujisawa, Japan

Location

Boehringer Ingelheim Investigational Site

Fujiyoshida, Japan

Location

Boehringer Ingelheim Investigational Site

Fukaya, Japan

Location

Boehringer Ingelheim Investigational Site

Fukui, Japan

Location

Boehringer Ingelheim Investigational Site

Fukuoka, Japan

Location

Boehringer Ingelheim Investigational Site

Fukushima, Japan

Location

Boehringer Ingelheim Investigational Site

Fukuyama, Japan

Location

Boehringer Ingelheim Investigational Site

Gifu, Japan

Location

Boehringer Ingelheim Investigational Site

Ginowan, Japan

Location

Boehringer Ingelheim Investigational Site

Hachinohe, Japan

Location

Boehringer Ingelheim Investigational Site

Hadano, Japan

Location

Boehringer Ingelheim Investigational Site

Hagahama, Japan

Location

Boehringer Ingelheim Investigational Site

Hakodate, Japan

Location

Boehringer Ingelheim Investigational Site

Hamada, Japan

Location

Boehringer Ingelheim Investigational Site

Hamamatsu, Japan

Location

Boehringer Ingelheim Investigational Site

Hayashima, Japan

Location

Boehringer Ingelheim Investigational Site

Higashimurayama, Japan

Location

Boehringer Ingelheim Investigational Site

Higashiosaka, Japan

Location

Boehringer Ingelheim Investigational Site

Higashiyamato, Japan

Location

Boehringer Ingelheim Investigational Site

Himeji, Japan

Location

Boehringer Ingelheim Investigational Site

Hiratsuka, Japan

Location

Boehringer Ingelheim Investigational Site

Hirokawa, Japan

Location

Boehringer Ingelheim Investigational Site

Hirosaki, Japan

Location

Boehringer Ingelheim Investigational Site

Hiroshima, Japan

Location

Boehringer Ingelheim Investigational Site

Hita, Japan

Location

Boehringer Ingelheim Investigational Site

Hōfu, Japan

Location

Boehringer Ingelheim Investigational Site

Ibaraki, Japan

Location

Boehringer Ingelheim Investigational Site

Ichikikushikino, Japan

Location

Boehringer Ingelheim Investigational Site

Ichinomiya, Japan

Location

Boehringer Ingelheim Investigational Site

Ichinoseki, Japan

Location

Boehringer Ingelheim Investigational Site

Iijima, Japan

Location

Boehringer Ingelheim Investigational Site

Iizuka, Japan

Location

Boehringer Ingelheim Investigational Site

Ikeda, Japan

Location

Boehringer Ingelheim Investigational Site

Ikoma, Japan

Location

Boehringer Ingelheim Investigational Site

Ina, Japan

Location

Boehringer Ingelheim Investigational Site

Inazawa, Japan

Location

Boehringer Ingelheim Investigational Site

Inba, Japan

Location

Boehringer Ingelheim Investigational Site

Inuyama, Japan

Location

Boehringer Ingelheim Investigational Site

Isesaki, Japan

Location

Boehringer Ingelheim Investigational Site

Itoigawa, Japan

Location

Boehringer Ingelheim Investigational Site

Iwaki, Japan

Location

Boehringer Ingelheim Investigational Site

Iwata, Japan

Location

Boehringer Ingelheim Investigational Site

Jōetsu, Japan

Location

Boehringer Ingelheim Investigational Site

Kagoshima, Japan

Location

Boehringer Ingelheim Investigational Site

Kahoku, Japan

Location

Boehringer Ingelheim Investigational Site

Kajiki, Japan

Location

Boehringer Ingelheim Investigational Site

Kakegawa, Japan

Location

Boehringer Ingelheim Investigational Site

Kakogawa, Japan

Location

Boehringer Ingelheim Investigational Site

Kamisu, Japan

Location

Boehringer Ingelheim Investigational Site

Kamogawa, Japan

Location

Boehringer Ingelheim Investigational Site

Kanazawa, Japan

Location

Boehringer Ingelheim Investigational Site

Kanegusuku, Japan

Location

Boehringer Ingelheim Investigational Site

Kannonji, Japan

Location

Boehringer Ingelheim Investigational Site

Karatsu, Japan

Location

Boehringer Ingelheim Investigational Site

Kashima, Japan

Location

Boehringer Ingelheim Investigational Site

Kashiwa, Japan

Location

Boehringer Ingelheim Investigational Site

Kashiwazaki, Japan

Location

Boehringer Ingelheim Investigational Site

Kasukabe, Japan

Location

Boehringer Ingelheim Investigational Site

Katō, Japan

Location

Boehringer Ingelheim Investigational Site

Kawagoe, Japan

Location

Boehringer Ingelheim Investigational Site

Kawasaki, Japan

Location

Boehringer Ingelheim Investigational Site

Kawatana, Japan

Location

Boehringer Ingelheim Investigational Site

Kikugawa, Japan

Location

Boehringer Ingelheim Investigational Site

Kirishima, Japan

Location

Boehringer Ingelheim Investigational Site

Kitakyushu, Japan

Location

Boehringer Ingelheim Investigational Site

Kiyose, Japan

Location

Boehringer Ingelheim Investigational Site

Kiyotake, Japan

Location

Boehringer Ingelheim Investigational Site

Kizugawa, Japan

Location

Boehringer Ingelheim Investigational Site

Kobayashi, Japan

Location

Boehringer Ingelheim Investigational Site

Kobe, Japan

Location

Boehringer Ingelheim Investigational Site

Kochi, Japan

Location

Boehringer Ingelheim Investigational Site

Kodaira, Japan

Location

Boehringer Ingelheim Investigational Site

Kofu, Japan

Location

Boehringer Ingelheim Investigational Site

Koga, Japan

Location

Boehringer Ingelheim Investigational Site

Koga, Japan

Location

Boehringer Ingelheim Investigational Site

Kokubunji, Japan

Location

Boehringer Ingelheim Investigational Site

Komae, Japan

Location

Boehringer Ingelheim Investigational Site

Komatsu, Japan

Location

Boehringer Ingelheim Investigational Site

Komoro, Japan

Location

Boehringer Ingelheim Investigational Site

Koshikawa, Japan

Location

Boehringer Ingelheim Investigational Site

Kōriyama, Japan

Location

Boehringer Ingelheim Investigational Site

Kōshi, Japan

Location

Boehringer Ingelheim Investigational Site

Kōtari, Japan

Location

Boehringer Ingelheim Investigational Site

Kumamoto, Japan

Location

Boehringer Ingelheim Investigational Site

Kurashiki, Japan

Location

Boehringer Ingelheim Investigational Site

Kurayoshi, Japan

Location

Boehringer Ingelheim Investigational Site

Kure, Japan

Location

Boehringer Ingelheim Investigational Site

Kurume, Japan

Location

Boehringer Ingelheim Investigational Site

Kushiro, Japan

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Boehringer Ingelheim Investigational Site

Kutchan, Japan

Location

Boehringer Ingelheim Investigational Site

Kuwana, Japan

Location

Boehringer Ingelheim Investigational Site

Kyoto, Japan

Location

Boehringer Ingelheim Investigational Site

Maebaru, Japan

Location

Boehringer Ingelheim Investigational Site

Maebashi, Japan

Location

Boehringer Ingelheim Investigational Site

Maibara, Japan

Location

Boehringer Ingelheim Investigational Site

Maizuru, Japan

Location

Boehringer Ingelheim Investigational Site

Marugame, Japan

Location

Boehringer Ingelheim Investigational Site

Matsuda, Japan

Location

Boehringer Ingelheim Investigational Site

Matsudo, Japan

Location

Boehringer Ingelheim Investigational Site

Matsue, Japan

Location

Boehringer Ingelheim Investigational Site

Matsumoto, Japan

Location

Boehringer Ingelheim Investigational Site

Matsuyama, Japan

Location

Boehringer Ingelheim Investigational Site

Mibu, Japan

Location

Boehringer Ingelheim Investigational Site

Mihara, Japan

Location

Boehringer Ingelheim Investigational Site

Miki, Japan

Location

Boehringer Ingelheim Investigational Site

Minakami, Japan

Location

Boehringer Ingelheim Investigational Site

Minamata, Japan

Location

Boehringer Ingelheim Investigational Site

Minobu, Japan

Location

Boehringer Ingelheim Investigational Site

Misashino, Japan

Location

Boehringer Ingelheim Investigational Site

Mito, Japan

Location

Boehringer Ingelheim Investigational Site

Miyaki, Japan

Location

Boehringer Ingelheim Investigational Site

Miyakonojō, Japan

Location

Boehringer Ingelheim Investigational Site

Miyazaki, Japan

Location

Boehringer Ingelheim Investigational Site

Mooka, Japan

Location

Boehringer Ingelheim Investigational Site

Moriguchi, Japan

Location

Boehringer Ingelheim Investigational Site

Morioka, Japan

Location

Boehringer Ingelheim Investigational Site

Moriya, Japan

Location

Boehringer Ingelheim Investigational Site

Moriyama, Japan

Location

Boehringer Ingelheim Investigational Site

Motona, Japan

Location

Boehringer Ingelheim Investigational Site

Mukai-awagasaki, Japan

Location

Boehringer Ingelheim Investigational Site

Muroran, Japan

Location

Boehringer Ingelheim Investigational Site

Nagakute, Japan

Location

Boehringer Ingelheim Investigational Site

Nagaoka, Japan

Location

Boehringer Ingelheim Investigational Site

Nagasaki, Japan

Location

Boehringer Ingelheim Investigational Site

Nagoya, Japan

Location

Boehringer Ingelheim Investigational Site

Nangōku, Japan

Location

Boehringer Ingelheim Investigational Site

Nara, Japan

Location

Boehringer Ingelheim Investigational Site

Narita, Japan

Location

Boehringer Ingelheim Investigational Site

Narutō, Japan

Location

Boehringer Ingelheim Investigational Site

Nichinan, Japan

Location

Boehringer Ingelheim Investigational Site

Niigata, Japan

Location

Boehringer Ingelheim Investigational Site

Niihama, Japan

Location

Boehringer Ingelheim Investigational Site

Nikkō, Japan

Location

Boehringer Ingelheim Investigational Site

Nishigō, Japan

Location

Boehringer Ingelheim Investigational Site

Nishihara, Japan

Location

Boehringer Ingelheim Investigational Site

Nishinomiya, Japan

Location

Boehringer Ingelheim Investigational Site

Nishio, Japan

Location

Boehringer Ingelheim Investigational Site

Nishitōkyō, Japan

Location

Boehringer Ingelheim Investigational Site

Nobeoka, Japan

Location

Boehringer Ingelheim Investigational Site

Noboribetsu, Japan

Location

Boehringer Ingelheim Investigational Site

Numazu, Japan

Location

Boehringer Ingelheim Investigational Site

Obama, Japan

Location

Boehringer Ingelheim Investigational Site

Obihiro, Japan

Location

Boehringer Ingelheim Investigational Site

Odawara, Japan

Location

Boehringer Ingelheim Investigational Site

Ohzu, Japan

Location

Boehringer Ingelheim Investigational Site

Ojiya, Japan

Location

Boehringer Ingelheim Investigational Site

Okayama, Japan

Location

Boehringer Ingelheim Investigational Site

Omaezaki, Japan

Location

Boehringer Ingelheim Investigational Site

Omuta, Japan

Location

Boehringer Ingelheim Investigational Site

Onomichi, Japan

Location

Boehringer Ingelheim Investigational Site

Osaka, Japan

Location

Boehringer Ingelheim Investigational Site

Ōdate, Japan

Location

Boehringer Ingelheim Investigational Site

Ōfunato, Japan

Location

Boehringer Ingelheim Investigational Site

Ōgaki, Japan

Location

Boehringer Ingelheim Investigational Site

Ōiso, Japan

Location

Boehringer Ingelheim Investigational Site

Ōita, Japan

Location

Boehringer Ingelheim Investigational Site

Ōkawa, Japan

Location

Boehringer Ingelheim Investigational Site

Ōmura, Japan

Location

Boehringer Ingelheim Investigational Site

Ōnojō, Japan

Location

Boehringer Ingelheim Investigational Site

Ōtsu, Japan

Location

Boehringer Ingelheim Investigational Site

Ōzu, Japan

Location

Boehringer Ingelheim Investigational Site

Sado, Japan

Location

Boehringer Ingelheim Investigational Site

Saga, Japan

Location

Boehringer Ingelheim Investigational Site

Sagamihara, Japan

Location

Boehringer Ingelheim Investigational Site

Saitama, Japan

Location

Boehringer Ingelheim Investigational Site

Sakai, Japan

Location

Boehringer Ingelheim Investigational Site

Sakaidechō, Japan

Location

Boehringer Ingelheim Investigational Site

Sakata, Japan

Location

Boehringer Ingelheim Investigational Site

Saku, Japan

Location

Boehringer Ingelheim Investigational Site

Sanjō, Japan

Location

Boehringer Ingelheim Investigational Site

Sano, Japan

Location

Boehringer Ingelheim Investigational Site

Sanyōonoda, Japan

Location

Boehringer Ingelheim Investigational Site

Sapporo, Japan

Location

Boehringer Ingelheim Investigational Site

Sasebo, Japan

Location

Boehringer Ingelheim Investigational Site

Seijō, Japan

Location

Boehringer Ingelheim Investigational Site

Sendai, Japan

Location

Boehringer Ingelheim Investigational Site

Shimabara, Japan

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Boehringer Ingelheim Investigational Site

Shimonoseki, Japan

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Boehringer Ingelheim Investigational Site

Shimotsuke, Japan

Location

Boehringer Ingelheim Investigational Site

Shingū, Japan

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Boehringer Ingelheim Investigational Site

Shinshiro, Japan

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Boehringer Ingelheim Investigational Site

Shizuoka, Japan

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Boehringer Ingelheim Investigational Site

Shūnan, Japan

Location

Boehringer Ingelheim Investigational Site

Soo, Japan

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Boehringer Ingelheim Investigational Site

Suita, Japan

Location

Boehringer Ingelheim Investigational Site

Tajimi, Japan

Location

Boehringer Ingelheim Investigational Site

Takamatsu, Japan

Location

Boehringer Ingelheim Investigational Site

Takanabe, Japan

Location

Boehringer Ingelheim Investigational Site

Takaoka, Japan

Location

Boehringer Ingelheim Investigational Site

Takasago, Japan

Location

Boehringer Ingelheim Investigational Site

Takasaki, Japan

Location

Boehringer Ingelheim Investigational Site

Takatsuki, Japan

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Boehringer Ingelheim Investigational Site

Takehara, Japan

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Boehringer Ingelheim Investigational Site

Takinomiya, Japan

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Boehringer Ingelheim Investigational Site

Toda, Japan

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Boehringer Ingelheim Investigational Site

Togitsu, Japan

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Boehringer Ingelheim Investigational Site

Tokoname, Japan

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Boehringer Ingelheim Investigational Site

Tokushima, Japan

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Boehringer Ingelheim Investigational Site

Tokyo Adachi-ku, Japan

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Boehringer Ingelheim Investigational Site

Tokyo Bunkyo-ku, Japan

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Boehringer Ingelheim Investigational Site

Tokyo Chiyoda-ku, Japan

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Boehringer Ingelheim Investigational Site

Tokyo Edogawa-ku, Japan

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Boehringer Ingelheim Investigational Site

Tokyo Itabashi-ku, Japan

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Boehringer Ingelheim Investigational Site

Tokyo Katsushika-ku, Japan

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Boehringer Ingelheim Investigational Site

Tokyo Kita-ku, Japan

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Boehringer Ingelheim Investigational Site

Tokyo Meguro-ku, Japan

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Boehringer Ingelheim Investigational Site

Tokyo Minayo-ku, Japan

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Boehringer Ingelheim Investigational Site

Tokyo Nakano-ku, Japan

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Boehringer Ingelheim Investigational Site

Tokyo Nerima-ku, Japan

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Boehringer Ingelheim Investigational Site

Tokyo Ota-ku, Japan

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Boehringer Ingelheim Investigational Site

Tokyo Setagaya-ku, Japan

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Boehringer Ingelheim Investigational Site

Tokyo Shinagawa-ku, Japan

Location

Boehringer Ingelheim Investigational Site

Tokyo Shinjuku-ku, Japan

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Boehringer Ingelheim Investigational Site

Tokyo Suginami-ku, Japan

Location

Boehringer Ingelheim Investigational Site

Tokyo Toshima-ku, Japan

Location

Boehringer Ingelheim Investigational Site

Tomakomai, Japan

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Boehringer Ingelheim Investigational Site

Tomiai, Japan

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Boehringer Ingelheim Investigational Site

Tondabayashi, Japan

Location

Boehringer Ingelheim Investigational Site

Toride, Japan

Location

Boehringer Ingelheim Investigational Site

Toyama, Japan

Location

Boehringer Ingelheim Investigational Site

Toyoake, Japan

Location

Boehringer Ingelheim Investigational Site

Toyokawa, Japan

Location

Boehringer Ingelheim Investigational Site

Toyonaka, Japan

Location

Boehringer Ingelheim Investigational Site

Toyooka, Japan

Location

Boehringer Ingelheim Investigational Site

Tōon, Japan

Location

Boehringer Ingelheim Investigational Site

Tsu, Japan

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Boehringer Ingelheim Investigational Site

Tsubata, Japan

Location

Boehringer Ingelheim Investigational Site

Tsuchiura, Japan

Location

Boehringer Ingelheim Investigational Site

Tsukuba, Japan

Location

Boehringer Ingelheim Investigational Site

Tsuruoka, Japan

Location

Boehringer Ingelheim Investigational Site

Ueda, Japan

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Boehringer Ingelheim Investigational Site

Uji, Japan

Location

Boehringer Ingelheim Investigational Site

Ujo, Japan

Location

Boehringer Ingelheim Investigational Site

Urayasu, Japan

Location

Boehringer Ingelheim Investigational Site

Uruma, Japan

Location

Boehringer Ingelheim Investigational Site

Utsunomiya, Japan

Location

Boehringer Ingelheim Investigational Site

Wajiki, Japan

Location

Boehringer Ingelheim Investigational Site

Wakayama, Japan

Location

Boehringer Ingelheim Investigational Site

Yamagata, Japan

Location

Boehringer Ingelheim Investigational Site

Yamaguchi, Japan

Location

Boehringer Ingelheim Investigational Site

Yamamoto, Japan

Location

Boehringer Ingelheim Investigational Site

Yanai, Japan

Location

Boehringer Ingelheim Investigational Site

Yao, Japan

Location

Boehringer Ingelheim Investigational Site

Yashiro, Japan

Location

Boehringer Ingelheim Investigational Site

Yazu, Japan

Location

Boehringer Ingelheim Investigational Site

Yokkaichi, Japan

Location

Boehringer Ingelheim Investigational Site

Yokohama, Japan

Location

Boehringer Ingelheim Investigational Site

Yokote, Japan

Location

Boehringer Ingelheim Investigational Site

Yoro, Japan

Location

Boehringer Ingelheim Investigational Site

Yoshinogawa, Japan

Location

Boehringer Ingelheim Investigational Site

Yufu, Japan

Location

Boehringer Ingelheim Investigational Site

Zama, Japan

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Results Point of Contact

Title
Boehringer Ingelheim Call Center
Organization
Boehringer Ingelheim Pharmaceuticals

Study Officials

  • Boehringer Ingelheim

    Boehringer Ingelheim

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 31, 2008

First Posted

February 14, 2008

Study Start

February 1, 2004

Primary Completion

March 1, 2009

Last Updated

July 11, 2014

Results First Posted

November 23, 2010

Record last verified: 2014-06

Locations