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Special Survey on Parkinson's Disease Patients Treated Long-term Use of Pramipexole

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ClinicalTrials.gov Identifier: NCT00615914
Recruitment Status : Completed
First Posted : February 14, 2008
Results First Posted : November 23, 2010
Last Update Posted : July 11, 2014
Sponsor:
Information provided by:
Boehringer Ingelheim

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.

Condition or disease
Parkinson Disease

Layout table for study information
Study Type : Observational
Actual Enrollment : 1645 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pramipexole Special Survey on Long-Term Use
Study Start Date : February 2004
Actual Primary Completion Date : March 2009

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Proportion of Adverse Events, Adverse Drug Reactions, Serious Adverse Events [ Time Frame: during 18 months ]
    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.


Secondary Outcome Measures :
  1. Clinical Global Impression of Improvement [ Time Frame: 18 months ]
    Investigators evaluation of the PD symptoms on a rating scale of 5 categories (very much improved, much improved, minimally improved, no effect, and unassessable).

  2. Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Total Score [ Time Frame: Baseline and at 18 months (or at the time of discontinuation) ]
    Motor examination is assessed by 27 questionnaire items in UPDRS Part III section. Each item is scored from 0 (best) to 4 (worst), and the total score of UPDRS Part III is from 0 (best) to 108 (worst). A decrease in the score means improvement.

  3. Change From Baseline in Modified Hoehn & Yahr Rating Scale [ Time Frame: Baseline and at 18 months (or at the time of discontinuation) ]
    A severity of PD symptom are assessed by Modified Hoehn & Yahr rating scale. This scale consist of 10 levels including additional evaluation levels defined in Japan. Ten levels are described by 0 (best), 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5 (worst).



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Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Parkinson's disease patients in daily clinical settings
Criteria

Inclusion Criteria:

Patients with Parkinson's disease

Exclusion Criteria:

Patients should have been treated according to the Japanese insert slip


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00615914


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Locations
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Japan
Boehringer Ingelheim Investigational Site
Agano, Japan
Boehringer Ingelheim Investigational Site
Aizuwakamatsu, Japan
Boehringer Ingelheim Investigational Site
Akashi, Japan
Boehringer Ingelheim Investigational Site
Akita, Japan
Boehringer Ingelheim Investigational Site
Asahikawa, Japan
Boehringer Ingelheim Investigational Site
Asakura, Japan
Boehringer Ingelheim Investigational Site
Ayagawa, Japan
Boehringer Ingelheim Investigational Site
Azumino, Japan
Boehringer Ingelheim Investigational Site
Bando, Japan
Boehringer Ingelheim Investigational Site
Beppu, Japan
Boehringer Ingelheim Investigational Site
Bihoro, Japan
Boehringer Ingelheim Investigational Site
Chiba, Japan
Boehringer Ingelheim Investigational Site
Chikusei, Japan
Boehringer Ingelheim Investigational Site
Chuo, Japan
Boehringer Ingelheim Investigational Site
Date, Japan
Boehringer Ingelheim Investigational Site
Ebetsu, Japan
Boehringer Ingelheim Investigational Site
Ebina, Japan
Boehringer Ingelheim Investigational Site
Eiheiji, Japan
Boehringer Ingelheim Investigational Site
Fuchu, Japan
Boehringer Ingelheim Investigational Site
Fujieda, Japan
Boehringer Ingelheim Investigational Site
Fujinomiya, Japan
Boehringer Ingelheim Investigational Site
Fujioka, Japan
Boehringer Ingelheim Investigational Site
Fujisawa, Japan
Boehringer Ingelheim Investigational Site
Fujiyoshida, Japan
Boehringer Ingelheim Investigational Site
Fuji, Japan
Boehringer Ingelheim Investigational Site
Fukaya, Japan
Boehringer Ingelheim Investigational Site
Fukui, Japan
Boehringer Ingelheim Investigational Site
Fukuoka, Japan
Boehringer Ingelheim Investigational Site
Fukushima, Japan
Boehringer Ingelheim Investigational Site
Fukuyama, Japan
Boehringer Ingelheim Investigational Site
Geisei, Japan
Boehringer Ingelheim Investigational Site
Gifu, Japan
Boehringer Ingelheim Investigational Site
Ginowan, Japan
Boehringer Ingelheim Investigational Site
Hachinohe, Japan
Boehringer Ingelheim Investigational Site
Hadano, Japan
Boehringer Ingelheim Investigational Site
Haebaru, Japan
Boehringer Ingelheim Investigational Site
Hagahama, Japan
Boehringer Ingelheim Investigational Site
Hakodate, Japan
Boehringer Ingelheim Investigational Site
Hamada, Japan
Boehringer Ingelheim Investigational Site
Hamamatsu, Japan
Boehringer Ingelheim Investigational Site
Hayashima, Japan
Boehringer Ingelheim Investigational Site
Higashimurayama, Japan
Boehringer Ingelheim Investigational Site
Higashiosaka, Japan
Boehringer Ingelheim Investigational Site
Higashiyamato, Japan
Boehringer Ingelheim Investigational Site
Himeji, Japan
Boehringer Ingelheim Investigational Site
Hiratsuka, Japan
Boehringer Ingelheim Investigational Site
Hirokawa, Japan
Boehringer Ingelheim Investigational Site
Hirosaki, Japan
Boehringer Ingelheim Investigational Site
Hiroshima, Japan
Boehringer Ingelheim Investigational Site
Hita, Japan
Boehringer Ingelheim Investigational Site
Hofu, Japan
Boehringer Ingelheim Investigational Site
Ibaragi, Japan
Boehringer Ingelheim Investigational Site
Ichikikushikino, Japan
Boehringer Ingelheim Investigational Site
Ichinomiya, Japan
Boehringer Ingelheim Investigational Site
Ichinoseki, Japan
Boehringer Ingelheim Investigational Site
Iizuka, Japan
Boehringer Ingelheim Investigational Site
Ikeda, Japan
Boehringer Ingelheim Investigational Site
Ikoma, Japan
Boehringer Ingelheim Investigational Site
Inazawa, Japan
Boehringer Ingelheim Investigational Site
Ina, Japan
Boehringer Ingelheim Investigational Site
Inba, Japan
Boehringer Ingelheim Investigational Site
Inuyama, Japan
Boehringer Ingelheim Investigational Site
Isezaki, Japan
Boehringer Ingelheim Investigational Site
Itoigawa, Japan
Boehringer Ingelheim Investigational Site
Iwaki, Japan
Boehringer Ingelheim Investigational Site
Iwata, Japan
Boehringer Ingelheim Investigational Site
Joetsu, Japan
Boehringer Ingelheim Investigational Site
Kagoshima, Japan
Boehringer Ingelheim Investigational Site
Kahoku, Japan
Boehringer Ingelheim Investigational Site
Kajiki, Japan
Boehringer Ingelheim Investigational Site
Kakegawa, Japan
Boehringer Ingelheim Investigational Site
Kakogawa, Japan
Boehringer Ingelheim Investigational Site
Kamisu, Japan
Boehringer Ingelheim Investigational Site
Kamogawa, Japan
Boehringer Ingelheim Investigational Site
Kanazawa, Japan
Boehringer Ingelheim Investigational Site
Kannonji, Japan
Boehringer Ingelheim Investigational Site
Karatsu, Japan
Boehringer Ingelheim Investigational Site
Kashima, Japan
Boehringer Ingelheim Investigational Site
Kashiwazaki, Japan
Boehringer Ingelheim Investigational Site
Kashiwa, Japan
Boehringer Ingelheim Investigational Site
Kasukabe, Japan
Boehringer Ingelheim Investigational Site
Kato, Japan
Boehringer Ingelheim Investigational Site
Kawagoe, Japan
Boehringer Ingelheim Investigational Site
Kawasaki, Japan
Boehringer Ingelheim Investigational Site
Kawatana, Japan
Boehringer Ingelheim Investigational Site
Kikugawa, Japan
Boehringer Ingelheim Investigational Site
Kirishima, Japan
Boehringer Ingelheim Investigational Site
Kitakyushu, Japan
Boehringer Ingelheim Investigational Site
Kiyose, Japan
Boehringer Ingelheim Investigational Site
Kiyotake, Japan
Boehringer Ingelheim Investigational Site
Kizugawa, Japan
Boehringer Ingelheim Investigational Site
Kobayashi, Japan
Boehringer Ingelheim Investigational Site
Kobe, Japan
Boehringer Ingelheim Investigational Site
Kochi, Japan
Boehringer Ingelheim Investigational Site
Kodaira, Japan
Boehringer Ingelheim Investigational Site
Kofu, Japan
Boehringer Ingelheim Investigational Site
Koga, Japan
Boehringer Ingelheim Investigational Site
Kokubunji, Japan
Boehringer Ingelheim Investigational Site
Komae, Japan
Boehringer Ingelheim Investigational Site
Komatsu, Japan
Boehringer Ingelheim Investigational Site
Komoro, Japan
Boehringer Ingelheim Investigational Site
Koriyama, Japan
Boehringer Ingelheim Investigational Site
Koshigawa, Japan
Boehringer Ingelheim Investigational Site
Koshi, Japan
Boehringer Ingelheim Investigational Site
Kumamoto, Japan
Boehringer Ingelheim Investigational Site
Kurashiki, Japan
Boehringer Ingelheim Investigational Site
Kurayoshi, Japan
Boehringer Ingelheim Investigational Site
Kure, Japan
Boehringer Ingelheim Investigational Site
Kurume, Japan
Boehringer Ingelheim Investigational Site
Kushiro, Japan
Boehringer Ingelheim Investigational Site
Kutchan, Japan
Boehringer Ingelheim Investigational Site
Kuwana, Japan
Boehringer Ingelheim Investigational Site
Kyonan, Japan
Boehringer Ingelheim Investigational Site
Kyoto, Japan
Boehringer Ingelheim Investigational Site
Maebaru, Japan
Boehringer Ingelheim Investigational Site
Maebashi, Japan
Boehringer Ingelheim Investigational Site
Maibara, Japan
Boehringer Ingelheim Investigational Site
Maizuru, Japan
Boehringer Ingelheim Investigational Site
Marugame, Japan
Boehringer Ingelheim Investigational Site
Matsuda, Japan
Boehringer Ingelheim Investigational Site
Matsudo, Japan
Boehringer Ingelheim Investigational Site
Matsue, Japan
Boehringer Ingelheim Investigational Site
Matsumoto, Japan
Boehringer Ingelheim Investigational Site
Matsuyama, Japan
Boehringer Ingelheim Investigational Site
Mibu, Japan
Boehringer Ingelheim Investigational Site
Mihara, Japan
Boehringer Ingelheim Investigational Site
Miki, Japan
Boehringer Ingelheim Investigational Site
Minakami, Japan
Boehringer Ingelheim Investigational Site
Minamata, Japan
Boehringer Ingelheim Investigational Site
Minobu, Japan
Boehringer Ingelheim Investigational Site
Misashino, Japan
Boehringer Ingelheim Investigational Site
Mito, Japan
Boehringer Ingelheim Investigational Site
Miyaki, Japan
Boehringer Ingelheim Investigational Site
Miyakonojo, Japan
Boehringer Ingelheim Investigational Site
Miyazaki, Japan
Boehringer Ingelheim Investigational Site
Mooka, Japan
Boehringer Ingelheim Investigational Site
Moriguchi, Japan
Boehringer Ingelheim Investigational Site
Morioka, Japan
Boehringer Ingelheim Investigational Site
Moriyama, Japan
Boehringer Ingelheim Investigational Site
Moriya, Japan
Boehringer Ingelheim Investigational Site
Muroran, Japan
Boehringer Ingelheim Investigational Site
Nagakute, Japan
Boehringer Ingelheim Investigational Site
Nagaokakyo, Japan
Boehringer Ingelheim Investigational Site
Nagaoka, Japan
Boehringer Ingelheim Investigational Site
Nagasaki, Japan
Boehringer Ingelheim Investigational Site
Nagoya, Japan
Boehringer Ingelheim Investigational Site
Nangoku, Japan
Boehringer Ingelheim Investigational Site
Nara, Japan
Boehringer Ingelheim Investigational Site
Narita, Japan
Boehringer Ingelheim Investigational Site
Naruto, Japan
Boehringer Ingelheim Investigational Site
Nichinan, Japan
Boehringer Ingelheim Investigational Site
Niigata, Japan
Boehringer Ingelheim Investigational Site
Niihama, Japan
Boehringer Ingelheim Investigational Site
Nikko, Japan
Boehringer Ingelheim Investigational Site
Nishigo, Japan
Boehringer Ingelheim Investigational Site
Nishihara, Japan
Boehringer Ingelheim Investigational Site
Nishinomiya, Japan
Boehringer Ingelheim Investigational Site
Nishio, Japan
Boehringer Ingelheim Investigational Site
Nishitokyo, Japan
Boehringer Ingelheim Investigational Site
Nobeoka, Japan
Boehringer Ingelheim Investigational Site
Noboribetsu, Japan
Boehringer Ingelheim Investigational Site
Numazu, Japan
Boehringer Ingelheim Investigational Site
Obama, Japan
Boehringer Ingelheim Investigational Site
Obihiro, Japan
Boehringer Ingelheim Investigational Site
Odate, Japan
Boehringer Ingelheim Investigational Site
Odawara, Japan
Boehringer Ingelheim Investigational Site
Ofunato, Japan
Boehringer Ingelheim Investigational Site
Ogaki, Japan
Boehringer Ingelheim Investigational Site
Ohzu, Japan
Boehringer Ingelheim Investigational Site
Oiso, Japan
Boehringer Ingelheim Investigational Site
Oita, Japan
Boehringer Ingelheim Investigational Site
Ojiya, Japan
Boehringer Ingelheim Investigational Site
Okawa, Japan
Boehringer Ingelheim Investigational Site
Okayama, Japan
Boehringer Ingelheim Investigational Site
Omaezaki, Japan
Boehringer Ingelheim Investigational Site
Omura, Japan
Boehringer Ingelheim Investigational Site
Omuta, Japan
Boehringer Ingelheim Investigational Site
Onga, Japan
Boehringer Ingelheim Investigational Site
Onojo, Japan
Boehringer Ingelheim Investigational Site
Onomichi, Japan
Boehringer Ingelheim Investigational Site
Osaka, Japan
Boehringer Ingelheim Investigational Site
Otsu, Japan
Boehringer Ingelheim Investigational Site
Ozu, Japan
Boehringer Ingelheim Investigational Site
Sado, Japan
Boehringer Ingelheim Investigational Site
Sagamihara, Japan
Boehringer Ingelheim Investigational Site
Saga, Japan
Boehringer Ingelheim Investigational Site
Saitama, Japan
Boehringer Ingelheim Investigational Site
Sakaide, Japan
Boehringer Ingelheim Investigational Site
Sakai, Japan
Boehringer Ingelheim Investigational Site
Sakata, Japan
Boehringer Ingelheim Investigational Site
Saku, Japan
Boehringer Ingelheim Investigational Site
Sanjo, Japan
Boehringer Ingelheim Investigational Site
Sano, Japan
Boehringer Ingelheim Investigational Site
Sanyoonoda, Japan
Boehringer Ingelheim Investigational Site
Sapporo, Japan
Boehringer Ingelheim Investigational Site
Sasebo, Japan
Boehringer Ingelheim Investigational Site
Seijo, Japan
Boehringer Ingelheim Investigational Site
Sendai, Japan
Boehringer Ingelheim Investigational Site
Shimabara, Japan
Boehringer Ingelheim Investigational Site
Shimonoseki, Japan
Boehringer Ingelheim Investigational Site
Shimotsuke, Japan
Boehringer Ingelheim Investigational Site
Shingu, Japan
Boehringer Ingelheim Investigational Site
Shinshiro, Japan
Boehringer Ingelheim Investigational Site
Shizuoka, Japan
Boehringer Ingelheim Investigational Site
Shunan, Japan
Boehringer Ingelheim Investigational Site
Soo, Japan
Boehringer Ingelheim Investigational Site
Suita, Japan
Boehringer Ingelheim Investigational Site
Tajimi, Japan
Boehringer Ingelheim Investigational Site
Takamatsu, Japan
Boehringer Ingelheim Investigational Site
Takanabe, Japan
Boehringer Ingelheim Investigational Site
Takaoka, Japan
Boehringer Ingelheim Investigational Site
Takasago, Japan
Boehringer Ingelheim Investigational Site
Takasaki, Japan
Boehringer Ingelheim Investigational Site
Takatsuki, Japan
Boehringer Ingelheim Investigational Site
Takehara, Japan
Boehringer Ingelheim Investigational Site
Toda, Japan
Boehringer Ingelheim Investigational Site
Togitsu, Japan
Boehringer Ingelheim Investigational Site
Tokoname, Japan
Boehringer Ingelheim Investigational Site
Tokushima, Japan
Boehringer Ingelheim Investigational Site
Tokyo Adachi-ku, Japan
Boehringer Ingelheim Investigational Site
Tokyo Bunkyo-ku, Japan
Boehringer Ingelheim Investigational Site
Tokyo Chiyoda-ku, Japan
Boehringer Ingelheim Investigational Site
Tokyo Edogawa-ku, Japan
Boehringer Ingelheim Investigational Site
Tokyo Itabashi-ku, Japan
Boehringer Ingelheim Investigational Site
Tokyo Katsushika-ku, Japan
Boehringer Ingelheim Investigational Site
Tokyo Kita-ku, Japan
Boehringer Ingelheim Investigational Site
Tokyo Meguro-ku, Japan
Boehringer Ingelheim Investigational Site
Tokyo Minayo-ku, Japan
Boehringer Ingelheim Investigational Site
Tokyo Nakano-ku, Japan
Boehringer Ingelheim Investigational Site
Tokyo Nerima-ku, Japan
Boehringer Ingelheim Investigational Site
Tokyo Ota-ku, Japan
Boehringer Ingelheim Investigational Site
Tokyo Setagaya-ku, Japan
Boehringer Ingelheim Investigational Site
Tokyo Shinagawa-ku, Japan
Boehringer Ingelheim Investigational Site
Tokyo Shinjuku-ku, Japan
Boehringer Ingelheim Investigational Site
Tokyo Suginami-ku, Japan
Boehringer Ingelheim Investigational Site
Tokyo Toshima-ku, Japan
Boehringer Ingelheim Investigational Site
Tomakomai, Japan
Boehringer Ingelheim Investigational Site
Tomiai, Japan
Boehringer Ingelheim Investigational Site
Tondabayashi, Japan
Boehringer Ingelheim Investigational Site
Toon, Japan
Boehringer Ingelheim Investigational Site
Toride, Japan
Boehringer Ingelheim Investigational Site
Toyama, Japan
Boehringer Ingelheim Investigational Site
Toyoake, Japan
Boehringer Ingelheim Investigational Site
Toyokawa, Japan
Boehringer Ingelheim Investigational Site
Toyonaka, Japan
Boehringer Ingelheim Investigational Site
Toyooka, Japan
Boehringer Ingelheim Investigational Site
Tsubata, Japan
Boehringer Ingelheim Investigational Site
Tsuchiura, Japan
Boehringer Ingelheim Investigational Site
Tsukuba, Japan
Boehringer Ingelheim Investigational Site
Tsuruoka, Japan
Boehringer Ingelheim Investigational Site
Tsu, Japan
Boehringer Ingelheim Investigational Site
Uchinada, Japan
Boehringer Ingelheim Investigational Site
Ueda, Japan
Boehringer Ingelheim Investigational Site
Uji, Japan
Boehringer Ingelheim Investigational Site
Ujo, Japan
Boehringer Ingelheim Investigational Site
Urayasu, Japan
Boehringer Ingelheim Investigational Site
Uruma, Japan
Boehringer Ingelheim Investigational Site
Utsunomiya, Japan
Boehringer Ingelheim Investigational Site
Wakayama, Japan
Boehringer Ingelheim Investigational Site
Yamagata, Japan
Boehringer Ingelheim Investigational Site
Yamaguchi, Japan
Boehringer Ingelheim Investigational Site
Yamamoto, Japan
Boehringer Ingelheim Investigational Site
Yanai, Japan
Boehringer Ingelheim Investigational Site
Yao, Japan
Boehringer Ingelheim Investigational Site
Yashiro, Japan
Boehringer Ingelheim Investigational Site
Yazu, Japan
Boehringer Ingelheim Investigational Site
Yokkaichi, Japan
Boehringer Ingelheim Investigational Site
Yokohama, Japan
Boehringer Ingelheim Investigational Site
Yokote, Japan
Boehringer Ingelheim Investigational Site
Yoro, Japan
Boehringer Ingelheim Investigational Site
Yoshinogawa, Japan
Boehringer Ingelheim Investigational Site
Yufu, Japan
Boehringer Ingelheim Investigational Site
Zama, Japan
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
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Study Chair: Boehringer Ingelheim Boehringer Ingelheim

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Responsible Party: Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT00615914     History of Changes
Other Study ID Numbers: 248.547
First Posted: February 14, 2008    Key Record Dates
Results First Posted: November 23, 2010
Last Update Posted: July 11, 2014
Last Verified: June 2014
Additional relevant MeSH terms:
Layout table for MeSH terms
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Pramipexole
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents