Survey on PD Patients With Depressive Symptoms

An observational study of Parkinson Disease, run by Boehringer Ingelheim at 238 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

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. Read more about this study

Who is it for?: Ages 20 years and older
Conditions the study is for: Parkinson Disease
Type of treatment: Pill or oral medicine
How many people: 1,089 participants
Where: 238 sitesJapan
Study dates: Jan 2007to Aug 2009
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 20 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: PD patients with depressive symptoms

Who may be able to join

PD patients with depressive symptoms Patients who have not received pramipexole hydrochloride hydrate preparations within 1 month before survey entrance.

Who cannot join

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

Trial locations and contacts

238 sites in 1 country.

City, postcode or hospital

238 sites in 1 country

Japan238 sites

Boehringer Ingelheim Investigational Site
Akashi
Boehringer Ingelheim Investigational Site 1
Akita
Boehringer Ingelheim Investigational Site 2
Akita
Boehringer Ingelheim Investigational Site
Asahikawa
Boehringer Ingelheim Investigational Site
Ashikaga
Boehringer Ingelheim Investigational Site
Awaji
Boehringer Ingelheim Investigational Site
Chitose
Boehringer Ingelheim Investigational Site
Chūō
Boehringer Ingelheim Investigational Site 1
Fuchū
Boehringer Ingelheim Investigational Site 2
Fuchū
Boehringer Ingelheim Investigational Site
Fuefuki
Boehringer Ingelheim Investigational Site
Fuehuki
Boehringer Ingelheim Investigational Site
Fujioka
Boehringer Ingelheim Investigational Site
Fujisaki
Boehringer Ingelheim Investigational Site
Fujisawa
Boehringer Ingelheim Investigational Site
Fukaya
Boehringer Ingelheim Investigational Site 1
Fukuoka
Boehringer Ingelheim Investigational Site 2
Fukuoka
Boehringer Ingelheim Investigational Site 3
Fukuoka
Boehringer Ingelheim Investigational Site 4
Fukuoka
Boehringer Ingelheim Investigational Site 5
Fukuoka
Boehringer Ingelheim Investigational Site 1
Fukushima
Boehringer Ingelheim Investigational Site 2
Fukushima
Boehringer Ingelheim Investigational Site
Funabashi
Boehringer Ingelheim Investigational Site 1
Gifu
Boehringer Ingelheim Investigational Site 2
Gifu
Boehringer Ingelheim Investigational Site
Habikino
Boehringer Ingelheim Investigational Site
Hachiōji
Boehringer Ingelheim Investigational Site 1
Hamamatsu
Boehringer Ingelheim Investigational Site 2
Hamamatsu
Boehringer Ingelheim Investigational Site 3
Hamamatsu
Boehringer Ingelheim Investigational Site 4
Hamamatsu
Boehringer Ingelheim Investigational Site 5
Hamamatsu
Boehringer Ingelheim Investigational Site
Hanamaki
Boehringer Ingelheim Investigational Site
Hayashima
Boehringer Ingelheim Investigational Site 1
Higashiosaka
Boehringer Ingelheim Investigational Site 2
Higashiosaka
Boehringer Ingelheim Investigational Site
Himeji
Boehringer Ingelheim Investigational Site
Hirakata
Boehringer Ingelheim Investigational Site
Hirishima
Boehringer Ingelheim Investigational Site
Hirosaki
Boehringer Ingelheim Investigational Site
Ibaraki
Boehringer Ingelheim Investigational Site
Iizuka
Boehringer Ingelheim Investigational Site
Inag
Boehringer Ingelheim Investigational Site
Irima
Boehringer Ingelheim Investigational Site
Isahaya
Boehringer Ingelheim Investigational Site
Iwaki
Boehringer Ingelheim Investigational Site
Iwamizawa
Boehringer Ingelheim Investigational Site
Iwata
Boehringer Ingelheim Investigational Site 1
Jyoetsu
Boehringer Ingelheim Investigational Site 2
Jyoetsu
Boehringer Ingelheim Investigational Site
Jyoyo
Boehringer Ingelheim Investigational Site 1
Kagoshima
Boehringer Ingelheim Investigational Site 2
Kagoshima
Boehringer Ingelheim Investigational Site 3
Kagoshima
Boehringer Ingelheim Investigational Site
Kahoku
Boehringer Ingelheim Investigational Site
Kamakura
Boehringer Ingelheim Investigational Site 1
Kanazawa
Boehringer Ingelheim Investigational Site 2
Kanazawa
Boehringer Ingelheim Investigational Site 1
Kanoya
Boehringer Ingelheim Investigational Site 2
Kanoya
Boehringer Ingelheim Investigational Site 1
Kashihara
Boehringer Ingelheim Investigational Site 2
Kashihara
Boehringer Ingelheim Investigational Site
Kasuga
Boehringer Ingelheim Investigational Site
Kawagchi
Boehringer Ingelheim Investigational Site
Kawaguchi
Boehringer Ingelheim Investigational Site 1
Kawasaki
Boehringer Ingelheim Investigational Site 2
Kawasaki
Boehringer Ingelheim Investigational Site
Kitakami
Boehringer Ingelheim Investigational Site 1
Kiyose
Boehringer Ingelheim Investigational Site 2
Kiyose
Boehringer Ingelheim Investigational Site
Kodaira
Boehringer Ingelheim Investigational Site
Kofu
Boehringer Ingelheim Investigational Site
Koga
Boehringer Ingelheim Investigational Site
Komae
Boehringer Ingelheim Investigational Site
Komatsu
Boehringer Ingelheim Investigational Site
Komatsushima
Boehringer Ingelheim Investigational Site 1
Kōriyama
Boehringer Ingelheim Investigational Site 2
Kōriyama
Boehringer Ingelheim Investigational Site
Koshigaya
Boehringer Ingelheim Investigational Site
Kōtari
Boehringer Ingelheim Investigational Site 1
Kumamoto
Boehringer Ingelheim Investigational Site 2
Kumamoto
Boehringer Ingelheim Investigational Site 3
Kumamoto
Boehringer Ingelheim Investigational Site
Kure
Boehringer Ingelheim Investigational Site
Kusatsu
Boehringer Ingelheim Investigational Site 1
Kyoto
Boehringer Ingelheim Investigational Site 2
Kyoto
Boehringer Ingelheim Investigational Site 3
Kyoto
Boehringer Ingelheim Investigational Site 4
Kyoto
Boehringer Ingelheim Investigational Site
Maebashi
Boehringer Ingelheim Investigational Site
Matsudo
Boehringer Ingelheim Investigational Site
Matsumoto
Boehringer Ingelheim Investigational Site
Mibu
Boehringer Ingelheim Investigational Site
Mihara
Boehringer Ingelheim Investigational Site
Mihoro
Boehringer Ingelheim Investigational Site
Miriyama
Boehringer Ingelheim Investigational Site
Misato
Boehringer Ingelheim Investigational Site
Miyako
Boehringer Ingelheim Investigational Site 1
Miyazaki
Boehringer Ingelheim Investigational Site 2
Miyazaki
Boehringer Ingelheim Investigational Site
Moriguchi
Boehringer Ingelheim Investigational Site 1
Morioka
Boehringer Ingelheim Investigational Site 2
Morioka
Boehringer Ingelheim Investigational Site
Moriya
Boehringer Ingelheim Investigational Site
Mukai-awagasaki
Boehringer Ingelheim Investigational Site
Musashino
Boehringer Ingelheim Investigational Site
Nagano
Boehringer Ingelheim Investigational Site
Nagaoka
Boehringer Ingelheim Investigational Site 1
Nagoya
Boehringer Ingelheim Investigational Site 2
Nagoya
Boehringer Ingelheim Investigational Site 3
Nagoya
Boehringer Ingelheim Investigational Site 4
Nagoya
Boehringer Ingelheim Investigational Site 1
Nara
Boehringer Ingelheim Investigational Site 2
Nara
Boehringer Ingelheim Investigational Site
Narashino
Boehringer Ingelheim Investigational Site
Narita
Boehringer Ingelheim Investigational Site
Narutō
Boehringer Ingelheim Investigational Site
Nasushiobara
Boehringer Ingelheim Investigational Site
Nichinan
Boehringer Ingelheim Investigational Site
Ninohe
Boehringer Ingelheim Investigational Site
Nishinomiya
Boehringer Ingelheim Investigational Site
Nishitōkyō
Boehringer Ingelheim Investigational Site
Ōgaki
Boehringer Ingelheim Investigational Site
Ōiso
Boehringer Ingelheim Investigational Site 1
Ōita
Boehringer Ingelheim Investigational Site 2
Ōita
Boehringer Ingelheim Investigational Site 3
Ōita
Boehringer Ingelheim Investigational Site
Okaya
Boehringer Ingelheim Investigational Site 1
Okayama
Boehringer Ingelheim Investigational Site 2
Okayama
Boehringer Ingelheim Investigational Site
Okazaki
Boehringer Ingelheim Investigational Site
Okinawa
Boehringer Ingelheim Investigational Site
Ōmura
Boehringer Ingelheim Investigational Site
Omuta
Boehringer Ingelheim Investigational Site
Ōnojō
Boehringer Ingelheim Investigational Site 1
Osaka
Boehringer Ingelheim Investigational Site 2
Osaka
Boehringer Ingelheim Investigational Site 3
Osaka
Boehringer Ingelheim Investigational Site 4
Osaka
Boehringer Ingelheim Investigational Site 5
Osaka
Boehringer Ingelheim Investigational Site 6
Osaka
Boehringer Ingelheim Investigational Site
Ōta-ku
Boehringer Ingelheim Investigational Site
Ōtake
Boehringer Ingelheim Investigational Site
Ōtsu
Boehringer Ingelheim Investigational Site
Ryūgasaki
Boehringer Ingelheim Investigational Site
Saeki
Boehringer Ingelheim Investigational Site
Saga
Boehringer Ingelheim Investigational Site 1
Sagamihara
Boehringer Ingelheim Investigational Site 2
Sagamihara
Boehringer Ingelheim Investigational Site 3
Sagamihara
Boehringer Ingelheim Investigational Site
Saijyo
Boehringer Ingelheim Investigational Site
Saitama
Boehringer Ingelheim Investigational Site 1
Sakai
Boehringer Ingelheim Investigational Site 2
Sakai
Boehringer Ingelheim Investigational Site 1
Sapporo
Boehringer Ingelheim Investigational Site 2
Sapporo
Boehringer Ingelheim Investigational Site 3
Sapporo
Boehringer Ingelheim Investigational Site 4
Sapporo
Boehringer Ingelheim Investigational Site 5
Sapporo
Boehringer Ingelheim Investigational Site 6
Sapporo
Boehringer Ingelheim Investigational Site 7
Sapporo
Boehringer Ingelheim Investigational Site 8
Sapporo
Boehringer Ingelheim Investigational Site 9
Sapporo
Boehringer Ingelheim Investigational Site
Sekigahara
Boehringer Ingelheim Investigational Site 1
Sendai
Boehringer Ingelheim Investigational Site 2
Sendai
Boehringer Ingelheim Investigational Site
Shimoda
Boehringer Ingelheim Investigational Site 1
Shimotsuke
Boehringer Ingelheim Investigational Site 2
Shimotsuke
Boehringer Ingelheim Investigational Site
Shinngu
Boehringer Ingelheim Investigational Site
Shiroishi
Boehringer Ingelheim Investigational Site 1
Shizuoka
Boehringer Ingelheim Investigational Site 2
Shizuoka
Boehringer Ingelheim Investigational Site
Shōwajima
Boehringer Ingelheim Investigational Site 1
Suita
Boehringer Ingelheim Investigational Site 2
Suita
Boehringer Ingelheim Investigational Site
Susono
Boehringer Ingelheim Investigational Site
Suzuka
Boehringer Ingelheim Investigational Site 1
Takaoka
Boehringer Ingelheim Investigational Site 2
Takaoka
Boehringer Ingelheim Investigational Site
Takatsuki
Boehringer Ingelheim Investigational Site
Tarimizu
Boehringer Ingelheim Investigational Site
Togitsu
Boehringer Ingelheim Investigational Site
Tokoname
Boehringer Ingelheim Investigational Site
Tokushima
Boehringer Ingelheim Investigational Site
Tokyo Arakawa-ku
Boehringer Ingelheim Investigational Site
Tokyo Bunkyo-ku
Boehringer Ingelheim Investigational Site 1
Tokyo Chuo-ku
Boehringer Ingelheim Investigational Site 2
Tokyo Chuo-ku
Boehringer Ingelheim Investigational Site
Tokyo Daito-ku
Boehringer Ingelheim Investigational Site
Tokyo Koto-ku
Boehringer Ingelheim Investigational Site 1
Tokyo Meguro-ku
Boehringer Ingelheim Investigational Site 2
Tokyo Meguro-ku
Boehringer Ingelheim Investigational Site 1
Tokyo Minato-ku
Boehringer Ingelheim Investigational Site 2
Tokyo Minato-ku
Boehringer Ingelheim Investigational Site 3
Tokyo Minato-ku
Boehringer Ingelheim Investigational Site
Tokyo Nakano-ku
Boehringer Ingelheim Investigational Site
Tokyo Nerima-ku
Boehringer Ingelheim Investigational Site 1
Tokyo Ota-ku
Boehringer Ingelheim Investigational Site 2
Tokyo Ota-ku
Boehringer Ingelheim Investigational Site
Tokyo Setagaya
Boehringer Ingelheim Investigational Site
Tokyo Setagaya-ku
Boehringer Ingelheim Investigational Site
Tokyo Shibuya-ku
Boehringer Ingelheim Investigational Site
Tokyo Shinagawa-ku
Boehringer Ingelheim Investigational Site 1
Tokyo Shinjyuku-ku
Boehringer Ingelheim Investigational Site 2
Tokyo Shinjyuku-ku
Boehringer Ingelheim Investigational Site 3
Tokyo Shinjyuku-ku
Boehringer Ingelheim Investigational Site
Tokyo Sibuya-ku
Boehringer Ingelheim Investigational Site
Tokyo Toshima-ku
Boehringer Ingelheim Investigational Site
Tokyo-Edogawa-ku
Boehringer Ingelheim Investigational Site
Tokyo-Itabashi-ku
Boehringer Ingelheim Investigational Site
Toride
Boehringer Ingelheim Investigational Site
Tosu
Boehringer Ingelheim Investigational Site 1
Toyama
Boehringer Ingelheim Investigational Site 2
Toyama
Boehringer Ingelheim Investigational Site 3
Toyama
Boehringer Ingelheim Investigational Site
Toyohashi
Boehringer Ingelheim Investigational Site
Toyokawa
Boehringer Ingelheim Investigational Site
Toyonaka
Boehringer Ingelheim Investigational Site
Ube
Boehringer Ingelheim Investigational Site
Ueda
Boehringer Ingelheim Investigational Site
Ushiku
Boehringer Ingelheim Investigational Site 1
Utsunomiya
Boehringer Ingelheim Investigational Site 2
Utsunomiya
Boehringer Ingelheim Investigational Site
Wakayama
Boehringer Ingelheim Investigational Site 1
Yachiyo
Boehringer Ingelheim Investigational Site 2
Yachiyo
Boehringer Ingelheim Investigational Site 3
Yachiyo
Boehringer Ingelheim Investigational Site
Yamanashi
Boehringer Ingelheim Investigational Site
Yanago
Boehringer Ingelheim Investigational Site
Yoichi
Boehringer Ingelheim Investigational Site 1
Yokohama
Boehringer Ingelheim Investigational Site 2
Yokohama
Boehringer Ingelheim Investigational Site 3
Yokohama
Boehringer Ingelheim Investigational Site 4
Yokohama
Boehringer Ingelheim Investigational Site
Yokosuka
Boehringer Ingelheim Investigational Site
Yoshinogawa

Other trials in Japan

About this study

Official title: BI_Sifrol Tablets Special Drug Use Surveillance(Survey on the Safety and Efficacy in Parkinson's Disease Patients With Depressive Symptoms)

Adverse drug reaction symptoms, incidence, and severity ii. Motor capacity during the investigation iii. Depressive symptoms during the investigation

Conditions: Parkinson Disease
Medical subject headings: Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00614575
Study group	Role	What they receive
BI-Sifrol® Tablets (Pramipexole)		BI-Sifrol® Tablets, pramipexole dose: 0.125 mg, 0.5 mg, No reference therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: for 12 weeks

Secondary outcomes (5)

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).
Measured: for 12 weeks after initiation of the treatment
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.
Measured: Baseline and after 12 weeks (or at the time of discontinuation)
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.
Measured: Baseline and after 12 weeks (or at the time of discontinuation)
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.
Measured: Baseline and after 12 weeks (or at the time of discontinuation)
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.
Measured: After 12 weeks or at the time of discontinuation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2007Aug 2009

First posted13 Feb 2008 (estimated)
Study startJan 2007
Primary completionAug 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 1,089 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00614575
Sponsor's protocol ID: 248.635
Status last verified: Aug 2014
First submitted: 31 Jan 2008
Last updated: 6 Aug 2014
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
Comparative Effects of Virtual Reality and Proprioceptive Neuromuscular Facilitation in Patients With Parkinson's Disease
Parkinson Disease
Active, not recruiting
Myrosinase Bioactivated Gglucoraphanin for the Treatment of Neurodegenerative Diseases (GRA-MYR-ND)
PARKINSON DISEASE (Disorder), Multiple Sclerosis (MS) - Relapsing-remitting
RecruitingPhase 1
Phase 1 Clinical Trial to Evaluate the Safety, Efficacy, and Pharmacokinetics of IPS101A in Parkinson's Disease Patients
Parkinson Disease, Parkinson's Disease
Not yet recruitingObservational study
Longitudinal Observation of Neurodegeneration in Parkinson's Disease Using Molecular Imaging and Blood Biomarkers
Idiopathic Parkinson Disease
Active, not recruitingPhase 2
A Study of Botensilimab and Balstilimab for the Treatment of Colorectal Cancer
Metastatic Colorectal Cancer

All Parkinson Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: BI_Sifrol Tablets Special Drug Use Surveillance(Survey on the Safety and Efficacy in Parkinson's Disease Patients With Depressive Symptoms)
ClinicalTrials.gov ID: NCT00614575
Acronym / sponsor ID: 248.635
Conditions: Parkinson Disease
Study type: Observational
Recruitment status: Completed
Enrolment: 1,089 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Jan 2007
Primary completion: Aug 2009 (actual)
First posted: 13 Feb 2008 (estimated)
Results: Posted 19 Jul 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Adverse drug reaction symptoms, incidence, and severity ii. Motor capacity during the investigation iii. Depressive symptoms during the investigation

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
BI-Sifrol® Tablets (Pramipexole)	–	–BI-Sifrol® Tablets, pramipexole dose: 0.125 mg, 0.5 mg, No reference therapy

Who may qualify

Ages: 20 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: PD patients with depressive symptoms

Key inclusion criteria (1 listed)

PD patients with depressive symptoms Patients who have not received pramipexole hydrochloride hydrate preparations within 1 month before survey entrance.

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Percentage of Participants With Adverse Events, Adverse Drug Reactions, and Serious Adverse Events
Time frame: for 12 weeks
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.

5 secondary outcomes

Clinical Global Impression of Improvement
Time frame: for 12 weeks after initiation of the treatment
Mean Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part III Total Score
Time frame: Baseline and after 12 weeks (or at the time of discontinuation)
Mean Change From Baseline in Beck's Depression Inventory (BDI) Total Score
Time frame: Baseline and after 12 weeks (or at the time of discontinuation)
Mean Change From Baseline in UPDRS (Unified Parkinson's Disease Rating Scale) Part I Item 3 Score
Time frame: Baseline and after 12 weeks (or at the time of discontinuation)
Mean Change From Baseline in Modified Hoehn & Yahr Rating Scale
Time frame: After 12 weeks or at the time of discontinuation

Results and safety

Results posted to the registry on 19 Jul 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
BI-Sifrol Tablets	1,089	861

Primary outcome: Percentage of Participants With Adverse Events, Adverse Drug Reactions, and Serious Adverse Events

Time frame: for 12 weeks. Number. Unit: percentage of participants

Measure	BI-Sifrol Tablets n = 1044
Proportion of Adverse Events	21.7
Proportion of Adverse Drug Reactions	19.2
Proportion of Serious Adverse Events	2.5

Population analysed: Safety Analysis Set

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: 12 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
BI-Sifrol Tablets	26 of 1,044 (2.5%)	71 of 1,044 (6.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.

Related trials for Parkinson Disease

Not yet recruiting
Comparative Effects of Virtual Reality and Proprioceptive Neuromuscular Facilitation in Patients With Parkinson's Disease
Parkinson Disease
Active, not recruiting
Myrosinase Bioactivated Gglucoraphanin for the Treatment of Neurodegenerative Diseases (GRA-MYR-ND)
PARKINSON DISEASE (Disorder), Multiple Sclerosis (MS) - Relapsing-remitting
RecruitingPhase 1
Phase 1 Clinical Trial to Evaluate the Safety, Efficacy, and Pharmacokinetics of IPS101A in Parkinson's Disease Patients
Parkinson Disease, Parkinson's Disease
Not yet recruitingObservational study
Longitudinal Observation of Neurodegeneration in Parkinson's Disease Using Molecular Imaging and Blood Biomarkers
Idiopathic Parkinson Disease
Active, not recruitingPhase 2
A Study of Botensilimab and Balstilimab for the Treatment of Colorectal Cancer
Metastatic Colorectal Cancer

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Boehringer Ingelheim study chair

Boehringer Ingelheim

238 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Parkinson Disease, run by Boehringer Ingelheim at 238 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 238 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Jul 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Adverse Events, Adverse Drug Reactions, and Serious Adverse Events (time frame: for 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00614575.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2014.