Parkinson DiseasePhase 3NCT00274131
Long-term Administration Study of SND 919 Tablets in Parkinson's Disease
A Phase 3 study testing Pramipexole 0.125 mg tablets and Pramipexole 0.5 mg tablets in people with Parkinson Disease, run by Boehringer Ingelheim.
Trial summary
To evaluate the efficacy and safety of long-term treatment with pramipexole tablets (BI Sifrol®) in Parkinson's disease (phase III study). Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Pramipexole 0.125 mg tablets and Pramipexole 0.5 mg tablets
- Type of treatment
- Pill or oral medicine
- How many people
- 170 participants
- Where
- No sites listed yet
- Study dates
- Dec 1998to Feb 2004
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
Who may be able to join
- Patients with a diagnosis of Parkinson's disease (including juvenile parkinsonism)
- Patients meeting all of the following inclusion criteria
- Patients of at least 20 years of age
- In- or outpatients of either sex.
- Patients in any stage on the modified Hoehn and Yahr severity scale
Who cannot join
- Patients with psychiatric symptoms such as confusion, hallucination, delusion, excitement, delirium, and abnormal behaviour.
- Patients with subjective symptoms derived from orthostatic hypotension.
- Patients with hypotension (systolic blood pressure <100 mmHg)
- Patients with concomitant illness such as severe cardiac, renal, and hepatic disease
- Patients with a current or past history of epilepsy
- Pregnant, possibly pregnant, or lactating women
Show all 9Show fewer
- Patients receiving any other investigational products or who have received any other investigational product within 6 months of the study.
- Patients who judged incompetent to give consent
- Others judged by the investigator or co-investigator to be ineligible as subjects.
About this study
To evaluate the efficacy and safety of long-term treatment with pramipexole tablets (BI Sifrol®) in Parkinson's disease (phase III study).
Read the detailed description
The efficacy and safety of long-term treatment with pramipexole (BI Sifrol®) were evaluated in Parkinson disease patients in an open-label non-controlled design. The treatment was initiated at 0.125 mg bid (after breakfast and supper).
The dose was increased stepwise with due caution regarding the symptoms and safety of each patient, up to 1.5 mg tid (after each meal). The treatment period was set at 56 weeks, followed by a stepwise dosedecreasing period (maximum 4 weeks).
Study Hypothesis:
Comparison(s):
- Conditions
- Parkinson Disease
- Being tested
- Pramipexole 0.125 mg tablets, Pramipexole 0.5 mg tablets
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pramipexole 0.125 mg tabletsDrug
Pramipexole 0.5 mg tabletsDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
UPDRS Part II (activities of daily living) total score UPDRS Part III (motor examination) total score
Secondary outcomes (1)
UPDRS Part I (mentation, behaviour and mood) total score UPDRS Part IV (complications of therapy) total score UPDRS Part I-III total score UPDRS Part I-IV total score Modified Hoehn and Yahr scale score Global impression of efficacy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2006 (estimated)
- Study startDec 1998
- Study completionFeb 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 170 participants
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Boehringer Ingelheim Study Coordinator, Study chair, Nippon Boehringer Ingelheim Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00274131
- Sponsor's protocol ID
- 248.506
- Status last verified
- May 2012
- First submitted
- 9 Jan 2006
- Last updated
- 21 May 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Administration Study of SND 919 Tablets in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT00274131
- Acronym / sponsor ID
- 248.506
- Conditions
- Parkinson Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 170 participants
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Dec 1998
- Study completion
- Feb 2004
- First posted
- 10 Jan 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the efficacy and safety of long-term treatment with pramipexole tablets (BI Sifrol®) in Parkinson's disease (phase III study).
Detailed description
The efficacy and safety of long-term treatment with pramipexole (BI Sifrol®) were evaluated in Parkinson disease patients in an open-label non-controlled design. The treatment was initiated at 0.125 mg bid (after breakfast and supper).
The dose was increased stepwise with due caution regarding the symptoms and safety of each patient, up to 1.5 mg tid (after each meal). The treatment period was set at 56 weeks, followed by a stepwise dosedecreasing period (maximum 4 weeks).
Study Hypothesis:
Comparison(s):
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with a diagnosis of Parkinson's disease (including juvenile parkinsonism)
- Patients meeting all of the following inclusion criteria
- Patients of at least 20 years of age
- In- or outpatients of either sex.
- Patients in any stage on the modified Hoehn and Yahr severity scale
Key exclusion criteria (9 listed)
- Patients with psychiatric symptoms such as confusion, hallucination, delusion, excitement, delirium, and abnormal behaviour.
- Patients with subjective symptoms derived from orthostatic hypotension.
- Patients with hypotension (systolic blood pressure <100 mmHg)
- Patients with concomitant illness such as severe cardiac, renal, and hepatic disease
- Patients with a current or past history of epilepsy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pramipexole 0.125 mg tablets | Drug | – |
| Pramipexole 0.5 mg tablets | Drug | – |
Primary outcome
UPDRS Part II (activities of daily living) total score UPDRS Part III (motor examination) total score
1 secondary outcome
UPDRS Part I (mentation, behaviour and mood) total score UPDRS Part IV (complications of therapy) total score UPDRS Part I-III total score UPDRS Part I-IV total score Modified Hoehn and Yahr scale score Global impression of efficacy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2012.
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Parkinson Disease
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 Coordinator study chair
Nippon Boehringer Ingelheim Co., Ltd.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Pramipexole 0.125 mg tablets and Pramipexole 0.5 mg tablets in people with Parkinson Disease, run by Boehringer Ingelheim.
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 5 inclusion and 9 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 21 May 2012. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
UPDRS Part II (activities of daily living) total score UPDRS Part III (motor examination) total score. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 May 2012; AzTrials last refreshed its copy on 6 Nov 2026.