Parkinson DiseasePhase 4NCT02231905
Safety, Tolerability and Efficacy of Switching From Talipexole to Pramipexole in Patients With Parkinson's Disease
A Phase 4 study testing BI-Sifrol® in people with Parkinson Disease, run by Boehringer Ingelheim.
Trial summary
Study to assess the safety, tolerability and effectiveness of a switching from Domin® (talipexole) tablet to BI Sifrol® (pramipexole) tablet in patients with Parkinson's disease 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?
- BI-Sifrol®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- No sites listed yet
- Study dates
- Jan 2004to Nov 2004
- Phase
- Phase 4
- 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
- Diagnosis of Parkinson's disease (included juvenile parkinsonism) and treated with talipexole (Domin®)
- Patients who present stable symptoms and maintain the doses of talipexole and other concomitant therapy for Parkinson's disease at least last 4 weeks
- Male or female patients aged 20 and over
- In or out-patients
- Patient's severity characterized as Stage 1 - 5 by Modified Hoehn \& Yahr scale
- Ability to provide written informed consent in accordance with the Good Clinical Practice (GCP), Good Post-marketing Surveillance Practice (GPMSP) and other relevant laws such as the Pharmaceutical Affairs Law
Who cannot join
- History of hypersensitivity of pramipexole
- Psychiatric symptoms such as confusion, hallucination, delusion, agitation, delirium and abnormal behavior
- Subjective symptom derived from orthostatic hypotension
- Hypotension (systolic blood pressure; 100 mmHg or less)
- Complication such as clinically significant cardiac, renal and hepatic diseases
- Patients who drive a car, operate a machine, work on heights or engage in other hazardous activities
Show all 9Show fewer
- Pregnant, possibly pregnant or female in lactation
- Patients who are participating in other drug studies or who receive other investigational drugs within last 3 months before enrolled this study
- Other than above, those who judged by the investigator or sub-investigator to be inappropriate as for the study
About this study
Official title: Open Label, Exploratory Clinical Trial to Assess the Safety, Tolerability and Effectiveness of a Switching From Talipexole to Pramipexole
Study to assess the safety, tolerability and effectiveness of a switching from Domin® (talipexole) tablet to BI Sifrol® (pramipexole) tablet in patients with Parkinson's disease
- Conditions
- Parkinson Disease
- Being tested
- BI-Sifrol®
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BI-Sifrol®Drug
| Study group | Role | What they receive |
|---|---|---|
| BI-Sifrol® | Experimental | Tablets were administrated after switching from prior treatment of dopamine agonist (talipexole), treatment period consisted of an ascending period and a maintenance period, total duration was 4 to 12 weeks. Receives: Drug: BI-Sifrol® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients who prematurely discontinued due to adverse event
Measured: up to 12 weeks
Secondary outcomes (8)
Change of the sum of Unified Parkinson's Disease Rating Scale (UPDRS) Part II (activities of daily living)
Measured: up to 12 weeks
Change of the sum of UPDRS Part III (motor examination)
Measured: up to 12 weeks
Change of Modified Hoehn & Yahr scale
Measured: up to 12 weeks
Change of Clinical global impression (CGI) of efficacy
Measured: up to 12 weeks
Number of patients with abnormal changes in laboratory parameters
Measured: up to 12 weeks
Number of patients with clinically significant changes in vital signs
Blood Pressure, Pulse Rate
Measured: up to 12 weeks
Number of patients with adverse events
Measured: up to 12 weeks
Number of patients with clinically significant changes in electrocardiogram (ECG)
Measured: up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2014 (estimated)
- Study startJan 2004
- Primary completionNov 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02231905
- Sponsor's protocol ID
- 248.544
- Status last verified
- Sep 2014
- First submitted
- 3 Sep 2014
- Last updated
- 4 Sep 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label, Exploratory Clinical Trial to Assess the Safety, Tolerability and Effectiveness of a Switching From Talipexole to Pramipexole
- ClinicalTrials.gov ID
- NCT02231905
- Acronym / sponsor ID
- 248.544
- Conditions
- Parkinson Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Jan 2004
- Primary completion
- Nov 2004 (actual)
- First posted
- 4 Sep 2014 (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.
Study to assess the safety, tolerability and effectiveness of a switching from Domin® (talipexole) tablet to BI Sifrol® (pramipexole) tablet in patients with Parkinson's disease
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BI-Sifrol® | Experimental | Drug: BI-Sifrol®Tablets were administrated after switching from prior treatment of dopamine agonist (talipexole), treatment period consisted of an ascending period and a maintenance period, total duration was 4 to 12 weeks. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of Parkinson's disease (included juvenile parkinsonism) and treated with talipexole (Domin®)
- Patients who present stable symptoms and maintain the doses of talipexole and other concomitant therapy for Parkinson's disease at least last 4 weeks
- Male or female patients aged 20 and over
- In or out-patients
- Patient's severity characterized as Stage 1 - 5 by Modified Hoehn \& Yahr scale
Key exclusion criteria (9 listed)
- History of hypersensitivity of pramipexole
- Psychiatric symptoms such as confusion, hallucination, delusion, agitation, delirium and abnormal behavior
- Subjective symptom derived from orthostatic hypotension
- Hypotension (systolic blood pressure; 100 mmHg or less)
- Complication such as clinically significant cardiac, renal and hepatic diseases
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 |
|---|---|---|
| BI-Sifrol® | Drug | BI-Sifrol® |
Primary outcome
Number of patients who prematurely discontinued due to adverse event
Time frame: up to 12 weeks
8 secondary outcomes
Change of the sum of Unified Parkinson's Disease Rating Scale (UPDRS) Part II (activities of daily living)
Time frame: up to 12 weeks
Change of the sum of UPDRS Part III (motor examination)
Time frame: up to 12 weeks
Change of Modified Hoehn & Yahr scale
Time frame: up to 12 weeks
Change of Clinical global impression (CGI) of efficacy
Time frame: up to 12 weeks
Number of patients with abnormal changes in laboratory parameters
Time frame: up to 12 weeks
Number of patients with clinically significant changes in vital signs
Time frame: up to 12 weeks
Number of patients with adverse events
Time frame: up to 12 weeks
Number of patients with clinically significant changes in electrocardiogram (ECG)
Time frame: up to 12 weeks
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 4 Sep 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing BI-Sifrol® 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 6 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 4 Sep 2014. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Number of patients who prematurely discontinued due to adverse event (time frame: up to 12 weeks). 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 4 Sep 2014.