Parkinson DiseasePhase 3NCT02172573
Safety and Efficacy of Pramipexole and Bromocriptine Combined With L-dopa in Parkinson's Disease
A Phase 3 study testing Pramipexole and Bromocriptine in people with Parkinson Disease, run by Boehringer Ingelheim.
Trial summary
The objective of the study was to evaluate the efficacy and safety of SND 919 (pramipexole) tablets administered in combination with L-dopa in patients with Parkinson's disease using placebo and bromocriptine tablets as comparators in a double-blind design (phase III comparative 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 and Bromocriptine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 315 participants
- Where
- No sites listed yet
- Study dates
- Apr 1999to Jul 2000
- 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 who meet all of the following inclusion criteria
- Patients who were at least 20 years of age
- In- or outpatients of either sex
- Patients in any stage on the modified Hoehn and Yahr scale
- Patients being treated with L-dopa who have any of the following clinical conditions and problems
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- Patients with the wearing-off phenomenon
- Patients with the on-off phenomenon
- Patients to whom a sufficient amount of L-dopa cannot be administered owing to the occurrence of an adverse event
- Patients in whom the effect of L-dopa is attenuated
- Patients in whom a dose increase of L-dopa has been refrained
- Patients with freezing phenomenon
Who cannot join
- Patients being treated with other dopamine agonists (bromocriptine, pergolide mesylate, talipexole hydrochloride). Patients who have been treated with other dopamine agonist for at least 4 weeks before the start of the study (the day of giving informed consent) are eligible for the study
- Patients with a history of hypersensitivity to ergot preparations
- 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 less than 100 mmHg)
- Patients wiht Raynaud disease
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- Patients with peptic ulcer
- Patients with complications such as severe cardiac, renal, hepatic disease etc.
- Patients with a current or past history of epilepsy
- Women who are or may be pregnant and lactating women
- Patients who are receiving any other investigational products or who have received any other investigational product within 6 months of the study
- Patients who are incompetent to give consent
- Others judged by the investigator or co-investigator to be ineligible as subjects
About this study
Official title: A Double-blind, Placebo-controlled, Randomised, Multicenter Trial to Compare the Safety and Efficacy of Oral Administration of Pramipexole up to 4.5mg and Bromocriptine up to 22.5mg Combined With L-dopa in Advanced Parkinson's Disease
The objective of the study was to evaluate the efficacy and safety of SND 919 (pramipexole) tablets administered in combination with L-dopa in patients with Parkinson's disease using placebo and bromocriptine tablets as comparators in a double-blind design (phase III comparative study).
- Conditions
- Parkinson Disease
- Being tested
- Pramipexole, Bromocriptine, Placebo pramipexole, Placebo bromocriptine
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PramipexoleDrug
BromocriptineDrug
Placebo pramipexoleDrug
Placebo bromocriptineDrug
| Study group | Role | What they receive |
|---|---|---|
| Pramipexole | Experimental | Not described Receives: Drug: Pramipexole |
| Bromocriptine | Experimental | Not described Receives: Drug: Bromocriptine |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo pramipexole; Drug: Placebo bromocriptine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in total score of the Unified Parkinson's Disease Rating Scale (UPDRS) Part II (Activities of Daily Living)
Measured: Baseline and week 12
Change from baseline in total score of UPDRS Part III (Motor Examination)
Measured: Baseline and week 12
Secondary outcomes (14)
Changes from baseline in sores of individual items on UPDRS Part II
Measured: Baseline and weeks 2, 4, 6, 8, 10, 12
Changes from baseline in scores of individual items on UPDRS Part III
Measured: Baseline and weeks 2, 4, 6, 8, 10, 12
Change from baseline in area under the curve (AUC) in the UPDRS Part II score
Measured: Baseline and weeks 2, 4, 6, 8, 10, 12
Change from baseline in area under the curve (AUC) in the UPDRS Part III score
Measured: Baseline and weeks 2, 4, 6, 8, 10, 12
Change from baseline in total score of UPDRS Part I (mentation, behaviour and mood)
Measured: Baseline and weeks 2, 4, 6, 8, 10, 12
Change from baseline in total score of UPDRS Part IV (complications of therapy)
Measured: Baseline and weeks 2, 4, 6, 8, 10, 12
Change from baseline in total score of UPDRS Part I-III
Measured: Baseline and weeks 2, 4, 6, 8, 10, 12
Change from baseline in total score of UPDRS Part I-IV
Measured: Baseline and weeks 2, 4, 6, 8, 10, 12
Change from baseline in Modified Hoehn & Yahr stage
Measured: Baseline and weeks 2, 4, 6, 8, 10, 12
Clinical global impression of efficacy
Measured: week 12
Number of patients with adverse events
Measured: up to 16 weeks
Number of patients with clinically significant changes in vital signs (blood pressure, pulse rate)
Measured: up to 12 weeks
Number of patients with abnormal changes in laboratory parameters
Measured: up to 12 weeks
Number of patients with abnormal changes in 12-lead 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 posted24 Jun 2014 (estimated)
- Study startApr 1999
- Primary completionJul 2000
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 315 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
- NCT02172573
- Sponsor's protocol ID
- 248.505
- Status last verified
- Jun 2014
- First submitted
- 20 Jun 2014
- Last updated
- 24 Jun 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Placebo-controlled, Randomised, Multicenter Trial to Compare the Safety and Efficacy of Oral Administration of Pramipexole up to 4.5mg and Bromocriptine up to 22.5mg Combined With L-dopa in Advanced Parkinson's Disease
- ClinicalTrials.gov ID
- NCT02172573
- Acronym / sponsor ID
- 248.505
- Conditions
- Parkinson Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 315 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Apr 1999
- Primary completion
- Jul 2000 (actual)
- First posted
- 24 Jun 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.
The objective of the study was to evaluate the efficacy and safety of SND 919 (pramipexole) tablets administered in combination with L-dopa in patients with Parkinson's disease using placebo and bromocriptine tablets as comparators in a double-blind design (phase III comparative study).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pramipexole | Experimental | Drug: Pramipexole |
| Bromocriptine | Experimental | Drug: Bromocriptine |
| Placebo | Placebo comparator | Drug: Placebo pramipexole, Drug: Placebo bromocriptine |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Patients with a diagnosis of Parkinson's disease (including juvenile parkinsonism)
- Patients who meet all of the following inclusion criteria
- Patients being treated with L-dopa who have any of the following clinical conditions and problems
Key exclusion criteria (13 listed)
- Patients being treated with other dopamine agonists (bromocriptine, pergolide mesylate, talipexole hydrochloride). Patients who have been treated with other dopamine agonist for at least 4 weeks before the start of the study (the day of giving informed consent) are eligible for the study
- Patients with a history of hypersensitivity to ergot preparations
- 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 less than 100 mmHg)
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 | Drug | Pramipexole |
| Bromocriptine | Drug | Bromocriptine |
| Placebo pramipexole | Drug | Placebo |
| Placebo bromocriptine | Drug | Placebo |
Primary outcome
Change from baseline in total score of the Unified Parkinson's Disease Rating Scale (UPDRS) Part II (Activities of Daily Living)
Time frame: Baseline and week 12
Change from baseline in total score of UPDRS Part III (Motor Examination)
Time frame: Baseline and week 12
14 secondary outcomes
Changes from baseline in sores of individual items on UPDRS Part II
Time frame: Baseline and weeks 2, 4, 6, 8, 10, 12
Changes from baseline in scores of individual items on UPDRS Part III
Time frame: Baseline and weeks 2, 4, 6, 8, 10, 12
Change from baseline in area under the curve (AUC) in the UPDRS Part II score
Time frame: Baseline and weeks 2, 4, 6, 8, 10, 12
Change from baseline in area under the curve (AUC) in the UPDRS Part III score
Time frame: Baseline and weeks 2, 4, 6, 8, 10, 12
Change from baseline in total score of UPDRS Part I (mentation, behaviour and mood)
Time frame: Baseline and weeks 2, 4, 6, 8, 10, 12
Change from baseline in total score of UPDRS Part IV (complications of therapy)
Time frame: Baseline and weeks 2, 4, 6, 8, 10, 12
Change from baseline in total score of UPDRS Part I-III
Time frame: Baseline and weeks 2, 4, 6, 8, 10, 12
Change from baseline in total score of UPDRS Part I-IV
Time frame: Baseline and weeks 2, 4, 6, 8, 10, 12
Change from baseline in Modified Hoehn & Yahr stage
Time frame: Baseline and weeks 2, 4, 6, 8, 10, 12
Clinical global impression of efficacy
Time frame: week 12
Number of patients with adverse events
Time frame: up to 16 weeks
Number of patients with clinically significant changes in vital signs (blood pressure, pulse rate)
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 abnormal changes in 12-lead 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 24 Jun 2014.
- Related InfoLink provided by the sponsor.
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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 3 study testing Pramipexole and Bromocriptine 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 12 inclusion and 13 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 24 Jun 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. Some participants in this study may receive a placebo. 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?
Change from baseline in total score of the Unified Parkinson's Disease Rating Scale (UPDRS) Part II (Activities of Daily Living) (time frame: Baseline and week 12). The study lists 2 primary outcomes in all. 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 24 Jun 2014.