Parkinson DiseasePhase 3NCT02177357
Pramipexole in Untreated and Levodopa-treated Parkinson's Disease Patients
A Phase 3 study testing Pramipexole in people with Parkinson Disease, run by Boehringer Ingelheim.
Trial summary
The objectives of this study were to evaluate the efficacy, safety, and tolerability of pramipexole, as single-agent therapy or in combination with levodopa, in patients with Parkinson disease living in Hong Kong and Taiwan. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Pramipexole
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- Nov 1998to Jan 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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or females at least 30 years of age with a diagnosis of symptomatic, idiopathic Parkinson disease, stage 1-4 on the Modified Hoehn and Yahr Scale
- Females either surgically sterile or at least 2 years postmenopausal, or using a reliable method of contraception for at least 2 months prior to study entry
- Females of childbearing potential with a negative pregnancy test at the screening visit and not nursing
- Patients with at least 3 of the 4 cardinal signs of Parkinson disease (i.e., rigidity, bradykinesia, resting tremor, postural instability) and without any other known or Suspected cause for their Parkinsonism
- Patients on levodopa therapy who show a good response to levodopa and be on a stable dosage of levodopa for least 1 month prior to study entry
- Patients able to take oral medication
- Patients must give voluntary written consent for study participation and must sign a Patient Informed Consent Form at the screening visit, prior to initiation of any study-related procedures
Who cannot join
- Atypical parkinsonian syndromes secondary to drugs (e.g., metoclopramide, flunarizine), metabolic disorders (e.g., Wilson disease), encephalitis, or degenerative diseases (e.g., progressive supranuclear palsy, multiple-system atrophy)
- Dementia that could impair compliance with medication and/or preclude giving informed consent (i.e., Mini-Mental Status Examination score ≤22)
- History of psychosis
- History of active epilepsy (e.g., occurrence of a seizure) within 1 year prior to screening
- Second or third degree atrioventricular block or sick sinus syndrome, resting heart rate below 50 beats per minute, congestive heart failure (New York Heart Association functional Class III or IV), myocardial infarction within 6 months of randomization, or other clinically significant heart conditions (e.g., coronary artery disease) that might negatively affect the possibility of the patient completing the study
- Clinically significant liver disease that may prevent the patient from completing the study and/or elevation in total bilirubin, alkaline phosphatase, lactate dehydrogenase (LDH), serum glutamate pyruvate transaminase (SGPT), or serum glutamate oxaloacetate transaminase (SGOT) of >1.5 times the upper limit of the normal values
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- Clinically significant renal disease that may prevent the patient from completing the study and/or elevation in serum creatinine of >1.5 times the upper limit of the normal values
- Presence of active neoplastic disease
- Surgery within 6 months of the baseline/randomization visit which, in the opinion of the investigator, might negatively impact the patient's participation in the study, or any history of stereotaxic brain surgery (e.g., thalamotomy, pallidotomy, or any other deep brain stimulation for reduction of parkinsonian symptoms)
- Supine systolic blood pressure less than 100 mm Hg or evidence of a ≥20-mm Hg decline in systolic blood pressure at 2 minutes after standing, compared with the previous supine systolic blood pressure obtained after 5 minutes of quiet rest, if the decline in blood pressure upon standing is associated with symptoms (i.e., symptomatic orthostatic hypotension)
- Use of dopamine agonist medications (e.g., bromocriptine, pergolide) in the 2 months prior to study entry (allowed medications: selegiline, anticholinergics, and amantadine therapy at a stable dosage for 60 days prior to study entry and remaining stable throughout the study)
- Use of neuroleptics, alpha-methyldopa, or flunarizine within the past 6 months
- Use of any of the following drugs within 3 months of study entry: methylphenidate, cinnarizine, reserpine, amphetamine, and monoamine oxidase-A inhibitors (e.g., pargyline, phenelzine, or tranylcypromine)
- Use of pramipexole within the past 3 months or a history of adverse reaction or allergy to pramipexole
- Unstable dosage of centrally active therapies (e.g., hypnotics, antidepressants, anxiolytics) within the past 60 days
- Electroconvulsive therapy within 90 days of the baseline/randomization visit
- Participation in other investigational drug studies or receipt of other investigational drugs within 30 days prior to baseline/randomization. Investigational drugs for Parkinson disease must have been discontinued for 90 days prior to baseline/randomization. Additionally, patients previously randomized into this study and who then discontinued study participation are not to be re-entered into the study
- Positive hepatitis B screen (assessed at the screening visit)
About this study
Official title: Pramipexole: Efficacy, Safety and Tolerability Study in Untreated and Levodopa-Treated Parkinson's Disease Patients, a Multinational Study
The objectives of this study were to evaluate the efficacy, safety, and tolerability of pramipexole, as single-agent therapy or in combination with levodopa, in patients with Parkinson disease living in Hong Kong and Taiwan.
- Conditions
- Parkinson Disease
- Being tested
- Pramipexole, Placebo
- 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
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Pramipexole - escalation dose | Experimental | Not described Receives: Drug: Pramipexole |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in the sum of the UPDRS (Unified Parkinson Disease Rating Scale) Parts II and III total scores.
Measured: up to 15 weeks
Number of patients with clinically significant changes in vital signs
Measured: up to 15 weeks
Number of patients with abnormal changes in laboratory parameters
Measured: up to 15 weeks
Number of patients with abnormal changes in 12-lead ECG (electrocardiogram)
Measured: up to 15 weeks
Number of patients with adverse events
Measured: up to 15 weeks
Secondary outcomes (5)
Change from baseline in the individual UPDRS Part II and Part III total scores
Measured: up to 15 weeks
Change from baseline the individual items in the UPDRS Part II and Part III
Measured: up to 15 weeks
Change from baseline in the Modified Hoehn and Yahr Scale
Measured: up to 15 weeks
Change from baseline in the number of "off" hours in those patients who had been on levodopa therapy
Measured: up to 15 weeks
Change from baseline in the Mini-Mental Status Examination
Measured: up to 15 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2014 (estimated)
- Study startNov 1998
- Primary completionJan 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
- 150 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
- NCT02177357
- Sponsor's protocol ID
- 248.362
- Status last verified
- Jun 2014
- First submitted
- 24 Jun 2014
- Last updated
- 27 Jun 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pramipexole: Efficacy, Safety and Tolerability Study in Untreated and Levodopa-Treated Parkinson's Disease Patients, a Multinational Study
- ClinicalTrials.gov ID
- NCT02177357
- Acronym / sponsor ID
- 248.362
- Conditions
- Parkinson Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Nov 1998
- Primary completion
- Jan 2000 (actual)
- First posted
- 27 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 objectives of this study were to evaluate the efficacy, safety, and tolerability of pramipexole, as single-agent therapy or in combination with levodopa, in patients with Parkinson disease living in Hong Kong and Taiwan.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pramipexole - escalation dose | Experimental | Drug: Pramipexole |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Males or females at least 30 years of age with a diagnosis of symptomatic, idiopathic Parkinson disease, stage 1-4 on the Modified Hoehn and Yahr Scale
- Females either surgically sterile or at least 2 years postmenopausal, or using a reliable method of contraception for at least 2 months prior to study entry
- Females of childbearing potential with a negative pregnancy test at the screening visit and not nursing
- Patients with at least 3 of the 4 cardinal signs of Parkinson disease (i.e., rigidity, bradykinesia, resting tremor, postural instability) and without any other known or Suspected cause for their Parkinsonism
- Patients on levodopa therapy who show a good response to levodopa and be on a stable dosage of levodopa for least 1 month prior to study entry
Key exclusion criteria (18 listed)
- Atypical parkinsonian syndromes secondary to drugs (e.g., metoclopramide, flunarizine), metabolic disorders (e.g., Wilson disease), encephalitis, or degenerative diseases (e.g., progressive supranuclear palsy, multiple-system atrophy)
- Dementia that could impair compliance with medication and/or preclude giving informed consent (i.e., Mini-Mental Status Examination score ≤22)
- History of psychosis
- History of active epilepsy (e.g., occurrence of a seizure) within 1 year prior to screening
- Second or third degree atrioventricular block or sick sinus syndrome, resting heart rate below 50 beats per minute, congestive heart failure (New York Heart Association functional Class III or IV), myocardial infarction within 6 months of randomization, or other clinically significant heart conditions (e.g., coronary artery disease) that might negatively affect the possibility of the patient completing the study
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 - escalation dose |
| Placebo | Drug | Placebo |
Primary outcome
Change from baseline in the sum of the UPDRS (Unified Parkinson Disease Rating Scale) Parts II and III total scores.
Time frame: up to 15 weeks
Number of patients with clinically significant changes in vital signs
Time frame: up to 15 weeks
Number of patients with abnormal changes in laboratory parameters
Time frame: up to 15 weeks
Number of patients with abnormal changes in 12-lead ECG (electrocardiogram)
Time frame: up to 15 weeks
Number of patients with adverse events
Time frame: up to 15 weeks
5 secondary outcomes
Change from baseline in the individual UPDRS Part II and Part III total scores
Time frame: up to 15 weeks
Change from baseline the individual items in the UPDRS Part II and Part III
Time frame: up to 15 weeks
Change from baseline in the Modified Hoehn and Yahr Scale
Time frame: up to 15 weeks
Change from baseline in the number of "off" hours in those patients who had been on levodopa therapy
Time frame: up to 15 weeks
Change from baseline in the Mini-Mental Status Examination
Time frame: up to 15 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 27 Jun 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 3 study testing Pramipexole 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 7 inclusion and 18 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 27 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 the sum of the UPDRS (Unified Parkinson Disease Rating Scale) Parts II and III total scores. (time frame: up to 15 weeks). The study lists 5 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 27 Jun 2014.