Parkinson DiseasePhase 3NCT00240409
Randomized Single-blind Placebo Controlled Comparative Trial of Pramipexole and Bromocriptine in Parkinson's Disease
A Phase 3 study testing Pramipexole and Bromocriptine in people with Parkinson Disease, run by Boehringer Ingelheim at 7 sites in China.
Trial summary
The objective of this study was to investigate the efficacy and safety of Pramipexole Tablets in patients with Parkinson's disease (who can be treated with L-DOPA concomitantly) in a single blind, comparative method using Bromocriptine tablets as comparators (phase III comparative trial) Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Pramipexole and Bromocriptine
- How many people
- 208 participants
- Where
- 7 sitesChina
- Study dates
- Jul 2003to Aug 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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 30-80 years
- Patients with idiopathic Parkinson's disease corresponding to stages II-IV according to the classification of Hoehn and Yahr during an "on" period, and/or patients in whom the individual optimized dosage of levodopa (and decarboxylase inhibitor) causes motor fluctuations characterized as end-of-dose phenomena or "wearing-off" effects for at least 30 days prior to initial administration of study medication and whose daily total "off" time is at least 2 hours and no more than 6 hours during waking time.
- Patients able to keep an accurate patient diary of the times of "on"- and "off"-periods during waking hours. Family members, guardians or nursing personnel may assist the patient.
- Informed Consent (consent in writing)
Who cannot join
- Patients with atypical parkinsonian syndromes due to drugs, metabolic disorders , encephalitis, or degenerative disease.
- Dementia that could impair compliance with medication, impair maintenance of accurate patient diaries, and/or preclude the signing of informed consent.
- History of psychosis except that which was elicited by treatment with levodopa or dopamine agonists unless the patient remains psychotic and in the opinion of the investigator would be unable to participate in the study.
- History of active epilepsy within the last two years prior to Visit 2.
- Patients with second or third degree AV block or sick sinus syndrome.
- Patients with resting heart rate below 50 beats per minute.
Show all 19Show fewer
- Patients with congestive heart failure classified as functional Class III or IV by the New York Heart Association.
- Patients with myocardial infarction within six months of randomization.
- Patients with other clinical significant heart conditions which would negatively impact on the patient completing the study.
- Clinically significant kidney disease which may prevent the patient from completing the study and/or an elevation in either blood creatinine or urea nitrogen >1.5 times the laboratory normal.
- Clinically significant liver disease which may prevent the patient from completing the study and/or an elevation in either total bilirubin, SGPT, or SGOT of >1.5 times the laboratory normal.
- Retinopathia pigmentosa
- Presence of active neoplastic disease
- Patients with surgery within 180 days of Visit 2 which in the opinion of the investigator would negatively impact on the patient's participation in the clinical study or a history of stereotaxic brain surgery.
- At screening supine systolic blood pressure less than 100mmHg or evidence of a 20 mmHg decline in systolic blood pressure at one minute after standing compared with the previous supine systolic blood pressure obtained after 5 minutes of quiet rest in the supine position if the decline in blood pressure upon standing is associated with symptoms. Blood pressure at study entry (supine and standing) is expressed as the average of the second and third measured values.
- Patients who have received any of the following drugs during the 30 days prior to administered of study medication unless a longer period of time is specifically noted: neuroleptics (60 days), a-methyl-dopa, metoclopramide (60 days), flunarizine, cinnarizine, parenteral ergot preparation, bromocriptine, pergolide, A monoamine oxidase (MAO) inhibitors excluding l-deprenyl, methylphenidate hydrochloride, amphetamine derivatives, beta blockers (e.g. propranolol) only if used as an adjunctive treatment for PD, or reserpine.
- Females of childbearing potential not using oral contraceptives or a medically recognized mechanical means of contraception.
- Electroconvulsive therapy within 90 days of Visit 2.
- Patients who are participating in other drug studies or who receive other investigational drugs within 30 days prior to Visit 2, nor the patients previously randomized into this study.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
China7 sites
First Hospital of Beijing University
Beijing, 100034
Beijing Tian Tan Hospital
Beijing, 100050
Beijing Hospital
Beijing, 100730
Peking Union Medical College Hospital
Beijing, 100730
General Hospital of PLA
Beijing, 100853
Shanghai Rui Jin Hospital
Shanghai, 200025
Hua Shan Hospital, Fu Dan University
Shanghai, 200040
About this study
Official title: A Randomized Single-blind Placebo Controlled Comparative Trial of Pramipexole Tablets and Bromocriptine Tablets in Patients With Parkinson's Disease.
The objective of this study was to investigate the efficacy and safety of Pramipexole Tablets in patients with Parkinson's disease (who can be treated with L-DOPA concomitantly) in a single blind, comparative method using Bromocriptine tablets as comparators (phase III comparative trial)
Read the detailed description
The trial was to investigate the efficacy and safety of Pramipexole in patients with Parkinson's disease who can be concomitantly treated with L-DOPA in a double-blindmethod using Bromocriptine tablets as comparators (phase III comparative trial).
For efficacy evaluation, two primary endpoints were chosen:
- Totalled score according to Part III of UPDRS (motor examination)
- Totalled score according to Part II of UPDRS (activities of daily living)
The safety profile of the study drug was evaluated by physical examination, blood pressure, Electrocardiogram, Laboratory tests, AEs and SAEs.
Patients eligible for the trial who met all inclusion and exclusion criteria and who gave their informed consent were randomized to one of two treatment groups, i.e., Pramipexole tablets or Bromocriptine tablets. Patients were administered the study drug according to the dosing schedule.
The treatment period lasted maximal 12 weeks (ascending dose interval: up to 8 weeks, maintenance dose interval: 4 weeks or longer). In addition, a descending dose interval was 1-4 weeks.
Each patient received 7 visits except the patients drops or withdrawals:
visit 1: screening visit 2: randomization and baseline visit 3-6: ascending dose interval visit 7: Maintenance dose interval
Study Hypothesis:
Primary variables are both total of UPDRS (Unified Parkinson's Disease Rating Scale) part III items and of UPDRS part II items in change from baseline. The trial hypothesis is to demonstrate non-inferiority to Bromocriptine over an equivalence margin(=delta; the clinically largest difference judged as clinically acceptable) with 90% power, one sided for the above two primary variables at the error probability of 2.5% each. The equivalency margin for the primary variables (total of UPDRS Part III, and of UPDRS Part II) can be determined as 2.0 and 1.0 respectively referring to the results of oversea pivotal study of Pramipexole (BI Trial No. 248.326; U96-0232) and judged by the study investigator.
Comparison(s):
The primary endpoint of the study was the change of totalled score according to Part III of UPDRS (motor examination) and totalled score according to Part II of UPDRS (activities of daily living) after 12 weeks treatment of the study drug.
- Conditions
- Parkinson Disease
- Being tested
- Pramipexole, 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
What is being measured
The primary outcome is the main question the study is designed to answer.
Totalled score according to Part III of UPDRS (motor examination) Totalled score according to Part II of UPDRS (activities of daily living)
Secondary outcomes (1)
Totalled score of UPDRS Part IV, UPDRS Part I, the Modified Hoehn and Yahr Staging, Parkinson Dyskinesia Scale, and patient records.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2005 (estimated)
- Study startJul 2003
- Primary completionAug 2004
- Study completionAug 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 208 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Boehringer Ingelheim Study Coordinator, Study chair, Boehringer Ingelheim Shanghai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00240409
- Sponsor's protocol ID
- 248.516
- Status last verified
- Nov 2013
- First submitted
- 14 Oct 2005
- Last updated
- 4 Nov 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Single-blind Placebo Controlled Comparative Trial of Pramipexole Tablets and Bromocriptine Tablets in Patients With Parkinson's Disease.
- ClinicalTrials.gov ID
- NCT00240409
- Acronym / sponsor ID
- 248.516
- Conditions
- Parkinson Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 208 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Jul 2003
- Primary completion
- Aug 2004 (actual)
- Study completion
- Aug 2004
- First posted
- 18 Oct 2005 (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 this study was to investigate the efficacy and safety of Pramipexole Tablets in patients with Parkinson's disease (who can be treated with L-DOPA concomitantly) in a single blind, comparative method using Bromocriptine tablets as comparators (phase III comparative trial)
Detailed description
The trial was to investigate the efficacy and safety of Pramipexole in patients with Parkinson's disease who can be concomitantly treated with L-DOPA in a double-blindmethod using Bromocriptine tablets as comparators (phase III comparative trial).
For efficacy evaluation, two primary endpoints were chosen:
- Totalled score according to Part III of UPDRS (motor examination)
- Totalled score according to Part II of UPDRS (activities of daily living)
The safety profile of the study drug was evaluated by physical examination, blood pressure, Electrocardiogram, Laboratory tests, AEs and SAEs.
Patients eligible for the trial who met all inclusion and exclusion criteria and who gave their informed consent were randomized to one of two treatment groups, i.e., Pramipexole tablets or Bromocriptine tablets. Patients were administered the study drug according to the dosing schedule.
The treatment period lasted maximal 12 weeks (ascending dose interval: up to 8 weeks, maintenance dose interval: 4 weeks or longer). In addition, a descending dose interval was 1-4 weeks.
Each patient received 7 visits except the patients drops or withdrawals:
visit 1: screening visit 2: randomization and baseline visit 3-6: ascending dose interval visit 7: Maintenance dose interval
Study Hypothesis:
Primary variables are both total of UPDRS (Unified Parkinson's Disease Rating Scale) part III items and of UPDRS part II items in change from baseline. The trial hypothesis is to demonstrate non-inferiority to Bromocriptine over an equivalence margin(=delta; the clinically largest difference judged as clinically acceptable) with 90% power, one sided for the above two primary variables at the error probability of 2.5% each. The equivalency margin for the primary variables (total of UPDRS Part III, and of UPDRS Part II) can be determined as 2.0 and 1.0 respectively referring to the results of oversea pivotal study of Pramipexole (BI Trial No. 248.326; U96-0232) and judged by the study investigator.
Comparison(s):
The primary endpoint of the study was the change of totalled score according to Part III of UPDRS (motor examination) and totalled score according to Part II of UPDRS (activities of daily living) after 12 weeks treatment of the study drug.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients aged 30-80 years
- Patients with idiopathic Parkinson's disease corresponding to stages II-IV according to the classification of Hoehn and Yahr during an "on" period, and/or patients in whom the individual optimized dosage of levodopa (and decarboxylase inhibitor) causes motor fluctuations characterized as end-of-dose phenomena or "wearing-off" effects for at least 30 days prior to initial administration of study medication and whose daily total "off" time is at least 2 hours and no more than 6 hours during waking time.
- Patients able to keep an accurate patient diary of the times of "on"- and "off"-periods during waking hours. Family members, guardians or nursing personnel may assist the patient.
- Informed Consent (consent in writing)
Key exclusion criteria (19 listed)
- Patients with atypical parkinsonian syndromes due to drugs, metabolic disorders , encephalitis, or degenerative disease.
- Dementia that could impair compliance with medication, impair maintenance of accurate patient diaries, and/or preclude the signing of informed consent.
- History of psychosis except that which was elicited by treatment with levodopa or dopamine agonists unless the patient remains psychotic and in the opinion of the investigator would be unable to participate in the study.
- History of active epilepsy within the last two years prior to Visit 2.
- Patients with second or third degree AV block or sick sinus syndrome.
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 | – |
| Bromocriptine | Drug | – |
Primary outcome
Totalled score according to Part III of UPDRS (motor examination) Totalled score according to Part II of UPDRS (activities of daily living)
1 secondary outcome
Totalled score of UPDRS Part IV, UPDRS Part I, the Modified Hoehn and Yahr Staging, Parkinson Dyskinesia Scale, and patient records.
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 Nov 2013.
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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.
Boehringer Ingelheim Study Coordinator study chair
Boehringer Ingelheim Shanghai
7 sites in 1 country: see every site and its status.
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 at 7 sites in China.
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 4 inclusion and 19 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 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in China. 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.
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?
Totalled score according to Part III of UPDRS (motor examination) Totalled score according to Part II of UPDRS (activities of daily living). 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 Nov 2013.