Parkinson DiseasePhase 3NCT00558025

Overnight Switch Trial From Pramipexole IR to Pramipexole ER in Patients With Early Parkinson Disease

A Phase 3 study testing Pramipexole Extended Release and Pramipexole Immediate Release in people with Parkinson Disease, run by Boehringer Ingelheim at 36 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The objectives of this trial conducted in early Parkinson's disease (PD) patients are: To assess if patients with early Parkinson's disease (PD) can be successfully switched (overnight switching) from Pramipexole (PPX) Immediate Release (IR) to Pramipexole Extended Release (ER). 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 Extended Release and Pramipexole Immediate Release
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 156 participants
Where: 36 sitesin 3 countries
Study dates: Oct 2007to May 2008
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Male or female patient with idiopathic Parkinson's disease (PD) confirmed by at least two of the following signs: resting tremor, bradykinesia, rigidity.
Parkinson's disease diagnosed within 5 years.
Patients 30 years of age or older at the time of diagnosis.
Modified Hoehn and Yahr stage of 1 to 3.
Patients receiving pramipexole IR for at least three months prior to baseline visit (randomization visit, V2).
Pramipexole dose should be optimized (according investigator¿s judgement), greater or equal to 1.5 mg/day, stable and equally divided 3 times per day, for a least 4 weeks prior to baseline visit (V2).
Patients willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures.
Signed informed consent obtained before any study procedures are carried out in accordance with International Conference on Harmonization - Good Clinical Practice (ICH-GCP) guidelines and local legislation).

Who cannot join

Motor complications under levodopa therapy at V1.
Atypical parkinsonian syndromes due to drugs, metabolic disorders, encephalitis or degenerative diseases.
Dementia, as defined by a Mini-Mental State Exam score < 24 at V1
Any psychiatric disorder according to Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) criteria
History of psychosis, except history of drug induced hallucinations
Clinically significant electrocardiogram (ECG) abnormalities at V1.

Show all 22Show fewer

Clinically significant hypotension either at screening visit or at baseline visit.
Malignant melanoma or history of previously treated malignant melanoma.
Any other clinically significant disease
Pregnancy or breast-feeding.
Sexually active female of childbearing potential
Serum levels of Aspartate Aminotransferase (Serum Glutamic Oxaloacetic Transaminase) (AST (SGOT)), Alanine Aminotransferase (Serum Glutamate Pyruvate Transaminase) (ALT (SGPT)), alkaline phosphatases or bilirubin > 2 Upper Limit of Normal (ULN) (on screening lab test).
Patients with a creatinine clearance < 50 mL/min
Any dopamine agonist (except pramipexole IR) within three months prior to baseline visit.
History of discontinuation of treatment with pramipexole IR
Previous treatment with pramipexole ER.
Any medication (including intra-muscular formulations) with central dopaminergic antagonist activity within 4 weeks prior to the baseline visit (i.e. typical neuroleptics, atypical antipsychotics, reserpine, methyldopa, centrally-active antiemetics, etc).
Any of the following drugs within 4 weeks prior to the baseline visit: methylphenidate, cinnarizine, amphetamines.
Flunarizine within 3 months prior to baseline visit.
Known hypersensitivity to Pramipexole or its excipients.
Drug abuse (including alcohol), according to Investigator¿s judgement, within 2 years prior to screening.
Participation in other investigational drug studies or use of other investigational drugs within 4 weeks or five times the half-life of the investigational drug (whichever is longer) prior to baseline visit.

Trial locations and contacts

36 sites in 3 countries.

Country

City, postcode or hospital

36 sites in 3 countries

France22 sites

248.636.3303A Boehringer Ingelheim Investigational Site
Aix-en-Provence
248.636.3303B Boehringer Ingelheim Investigational Site
Aix-en-Provence
248.636.3303C Boehringer Ingelheim Investigational Site
Aix-en-Provence
248.636.3307C Boehringer Ingelheim Investigational Site
Bron
248.636.3309B Boehringer Ingelheim Investigational Site
Clermont-Ferrand
248.636.3305A Boehringer Ingelheim Investigational Site
Créteil
248.636.3305B Boehringer Ingelheim Investigational Site
Créteil
248.636.3313A Boehringer Ingelheim Investigational Site
Dijon
248.636.3304A Boehringer Ingelheim Investigational Site
Évreux
248.636.3308B Boehringer Ingelheim Investigational Site
Lille
248.636.3308C Boehringer Ingelheim Investigational Site
Lille
248.636.3308D Boehringer Ingelheim Investigational Site
Lille
248.636.3308E Boehringer Ingelheim Investigational Site
Lille
248.636.3302A Boehringer Ingelheim Investigational Site
Marseille
248.636.3302B Boehringer Ingelheim Investigational Site
Marseille
248.636.3306B Boehringer Ingelheim Investigational Site
Montpellier
248.636.3312A Boehringer Ingelheim Investigational Site
Rouen
248.636.3312B Boehringer Ingelheim Investigational Site
Rouen
248.636.3311A Boehringer Ingelheim Investigational Site
Strasbourg
248.636.3301A Boehringer Ingelheim Investigational Site
Toulouse
248.636.3301B Boehringer Ingelheim Investigational Site
Toulouse
248.636.3301D Boehringer Ingelheim Investigational Site
Toulouse

Other trials in France

Germany8 sites

248.636.49006 Boehringer Ingelheim Investigational Site
Achim Bei Bremen
248.636.49004 Boehringer Ingelheim Investigational Site
Berlin
248.636.49007 Boehringer Ingelheim Investigational Site
Berlin
248.636.49008 Boehringer Ingelheim Investigational Site
Berlin
248.636.49002 Boehringer Ingelheim Investigational Site
Gera
248.636.49001 Boehringer Ingelheim Investigational Site
Karlsruhe
248.636.49003 Boehringer Ingelheim Investigational Site
Steglitz
248.636.49005 Boehringer Ingelheim Investigational Site
Unterhaching

Other trials in Germany

Netherlands6 sites

248.636.31005 Boehringer Ingelheim Investigational Site
's-Hertogenbosch
248.636.31002 Boehringer Ingelheim Investigational Site
Geldrop
248.636.31003 Boehringer Ingelheim Investigational Site
Helmond
248.636.31006 Boehringer Ingelheim Investigational Site
Maastricht
248.636.31004 Boehringer Ingelheim Investigational Site
Nijmegen
248.636.31001 Boehringer Ingelheim Investigational Site
Sittard

Other trials in Netherlands

About this study

Official title: A Double-blind, Double-dummy, Randomized, Parallel Groups Study to Assess the Efficacy, Safety and Tolerability of Switching Patients With Early Parkinson's Disease (PD) From Pramipexole IR to Pramipexole ER or Pramipexole IR

The objectives of this trial conducted in early Parkinson's disease (PD) patients are:

To assess if patients with early Parkinson's disease (PD) can be successfully switched (overnight switching) from Pramipexole (PPX) Immediate Release (IR) to Pramipexole Extended Release (ER). A successful switch at a specific visit is defined as no worsening of the Unified Parkinsons Disease Rating Scale (UPDRS) parts II+III score by more than 15% from baseline and no drug-related adverse events leading to withdrawal;
To establish if this successful switch can be obtained with or without dose-adaptation;
To provide information about the conversion ratio (mg:mg) from Pramipexole IR to Pramipexole ER.

Conditions: Parkinson Disease
Being tested: Pramipexole Extended Release, Pramipexole Immediate Release
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 Extended ReleaseDrug
Pramipexole Immediate ReleaseDrug

Study groups in NCT00558025
Study group	Role	What they receive
Pramipexole Extended Release (ER)	Experimental	Pramipexole Extended Release (ER) once daily Receives: Drug: Pramipexole Extended Release
Pramipexole Immediate Release (IR)	Experimental	Pramipexole Immediate Release (IR) once daily Receives: Drug: Pramipexole Immediate Release

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Patients Who Successfully Switched From Pramipexole Immediate Release (IR) to Pramipexole ER After a Possible Dose Adaptation, Full Analysis Set (FAS), Last Observation Carried Forward (LOCF)
A successful switch was defined by no change of the Unified Parkinson's Disease Rating Scale (UPDRS) II+III by more than 15% from baseline to week 9, UPDRS II+III score ranging from 0 (no impairment) to 160 (worst impairment)
Measured: from baseline to week 9

Secondary outcomes (8)

Percentage of Patients Who Successfully Switched From Pramipexole IR to Pramipexole ER With no Dose Adaptation, FAS (LOCF)
A successful switch was defined by no change of the UPDRS II+III by more than 15% from baseline to week 4, UPDRS II+III score ranging from 0 (no impairment) to 160 (worst impairment).
Measured: from baseline to week 4
Change From Baseline in UPDRS Part II+III Total Score at Week 9, FAS (LOCF)
Unified Parkinson's Disease Rating Scale part II+III total score on FAS, Week 9 - baseline, UPDRS II+III score ranging from 0 (no impairment) to 160 (worst impairment)
Measured: Baseline and week 9
Change From Baseline in UPDRS Part II Total Score at Week 9, FAS (LOCF)
Unified Parkinson's Disease Rating Scale part II total score on FAS, Week 9 - baseline, UPDRS II score ranging from 0 (no impairment) to 52 (worst impairment)
Measured: Baseline and week 9
Change From Baseline in UPDRS Part III Total Score at Week 9, FAS (LOCF)
Unified Parkinson's Disease Rating Scale part III total score on FAS, week 9 - baseline, UPDRS II+III score ranging from 0 (no impairment) to 108 (worst impairment)
Measured: Baseline and week 9
Clinical Global Impression - Improvement (CGI-I), FAS (LOCF)
Clinical Global Impression - Improvement on FAS, CGI-I was rated from 1: very much improved, to 7: very much worse, CGI-I responder are defined as being rated as 'unchanged', 'minimally improved', 'much improved', or 'very much improved', CGI-I non-responder are defined as being rated 'minimally worse', 'much worse' or 'very much worse'
Measured: Week 9
Patient Global Impression - Improvement (PGI-I), FAS (LOCF)
Patient Global Impression - Improvement on FAS, PGI-I was rated from 1: very much better, to 7: very much worse, PGI-I responder are defined as being rated as 'unchanged', 'minimally better', 'much better', or 'very much better', PGI-I non-responder are defined as being rated as 'minimally worse', 'much worse', or 'very much worse'
Measured: Week 9
Pramipexole Dose Adaptation, FAS (LOCF)
Patients with increase in daily Pramipexole dose on FAS
Measured: Week 9
Final Pramipexole Dose (mg) After 9 Weeks, Treated Set
The mean final daily Pramipexole dose is displayed
Measured: Week 9

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2007May 2008

First posted14 Nov 2007 (estimated)
Study startOct 2007
Primary completionMay 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 156 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00558025
Sponsor's protocol ID: 248.636
Other IDs: Eudract 2007-003353-90
Status last verified: May 2012
First submitted: 12 Nov 2007
Last updated: 16 May 2014
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 16 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Double-blind, Double-dummy, Randomized, Parallel Groups Study to Assess the Efficacy, Safety and Tolerability of Switching Patients With Early Parkinson's Disease (PD) From Pramipexole IR to Pramipexole ER or Pramipexole IR
ClinicalTrials.gov ID: NCT00558025
Acronym / sponsor ID: 248.636
Conditions: Parkinson Disease
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 156 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Oct 2007
Primary completion: May 2008 (actual)
First posted: 14 Nov 2007 (estimated)
Results: Posted 20 Nov 2009

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 trial conducted in early Parkinson's disease (PD) patients are:

To assess if patients with early Parkinson's disease (PD) can be successfully switched (overnight switching) from Pramipexole (PPX) Immediate Release (IR) to Pramipexole Extended Release (ER). A successful switch at a specific visit is defined as no worsening of the Unified Parkinsons Disease Rating Scale (UPDRS) parts II+III score by more than 15% from baseline and no drug-related adverse events leading to withdrawal;
To establish if this successful switch can be obtained with or without dose-adaptation;
To provide information about the conversion ratio (mg:mg) from Pramipexole IR to Pramipexole ER.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Pramipexole Extended Release (ER)	Experimental	Drug: Pramipexole Extended ReleasePramipexole Extended Release (ER) once daily
Pramipexole Immediate Release (IR)	Experimental	Drug: Pramipexole Immediate ReleasePramipexole Immediate Release (IR) once daily

Who may qualify

Ages: 30 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Male or female patient with idiopathic Parkinson's disease (PD) confirmed by at least two of the following signs: resting tremor, bradykinesia, rigidity.
Parkinson's disease diagnosed within 5 years.
Patients 30 years of age or older at the time of diagnosis.
Modified Hoehn and Yahr stage of 1 to 3.
Patients receiving pramipexole IR for at least three months prior to baseline visit (randomization visit, V2).

Key exclusion criteria (22 listed)

Motor complications under levodopa therapy at V1.
Atypical parkinsonian syndromes due to drugs, metabolic disorders, encephalitis or degenerative diseases.
Dementia, as defined by a Mini-Mental State Exam score < 24 at V1
Any psychiatric disorder according to Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) criteria
History of psychosis, except history of drug induced hallucinations

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 Extended Release	Drug	Pramipexole Extended Release (ER)
Pramipexole Immediate Release	Drug	Pramipexole Immediate Release (IR)

Primary outcome

Percentage of Patients Who Successfully Switched From Pramipexole Immediate Release (IR) to Pramipexole ER After a Possible Dose Adaptation, Full Analysis Set (FAS), Last Observation Carried Forward (LOCF)
Time frame: from baseline to week 9
A successful switch was defined by no change of the Unified Parkinson's Disease Rating Scale (UPDRS) II+III by more than 15% from baseline to week 9, UPDRS II+III score ranging from 0 (no impairment) to 160 (worst impairment)

8 secondary outcomes

Percentage of Patients Who Successfully Switched From Pramipexole IR to Pramipexole ER With no Dose Adaptation, FAS (LOCF)
Time frame: from baseline to week 4
Change From Baseline in UPDRS Part II+III Total Score at Week 9, FAS (LOCF)
Time frame: Baseline and week 9
Change From Baseline in UPDRS Part II Total Score at Week 9, FAS (LOCF)
Time frame: Baseline and week 9
Change From Baseline in UPDRS Part III Total Score at Week 9, FAS (LOCF)
Time frame: Baseline and week 9
Clinical Global Impression - Improvement (CGI-I), FAS (LOCF)
Time frame: Week 9
Patient Global Impression - Improvement (PGI-I), FAS (LOCF)
Time frame: Week 9
Pramipexole Dose Adaptation, FAS (LOCF)
Time frame: Week 9
Final Pramipexole Dose (mg) After 9 Weeks, Treated Set
Time frame: Week 9

Results and safety

Results posted to the registry on 20 Nov 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Pramipexole Extended Release (ER)	104	100
Pramipexole Immediate Release (IR)	52	49

Primary outcome: Percentage of Patients Who Successfully Switched From Pramipexole Immediate Release (IR) to Pramipexole ER After a Possible Dose Adaptation, Full Analysis Set (FAS), Last Observation Carried Forward (LOCF)

Time frame: from baseline to week 9. Number. Unit: Percentage of participants

Measure	Pramipexole Extended Release (ER) n = 103	Pramipexole Immediate Release (IR) n = 52
Successfully switched	84.5	94.2
Not successfully switched	15.5	5.8

Population analysed: Full Analysis Set (FAS), all randomized patients that received treatment and had baseline and post baseline measurements for the primary endpoint

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: 9 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pramipexole Extended Release (ER)	0 of 104 (0%)	0 of 104 (0%)	Not reported
Pramipexole Immediate Release (IR)	0 of 52 (0%)	0 of 52 (0%)	Not reported

Limitations and caveats (from the sponsor): There were no serious adverse events in the trial and no non-serious adverse events with an incidence \>5%.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.

Boehringer Ingelheim study chair

Boehringer Ingelheim

36 sites in 3 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Pramipexole Extended Release and Pramipexole Immediate Release in people with Parkinson Disease, run by Boehringer Ingelheim at 36 sites in 3 countries.

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 8 inclusion and 22 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 16 May 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 36 sites in France, Germany, Netherlands. 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?

Yes. Results are posted in the registry (first posted 20 Nov 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percentage of Patients Who Successfully Switched From Pramipexole Immediate Release (IR) to Pramipexole ER After a Possible Dose Adaptation, Full Analysis Set (FAS), Last Observation Carried Forward (LOCF) (time frame: from baseline to week 9). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00558025.

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 16 May 2014.