Parkinson DiseaseNCT00651183

Non-motor Symptoms (Depressive Symptoms) of Parkinson's Disease and Their Course Under Pramipexole Treatment

An observational study of Parkinson Disease, run by Boehringer Ingelheim at 57 sites in Austria.

Completed

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

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Parkinson Disease
What is being tested?: Pramipexole immediate release
How many people: 286 participants
Where: 57 sitesAustria
Study dates: Start not givento Apr 2008
Phase: Observational
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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: PD patients

Who may be able to join

Idiopathic PD with or without fluctuations
Indication for treatment with Pramipexole
Presence of at least mild depressive symptoms (as judged by the treating physician)
Ability to reliably complete a self-rating scale (Hospital Anxiety and Depression Scale (HADS))

Who cannot join

Any contraindications according to the Summary of Product Characteristics (SPC), hypersensitivity to pramipexole or to any of the excipients
Ongoing treatment with pramipexole

Trial locations and contacts

57 sites in 1 country.

City, postcode or hospital

57 sites in 1 country

Austria57 sites

Boehringer Ingelheim Investigational Site
Amstetten
Boehringer Ingelheim Investigational Site
Bad Hall
Boehringer Ingelheim Investigational Site
Bad Ischl
Boehringer Ingelheim Investigational Site
Bad Radkersburg
Boehringer Ingelheim Investigational Site
Baden
Boehringer Ingelheim Investigational Site
Bregenz
Boehringer Ingelheim Investigational Site
Bruck an der Mur
Boehringer Ingelheim Investigational Site
Deutschlandsberg
Boehringer Ingelheim Investigational Site
Dornbirn
Boehringer Ingelheim Investigational Site
Eisenstadt
Boehringer Ingelheim Investigational Site
Feldkirch
Boehringer Ingelheim Investigational Site
Feldkirchen in Kärnten
Boehringer Ingelheim Investigational Site
Gänserndorf
Boehringer Ingelheim Investigational Site
Gmunden
Boehringer Ingelheim Investigational Site
Graz
Boehringer Ingelheim Investigational Site
Grieskirchen
Boehringer Ingelheim Investigational Site
Hall in Tirol
Boehringer Ingelheim Investigational Site
Hallein
Boehringer Ingelheim Investigational Site
Hermagor
Boehringer Ingelheim Investigational Site
Hohenems
Boehringer Ingelheim Investigational Site
Hollabrunn
Boehringer Ingelheim Investigational Site
Horn
Boehringer Ingelheim Investigational Site
Imst
Boehringer Ingelheim Investigational Site
Innsbruck
Boehringer Ingelheim Investigational Site
Judenburg
Boehringer Ingelheim Investigational Site
Kapfenberg
Boehringer Ingelheim Investigational Site
Klagenfurt
Boehringer Ingelheim Investigational Site
Klosterneuburg
Boehringer Ingelheim Investigational Site
Knittelfeld
Boehringer Ingelheim Investigational Site
Krems
Boehringer Ingelheim Investigational Site
Kufstein
Boehringer Ingelheim Investigational Site
Leoben
Boehringer Ingelheim Investigational Site
Lienz
Boehringer Ingelheim Investigational Site
Lilienfeld
Boehringer Ingelheim Investigational Site
Linz
Boehringer Ingelheim Investigational Site
Melk
Boehringer Ingelheim Investigational Site
Neunkirchen
Boehringer Ingelheim Investigational Site
Oberwart
Boehringer Ingelheim Investigational Site
Ried im Innkreis
Boehringer Ingelheim Investigational Site
Salzburg
Boehringer Ingelheim Investigational Site
Sankt Pölten
Boehringer Ingelheim Investigational Site
Sankt Veit an der Glan
Boehringer Ingelheim Investigational Site
Scheibbs
Boehringer Ingelheim Investigational Site
Schwechat
Boehringer Ingelheim Investigational Site
Spital An Der Drau
Boehringer Ingelheim Investigational Site
St Johann im Pongau
Boehringer Ingelheim Investigational Site
Stegersbach
Boehringer Ingelheim Investigational Site
Stockerau
Boehringer Ingelheim Investigational Site
Telfs
Boehringer Ingelheim Investigational Site
Traun
Boehringer Ingelheim Investigational Site
Vienna
Boehringer Ingelheim Investigational Site
Villach
Boehringer Ingelheim Investigational Site
Vöcklabruck
Boehringer Ingelheim Investigational Site
W. Neustadt
Boehringer Ingelheim Investigational Site
Wels
Boehringer Ingelheim Investigational Site
Wolfsberg
Boehringer Ingelheim Investigational Site
Wörgl

Other trials in Austria

About this study

The objective of this PMS study is the evaluation of depressive symptoms measured with Unified Parkinson's Disease Rating Scale (UPDRS) Part I (mentation, behavior and mood) and with Hospital Anxiety and Depression Scale Depression Subscore (HADS-D) under pramipexole treatment in early and advanced PD patients. In addition it will be investigated whether improvement of depressive symptoms is linked to improvement in motor function (UPDRS Part III). 250 patients diagnosed with Parkinson's disease (PD) will be investigated by 80 specialists (neurologists or neurologists/psychiatrists) across Austria. Pramipexole will be taken orally at an initial dosage of 0.375 mg/day (using a three times daily schedule independently of food intake) and can be titrated upwards, as required, at weekly intervals to a maximum total daily dose of 4,5 mg (TID) as per Summary of Product Characteristics (SPC).

Conditions: Parkinson Disease
Being tested: 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 immediate releaseDrug

What is being measured

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

Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part I (Mentation, Behaviour and Mood)
Rating scale scored from 0 (none) - 4 (severe). The UPDRS Part I (Mentation, Behaviour and Mood during the Past Week) consist of 4 items, each of them is scored from 0 (normal) to 4 (severe). Reduction in this score over time is interpreted as improvement.
Total UPDRS part I score ranges from 0 = best score to 16 = worst score
Measured: Baseline and Final (visit 3) - Change from baseline (i.e. decrease of score)
Change From Baseline in Hospital Anxiety and Depression Scale - HADS-D Depression Subscore
Depression Scale - 7 items scored for each individual question from 0 = best and 3 = worst.
HADS is a self-assessment scale for the symptom severity of anxiety disorders and depression.
It comprises of 14 items, thereof seven statements describe anxiety and seven statements depression. Each answer is rated on a four-point scale (0-3). All seven answers are summarized and calculated to a total score to the anxiety scale and to the depression scale with a maximum score of 21 points for each scale.
Measured: Baseline and Final (visit 3) - Change from baseline (i.e. decrease of score)
Change From Baseline in Hospital Anxiety and Depression Scale - HADS-A Anxiety Subscore
Anxiety Scale - 7 items scored for each individual question from 0 = best and 3 = worst.
HADS is a self-assessment scale for the symptom severity of anxiety disorders and depression.
It comprises of 14 items, thereof seven statements describe anxiety and seven statements depression. Each answer is rated on a four-point scale (0-3). All seven answers are summarized and calculated to a total score to the anxiety scale and to the depression scale with a maximum score of 21 points for each scale.
Measured: Baseline and Final (visit 3) - Change from baseline (i.e. decrease of score)
Change From Baseline in UPDRS Part III (Motor Examination)
14 components rating scale with 27 items scored by 0 (none) - 4 (severe)
Measured: Baseline and Final (visit 3) - Change from baseline (i.e. decrease of score)

Timeline

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

?Apr 2008

First posted2 Apr 2008 (estimated)
Primary completionApr 2008
Study completionApr 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: Observational
Time perspective: Prospective
Enrolment: 286 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00651183
Sponsor's protocol ID: 248.649
Status last verified: May 2014
First submitted: 31 Mar 2008
Last updated: 20 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 20 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Non-motor Symptoms (Depressive Symptoms) of Parkinson's Disease and Their Course Under Pramipexole Treatment
ClinicalTrials.gov ID: NCT00651183
Acronym / sponsor ID: 248.649
Conditions: Parkinson Disease
Study type: Observational
Recruitment status: Completed
Enrolment: 286 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Primary completion: Apr 2008 (actual)
Study completion: Apr 2008 (actual)
First posted: 2 Apr 2008 (estimated)
Results: Posted 3 Mar 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Time perspective: Prospective

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: PD patients

Key inclusion criteria (4 listed)

Idiopathic PD with or without fluctuations
Indication for treatment with Pramipexole
Presence of at least mild depressive symptoms (as judged by the treating physician)
Ability to reliably complete a self-rating scale (Hospital Anxiety and Depression Scale (HADS))

Key exclusion criteria (2 listed)

Any contraindications according to the Summary of Product Characteristics (SPC), hypersensitivity to pramipexole or to any of the excipients
Ongoing treatment with pramipexole

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 immediate release	Drug	–

Primary outcome

Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part I (Mentation, Behaviour and Mood)
Time frame: Baseline and Final (visit 3) - Change from baseline (i.e. decrease of score)
Rating scale scored from 0 (none) - 4 (severe). The UPDRS Part I (Mentation, Behaviour and Mood during the Past Week) consist of 4 items, each of them is scored from 0 (normal) to 4 (severe). Reduction in this score over time is interpreted as improvement. Total UPDRS part I score ranges from 0 = best score to 16 = worst score
Change From Baseline in Hospital Anxiety and Depression Scale - HADS-D Depression Subscore
Time frame: Baseline and Final (visit 3) - Change from baseline (i.e. decrease of score)
Depression Scale - 7 items scored for each individual question from 0 = best and 3 = worst. HADS is a self-assessment scale for the symptom severity of anxiety disorders and depression. It comprises of 14 items, thereof seven statements describe anxiety and seven statements depression. Each answer is rated on a four-point scale (0-3). All seven answers are summarized and calculated to a total score to the anxiety scale and to the depression scale with a maximum score of 21 points for each scale.
Change From Baseline in Hospital Anxiety and Depression Scale - HADS-A Anxiety Subscore
Time frame: Baseline and Final (visit 3) - Change from baseline (i.e. decrease of score)
Anxiety Scale - 7 items scored for each individual question from 0 = best and 3 = worst. HADS is a self-assessment scale for the symptom severity of anxiety disorders and depression. It comprises of 14 items, thereof seven statements describe anxiety and seven statements depression. Each answer is rated on a four-point scale (0-3). All seven answers are summarized and calculated to a total score to the anxiety scale and to the depression scale with a maximum score of 21 points for each scale.
Change From Baseline in UPDRS Part III (Motor Examination)
Time frame: Baseline and Final (visit 3) - Change from baseline (i.e. decrease of score)
14 components rating scale with 27 items scored by 0 (none) - 4 (severe)

Results and safety

Results posted to the registry on 3 Mar 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Early (PD)	189	169
Advanced PD	97	87

Primary outcome: Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part I (Mentation, Behaviour and Mood)

Time frame: Baseline and Final (visit 3) - Change from baseline (i.e. decrease of score). Median (Inter-Quartile Range). Unit: Points on a scale

Measure	Early PD n = 165	Advanced PD n = 85
Value	2 (1.00 to 3.00)	2 (1.00 to 3.00)

Population analysed: Only those patients of the full analysis set (FAS) with an evaluation of UPDRS Part I at visit 3 were included in this analysis

Primary outcome: Change From Baseline in Hospital Anxiety and Depression Scale - HADS-D Depression Subscore

Time frame: Baseline and Final (visit 3) - Change from baseline (i.e. decrease of score). Median (Inter-Quartile Range). Unit: Points on a scale

Measure	Early PD n = 161	Advanced PD n = 79
Value	3 (1.00 to 6.00)	4 (2.00 to 7.00)

Population analysed: Only those patients of the full analysis set (FAS) with an evaluation of HADS-D at visit 3 were included in this analysis

Primary outcome: Change From Baseline in Hospital Anxiety and Depression Scale - HADS-A Anxiety Subscore

Time frame: Baseline and Final (visit 3) - Change from baseline (i.e. decrease of score). Median (Inter-Quartile Range). Unit: Points on a scale

Measure	Early PD n = 161	Advanced PD n = 79
Value	2 (1.00 to 4.00)	4 (1.00 to 6.00)

Population analysed: Only those patients of the full analysis set (FAS) with an evaluation of HADS-A at visit 3 were included in this analysis

Primary outcome: Change From Baseline in UPDRS Part III (Motor Examination)

Time frame: Baseline and Final (visit 3) - Change from baseline (i.e. decrease of score). Median (Inter-Quartile Range). Unit: Points on a scale

Measure	Early PD n = 172	Advanced PD n = 87
Value	9 (4.00 to 14.00)	10 (6.00 to 17.00)

Population analysed: Only those patients of the full analysis set (FAS) with an evaluation of UPDRS Part III at visit 3 were included in this analysis

Adverse events

Time frame: Up to 16 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Early PD	0 of 189 (0%)	0 of 189 (0%)	Not reported
Advanced PD	1 of 97 (1%)	0 of 97 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.

Related trials for Parkinson Disease

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Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
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RecruitingPhase 3
A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) as First-line Maintenance Treatment of Cervical Cancer (MK-2870-036/TroFuse-036/GOG-3123/ENGOT-cx22)
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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

57 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Parkinson Disease, run by Boehringer Ingelheim at 57 sites in Austria.

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 2 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 20 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 57 sites in Austria. 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Mar 2010). 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?

Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part I (Mentation, Behaviour and Mood) (time frame: Baseline and Final (visit 3) - Change from baseline (i.e. decrease of score)). The study lists 4 primary outcomes in all. 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 NCT00651183.

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 20 May 2014.