Kinetic Tremor in Parkinsons Disease: Its Course Under Pramipexole (Mirapexin®) Treatment and Impact on Quality of Life

An observational study of Parkinson Disease, run by Boehringer Ingelheim at 215 sites in 8 countries.

Completed

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

Trial summary

The study will compare the effect of pramipexole on different types of tremor and particularly kinetic tremor in early and advanced Parkinson's disease patients and will evaluate the course of tremor measured with spiralometry under pramipexole treatment. Read more about this study

Who is it for?: Any age
Conditions the study is for: Parkinson Disease
How many people: 1,703 participants
Where: 215 sitesin 8 countries
Study dates: Feb 2008to Aug 2009
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 Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: Neurologists

Who may be able to join

Idiopathic Parkinson's disease with or without fluctuations
Indication for treatment with pramipexole (Mirapexin®)
Presence of at least mild tremor symptoms (as judged by the treating physician)

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 (Mirapexin®)

Trial locations and contacts

215 sites in 8 countries.

Country

City, postcode or hospital

215 sites in 8 countries

Romania93 sites

Boehringer Ingelheim Investigational Site 32
Aiud
Boehringer Ingelheim Investigational Site 33
Arges
Boehringer Ingelheim Investigational Site 34
Arges
Boehringer Ingelheim Investigational Site 35
Arges
Boehringer Ingelheim Investigational Site 36
Arges
Boehringer Ingelheim Investigational Site 37
Arges
Boehringer Ingelheim Investigational Site 38
Arges
Boehringer Ingelheim Investigational Site 39
Arges
Boehringer Ingelheim Investigational Site 40
Bacau
Boehringer Ingelheim Investigational Site 41
Bacau
Boehringer Ingelheim Investigational Site 42
Bistriţa
Boehringer Ingelheim Investigational Site 43
Botoșani
Boehringer Ingelheim Investigational Site 44
Botoșani
Boehringer Ingelheim Investigational Site 45
Brăila
Boehringer Ingelheim Investigational Site 46
Brăila
Boehringer Ingelheim Investigational Site 47
Brasov
Boehringer Ingelheim Investigational Site 48
Brasov
Boehringer Ingelheim Investigational Site 49
Bucharest
Boehringer Ingelheim Investigational Site 50
Bucharest
Boehringer Ingelheim Investigational Site 51
Bucharest
Boehringer Ingelheim Investigational Site 52
Bucharest
Boehringer Ingelheim Investigational Site 53
Bucharest
Boehringer Ingelheim Investigational Site 54
Bucharest
Boehringer Ingelheim Investigational Site 55
Bucharest
Boehringer Ingelheim Investigational Site 56
Bucharest
Boehringer Ingelheim Investigational Site 57
Bucharest
Boehringer Ingelheim Investigational Site 58
Bucharest
Boehringer Ingelheim Investigational Site 59
Bucharest
Boehringer Ingelheim Investigational Site 60
Bucharest
Boehringer Ingelheim Investigational Site 61
Bucharest
Boehringer Ingelheim Investigational Site 62
Bucharest
Boehringer Ingelheim Investigational Site 63
Bucharest
Boehringer Ingelheim Investigational Site 64
Bucharest
Boehringer Ingelheim Investigational Site 65
Bucharest
Boehringer Ingelheim Investigational Site 66
Bucharest
Boehringer Ingelheim Investigational Site 67
Bucharest
Boehringer Ingelheim Investigational Site 68
Bucharest
Boehringer Ingelheim Investigational Site 69
Bucharest
Boehringer Ingelheim Investigational Site 70
Bucharest
Boehringer Ingelheim Investigational Site 71
Bucharest
Boehringer Ingelheim Investigational Site 72
Buzău
Boehringer Ingelheim Investigational Site 73
Buzău
Boehringer Ingelheim Investigational Site 74
Caracal
Boehringer Ingelheim Investigational Site 75
Cluj-Napoca
Boehringer Ingelheim Investigational Site 76
Cluj-Napoca
Boehringer Ingelheim Investigational Site 77
Cluj-Napoca
Boehringer Ingelheim Investigational Site 78
Cluj-Napoca
Boehringer Ingelheim Investigational Site 79
Cluj-Napoca
Boehringer Ingelheim Investigational Site 80
Cluj-Napoca
Boehringer Ingelheim Investigational Site 81
Constanța
Boehringer Ingelheim Investigational Site 82
Constanța
Boehringer Ingelheim Investigational Site 83
Craiova
Boehringer Ingelheim Investigational Site 84
Craiova
Boehringer Ingelheim Investigational Site 85
Craiova
Boehringer Ingelheim Investigational Site 86
Craiova
Boehringer Ingelheim Investigational Site 87
Deva
Boehringer Ingelheim Investigational Site 88
Deva
Boehringer Ingelheim Investigational Site 89
Focşani
Boehringer Ingelheim Investigational Site 90
Focşani
Boehringer Ingelheim Investigational Site 91
Galati
Boehringer Ingelheim Investigational Site 92
Galati
Boehringer Ingelheim Investigational Site 93
Hunedoara
Boehringer Ingelheim Investigational Site 94
Hunedoara
Boehringer Ingelheim Investigational Site 95
Iași
Boehringer Ingelheim Investigational Site 96
Iași
Boehringer Ingelheim Investigational Site 97
Iași
Boehringer Ingelheim Investigational Site 98
Iași
Boehringer Ingelheim Investigational Site 99
Lugoj
Boehringer Ingelheim Investigational Site 100
Maramures
Boehringer Ingelheim Investigational Site 101
Orăştie
Boehringer Ingelheim Investigational Site 102
Paşcani
Boehringer Ingelheim Investigational Site 103
Paşcani
Boehringer Ingelheim Investigational Site 104
Petroşani
Boehringer Ingelheim Investigational Site 105
Piatra Neamţ
Boehringer Ingelheim Investigational Site 106
Prahova
Boehringer Ingelheim Investigational Site 107
Prahova
Boehringer Ingelheim Investigational Site 108
Prahova
Boehringer Ingelheim Investigational Site 109
Radauti
Boehringer Ingelheim Investigational Site 110
Reşiţa
Boehringer Ingelheim Investigational Site 111
Satu Mare
Boehringer Ingelheim Investigational Site 112
Sibiu
Boehringer Ingelheim Investigational Site 113
Sibiu
Boehringer Ingelheim Investigational Site 114
Slatina
Boehringer Ingelheim Investigational Site 115
Suceava
Boehringer Ingelheim Investigational Site 116
Suceava
Boehringer Ingelheim Investigational Site 117
Teleorman
Boehringer Ingelheim Investigational Site 118
Tg. Mures
Boehringer Ingelheim Investigational Site 119
Timișoara
Boehringer Ingelheim Investigational Site 120
Timișoara
Boehringer Ingelheim Investigational Site 121
Timișoara
Boehringer Ingelheim Investigational Site 122
Timișoara
Boehringer Ingelheim Investigational Site 123
Tulcea
Boehringer Ingelheim Investigational Site 124
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Slovakia55 sites

Boehringer Ingelheim Investigational Site 155
?adca
Boehringer Ingelheim Investigational Site 146
Banská Bystrica
Boehringer Ingelheim Investigational Site 147
Bardejov
Boehringer Ingelheim Investigational Site 148
Bratislava
Boehringer Ingelheim Investigational Site 149
Bratislava
Boehringer Ingelheim Investigational Site 150
Bratislava
Boehringer Ingelheim Investigational Site 151
Bratislava
Boehringer Ingelheim Investigational Site 152
Bratislava
Boehringer Ingelheim Investigational Site 153
Bratislava
Boehringer Ingelheim Investigational Site 154
Brezno
Boehringer Ingelheim Investigational Site 156
Humenné
Boehringer Ingelheim Investigational Site 157
Ilava
Boehringer Ingelheim Investigational Site 158
Komárno
Boehringer Ingelheim Investigational Site 159
Košice
Boehringer Ingelheim Investigational Site 160
Košice
Boehringer Ingelheim Investigational Site 161
Košice
Boehringer Ingelheim Investigational Site 162
Košice
Boehringer Ingelheim Investigational Site 163
Kosice- Saca
Boehringer Ingelheim Investigational Site 164
Krompachy
Boehringer Ingelheim Investigational Site 165
Levice
Boehringer Ingelheim Investigational Site 166
Liptovský Mikulás
Boehringer Ingelheim Investigational Site 167
Lučenec
Boehringer Ingelheim Investigational Site 168
Martin
Boehringer Ingelheim Investigational Site 169
Nitra
Boehringer Ingelheim Investigational Site 170
Nitra
Boehringer Ingelheim Investigational Site 171
Nitra
Boehringer Ingelheim Investigational Site 172
Nováky
Boehringer Ingelheim Investigational Site 173
Nové Mesto N/ Váhom
Boehringer Ingelheim Investigational Site 174
Pezinok
Boehringer Ingelheim Investigational Site 175
Pies?any
Boehringer Ingelheim Investigational Site 176
Povazská Bystrica
Boehringer Ingelheim Investigational Site 177
Prešov
Boehringer Ingelheim Investigational Site 178
Prešov
Boehringer Ingelheim Investigational Site 179
Prešov
Boehringer Ingelheim Investigational Site 180
Revúca
Boehringer Ingelheim Investigational Site 181
Rimavská Sobota
Boehringer Ingelheim Investigational Site 182
Rožňava
Boehringer Ingelheim Investigational Site 183
Rožňava
Boehringer Ingelheim Investigational Site 184
Šaľa
Boehringer Ingelheim Investigational Site 185
Sereď
Boehringer Ingelheim Investigational Site 186
Skalica
Boehringer Ingelheim Investigational Site 187
Stropkov
Boehringer Ingelheim Investigational Site 188
Šurany
Boehringer Ingelheim Investigational Site 189
Trebišov
Boehringer Ingelheim Investigational Site 190
Tren?in
Boehringer Ingelheim Investigational Site 191
Trnava
Boehringer Ingelheim Investigational Site 192
Trnava
Boehringer Ingelheim Investigational Site 193
Trstená
Boehringer Ingelheim Investigational Site 194
Veľké Kapušany
Boehringer Ingelheim Investigational Site 195
Ziar N/Hronom
Boehringer Ingelheim Investigational Site 196
Žilina
Boehringer Ingelheim Investigational Site 197
Žilina
Boehringer Ingelheim Investigational Site 198
Zlaté Moravce
Boehringer Ingelheim Investigational Site 199
Zvolen
Boehringer Ingelheim Investigational Site 200
Zvolen

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Liepāja
Boehringer Ingelheim Investigational Site 15
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Boehringer Ingelheim Investigational Site 10
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Boehringer Ingelheim Investigational Site 24
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Boehringer Ingelheim Investigational Site 138
Kruševac
Boehringer Ingelheim Investigational Site 141
Niš
Boehringer Ingelheim Investigational Site 142
Niš
Boehringer Ingelheim Investigational Site 137
Novi Sad
Boehringer Ingelheim Investigational Site 143
Sombor
Boehringer Ingelheim Investigational Site 145
Užice
Boehringer Ingelheim Investigational Site 139
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Boehringer Ingelheim Investigational Site 131
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Moscow
Boehringer Ingelheim Investigational Site 126
Moscow
Boehringer Ingelheim Investigational Site 127
Moscow
Boehringer Ingelheim Investigational Site 128
Novosibirsk
Boehringer Ingelheim Investigational Site 132
Saint Petersburg
Boehringer Ingelheim Investigational Site 133
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Boehringer Ingelheim Investigational Site 134
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Boehringer Ingelheim Investigational Site 129
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Boehringer Ingelheim Investigational Site 206
Celje
Boehringer Ingelheim Investigational Site 201
Ljubljana
Boehringer Ingelheim Investigational Site 202
Ljubljana
Boehringer Ingelheim Investigational Site 207
Maribor
Boehringer Ingelheim Investigational Site 208
Maribor
Boehringer Ingelheim Investigational Site 209
Maribor
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Boehringer Ingelheim Investigational Site 203
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Boehringer Ingelheim Investigational Site 214
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About this study

Conditions: Parkinson Disease
Medical subject headings: Parkinson Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01100073
Study group	Role	What they receive
Patients with Parkinson's disease		Early and advanced Parkinson's disease patients

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 II Score at the End of Maintenance
Change (reduction) in UPDRS Part II score (activities of daily living) from baseline to end of study. Score ranging from 0 - 52 (0=no disability, 52=maximum disability)
Measured: Week 0 to weeks 9-16 (Visit 3)
Change From Baseline in UPDRS Part III Score at the End of Maintenance
Change (reduction) in UPDRS Part III score (motor function) from baseline to end of study. Score ranging from 0 - 108 (0=no disability, 108=maximum disability)
Measured: Week 0 to weeks 9-16
Change From Baseline in Spiralometry Measurement at the End of Maintenance (Right Hand)
Change (reduction) in tremor amplitude from baseline to end of study for the right hand
Measured: Week 0 to weeks 9-16 (Visit 3)
Change From Baseline in Spiralometry Measurement at the End of Maintenance (Left Hand)
Change (reduction) in tremor amplitude from baseline to end of study for the left hand
Measured: Week 0 to weeks 9-16 (Visit 3)
Change From Baseline in Tremor Score From UPDRS (Items 16, 20, 21) at the End of Maintenance (Visit 3)
Change (reduction)in tremor score from baseline to end of study. Score ranging from 0 - 32 (0=no tremor, 32=high tremor)
Measured: Week 0 to weeks 9-16 (Visit 3)
Change From Baseline in 39 Item Parkinson's Disease Questionnaire (PDQ-39) Score at the End of Maintenance
Change (reduction) in PDQ-39 score (quality of life) from baseline to end of study. Score ranging from 0-100 (0=perfect health, 100=worst health as assessed by the measure)
Measured: Week 0 to weeks 9-16 (Visit 3)

Secondary outcomes (6)

Final Dose Distribution
Final Mirapexin® dose distribution at the end of study
Measured: Enter Week 0 to weeks 9-16 (Visit 3)
Change From Baseline in UPDRS Part II Score at the End of Up-titration
Change (reduction) in UPDRS Part II score (activities of daily living) from baseline to Visit 2. Score ranging from 0 - 52 (0=no disability, 52=maximum disability)
Measured: Enter Week 0 to weeks 1-8 (Visit 2)
Change From Baseline in UPDRS Part III Score at the End of Up-titration
Change (reduction) in UPDRS Part III score (motor function) from baseline to Visit 2. Score ranging from 0 - 108 (0=no disability, 108=maximum disability)
Measured: Enter Week 0 to weeks 1-8 (Visit 2)
Change in Tremor Score (UPDRS Items 16, 20, 21) at the End of Up-titration
Change (reduction) from baseline in tremor score, derived from UPDRS from baseline to Visit 2. Score ranging from 0 - 32 (0=no tremor, 32=high tremor)
Measured: Enter Week 0 to weeks 1-8 (Visit 2)
Incidence, Relationship and Seriousness of Adverse Events
Total number of adverse events (AEs), causality and level of seriousness
Measured: Week 0 to weeks 9-16 (end of study)
Number of Premature Discontinuations
Number of patients discontinuing the study prematurely
Measured: Week 0 to weeks 9-16 (end of study)

Timeline

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

Feb 2008Aug 2009

First posted8 Apr 2010 (estimated)
Study startFeb 2008
Primary completionAug 2009

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
Observational model: Cohort
Time perspective: Prospective
Enrolment: 1,703 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01100073
Sponsor's protocol ID: 248.657
Status last verified: Mar 2014
First submitted: 18 Mar 2010
Last updated: 11 Apr 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 11 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Kinetic Tremor in Parkinsons Disease: Its Course Under Pramipexole (Mirapexin®) Treatment and Impact on Quality of Life
ClinicalTrials.gov ID: NCT01100073
Acronym / sponsor ID: 248.657
Conditions: Parkinson Disease
Study type: Observational
Recruitment status: Completed
Enrolment: 1,703 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Feb 2008
Primary completion: Aug 2009 (actual)
First posted: 8 Apr 2010 (estimated)
Results: Posted 20 Sep 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

Observational model: Cohort
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Patients with Parkinson's disease	–	–Early and advanced Parkinson's disease patients

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: Neurologists

Key inclusion criteria (3 listed)

Idiopathic Parkinson's disease with or without fluctuations
Indication for treatment with pramipexole (Mirapexin®)
Presence of at least mild tremor symptoms (as judged by the treating physician)

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 (Mirapexin®)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part II Score at the End of Maintenance
Time frame: Week 0 to weeks 9-16 (Visit 3)
Change (reduction) in UPDRS Part II score (activities of daily living) from baseline to end of study. Score ranging from 0 - 52 (0=no disability, 52=maximum disability)
Change From Baseline in UPDRS Part III Score at the End of Maintenance
Time frame: Week 0 to weeks 9-16
Change (reduction) in UPDRS Part III score (motor function) from baseline to end of study. Score ranging from 0 - 108 (0=no disability, 108=maximum disability)
Change From Baseline in Spiralometry Measurement at the End of Maintenance (Right Hand)
Time frame: Week 0 to weeks 9-16 (Visit 3)
Change (reduction) in tremor amplitude from baseline to end of study for the right hand
Change From Baseline in Spiralometry Measurement at the End of Maintenance (Left Hand)
Time frame: Week 0 to weeks 9-16 (Visit 3)
Change (reduction) in tremor amplitude from baseline to end of study for the left hand
Change From Baseline in Tremor Score From UPDRS (Items 16, 20, 21) at the End of Maintenance (Visit 3)
Time frame: Week 0 to weeks 9-16 (Visit 3)
Change (reduction)in tremor score from baseline to end of study. Score ranging from 0 - 32 (0=no tremor, 32=high tremor)
Change From Baseline in 39 Item Parkinson's Disease Questionnaire (PDQ-39) Score at the End of Maintenance
Time frame: Week 0 to weeks 9-16 (Visit 3)
Change (reduction) in PDQ-39 score (quality of life) from baseline to end of study. Score ranging from 0-100 (0=perfect health, 100=worst health as assessed by the measure)

6 secondary outcomes

Final Dose Distribution
Time frame: Enter Week 0 to weeks 9-16 (Visit 3)
Change From Baseline in UPDRS Part II Score at the End of Up-titration
Time frame: Enter Week 0 to weeks 1-8 (Visit 2)
Change From Baseline in UPDRS Part III Score at the End of Up-titration
Time frame: Enter Week 0 to weeks 1-8 (Visit 2)
Change in Tremor Score (UPDRS Items 16, 20, 21) at the End of Up-titration
Time frame: Enter Week 0 to weeks 1-8 (Visit 2)
Incidence, Relationship and Seriousness of Adverse Events
Time frame: Week 0 to weeks 9-16 (end of study)
Number of Premature Discontinuations
Time frame: Week 0 to weeks 9-16 (end of study)

Results and safety

Results posted to the registry on 20 Sep 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
Mirapexin® (Pramipexole)	1,699	1,599

Primary outcome: Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Part II Score at the End of Maintenance

Time frame: Week 0 to weeks 9-16 (Visit 3). Mean (Standard Deviation). Unit: Points on UPDRS scale

Measure	Mirapexin® (Pramipexole) n = 1424
Value	5.20 (4.5)

Population analysed: Full analysis set (FAS) - Patients for whom baseline and end of study UPDRS Part II scores available

Primary outcome: Change From Baseline in UPDRS Part III Score at the End of Maintenance

Time frame: Week 0 to weeks 9-16. Mean (Standard Deviation). Unit: Points on UPDRS scale

Measure	Mirapexin® (Pramipexole) n = 1094
Value	12 (9.9)

Population analysed: Full analysis set (FAS) - Patients for whom baseline and end of study UPDRS Part III scores available

Primary outcome: Change From Baseline in Spiralometry Measurement at the End of Maintenance (Right Hand)

Time frame: Week 0 to weeks 9-16 (Visit 3). Mean (Standard Deviation). Unit: millimeters of tremor amplitude

Measure	Mirapexin® (Pramipexole) n = 949
Value	0.3 (1.6)

Population analysed: Full analysis set (FAS) - Patients for whom baseline and end of study spiralometry measurement (right hand) available

Primary outcome: Change From Baseline in Spiralometry Measurement at the End of Maintenance (Left Hand)

Time frame: Week 0 to weeks 9-16 (Visit 3). Mean (Standard Deviation). Unit: millimeters of tremor amplitude

Measure	Mirapexin® (Pramipexole) n = 962
Value	0.2 (1.7)

Population analysed: Full analysis set (FAS) - Patients for whom baseline and end of study spiralometry measurement (left hand) available

6 secondary outcomes are reported in the full results.

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
Mirapexin® (Pramipexole)	3 of 1,699 (0.2%)	0 of 1,699 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related InfoLink provided by the sponsor.
Related InfoLink provided by the sponsor.

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Clinical Safety and Efficacy of Umbilical Cord Mesenchymal Stromal Cells-derived Exosomes in Patients With Parkinson's Disease
Parkinson Disease (PD)
Active, not recruitingObservational study
Adaptive DBS to Offset STN Dysregulation During Exercise in PD
Parkinson Disease

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

215 sites in 8 countries: 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 215 sites in 8 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 3 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 11 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 215 sites in Romania, Slovakia, Latvia, Serbia, Russia and 3 more countries. 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 20 Sep 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 II Score at the End of Maintenance (time frame: Week 0 to weeks 9-16 (Visit 3)). The study lists 6 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 NCT01100073.

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 11 Apr 2014.