Assessment of the Safety and Efficacy of Pramipexole Extended Release in Patients With Parkinson's Disease in Routine Clinical Practice

An observational study of Parkinson's Disease, run by Boehringer Ingelheim at 284 sites in 7 countries.

Completed

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

Trial summary

The general aim of this non-interventional study is to assess the safety and efficacy of pramipexole extended release in patients with Parkinson's disease in routine clinical practice. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Parkinson's Disease
How many people: 1,814 participants
Where: 284 sitesin 7 countries
Study dates: Nov 2009to Jun 2013
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: Patients

Who may be able to join

Early and advanced idiopathic Parkinson's disease
Male and female patients over 18 years of age
Indication for treatment with pramipexole ER according to Summary of Product Characteristics (SmPC)

Who cannot join

Ongoing treatment with pramipexole ER
In particular hypersensitivity to pramipexole or to any of the excipients and pregnancy and lactation as stated in the SmPC.

Trial locations and contacts

284 sites in 7 countries.

Country

City, postcode or hospital

284 sites in 7 countries

Austria111 sites

Boehringer Ingelheim Investigational Site 1
Bad Ischl
Boehringer Ingelheim Investigational Site 2
Bad Radkersburg
Boehringer Ingelheim Investigational Site 3
Baden
Boehringer Ingelheim Investigational Site 4
Baden
Boehringer Ingelheim Investigational Site 5
Bludenz
Boehringer Ingelheim Investigational Site 6
Braunau/Inn
Boehringer Ingelheim Investigational Site 7
Deutschlandsberg
Boehringer Ingelheim Investigational Site 8
Dornbirn
Boehringer Ingelheim Investigational Site 9
Dornbirn
Boehringer Ingelheim Investigational Site 10
Ehenbichl
Boehringer Ingelheim Investigational Site 11
Eisenstadt
Boehringer Ingelheim Investigational Site 12
Eisenstadt
Boehringer Ingelheim Investigational Site 13
Feldbach
Boehringer Ingelheim Investigational Site 14
Feldkirchen in Kärnten
Boehringer Ingelheim Investigational Site 15
Gänserndorf
Boehringer Ingelheim Investigational Site 16
Graz
Boehringer Ingelheim Investigational Site 17
Graz
Boehringer Ingelheim Investigational Site 18
Graz
Boehringer Ingelheim Investigational Site 19
Graz
Boehringer Ingelheim Investigational Site 20
Grieskirchen
Boehringer Ingelheim Investigational Site 21
Grimmenstein
Boehringer Ingelheim Investigational Site 22
Hainburg an der Donau
Boehringer Ingelheim Investigational Site 23
Hall/Tirol
Boehringer Ingelheim Investigational Site 24
Hallein
Boehringer Ingelheim Investigational Site 25
Hartberg
Boehringer Ingelheim Investigational Site 26
Hermagor
Boehringer Ingelheim Investigational Site 27
Hohenems
Boehringer Ingelheim Investigational Site 28
Horn
Boehringer Ingelheim Investigational Site 29
Horn
Boehringer Ingelheim Investigational Site 30
Imst
Boehringer Ingelheim Investigational Site 31
Innsbruck
Boehringer Ingelheim Investigational Site 32
Innsbruck
Boehringer Ingelheim Investigational Site 33
Innsbruck
Boehringer Ingelheim Investigational Site 34
Judenburg
Boehringer Ingelheim Investigational Site 35
Kapfenberg
Boehringer Ingelheim Investigational Site 36
Klagenfurt
Boehringer Ingelheim Investigational Site 37
Klagenfurt
Boehringer Ingelheim Investigational Site 38
Klagenfurt
Boehringer Ingelheim Investigational Site 39
Klagenfurt
Boehringer Ingelheim Investigational Site 40
Knittelfeld
Boehringer Ingelheim Investigational Site 41
Krems
Boehringer Ingelheim Investigational Site 42
Kufstein
Boehringer Ingelheim Investigational Site 43
Lassnitzhöhe
Boehringer Ingelheim Investigational Site 44
Leibnitz, Styria
Boehringer Ingelheim Investigational Site 45
Leoben
Boehringer Ingelheim Investigational Site 46
Lienz
Boehringer Ingelheim Investigational Site 47
Lienz
Boehringer Ingelheim Investigational Site 48
Lilienfeld
Boehringer Ingelheim Investigational Site 49
Linz
Boehringer Ingelheim Investigational Site 50
Linz
Boehringer Ingelheim Investigational Site 51
Melk
Boehringer Ingelheim Investigational Site 52
Mürzzuschlag
Boehringer Ingelheim Investigational Site 53
Neulengbach
Boehringer Ingelheim Investigational Site 54
Neulengbach
Boehringer Ingelheim Investigational Site 55
Neunkirchen
Boehringer Ingelheim Investigational Site 56
Neunkirchen
Boehringer Ingelheim Investigational Site 57
Neusiedl am See
Boehringer Ingelheim Investigational Site 58
Oberwart
Boehringer Ingelheim Investigational Site 59
Oberwart
Boehringer Ingelheim Investigational Site 60
Oberwart
Boehringer Ingelheim Investigational Site 61
Regelsbrunn
Boehringer Ingelheim Investigational Site 62
Ried im Innkreis
Boehringer Ingelheim Investigational Site 63
Ried im Innkreis
Boehringer Ingelheim Investigational Site 64
Rohrbach
Boehringer Ingelheim Investigational Site 65
Salzburg
Boehringer Ingelheim Investigational Site 66
Salzburg
Boehringer Ingelheim Investigational Site 67
Salzburg
Boehringer Ingelheim Investigational Site 68
Salzburg
Boehringer Ingelheim Investigational Site 71
Sankt Pölten
Boehringer Ingelheim Investigational Site 72
Sankt Pölten
Boehringer Ingelheim Investigational Site 73
Sankt Veit an der Glan
Boehringer Ingelheim Investigational Site 69
Scheibbs
Boehringer Ingelheim Investigational Site 70
St Johann im Pongau
Boehringer Ingelheim Investigational Site 74
Telfs
Boehringer Ingelheim Investigational Site 75
Tulln
Boehringer Ingelheim Investigational Site 76
Tullnerbach-Lawies
Boehringer Ingelheim Investigational Site 100
Vienna
Boehringer Ingelheim Investigational Site 101
Vienna
Boehringer Ingelheim Investigational Site 102
Vienna
Boehringer Ingelheim Investigational Site 103
Vienna
Boehringer Ingelheim Investigational Site 104
Vienna
Boehringer Ingelheim Investigational Site 105
Vienna
Boehringer Ingelheim Investigational Site 106
Vienna
Boehringer Ingelheim Investigational Site 107
Vienna
Boehringer Ingelheim Investigational Site 84
Vienna
Boehringer Ingelheim Investigational Site 85
Vienna
Boehringer Ingelheim Investigational Site 86
Vienna
Boehringer Ingelheim Investigational Site 87
Vienna
Boehringer Ingelheim Investigational Site 88
Vienna
Boehringer Ingelheim Investigational Site 89
Vienna
Boehringer Ingelheim Investigational Site 90
Vienna
Boehringer Ingelheim Investigational Site 91
Vienna
Boehringer Ingelheim Investigational Site 92
Vienna
Boehringer Ingelheim Investigational Site 93
Vienna
Boehringer Ingelheim Investigational Site 94
Vienna
Boehringer Ingelheim Investigational Site 95
Vienna
Boehringer Ingelheim Investigational Site 96
Vienna
Boehringer Ingelheim Investigational Site 97
Vienna
Boehringer Ingelheim Investigational Site 98
Vienna
Boehringer Ingelheim Investigational Site 99
Vienna
Boehringer Ingelheim Investigational Site 77
Villach
Boehringer Ingelheim Investigational Site 78
Villach
Boehringer Ingelheim Investigational Site 79
Villach-Warmbad
Boehringer Ingelheim Investigational Site 80
Vöcklabruck
Boehringer Ingelheim Investigational Site 81
Vöcklabruck
Boehringer Ingelheim Investigational Site 82
Völkermarkt
Boehringer Ingelheim Investigational Site 83
Wagna
Boehringer Ingelheim Investigational Site 108
Wiener Neustadt
Boehringer Ingelheim Investigational Site 109
Wolfsberg
Boehringer Ingelheim Investigational Site 110
Zirl
Boehringer Ingelheim Investigational Site 111
Zwettl Stadt

Other trials in Austria

Romania82 sites

Boehringer Ingelheim Investigational Site 193
Alba Iulia
Boehringer Ingelheim Investigational Site 194
Bacau
Boehringer Ingelheim Investigational Site 195
Bacau
Boehringer Ingelheim Investigational Site 196
Bacau
Boehringer Ingelheim Investigational Site 197
Baia Mare
Boehringer Ingelheim Investigational Site 198
Baia Mare
Boehringer Ingelheim Investigational Site 199
Botoșani
Boehringer Ingelheim Investigational Site 200
Brasov
Boehringer Ingelheim Investigational Site 201
Brasov
Boehringer Ingelheim Investigational Site 202
Bucharest
Boehringer Ingelheim Investigational Site 203
Bucharest
Boehringer Ingelheim Investigational Site 204
Bucharest
Boehringer Ingelheim Investigational Site 205
Bucharest
Boehringer Ingelheim Investigational Site 206
Bucharest
Boehringer Ingelheim Investigational Site 207
Bucharest
Boehringer Ingelheim Investigational Site 208
Bucharest
Boehringer Ingelheim Investigational Site 209
Bucharest
Boehringer Ingelheim Investigational Site 210
Bucharest
Boehringer Ingelheim Investigational Site 211
Bucharest
Boehringer Ingelheim Investigational Site 212
Bucharest
Boehringer Ingelheim Investigational Site 213
Bucharest
Boehringer Ingelheim Investigational Site 214
Bucharest
Boehringer Ingelheim Investigational Site 215
Bucharest
Boehringer Ingelheim Investigational Site 216
Bucharest
Boehringer Ingelheim Investigational Site 217
Bucharest
Boehringer Ingelheim Investigational Site 218
Bucharest
Boehringer Ingelheim Investigational Site 219
Bucharest
Boehringer Ingelheim Investigational Site 220
Buzău
Boehringer Ingelheim Investigational Site 221
Buzău
Boehringer Ingelheim Investigational Site 222
Campulung Muscel
Boehringer Ingelheim Investigational Site 223
Cluj-Napoca
Boehringer Ingelheim Investigational Site 224
Cluj-Napoca
Boehringer Ingelheim Investigational Site 225
Constanța
Boehringer Ingelheim Investigational Site 226
Constanța
Boehringer Ingelheim Investigational Site 227
Constanța
Boehringer Ingelheim Investigational Site 228
Craiova
Boehringer Ingelheim Investigational Site 229
Craiova
Boehringer Ingelheim Investigational Site 230
Craiova
Boehringer Ingelheim Investigational Site 231
Craiova
Boehringer Ingelheim Investigational Site 232
Craiova
Boehringer Ingelheim Investigational Site 233
Curtea de Argeş
Boehringer Ingelheim Investigational Site 234
Focşani
Boehringer Ingelheim Investigational Site 235
Focşani
Boehringer Ingelheim Investigational Site 236
Galati
Boehringer Ingelheim Investigational Site 237
Iași
Boehringer Ingelheim Investigational Site 238
Iași
Boehringer Ingelheim Investigational Site 239
Iași
Boehringer Ingelheim Investigational Site 240
Medgidia
Boehringer Ingelheim Investigational Site 241
Oradea
Boehringer Ingelheim Investigational Site 242
Oradea
Boehringer Ingelheim Investigational Site 243
Piatra Neamţ
Boehringer Ingelheim Investigational Site 244
Piatra Neamţ
Boehringer Ingelheim Investigational Site 245
Piteşti
Boehringer Ingelheim Investigational Site 246
Piteşti
Boehringer Ingelheim Investigational Site 247
Ploieşti
Boehringer Ingelheim Investigational Site 248
Prahova
Boehringer Ingelheim Investigational Site 249
Radauti
Boehringer Ingelheim Investigational Site 250
Râmnicu Vâlcea
Boehringer Ingelheim Investigational Site 251
Râmnicu Vâlcea
Boehringer Ingelheim Investigational Site 252
Râmnicu Vâlcea
Boehringer Ingelheim Investigational Site 253
Satu Mare
Boehringer Ingelheim Investigational Site 254
Satu Mare
Boehringer Ingelheim Investigational Site 255
Sibiu
Boehringer Ingelheim Investigational Site 256
Sibiu
Boehringer Ingelheim Investigational Site 257
Simleul Silvaniei
Boehringer Ingelheim Investigational Site 258
Slobozia
Boehringer Ingelheim Investigational Site 259
Suceava
Boehringer Ingelheim Investigational Site 260
Targoviste
Boehringer Ingelheim Investigational Site 261
Targoviste
Boehringer Ingelheim Investigational Site 262
Târgu Mureş
Boehringer Ingelheim Investigational Site 263
Târnăveni
Boehringer Ingelheim Investigational Site 264
Târnăveni
Boehringer Ingelheim Investigational Site 265
Timișoara
Boehringer Ingelheim Investigational Site 266
Timișoara
Boehringer Ingelheim Investigational Site 267
Timișoara
Boehringer Ingelheim Investigational Site 268
Timișoara
Boehringer Ingelheim Investigational Site 269
Tulcea
Boehringer Ingelheim Investigational Site 270
Tulcea
Boehringer Ingelheim Investigational Site 271
Tulcea
Boehringer Ingelheim Investigational Site 272
Turda
Boehringer Ingelheim Investigational Site 273
Turnu Măgurele
Boehringer Ingelheim Investigational Site 274
Zalău

Other trials in Romania

Slovakia61 sites

Boehringer Ingelheim Investigational Site 122
Banská Bystrica
Boehringer Ingelheim Investigational Site 123
Bardejov
Boehringer Ingelheim Investigational Site 124
Bardejov
Boehringer Ingelheim Investigational Site 125
Bratislava
Boehringer Ingelheim Investigational Site 126
Bratislava
Boehringer Ingelheim Investigational Site 127
Bratislava
Boehringer Ingelheim Investigational Site 128
Bratislava
Boehringer Ingelheim Investigational Site 129
Bratislava
Boehringer Ingelheim Investigational Site 130
Bratislava
Boehringer Ingelheim Investigational Site 131
Bratislava
Boehringer Ingelheim Investigational Site 132
Bratislava
Boehringer Ingelheim Investigational Site 133
Brezno
Boehringer Ingelheim Investigational Site 134
Detva
Boehringer Ingelheim Investigational Site 135
Dolný Kubín
Boehringer Ingelheim Investigational Site 136
Dolný Kubín
Boehringer Ingelheim Investigational Site 137
Hlohovec
Boehringer Ingelheim Investigational Site 138
Hlohovec
Boehringer Ingelheim Investigational Site 139
Humenné
Boehringer Ingelheim Investigational Site 140
Kežmarok
Boehringer Ingelheim Investigational Site 141
Kežmarok
Boehringer Ingelheim Investigational Site 142
Komárno
Boehringer Ingelheim Investigational Site 143
Košice
Boehringer Ingelheim Investigational Site 144
Košice
Boehringer Ingelheim Investigational Site 145
Košice
Boehringer Ingelheim Investigational Site 146
Košice
Boehringer Ingelheim Investigational Site 147
Košice
Boehringer Ingelheim Investigational Site 148
Krompachy
Boehringer Ingelheim Investigational Site 149
Liptovský Mikulás
Boehringer Ingelheim Investigational Site 150
Lučenec
Boehringer Ingelheim Investigational Site 151
Lučenec
Boehringer Ingelheim Investigational Site 152
Lučenec
Boehringer Ingelheim Investigational Site 153
Martin
Boehringer Ingelheim Investigational Site 154
Martin
Boehringer Ingelheim Investigational Site 155
Myjava
Boehringer Ingelheim Investigational Site 156
Námestovo
Boehringer Ingelheim Investigational Site 157
Nitra
Boehringer Ingelheim Investigational Site 158
Nitra
Boehringer Ingelheim Investigational Site 159
Nitra
Boehringer Ingelheim Investigational Site 160
Nitra
Boehringer Ingelheim Investigational Site 161
Pezinok
Boehringer Ingelheim Investigational Site 162
Piešťany
Boehringer Ingelheim Investigational Site 163
Prešov
Boehringer Ingelheim Investigational Site 164
Prešov
Boehringer Ingelheim Investigational Site 165
Prešov
Boehringer Ingelheim Investigational Site 166
Prešov
Boehringer Ingelheim Investigational Site 167
Šahy
Boehringer Ingelheim Investigational Site 168
Šaľa
Boehringer Ingelheim Investigational Site 169
Skalica
Boehringer Ingelheim Investigational Site 170
Stará Lubovna
Boehringer Ingelheim Investigational Site 171
Šurany
Boehringer Ingelheim Investigational Site 172
Topoľčany
Boehringer Ingelheim Investigational Site 173
Trebišov
Boehringer Ingelheim Investigational Site 174
Trencín
Boehringer Ingelheim Investigational Site 175
Trnava
Boehringer Ingelheim Investigational Site 176
Trnava
Boehringer Ingelheim Investigational Site 177
Trstená
Boehringer Ingelheim Investigational Site 178
Vranov Nad Top?ou
Boehringer Ingelheim Investigational Site 179
Žiar nad Hronom
Boehringer Ingelheim Investigational Site 180
Žilina
Boehringer Ingelheim Investigational Site 182
Zlaté Moravce
Boehringer Ingelheim Investigational Site 181
Zvolen

Other trials in Slovakia

Estonia10 sites

Boehringer Ingelheim Investigational Site 115
Järvamaa
Boehringer Ingelheim Investigational Site 114
Kohtla-Järve
Boehringer Ingelheim Investigational Site 121
Kuressaare
Boehringer Ingelheim Investigational Site 116
Rakvere
Boehringer Ingelheim Investigational Site 112
Tallinn
Boehringer Ingelheim Investigational Site 113
Tallinn
Boehringer Ingelheim Investigational Site 117
Tartu
Boehringer Ingelheim Investigational Site 118
Valga
Boehringer Ingelheim Investigational Site 119
Viimsi
Boehringer Ingelheim Investigational Site 120
Viljandi

Other trials in Estonia

Slovenia10 sites

Boehringer Ingelheim Investigational Site 183
Celje
Boehringer Ingelheim Investigational Site 184
Lesce
Boehringer Ingelheim Investigational Site 185
Ljubljana
Boehringer Ingelheim Investigational Site 186
Ljubljana
Boehringer Ingelheim Investigational Site 187
Maribor
Boehringer Ingelheim Investigational Site 188
Maribor
Boehringer Ingelheim Investigational Site 190
Sempeter
Boehringer Ingelheim Investigational Site 191
Sempeter
Boehringer Ingelheim Investigational Site 189
Slovenj Gradec
Boehringer Ingelheim Investigational Site 192
Velenje

Other trials in Slovenia

Serbia7 sites

Boehringer Ingelheim Investigational Site 275
Belgrade
Boehringer Ingelheim Investigational Site 276
Belgrade
Boehringer Ingelheim Investigational Site 278
Kragujevac
Boehringer Ingelheim Investigational Site 281
Kraljevo
Boehringer Ingelheim Investigational Site 279
Niš
Boehringer Ingelheim Investigational Site 277
Novi Sad
Boehringer Ingelheim Investigational Site 280
Užice

Other trials in Serbia

Kazakhstan3 sites

Boehringer Ingelheim Investigational Site 283
Almaty
Boehringer Ingelheim Investigational Site 284
Astana
Boehringer Ingelheim Investigational Site 282
Shymkent

Other trials in Kazakhstan

About this study

The general aim of this non-interventional study is to assess the safety and efficacy of pramipexole extended release in patients with Parkinson's disease in routine clinical practice.

Conditions: Parkinson's 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 NCT01061567
Study group	Role	What they receive
Male and female patients with Parkinson's disease		Not described

What is being measured

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

Incidence of Adverse Events
The number of patients with any adverse events (AEs), patients with drug-related AEs.
Measured: From the treatment initiation to the end of study, on average 92.9 days
Proportion of Patients With Withdrawals Due to Adverse Events.
Patients who discontinued treatment due to adverse events including deaths.
Measured: 16 weeks

Secondary outcomes (4)

Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Parts I and III Total Score
Mentation, behaviour and mood is scored from 0-16 in UPDRS I (0 = best score to 16 = worst score), result of motor examination scored from 0-108 in UPDRS III (0=no disability, 108=maximum disability) . The change was calculated by Baseline value minus value at visit 3. A decrease (change>0) in the score means improvement.
Measured: Baseline and the end of study (up to 16 weeks)
Clinical Global Impression of Improvement (CGI-I) Responder Rate
The CGI-I was rated (from 1: very much improved, to 7: very much worse) to assess the overall status of Parkinson's disease. The clinician rated how much a patient's condition had improved or worsened relative to baseline state. The patients are considered to be a CGI-I responder if they are rated at least by minimally improved.
Measured: Baseline and the end of study (up to 16 weeks)
Change From Baseline in Visual Analogue Scale (VAS) of Patient Satisfaction
The visual analogue scale measures overall patient satisfaction with treatment on a continuous axis ranging from 0 (no satisfaction) to 100 (highest patient satisfaction). The change was calculated by the value at the final visit minus the value at baseline. Therefore, an increase (change>0) reflects an improvement in patient satisfaction.
Measured: Baseline and the end of study (up to 16 weeks)
Change From Baseline in Morisky Medication Adherence Scale (MMAS) 4 Item Score
The Morisky Medication Adherence Scale with 4 items was administered to examine medication adherence. The score ranges from 0 (best adherence) to 4 (worst adherence). The change was calculated by the value at baseline minus the value at visit 3. Therefore, a change >0 reflects an improvement
Measured: Baseline and the end of study (up to 16 weeks)

Timeline

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

Nov 2009Jun 2013

First posted3 Feb 2010 (estimated)
Study startNov 2009
Primary completionJun 2013
Study completionJun 2013

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's 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: 1,814 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01061567
Sponsor's protocol ID: 248.675
Status last verified: Jun 2014
First submitted: 24 Dec 2009
Last updated: 8 Jul 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

Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
Active, not recruitingPhase 1/2
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
Not yet recruiting
Compulsive Eating and Brain's Reward System in Different Pathologies
PARKINSON DISEASE (Disorder), Bipolar 1 Disorder
Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)

All Parkinson's Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Assessment of the Safety and Efficacy of Pramipexole Extended Release in Patients With Parkinson's Disease in Routine Clinical Practice
ClinicalTrials.gov ID: NCT01061567
Acronym / sponsor ID: 248.675
Conditions: Parkinson's Disease
Study type: Observational
Recruitment status: Completed
Enrolment: 1,814 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Nov 2009
Primary completion: Jun 2013 (actual)
Study completion: Jun 2013 (actual)
First posted: 3 Feb 2010 (estimated)
Results: Posted 8 Jul 2014

Clinical summary

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

The general aim of this non-interventional study is to assess the safety and efficacy of pramipexole extended release in patients with Parkinson's disease in routine clinical practice.

Study design

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

Arm	Type	Receives
Male and female patients with Parkinson's disease	–	–

Who may qualify

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

Key inclusion criteria (3 listed)

Early and advanced idiopathic Parkinson's disease
Male and female patients over 18 years of age
Indication for treatment with pramipexole ER according to Summary of Product Characteristics (SmPC)

Key exclusion criteria (2 listed)

Ongoing treatment with pramipexole ER
In particular hypersensitivity to pramipexole or to any of the excipients and pregnancy and lactation as stated in the SmPC.

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

Incidence of Adverse Events
Time frame: From the treatment initiation to the end of study, on average 92.9 days
The number of patients with any adverse events (AEs), patients with drug-related AEs.
Proportion of Patients With Withdrawals Due to Adverse Events.
Time frame: 16 weeks
Patients who discontinued treatment due to adverse events including deaths.

4 secondary outcomes

Change From Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Parts I and III Total Score
Time frame: Baseline and the end of study (up to 16 weeks)
Clinical Global Impression of Improvement (CGI-I) Responder Rate
Time frame: Baseline and the end of study (up to 16 weeks)
Change From Baseline in Visual Analogue Scale (VAS) of Patient Satisfaction
Time frame: Baseline and the end of study (up to 16 weeks)
Change From Baseline in Morisky Medication Adherence Scale (MMAS) 4 Item Score
Time frame: Baseline and the end of study (up to 16 weeks)

Results and safety

Results posted to the registry on 8 Jul 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
All Patients	1,814	1,738

Primary outcome: Incidence of Adverse Events

Time frame: From the treatment initiation to the end of study, on average 92.9 days. Number. Unit: participants

Measure	All Patients n = 1814
Patients with any AE	105
Patients with drug-related AEs	56

Population analysed: Patients from the Treated Set (TS).

Primary outcome: Proportion of Patients With Withdrawals Due to Adverse Events.

Time frame: 16 weeks. Number. Unit: proportion of participants

Measure	All Patients n = 1814
Value	0.019

Population analysed: Patients from the Treated Set (TS).

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: From the treatment initiation to the end of study, on average 92.9 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
All Patients	4 of 1,814 (0.2%)	0 of 1,814 (0%)	Not reported

Limitations and caveats (from the sponsor): There was no PI assigned for the overall study.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Parkinson's Disease

Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
Active, not recruitingPhase 1/2
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
Not yet recruiting
Compulsive Eating and Brain's Reward System in Different Pathologies
PARKINSON DISEASE (Disorder), Bipolar 1 Disorder
Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)

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

284 sites in 7 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Parkinson's Disease, run by Boehringer Ingelheim at 284 sites in 7 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 8 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 284 sites in Austria, Romania, Slovakia, Estonia, Slovenia and 2 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 8 Jul 2014). 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?

Incidence of Adverse Events (time frame: From the treatment initiation to the end of study, on average 92.9 days). The study lists 2 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 NCT01061567.

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 8 Jul 2014.