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

March 14, 2014 updated by: Boehringer Ingelheim
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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

1703

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Estonia
      • Keila, Estonia
        • Boehringer Ingelheim Investigational Site 5
      • Kohtla-Järve, Estonia
        • Boehringer Ingelheim Investigational Site 4
      • Rakvere, Estonia
        • Boehringer Ingelheim Investigational Site 6
      • Tallinn, Estonia
        • Boehringer Ingelheim Investigational Site 1
      • Tallinn, Estonia
        • Boehringer Ingelheim Investigational Site 2
      • Tallinn, Estonia
        • Boehringer Ingelheim Investigational Site 3
      • Tartu, Estonia
        • Boehringer Ingelheim Investigational Site 7
      • Valga, Estonia
        • Boehringer Ingelheim Investigational Site 8
  • Latvia
      • Kuldiga, Latvia
        • Boehringer Ingelheim Investigational Site 9
      • Liepaja, Latvia
        • Boehringer Ingelheim Investigational Site 12
      • Liepaja, Latvia
        • Boehringer Ingelheim Investigational Site 13
      • Liepaja, Latvia
        • Boehringer Ingelheim Investigational Site 14
      • Liepaja, Latvia
        • Boehringer Ingelheim Investigational Site 15
      • Limbazi, Latvia
        • Boehringer Ingelheim Investigational Site 10
      • Limbazi, Latvia
        • Boehringer Ingelheim Investigational Site 11
      • Riga, Latvia
        • Boehringer Ingelheim Investigational Site 16
      • Riga, Latvia
        • Boehringer Ingelheim Investigational Site 17
      • Riga, Latvia
        • Boehringer Ingelheim Investigational Site 18
      • Riga, Latvia
        • Boehringer Ingelheim Investigational Site 19
      • Riga, Latvia
        • Boehringer Ingelheim Investigational Site 20
      • Riga, Latvia
        • Boehringer Ingelheim Investigational Site 21
      • Riga, Latvia
        • Boehringer Ingelheim Investigational Site 22
      • Riga, Latvia
        • Boehringer Ingelheim Investigational Site 23
      • Riga, Latvia
        • Boehringer Ingelheim Investigational Site 24
      • Riga, Latvia
        • Boehringer Ingelheim Investigational Site 25
      • Riga, Latvia
        • Boehringer Ingelheim Investigational Site 26
      • Riga, Latvia
        • Boehringer Ingelheim Investigational Site 27
      • Riga, Latvia
        • Boehringer Ingelheim Investigational Site 28
      • Riga, Latvia
        • Boehringer Ingelheim Investigational Site 29
      • Riga, Latvia
        • Boehringer Ingelheim Investigational Site 30
      • Riga, Latvia
        • Boehringer Ingelheim Investigational Site 31
  • Romania
      • Aiud, Romania
        • Boehringer Ingelheim Investigational Site 32
      • Arges, Romania
        • Boehringer Ingelheim Investigational Site 33
      • Arges, Romania
        • Boehringer Ingelheim Investigational Site 34
      • Arges, Romania
        • Boehringer Ingelheim Investigational Site 35
      • Arges, Romania
        • Boehringer Ingelheim Investigational Site 36
      • Arges, Romania
        • Boehringer Ingelheim Investigational Site 37
      • Arges, Romania
        • Boehringer Ingelheim Investigational Site 38
      • Arges, Romania
        • Boehringer Ingelheim Investigational Site 39
      • Bacau, Romania
        • Boehringer Ingelheim Investigational Site 40
      • Bacau, Romania
        • Boehringer Ingelheim Investigational Site 41
      • Bistrita, Romania
        • Boehringer Ingelheim Investigational Site 42
      • Botosani, Romania
        • Boehringer Ingelheim Investigational Site 43
      • Botosani, Romania
        • Boehringer Ingelheim Investigational Site 44
      • Braila, Romania
        • Boehringer Ingelheim Investigational Site 45
      • Braila, Romania
        • Boehringer Ingelheim Investigational Site 46
      • Brasov, Romania
        • Boehringer Ingelheim Investigational Site 47
      • Brasov, Romania
        • Boehringer Ingelheim Investigational Site 48
      • Bucuresti, Romania
        • Boehringer Ingelheim Investigational Site 49
      • Bucuresti, Romania
        • Boehringer Ingelheim Investigational Site 50
      • Bucuresti, Romania
        • Boehringer Ingelheim Investigational Site 51
      • Bucuresti, Romania
        • Boehringer Ingelheim Investigational Site 52
      • Bucuresti, Romania
        • Boehringer Ingelheim Investigational Site 53
      • Bucuresti, Romania
        • Boehringer Ingelheim Investigational Site 54
      • Bucuresti, Romania
        • Boehringer Ingelheim Investigational Site 55
      • Bucuresti, Romania
        • Boehringer Ingelheim Investigational Site 56
      • Bucuresti, Romania
        • Boehringer Ingelheim Investigational Site 57
      • Bucuresti, Romania
        • Boehringer Ingelheim Investigational Site 58
      • Bucuresti, Romania
        • Boehringer Ingelheim Investigational Site 59
      • Bucuresti, Romania
        • Boehringer Ingelheim Investigational Site 60
      • Bucuresti, Romania
        • Boehringer Ingelheim Investigational Site 61
      • Bucuresti, Romania
        • Boehringer Ingelheim Investigational Site 62
      • Bucuresti, Romania
        • Boehringer Ingelheim Investigational Site 63
      • Bucuresti, Romania
        • Boehringer Ingelheim Investigational Site 64
      • Bucuresti, Romania
        • Boehringer Ingelheim Investigational Site 65
      • Bucuresti, Romania
        • Boehringer Ingelheim Investigational Site 66
      • Bucuresti, Romania
        • Boehringer Ingelheim Investigational Site 67
      • Bucuresti, Romania
        • Boehringer Ingelheim Investigational Site 68
      • Bucuresti, Romania
        • Boehringer Ingelheim Investigational Site 69
      • Bucuresti, Romania
        • Boehringer Ingelheim Investigational Site 70
      • Bucuresti, Romania
        • Boehringer Ingelheim Investigational Site 71
      • Buzau, Romania
        • Boehringer Ingelheim Investigational Site 72
      • Buzau, Romania
        • Boehringer Ingelheim Investigational Site 73
      • Caracal, Romania
        • Boehringer Ingelheim Investigational Site 74
      • Cluj, Romania
        • Boehringer Ingelheim Investigational Site 75
      • Cluj, Romania
        • Boehringer Ingelheim Investigational Site 76
      • Cluj, Romania
        • Boehringer Ingelheim Investigational Site 77
      • Cluj, Romania
        • Boehringer Ingelheim Investigational Site 78
      • Cluj, Romania
        • Boehringer Ingelheim Investigational Site 79
      • Cluj, Romania
        • Boehringer Ingelheim Investigational Site 80
      • Constanta, Romania
        • Boehringer Ingelheim Investigational Site 81
      • Constanta, Romania
        • Boehringer Ingelheim Investigational Site 82
      • Craiova, Romania
        • Boehringer Ingelheim Investigational Site 83
      • Craiova, Romania
        • Boehringer Ingelheim Investigational Site 84
      • Craiova, Romania
        • Boehringer Ingelheim Investigational Site 85
      • Craiova, Romania
        • Boehringer Ingelheim Investigational Site 86
      • Deva, Romania
        • Boehringer Ingelheim Investigational Site 87
      • Deva, Romania
        • Boehringer Ingelheim Investigational Site 88
      • Focsani, Romania
        • Boehringer Ingelheim Investigational Site 89
      • Focsani, Romania
        • Boehringer Ingelheim Investigational Site 90
      • Galati, Romania
        • Boehringer Ingelheim Investigational Site 91
      • Galati, Romania
        • Boehringer Ingelheim Investigational Site 92
      • Hunedoara, Romania
        • Boehringer Ingelheim Investigational Site 93
      • Hunedoara, Romania
        • Boehringer Ingelheim Investigational Site 94
      • Iasi, Romania
        • Boehringer Ingelheim Investigational Site 95
      • Iasi, Romania
        • Boehringer Ingelheim Investigational Site 96
      • Iasi, Romania
        • Boehringer Ingelheim Investigational Site 97
      • Iasi, Romania
        • Boehringer Ingelheim Investigational Site 98
      • Lugoj, Romania
        • Boehringer Ingelheim Investigational Site 99
      • Maramures, Romania
        • Boehringer Ingelheim Investigational Site 100
      • Orastie, Romania
        • Boehringer Ingelheim Investigational Site 101
      • Pascani, Romania
        • Boehringer Ingelheim Investigational Site 102
      • Pascani, Romania
        • Boehringer Ingelheim Investigational Site 103
      • Petrosani, Romania
        • Boehringer Ingelheim Investigational Site 104
      • Piatra Neamt, Romania
        • Boehringer Ingelheim Investigational Site 105
      • Prahova, Romania
        • Boehringer Ingelheim Investigational Site 106
      • Prahova, Romania
        • Boehringer Ingelheim Investigational Site 107
      • Prahova, Romania
        • Boehringer Ingelheim Investigational Site 108
      • Radauti, Romania
        • Boehringer Ingelheim Investigational Site 109
      • Resita, Romania
        • Boehringer Ingelheim Investigational Site 110
      • Satu Mare, Romania
        • Boehringer Ingelheim Investigational Site 111
      • Sibiu, Romania
        • Boehringer Ingelheim Investigational Site 112
      • Sibiu, Romania
        • Boehringer Ingelheim Investigational Site 113
      • Slatina, Romania
        • Boehringer Ingelheim Investigational Site 114
      • Suceava, Romania
        • Boehringer Ingelheim Investigational Site 115
      • Suceava, Romania
        • Boehringer Ingelheim Investigational Site 116
      • Teleorman, Romania
        • Boehringer Ingelheim Investigational Site 117
      • Tg. Mures, Romania
        • Boehringer Ingelheim Investigational Site 118
      • Timisoara, Romania
        • Boehringer Ingelheim Investigational Site 119
      • Timisoara, Romania
        • Boehringer Ingelheim Investigational Site 120
      • Timisoara, Romania
        • Boehringer Ingelheim Investigational Site 121
      • Timisoara, Romania
        • Boehringer Ingelheim Investigational Site 122
      • Tulcea, Romania
        • Boehringer Ingelheim Investigational Site 123
      • Tulcea, Romania
        • Boehringer Ingelheim Investigational Site 124
  • Russian Federation
      • Krasnodar, Russian Federation
        • Boehringer Ingelheim Investigational Site 131
      • Krasnoyarsk, Russian Federation
        • Boehringer Ingelheim Investigational Site 130
      • Moscow, Russian Federation
        • Boehringer Ingelheim Investigational Site 125
      • Moscow, Russian Federation
        • Boehringer Ingelheim Investigational Site 126
      • Moscow, Russian Federation
        • Boehringer Ingelheim Investigational Site 127
      • Novosibirsk, Russian Federation
        • Boehringer Ingelheim Investigational Site 128
      • Saint-Petersburg, Russian Federation
        • Boehringer Ingelheim Investigational Site 132
      • Saint-Petersburg, Russian Federation
        • Boehringer Ingelheim Investigational Site 133
      • Saint-Petersburg, Russian Federation
        • Boehringer Ingelheim Investigational Site 134
      • Tomsk, Russian Federation
        • Boehringer Ingelheim Investigational Site 129
  • Serbia
      • Belgrade, Serbia
        • Boehringer Ingelheim Investigational Site 135
      • Belgrade, Serbia
        • Boehringer Ingelheim Investigational Site 136
      • Kragujevac, Serbia
        • Boehringer Ingelheim Investigational Site 140
      • Krusevac, Serbia
        • Boehringer Ingelheim Investigational Site 138
      • Nis, Serbia
        • Boehringer Ingelheim Investigational Site 141
      • Nis, Serbia
        • Boehringer Ingelheim Investigational Site 142
      • Novi Sad, Serbia
        • Boehringer Ingelheim Investigational Site 137
      • Sombor, Serbia
        • Boehringer Ingelheim Investigational Site 143
      • Uzice, Serbia
        • Boehringer Ingelheim Investigational Site 145
      • Valjevo, Serbia
        • Boehringer Ingelheim Investigational Site 139
      • Vranje, Serbia
        • Boehringer Ingelheim Investigational Site 144
  • Slovakia
      • ?adca, Slovakia
        • Boehringer Ingelheim Investigational Site 155
      • Banská Bystrica, Slovakia
        • Boehringer Ingelheim Investigational Site 146
      • Bardejov, Slovakia
        • Boehringer Ingelheim Investigational Site 147
      • Bratislava, Slovakia
        • Boehringer Ingelheim Investigational Site 148
      • Bratislava, Slovakia
        • Boehringer Ingelheim Investigational Site 149
      • Bratislava, Slovakia
        • Boehringer Ingelheim Investigational Site 150
      • Bratislava, Slovakia
        • Boehringer Ingelheim Investigational Site 151
      • Bratislava, Slovakia
        • Boehringer Ingelheim Investigational Site 152
      • Bratislava, Slovakia
        • Boehringer Ingelheim Investigational Site 153
      • Brezno, Slovakia
        • Boehringer Ingelheim Investigational Site 154
      • Humenné, Slovakia
        • Boehringer Ingelheim Investigational Site 156
      • Ilava, Slovakia
        • Boehringer Ingelheim Investigational Site 157
      • Komárno, Slovakia
        • Boehringer Ingelheim Investigational Site 158
      • Kosice, Slovakia
        • Boehringer Ingelheim Investigational Site 159
      • Kosice, Slovakia
        • Boehringer Ingelheim Investigational Site 160
      • Kosice, Slovakia
        • Boehringer Ingelheim Investigational Site 161
      • Kosice, Slovakia
        • Boehringer Ingelheim Investigational Site 162
      • Kosice- Saca, Slovakia
        • Boehringer Ingelheim Investigational Site 163
      • Krompachy, Slovakia
        • Boehringer Ingelheim Investigational Site 164
      • Levice, Slovakia
        • Boehringer Ingelheim Investigational Site 165
      • Liptovský Mikulás, Slovakia
        • Boehringer Ingelheim Investigational Site 166
      • Lucenec, Slovakia
        • Boehringer Ingelheim Investigational Site 167
      • Martin, Slovakia
        • Boehringer Ingelheim Investigational Site 168
      • Nitra, Slovakia
        • Boehringer Ingelheim Investigational Site 169
      • Nitra, Slovakia
        • Boehringer Ingelheim Investigational Site 170
      • Nitra, Slovakia
        • Boehringer Ingelheim Investigational Site 171
      • Nováky, Slovakia
        • Boehringer Ingelheim Investigational Site 172
      • Nové Mesto n/ Váhom, Slovakia
        • Boehringer Ingelheim Investigational Site 173
      • Pezinok, Slovakia
        • Boehringer Ingelheim Investigational Site 174
      • Pies?any, Slovakia
        • Boehringer Ingelheim Investigational Site 175
      • Povazská Bystrica, Slovakia
        • Boehringer Ingelheim Investigational Site 176
      • Presov, Slovakia
        • Boehringer Ingelheim Investigational Site 177
      • Presov, Slovakia
        • Boehringer Ingelheim Investigational Site 178
      • Presov, Slovakia
        • Boehringer Ingelheim Investigational Site 179
      • Revúca, Slovakia
        • Boehringer Ingelheim Investigational Site 180
      • Rimavská Sobota, Slovakia
        • Boehringer Ingelheim Investigational Site 181
      • Roznava, Slovakia
        • Boehringer Ingelheim Investigational Site 182
      • Roznava, Slovakia
        • Boehringer Ingelheim Investigational Site 183
      • Sal'a, Slovakia
        • Boehringer Ingelheim Investigational Site 184
      • Sered, Slovakia
        • Boehringer Ingelheim Investigational Site 185
      • Skalica, Slovakia
        • Boehringer Ingelheim Investigational Site 186
      • Stropkov, Slovakia
        • Boehringer Ingelheim Investigational Site 187
      • Surany, Slovakia
        • Boehringer Ingelheim Investigational Site 188
      • Trebisov, Slovakia
        • Boehringer Ingelheim Investigational Site 189
      • Tren?in, Slovakia
        • Boehringer Ingelheim Investigational Site 190
      • Trnava, Slovakia
        • Boehringer Ingelheim Investigational Site 191
      • Trnava, Slovakia
        • Boehringer Ingelheim Investigational Site 192
      • Trstená, Slovakia
        • Boehringer Ingelheim Investigational Site 193
      • Vel'ke Kapusany, Slovakia
        • Boehringer Ingelheim Investigational Site 194
      • Ziar N/Hronom, Slovakia
        • Boehringer Ingelheim Investigational Site 195
      • Zilina, Slovakia
        • Boehringer Ingelheim Investigational Site 196
      • Zilina, Slovakia
        • Boehringer Ingelheim Investigational Site 197
      • Zlaté Moravce, Slovakia
        • Boehringer Ingelheim Investigational Site 198
      • Zvolen, Slovakia
        • Boehringer Ingelheim Investigational Site 199
      • Zvolen, Slovakia
        • Boehringer Ingelheim Investigational Site 200
  • Slovenia
      • Bled, Slovenia
        • Boehringer Ingelheim Investigational Site 205
      • Celje, Slovenia
        • Boehringer Ingelheim Investigational Site 206
      • Ljubljana, Slovenia
        • Boehringer Ingelheim Investigational Site 201
      • Ljubljana, Slovenia
        • Boehringer Ingelheim Investigational Site 202
      • Maribor, Slovenia
        • Boehringer Ingelheim Investigational Site 207
      • Maribor, Slovenia
        • Boehringer Ingelheim Investigational Site 208
      • Maribor, Slovenia
        • Boehringer Ingelheim Investigational Site 209
      • Maribor, Slovenia
        • Boehringer Ingelheim Investigational Site 210
      • Sempeter pri Gorici, Slovenia
        • Boehringer Ingelheim Investigational Site 203
      • Sempeter pri Gorici, Slovenia
        • Boehringer Ingelheim Investigational Site 204
  • Ukraine
      • Kharkiv, Ukraine
        • Boehringer Ingelheim Investigational Site 212
      • Kyiv, Ukraine
        • Boehringer Ingelheim Investigational Site 211
      • Lviv, Ukraine
        • Boehringer Ingelheim Investigational Site 215
      • Ternopil, Ukraine
        • Boehringer Ingelheim Investigational Site 214
      • Vinnitsa, Ukraine
        • Boehringer Ingelheim Investigational Site 213

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Neurologists

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. Any contraindications according to the Summary of Product Characteristics (SPC): hypersensitivity to pramipexole or to any of the excipients.
  2. Ongoing treatment with pramipexole (Mirapexin®)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Patients with Parkinson's disease
Early and advanced Parkinson's disease patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Week 0 to weeks 9-16 (Visit 3)
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)
Week 0 to weeks 9-16
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
Week 0 to weeks 9-16 (Visit 3)
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
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)
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)
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
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)
Week 0 to weeks 9-16 (Visit 3)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Final Dose Distribution
Time Frame: Enter Week 0 to weeks 9-16 (Visit 3)
Final Mirapexin® dose distribution at the end of study
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 (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)
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 (reduction) in UPDRS Part III score (motor function) from baseline to Visit 2. Score ranging from 0 - 108 (0=no disability, 108=maximum disability)
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)
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)
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)
Total number of adverse events (AEs), causality and level of seriousness
Week 0 to weeks 9-16 (end of study)
Number of Premature Discontinuations
Time Frame: Week 0 to weeks 9-16 (end of study)
Number of patients discontinuing the study prematurely
Week 0 to weeks 9-16 (end of study)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Actual)

August 1, 2009

Study Registration Dates

First Submitted

March 18, 2010

First Submitted That Met QC Criteria

April 7, 2010

First Posted (Estimate)

April 8, 2010

Study Record Updates

Last Update Posted (Estimate)

April 11, 2014

Last Update Submitted That Met QC Criteria

March 14, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 248.657

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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