Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| Eudract 2005-003788-22 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Parkinsons Disease (PD) is caused by a decrease of dopamine in a particular part of the brain. Dopamine is a messenger substance (neurotransmitter) that is used by the cells of the brain (nerve cells) to control and harmonize muscle movements. Consequently, the main manifestations of the disease affect movement and include tremor, muscular rigidity, slowness in performing movements and loss of balance.
However, the disease affects also other, non motor functions and may cause other disorders, such as depression. Depression may be a reaction to the disability caused by the disease, but many studies show that depression is more common in PD than in other chronic debilitating illnesses. Moreover, there is also a biological explanation for the phenomenon: dopamine is also used in brain circuits involved in the experience of pleasure, and loss of pleasure in daily physical or social activity is one of the key manifestations of depression.
The objective of the study is to assess whether pramipexole, at doses approved for the treatment of PD symptoms, is more effective than placebo in resolving depressive symptoms in PD patients.
Also data on the safety of the product in the disease will be collected.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| pramipexole | Experimental | A daily dose of pramipexole 0.125 mg t.i.d.; titration-to-response up to 1.0 mg t.i.d. |
|
| placebo | Placebo Comparator | Placebo (matching) tablets |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pramipexole | Drug | Dopamine agonist |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Week 12 | The BDI measures symptoms of depression on an ordinal scale ranging from 0 (no symptoms) to 63 (worst symptoms) | Baseline and Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in BDI-IA Clinical Response (at Least 50% Reduction in Symptoms) at Week 12 | BDI clinical response was defined as a reduction of ≥50% from baseline | Week 12 |
| Change From Baseline in the Geriatric Depression Scale-Short Form (GDS-SF) (15-item Version) Total Score at Week 12 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Boehringer Ingelheim | Boehringer Ingelheim | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 248.596.43003 Boehringer Ingelheim Investigational Site | Graz | Austria | ||||
| 248.596.43001 Boehringer Ingelheim Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20452823 | Derived | Barone P, Poewe W, Albrecht S, Debieuvre C, Massey D, Rascol O, Tolosa E, Weintraub D. Pramipexole for the treatment of depressive symptoms in patients with Parkinson's disease: a randomised, double-blind, placebo-controlled trial. Lancet Neurol. 2010 Jun;9(6):573-80. doi: 10.1016/S1474-4422(10)70106-X. Epub 2010 May 7. |
| Label | URL |
|---|---|
| Related Info | View source |
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Placebo tablet matching active treatment |
| FG001 | Pramipexole | Ascending dose titration of Pramipexole. Pramipexole doses consisted of 0.125 mg three times daily (t.i.d), 0.25mg t.i.d, 0.5mg, t.i.d, 0.25mg+0.5mg t.i.d and 1.0 mg t.i.d. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Other |
|
The GDS measures symptoms of depression on an ordinal scale ranging from 0 (no symptoms) to 15 (worst symptoms) |
| Baseline and Week 12 |
| Change From Baseline in Snaith-Hamilton Pleasure Scale (SHAPS) Total Score at Week 12 | The SHAPS measures anhedonia (inability to experience pleasure) on an ordinal scale ranging from 0 (no anhedonia) to 14 (worst anhedonia) | Baseline and Week 12 |
| Change From Baseline in the Unified Parkinson's Disease Rating Scale (UPDRS) Part I Depression Score at Week 12 | The UPDRS part I depression score measures depression on an ordinal scale ranging from 0 (none) to 4 (sustained depression/suicidal thoughts) | Baseline and Week 12 |
| Change From Baseline in the UPDRS Part II Total Score at Week 12 | Unified Parkinson's Disease Rating Scale part II total score on FAS The UPDRS part II total score measures the impact of PD on activities of daily living on an ordinal scale ranging from 0 (normal) to 52 (worst symptoms) | Baseline and Week 12 |
| Change From Baseline in the UPDRS Part III Total Score at Week 12 | The UPDRS part III total score measures the impact of PD on motor skills on an ordinal scale ranging from 0 (normal) to 108 (worst symptoms) | Baseline and Week 12 |
| Change From Baseline in the UPDRS Part II+III Total Score at Week 12 | The UPDRS part II+III total score measures the impact of PD on activities of daily living and motor skills on an ordinal scale ranging from 0 (normal) to 160 (worst symptoms) | Baseline and Week 12 |
| Clinical Global Impressions of Global Improvement (CGI-I) at Week 12 | The CGI-I measures the overall improvement in the participants condition from baseline on an ordinal scale ranging from 1 (very much improved) to 7 (very much worse) | Week 12 |
| Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Overall Index Score at Week 12 | The PDQ-39 measures aspects of health in PD participants, the overall index score is the mean of the eight individual domain scores measured on a continuous scale ranging from 0 (no problem at all) to 100 (maximum level of the problem) | Baseline and Week 12 |
| Change From Baseline in the European Quality of Life Scale (EUROQOL (EQ)-5D) Overall Index Score at Week 12 | This is a 5-item patient reported measure of health status developed for use in evaluating health and healthcare. It produces a numeric score for health status on which full health has a value of 1 and death has a value of 0. Euro-QOL describes health status in terms of 5 dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. The EQ-5D measures health status on a continuous scale ranging from 0 (dead) to 1 (full health) | Baseline and Week 12 |
| Change From Baseline to End of Maintenance Phase in European Quality of Life Visual Analogue Scale (EUROQOL (EQ) VAS) Pain Score at Week 12 | The VAS is a method used for the measurement of pain. The patient is asked to place a mark on an uncalibrated (usually 0 - 10 cm) line representing the patient's degree of general pain. The two extremities of the line were taken to represent 'no pain' and 'unbearable pain', respectively. VAS pain scores could range from 0 (no pain) to 100 (unbearable pain). | Baseline and Week 12 |
| Change From Baseline in the UPDRS Part I Total Score at Week 12 | The UPDRS part I total score measures depression on an ordinal scale ranging from 0 to 16. UPDRS Part I total scores could range from 0 to 16; where higher scores were indicative of worse symptoms. | Baseline and Week 12 |
| Change From Baseline in the UPDRS Part IV Total Score at Week 12 | The UPDRS Part IV measures motor complications (dyskinesia) and the total score could range from 0 to 23; where higher scores were indicative of worse symptoms. | Baseline and Week 12 |
| Abnormal Findings: Clinical Laboratory Evaluations (Biochemistry and Haematology)and Vital Signs | Baseline and Week 12 |
| Innsbruck |
| Austria |
| 248.596.43005 Boehringer Ingelheim Investigational Site | Linz | Austria |
| 248.596.43004 Boehringer Ingelheim Investigational Site | Sankt Pölten | Austria |
| 248.596.43002 Boehringer Ingelheim Investigational Site | Vienna | Austria |
| 248.596.35801 Boehringer Ingelheim Investigational Site | Oulu | Finland |
| 248.596.3302A Centre Hospitalier du Pays d'Aix | Aix-en-Provence | France |
| 248.596.3302B Centre Hospitalier du Pays d'Aix | Aix-en-Provence | France |
| 248.596.3306A Hôpital Pierre Wertheimer | Bron | France |
| 248.596.3308A Hôpital Gabriel Montpied | Clermont-Ferrand | France |
| 248.596.3309A Cabinet Médical | Évreux | France |
| 248.596.3307A Hôpital Roger Salengro | Lille | France |
| 248.596.3307B Hôpital Roger Salengro | Lille | France |
| 248.596.3307C Hôpital Roger Salengro | Lille | France |
| 248.596.3303A Hôpital La Timone | Marseille | France |
| 248.596.3305A Hôpital du Haut Levêque | Pessac Cédex | France |
| 248.596.3305B Hôpital du Haut Levêque | Pessac Cédex | France |
| 248.596.3301A Hôpital Guillaume et René Laennec | Saint-Herblain | France |
| 248.596.49002 Boehringer Ingelheim Investigational Site | Berlin | Germany |
| 248.596.49013 Boehringer Ingelheim Investigational Site | Berlin | Germany |
| 248.596.49015 Boehringer Ingelheim Investigational Site | Berlin | Germany |
| 248.596.49003 Boehringer Ingelheim Investigational Site | Bremerhaven | Germany |
| 248.596.49016 Boehringer Ingelheim Investigational Site | Cologne | Germany |
| 248.596.49004 Boehringer Ingelheim Investigational Site | Gera | Germany |
| 248.596.49001 Boehringer Ingelheim Investigational Site | Karlsruhe | Germany |
| 248.596.49005 Boehringer Ingelheim Investigational Site | Marburg | Germany |
| 248.596.49014 Boehringer Ingelheim Investigational Site | Mittweida | Germany |
| 248.596.49008 Boehringer Ingelheim Investigational Site | München | Germany |
| 248.596.49012 Boehringer Ingelheim Investigational Site | Steglitz | Germany |
| 248.596.39008 Clinica Neurologica I Policlinico di Catania | Catania | Italy |
| 248.596.39004 Neurologia Ospedale della Misericordia | Grosseto | Italy |
| 248.596.39005 Clinica Neurologica Policlinico G. Martino | Messina | Italy |
| 248.596.39009 Istituti Clinici di Perfezionamento | Milan | Italy |
| 248.596.39003 Università degli studi di Napoli "Federico II" | Naples | Italy |
| 248.596.39001 Ospedale Civile S. Spirito, Università "G. D'Annunzio" | Pescara | Italy |
| 248.596.39007 Clinica Neurologica Policlinico Tor Vergata | Roma | Italy |
| 248.596.39006 Neurologia Ospedale Evangelico Valdese | Torino | Italy |
| 248.596.31003 Jeroen Bosch Ziekenhuis, locatie WA | 's-Hertogenbosch | Netherlands |
| 248.596.31007 Afdeling neurologie | Amsterdam | Netherlands |
| 248.596.31005 Ziekenhuis Gooi-Noord | Blaricum | Netherlands |
| 248.596.31004 Amphia ziekenhuis, Locatie Molengracht | Breda | Netherlands |
| 248.596.31002 Canisius-Wilhelmina Ziekenhuis | Nijmegen | Netherlands |
| 248.596.31001 Maasland Ziekenhuis | Sittard | Netherlands |
| 248.596.47002 Boehringer Ingelheim Investigational Site | Arendal | Norway |
| 248.596.47004 Boehringer Ingelheim Investigational Site | Lillehammer | Norway |
| 248.596.47003 Boehringer Ingelheim Investigational Site | Sandvika | Norway |
| 248.596.40003 Boehringer Ingelheim Investigational Site | Bucharest | Romania |
| 248.596.40004 Boehringer Ingelheim Investigational Site | Bucharest | Romania |
| 248.596.40005 Boehringer Ingelheim Investigational Site | Bucharest | Romania |
| 248.596.40001 Boehringer Ingelheim Investigational Site | Cluj-Napoca | Romania |
| 248.596.40002 Boehringer Ingelheim Investigational Site | Iași | Romania |
| 248.596.40006 Country Clinical Emergency Hospital | Târgu Mureş | Romania |
| 248.596.70001 Boehringer Ingelheim Investigational Site | Moscow | Russia |
| 248.596.70003 Boehringer Ingelheim Investigational Site | Moscow | Russia |
| 248.596.70002 Boehringer Ingelheim Investigational Site | Saint Petersburg | Russia |
| 248.596.70004 Boehringer Ingelheim Investigational Site | Saint Petersburg | Russia |
| 248.596.70005 Boehringer Ingelheim Investigational Site | Saint Petersburg | Russia |
| 248.596.27001 Boehringer Ingelheim Investigational Site | Cape Town | South Africa |
| 248.596.27003 Boehringer Ingelheim Investigational Site | Cape Town | South Africa |
| 248.596.27007 Boehringer Ingelheim Investigational Site | Cape Town | South Africa |
| 248.596.27008 Boehringer Ingelheim Investigational Site | Johannesburg | South Africa |
| 248.596.27004 Boehringer Ingelheim Investigational Site | Pretoria | South Africa |
| 248.596.27006 Boehringer Ingelheim Investigational Site | Richards Bay | South Africa |
| 248.596.34003 Hospital de Alcorcón. Departamento de Neurología | Alcorcon (Madrid) | Spain |
| 248.596.34001 Hospital Sta Creu i Sant Pau. Departamento de Neurología | Barcelona | Spain |
| 248.596.34002 Hospital Clinic i Provincial. Departamento de Neurología | Barcelona | Spain |
| 248.596.34005 Hosp. Univ. Vall d'Hebron. Departamento de Neurología | Barcelona | Spain |
| 248.596.34007 Hosp Gral Univ Gregorio Marañón. Departamento de Neurología | Madrid | Spain |
| 248.596.34004 Hospital General de Catalunya. Departamento de Neurología | San Cugat Del Valles (Barcelona) | Spain |
| 248.596.46004 Boehringer Ingelheim Investigational Site | Linköping | Sweden |
| 248.596.46001 Boehringer Ingelheim Investigational Site | Stockholm | Sweden |
| 248.596.46002 Boehringer Ingelheim Investigational Site | Stockholm | Sweden |
| 248.596.38004 Boehringer Ingelheim Investigational Site | Donetsk | Ukraine |
| 248.596.38005 Boehringer Ingelheim Investigational Site | Kharkiv | Ukraine |
| 248.596.38002 Boehringer Ingelheim Investigational Site | Kiev | Ukraine |
| 248.596.38006 Boehringer Ingelheim Investigational Site | Simferopol | Ukraine |
| 248.596.38003 Boehringer Ingelheim Investigational Site | Vinnytzya | Ukraine |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Placebo tablet matching active treatment |
| BG001 | Pramipexole | Ascending dose titration of Pramipexole. Pramipexole doses consisted of 0.125 mg three times daily (t.i.d), 0.25mg t.i.d, 0.5mg, t.i.d, 0.25mg+0.5mg t.i.d and 1.0 mg t.i.d. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in the Beck Depression Inventory-Version 1A (BDI-IA) Total Score at Week 12 | The BDI measures symptoms of depression on an ordinal scale ranging from 0 (no symptoms) to 63 (worst symptoms) | The Full analysis set (FAS) made up of all randomised and treated participants with a baseline and at least one on-treatment assessment of the BDI. 9 participants from those randomised and treated were excluded due to insufficient BDI data. | Posted | Least Squares Mean | Standard Error | Score on scale | Baseline and Week 12 |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in BDI-IA Clinical Response (at Least 50% Reduction in Symptoms) at Week 12 | BDI clinical response was defined as a reduction of ≥50% from baseline | FAS. 10 participants from those randomised and treated were excluded due to insufficient BDI data (1 due to a zero baseline score). | Posted | Number | participants | Week 12 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the Geriatric Depression Scale-Short Form (GDS-SF) (15-item Version) Total Score at Week 12 | The GDS measures symptoms of depression on an ordinal scale ranging from 0 (no symptoms) to 15 (worst symptoms) | FAS. 9 participants from those randomised and treated were excluded due to insufficient GDS data. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline and Week 12 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Snaith-Hamilton Pleasure Scale (SHAPS) Total Score at Week 12 | The SHAPS measures anhedonia (inability to experience pleasure) on an ordinal scale ranging from 0 (no anhedonia) to 14 (worst anhedonia) | FAS. 9 participants from those randomised and treated were excluded due to insufficient SHAPS data. | Posted | Median | Inter-Quartile Range | units on a scale | Baseline and Week 12 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the Unified Parkinson's Disease Rating Scale (UPDRS) Part I Depression Score at Week 12 | The UPDRS part I depression score measures depression on an ordinal scale ranging from 0 (none) to 4 (sustained depression/suicidal thoughts) | FAS. 9 participants from those randomised and treated were excluded due to insufficient UPDRS data. | Posted | Median | Inter-Quartile Range | units on a scale | Baseline and Week 12 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the UPDRS Part II Total Score at Week 12 | Unified Parkinson's Disease Rating Scale part II total score on FAS The UPDRS part II total score measures the impact of PD on activities of daily living on an ordinal scale ranging from 0 (normal) to 52 (worst symptoms) | FAS. 9 participants from those randomised and treated were excluded due to insufficient UPDRS data. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline and Week 12 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the UPDRS Part III Total Score at Week 12 | The UPDRS part III total score measures the impact of PD on motor skills on an ordinal scale ranging from 0 (normal) to 108 (worst symptoms) | FAS. 10 participants from those randomised and treated were excluded due to insufficient UPDRS data. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline and Week 12 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the UPDRS Part II+III Total Score at Week 12 | The UPDRS part II+III total score measures the impact of PD on activities of daily living and motor skills on an ordinal scale ranging from 0 (normal) to 160 (worst symptoms) | FAS. 10 participants from those randomised and treated were excluded due to insufficient UPDRS data. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline and Week 12 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Clinical Global Impressions of Global Improvement (CGI-I) at Week 12 | The CGI-I measures the overall improvement in the participants condition from baseline on an ordinal scale ranging from 1 (very much improved) to 7 (very much worse) | FAS. 9 participants from those randomised and treated were excluded due to insufficient CGI-I data. | Posted | Median | Full Range | units on a scale | Week 12 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the Parkinson's Disease Questionnaire-39 (PDQ-39) Overall Index Score at Week 12 | The PDQ-39 measures aspects of health in PD participants, the overall index score is the mean of the eight individual domain scores measured on a continuous scale ranging from 0 (no problem at all) to 100 (maximum level of the problem) | FAS. 52 participants from those randomised and treated were excluded due to insufficient PDQ-39 data. | Posted | Median | Inter-Quartile Range | units on a scale | Baseline and Week 12 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the European Quality of Life Scale (EUROQOL (EQ)-5D) Overall Index Score at Week 12 | This is a 5-item patient reported measure of health status developed for use in evaluating health and healthcare. It produces a numeric score for health status on which full health has a value of 1 and death has a value of 0. Euro-QOL describes health status in terms of 5 dimensions: mobility, self-care, usual activity, pain/discomfort, and anxiety/depression. The EQ-5D measures health status on a continuous scale ranging from 0 (dead) to 1 (full health) | FAS. 16 participants from those randomised and treated were excluded due to insufficient EQ-5D data. | Posted | Median | Inter-Quartile Range | units on a scale | Baseline and Week 12 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to End of Maintenance Phase in European Quality of Life Visual Analogue Scale (EUROQOL (EQ) VAS) Pain Score at Week 12 | The VAS is a method used for the measurement of pain. The patient is asked to place a mark on an uncalibrated (usually 0 - 10 cm) line representing the patient's degree of general pain. The two extremities of the line were taken to represent 'no pain' and 'unbearable pain', respectively. VAS pain scores could range from 0 (no pain) to 100 (unbearable pain). | FAS. 15 participants from those randomised and treated were excluded due to insufficient EQ-5D data. | Posted | Least Squares Mean | Standard Error | mm | Baseline and Week 12 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the UPDRS Part I Total Score at Week 12 | The UPDRS part I total score measures depression on an ordinal scale ranging from 0 to 16. UPDRS Part I total scores could range from 0 to 16; where higher scores were indicative of worse symptoms. | FAS. 9 participants from those randomised and treated were excluded due to insufficient UPDRS data. | Posted | Median | Inter-Quartile Range | units on a scale | Baseline and Week 12 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the UPDRS Part IV Total Score at Week 12 | The UPDRS Part IV measures motor complications (dyskinesia) and the total score could range from 0 to 23; where higher scores were indicative of worse symptoms. | FAS. 28 participants from those randomised and treated were excluded due to insufficient UPDRS data. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline and Week 12 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Abnormal Findings: Clinical Laboratory Evaluations (Biochemistry and Haematology)and Vital Signs | Posted | Number | participants | Baseline and Week 12 |
|
|
First drug intake up to 48 hours after the last drug intake
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Placebo tablet matching active treatment | 6 | 58 | ||||
| EG001 | Pramipexole | Ascending dose titration of Pramipexole. Pramipexole doses consisted of 0.125 mg three times daily (t.i.d), 0.25mg t.i.d, 0.5mg, t.i.d, 0.25mg+0.5mg t.i.d and 1.0 mg t.i.d. | 6 | 71 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Endocarditis | Infections and infestations | MedDRA 11.0 | Systematic Assessment |
| |
| Hyperlipidaemia | Metabolism and nutrition disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Hallucination | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Cerebral haemorrhage | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Parkinson disease | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Radicular pain | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Angina unstable | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Cardiac failure | Cardiac disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Gastroduodenal ulcer | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Volvulus | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Anuria | Renal and urinary disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Accident at home | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Comminuted fracture | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Femoral neck fracture | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Skull fracture base | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
| |
| Traumatic brain injury | Injury, poisoning and procedural complications | MedDRA 11.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Insomnia | Psychiatric disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Dyskinesia | Nervous system disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 11.0 | Systematic Assessment |
|
Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim Pharmaceuticals | Boehringer Ingelheim Pharmaceuticals | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D003863 | Depression |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
Not provided
Not provided
| ID | Term |
|---|---|
| D000077487 | Pramipexole |
| ID | Term |
|---|---|
| D052160 | Benzothiazoles |
| D013844 | Thiazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
Not provided
Not provided
| Male |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|