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To demonstrate that Intrathecal Baclofen (ITB) Therapy, compared to Best Medical Treatment (BMT), has superior efficacy in the treatment of severe spasticity in adult post-stroke patients with generalized spastic hypertonia who have not reached their therapy goal with other treatment interventions assessed by a decrease in the average Ashworth Scale (AS) score in the lower extremities.
This is a randomized, controlled open-label parallel group study to demonstrate the efficacy benefit of ITB Therapy over BMT in post-stroke patients with severe spasticity who have not reached their therapy goal with other treatment interventions.
In order to evaluate the efficacy benefit of ITB Therapy over BMT in post-stroke patients, a two-arm parallel group design will be applied. Patients will be equally randomized to one of two treatment arms:
The study consists of a run-in phase of 21 days for the BMT treatment arm and 2-25 days for the ITB Therapy treatment arm, followed by a 6 month active trial.
The BMT treatment arm will receive a combination of oral antispastic medication and physiotherapy. Patients must be prescribed at least one or a combination of the following oral antispastic medications: oral baclofen, tizanidine, diazepam (or other benzodiazepines) or dantrolene. Following the run-in phase, patients will enter the 6 month active trial.
The ITB Therapy treatment arm will receive a combination of ITB Therapy and physiotherapy. During the run-in phase, a test with intrathecal baclofen will be performed to evaluate the response of the patient. Patients fulfilling the test success criterium will be implanted with a Medtronic SynchroMed®II infusion system. Following implant, patients will enter into the 6 month active trial, which includes a 6 week titration phase, during which time oral antispastic medications must be gradually reduced with complete discontinuation by the end of the titration period.
During the 6 month active trial, patients will be assessed at 3 and 6 months. All primary and secondary endpoint assessments will be performed by a blinded assessor.
The total study duration is expected to be 60 months, including a 39 month enrollment period. The total duration per patient is approximately 7 months (approximately 1 month run-in period followed by 6 months active treatment).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ITB therapy | Active Comparator | Intrathecal Baclofen therapy (Intrathecal baclofen + implantable pump) |
|
| Best Medical Treatment (BMT) | No Intervention | Use one or a combination oral antispastic medication. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| intrathecal baclofen | Drug | ITB test, implant, 6 months follow-up |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Average Ashworth Scale (AS) in Affected Lower Extremities From Baseline to Month 6 | AS is a manual test, measuring the resistance to passive movement about a joint with varying degrees of velocity. Scores range from 1-5, with 5 choices. A score of 1 indicates no resistance, and 5 indicates rigidity. The following muscle groups in the lower extremities were assessed: hip flexors, hip adductors, knee extensors, knee flexors, plantar flexors and ankle-dorsal flexors. Average AS was calculated as the average of AS scores of the 6 muscles of the affected lower extremity. Change in average AS in affected lower extremities from baseline to month 6 between ITB and BMT arm was assessed. Change= AS at month 6 - AS at baseline. | Baseline and month 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Average Ashworth Scale (AS) in Affected Upper Extremities From Baseline to Month 6 | AS is a manual test, measuring the resistance to passive movement about a joint with varying degrees of velocity. Scores range from 1-5, with 5 choices. A score of 1 indicates no resistance, and 5 indicates rigidity. The following muscle groups in the upper extremities were assessed: wrist flexors, elbow flexors, elbow extensors, shoulder abductors and shoulder adductors. Average AS was calculated as the average of AS scores of the 5 muscles of the affected lower extremities. Change in average AS in affected upper extremities from baseline to month 6 between ITB and BMT arm was assessed. Change= AS at month 6 - AS at baseline. |
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Inclusion criteria:
To be eligible for inclusion into this study, patients must fulfill all of the following criteria prior to study enrollment:
Exclusion criteria:
To be eligible for inclusion in this study the patients must not meet any of the following criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Leopold SALTUARI, Prof. | Landeskrankenhaus Hochzirl, Zirl (Austria) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California Irvine | Irvine | California | 92697 | United States | ||
| MedStar National Rehabilitation Network |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30354975 | Derived | Creamer M, Cloud G, Kossmehl P, Yochelson M, Francisco GE, Ward AB, Wissel J, Zampolini M, Abouihia A, Calabrese A, Saltuari L. Effect of Intrathecal Baclofen on Pain and Quality of Life in Poststroke Spasticity. Stroke. 2018 Sep;49(9):2129-2137. doi: 10.1161/STROKEAHA.118.022255. | |
| 29326296 | Derived | Creamer M, Cloud G, Kossmehl P, Yochelson M, Francisco GE, Ward AB, Wissel J, Zampolini M, Abouihia A, Berthuy N, Calabrese A, Loven M, Saltuari L. Intrathecal baclofen therapy versus conventional medical management for severe poststroke spasticity: results from a multicentre, randomised, controlled, open-label trial (SISTERS). J Neurol Neurosurg Psychiatry. 2018 Jun;89(6):642-650. doi: 10.1136/jnnp-2017-317021. Epub 2018 Jan 11. |
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A total of 61 patients were enrolled. One patient did not meet the inclusion criteria (screening failure). 60 patients were then randomized into the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | ITB Therapy | Intrathecal Baclofen therapy (Intrathecal baclofen + implantable pump) |
| FG001 | Best Medical Treatment (BMT) | Use one or a combination oral antispastic medication |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Baseline and month 6 |
| Change in Functional Independence Measure (FIM) Score From Baseline to Month 6 | FIM contains 18 items composed of 13 motor tasks and 5 cognitive tasks. Tasks are rated on a 7-point ordinal scale that ranges from total assistance (or complete dependence) to complete independence. Ratings should reflect actual observed performance, not capability. Total score ranges from 18 (lowest) to 126 (highest) level of independence. Change in FIM total score from baseline to month 6 between ITB and BMT arm was assessed. Change=FIM score at month 6 - FIM score at baseline. | Baseline and month 6 |
| Change in Average 10 Meter Time Walking Test (10MTWT) From Baseline to Month 6 | Change in average 10MTWT from baseline to month 6 beetween ITB and BMT arm. Change=10MTWT at month 6 - 10MTWT at baseline | Baseline and month 6 |
| Number of Participants Who Were Able to Transfer From the Wheelchair to Bed Without Human Assistance | Patient was asked to transfer from the wheelchair to bed without human assistance. High level functional patient (HLP) could transfer. Low level functional patient (LLP) was not able to transfer. Comparison of the number and percentage of HLP and LLP between ITB and BMT arms was evaluated. | baseline, month 3, month 6 |
| Change in Numeric Pain Rating Scale (NPRS) From Baseline to Month 6 | NPRS is designed to assess the level of pain a patient is feeling at a point in time. The following questions has been presented to patients: What is your actual spasticity-related or spasm-related pain? What was your least spasticity-related or spasm-related pain during the last week? What was your worst spasticity-related or spasm-related pain during the last week? The patient indicated how much pain he is feeling on a scale from 0 to 10. A score of 0 (zero) is "no pain" while a score of 10 (ten) is "worst possible pain". Change in NPRS related to actual, least or worst pain from baseline to month 6 between ITB and BMT arm was assessed. Change=NPRS at month 6 - NPRS at baseline. | Baseline and month 6 |
| Number of Participants Who Achieved Their Primary Therapeutic Goal Assessed With the Goal Attainment Scale (GAS) | GAS is designed to measure the achievement of treatment goals using the following 6 levels of achievement: worse than start (-3), much less than expected (-2), somewhat less than expected (-1), as expected (0), somewhat more than expected (+1), much more than expected (+2). The primary therapy goal and the criteria for the levels of achievement was defined by the medical team together with the patient and his/her family/legal representative/caregiver at the first day of the study. The number and percentage of patients who achieved the therapeutic goal at Month 6 was compared between the ITB and BMT arm. | month 6 |
| Change in Euro QoL Group-5 Dimensional, 3 Level Version (EQ-5D-3L) From Baseline to Month 6 | The EQ-5D-3L is a generic measure of health status consisting in the EQ-5D-3L descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D-3L descriptive system is characterized on five dimensions: mobility, self-care, ability to undertake usual activities, pain and anxiety/depression. Patients were asked to indicate their level of health on each dimension using one of three levels: "no health problems", "moderate health problems", and "severe health problems". Responses from the questionnaire were converted to a single health index utility score; this ranges from -0.595 to 1. EQ VAS records the patient's self-rated health on a vertical visual analogue scale from 0 to 100 where the endpoints are labelled 'Best imaginable health state' (100) and 'Worst imaginable health state' (0). Change in EQ-5D-3L utility score and VAS score from baseline to month 6 between ITB and BMT arm were assessed. Change=EQ-5D-3L utility or VAS score at month 6 - EQ-5D-3L utility or VAS score. | Baseline and month 6 |
| Change in SF-12 (12-item Short Form) From Baseline to Month 6 | The SF-12 is generic assessment of health-related quality of life, which evaluates 8 health dimensions (physical functioning, role physical, bodily pain, vitality, social functioning, role emotional, mental health, and general health). Subscale scores for each dimension were aggregated into summary scores for physical (PCS) and mental health (MCS) components (ranging from 0 to 100, with higher scores indicating better health). Changes in the PCS and MCS from baseline to Month 6 were both compared between the BMT and ITB arms. Change=SF-12 score at month 6 - SF-12 score at baseline. | Baseline and month 6 |
| Change in Stroke Specific Quality of Life (SS-QoL ) From Baseline to Month 6 | SS-QoL questionnaire is a self-assessed quality of life questionnaire specifically designed for post-stroke patients. It evaluates 49 items across 12-domains: personality, energy, language, mobility, vision, upper extremity function, thinking, mood, work/productivity, self-care, and family and social roles. Each item is rated on a 5-point Likert Scale, measuring either positive or negative response to a statement. Summary score is composed of an unweighted average of the 12 domain scores, with higher scores indicating better QoL. Total score ranges from 1 to 5. Change in SS-QoL summary score from baseline to month 6 between ITB and BMT arm was assessed. Change=SS-QoL score at month 6 - SS-QoL score at baseline. | Baseline and month 6 |
| Therapy Satisfaction | Patients were presented with two statements ("I am satisfied with the reduction in spasticity provided by my treatment", and "I would recommend this therapy to a friend"). They agreed, disagreed or were neutral with the statements. | month 6 |
| Healthcare Resource Utilization | Number of patients with healthcare professional contacts outside of study visits in the ITB and BMT between baseline and months 6 | baseline, ITB test (only ITB arm), second assessment (only BMT arm), week 6 (only ITB arm), month 3, month 6 |
| Washington D.C. |
| District of Columbia |
| 20010 |
| United States |
| Design Neuroscience Center | Doral | Florida | 33172 | United States |
| Rehabilitation Medical Group - Florida Hospital | Orlando | Florida | 32806 | United States |
| Tallahassee Neurological Clinic Department of Neurosurgery | Tallahassee | Florida | 32308 | United States |
| Saint Alphonsus Regional Med Center | Boise | Idaho | 83704 | United States |
| Research Medical Center | Kansas City | Missouri | 64132 | United States |
| Einstein Hospital/Moss Rehabilitation | Elkins Park | Pennsylvania | 19027-2220 | United States |
| TIRR Memorial Herman Hospital | Houston | Texas | 77030 | United States |
| Sozialmedizinisches Zentrum Baumgartner Höhe Otto-Wagner-Spital | Vienna | 1140 | Austria |
| Landeskrankenhaus Hochzirl | Zirl | 6170 | Austria |
| Clin. Univ. UCL Saint Luc | Brussels | 1200 | Belgium |
| Universitair Ziekenhuis Gent | Ghent | 9000 | Belgium |
| Universitaire Ziekenhuizen Leuven, campus Pellenberg | Leuven | B-3000 | Belgium |
| Kliniken Beelitz GmbH Neurologische Rehabilitationsklinik | Beelitz-Heilstätten | 14547 | Germany |
| Ambulantes Neurologisches Rehabilitationszentrum | Bonn | 53117 | Germany |
| Therapiezentrum Burgau | Burgau | 89331 | Germany |
| Rhein-Sieg-Klinik Dr. Becker Klinikgesellschaft | Nümbrecht | 51588 | Germany |
| Centro di Riabilitazione "Villa Beretta" | Costa Masnaga | 23845 | Italy |
| Fondazione Salvatore Maugeri Clinica del lavoro e della riabilitazione IRCSS | Pavia | 27100 | Italy |
| Afdeling Revalidatie Academisch Ziekenhuis Maastricht | Maastricht | 6229 | Netherlands |
| Univerzitetni rehabilitacijski inštitut Republike Slovenije Soča | Ljubljana | 1000 | Slovenia |
| Fundació Privada Institut de Neurorehabilitació Guttmann, Badalona | Barcelona | 08916 | Spain |
| Hospital Universitario La Paz | Madrid | 28046 | Spain |
| St George's Hospital | London | SW17 0 QT | United Kingdom |
| Implant |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | ITB Therapy | Intrathecal Baclofen therapy (Intrathecal baclofen + implantable pump) |
| BG001 | Best Medical Treatment (BMT) | Use one or a combination oral antispastic medication. |
| 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 |
| ||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
| ||||||||||||||||
| Time since stroke | Mean | Standard Deviation | years |
|
| 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 in Average Ashworth Scale (AS) in Affected Lower Extremities From Baseline to Month 6 | AS is a manual test, measuring the resistance to passive movement about a joint with varying degrees of velocity. Scores range from 1-5, with 5 choices. A score of 1 indicates no resistance, and 5 indicates rigidity. The following muscle groups in the lower extremities were assessed: hip flexors, hip adductors, knee extensors, knee flexors, plantar flexors and ankle-dorsal flexors. Average AS was calculated as the average of AS scores of the 6 muscles of the affected lower extremity. Change in average AS in affected lower extremities from baseline to month 6 between ITB and BMT arm was assessed. Change= AS at month 6 - AS at baseline. | Intent to treat analysis. Last Observation Carried Forward (LOCF) imputation method. | Posted | Mean | Standard Deviation | units on a scale | Baseline and month 6 |
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| Secondary | Change in Average Ashworth Scale (AS) in Affected Upper Extremities From Baseline to Month 6 | AS is a manual test, measuring the resistance to passive movement about a joint with varying degrees of velocity. Scores range from 1-5, with 5 choices. A score of 1 indicates no resistance, and 5 indicates rigidity. The following muscle groups in the upper extremities were assessed: wrist flexors, elbow flexors, elbow extensors, shoulder abductors and shoulder adductors. Average AS was calculated as the average of AS scores of the 5 muscles of the affected lower extremities. Change in average AS in affected upper extremities from baseline to month 6 between ITB and BMT arm was assessed. Change= AS at month 6 - AS at baseline. | Intent to treat analysis. Last Observation Carried Forward (LOCF) imputation method. | Posted | Mean | Standard Deviation | units on a scale | Baseline and month 6 |
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| Secondary | Change in Functional Independence Measure (FIM) Score From Baseline to Month 6 | FIM contains 18 items composed of 13 motor tasks and 5 cognitive tasks. Tasks are rated on a 7-point ordinal scale that ranges from total assistance (or complete dependence) to complete independence. Ratings should reflect actual observed performance, not capability. Total score ranges from 18 (lowest) to 126 (highest) level of independence. Change in FIM total score from baseline to month 6 between ITB and BMT arm was assessed. Change=FIM score at month 6 - FIM score at baseline. | Intent to treat analysis. Last Observation Carried Forward (LOCF) imputation method. | Posted | Mean | Standard Deviation | units on a scale | Baseline and month 6 |
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| Secondary | Change in Average 10 Meter Time Walking Test (10MTWT) From Baseline to Month 6 | Change in average 10MTWT from baseline to month 6 beetween ITB and BMT arm. Change=10MTWT at month 6 - 10MTWT at baseline | Intent to treat analysis. Last Observation Carried Forward (LOCF) imputation method.Only High level functional patients (HLP) were analyzed. HLP were defined as patients able to transfer from the wheelchair to bed without human assistance. | Posted | Mean | Standard Deviation | seconds | Baseline and month 6 |
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| Secondary | Number of Participants Who Were Able to Transfer From the Wheelchair to Bed Without Human Assistance | Patient was asked to transfer from the wheelchair to bed without human assistance. High level functional patient (HLP) could transfer. Low level functional patient (LLP) was not able to transfer. Comparison of the number and percentage of HLP and LLP between ITB and BMT arms was evaluated. | Intent to treat analysis | Posted | Count of Participants | Participants | baseline, month 3, month 6 |
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| Secondary | Change in Numeric Pain Rating Scale (NPRS) From Baseline to Month 6 | NPRS is designed to assess the level of pain a patient is feeling at a point in time. The following questions has been presented to patients: What is your actual spasticity-related or spasm-related pain? What was your least spasticity-related or spasm-related pain during the last week? What was your worst spasticity-related or spasm-related pain during the last week? The patient indicated how much pain he is feeling on a scale from 0 to 10. A score of 0 (zero) is "no pain" while a score of 10 (ten) is "worst possible pain". Change in NPRS related to actual, least or worst pain from baseline to month 6 between ITB and BMT arm was assessed. Change=NPRS at month 6 - NPRS at baseline. | Intent to treat analysis. Last Observation Carried Forward (LOCF) imputation method. | Posted | Mean | Standard Deviation | units on a scale | Baseline and month 6 |
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| Secondary | Number of Participants Who Achieved Their Primary Therapeutic Goal Assessed With the Goal Attainment Scale (GAS) | GAS is designed to measure the achievement of treatment goals using the following 6 levels of achievement: worse than start (-3), much less than expected (-2), somewhat less than expected (-1), as expected (0), somewhat more than expected (+1), much more than expected (+2). The primary therapy goal and the criteria for the levels of achievement was defined by the medical team together with the patient and his/her family/legal representative/caregiver at the first day of the study. The number and percentage of patients who achieved the therapeutic goal at Month 6 was compared between the ITB and BMT arm. | Intent to treat analysis | Posted | Count of Participants | Participants | month 6 |
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| Secondary | Change in Euro QoL Group-5 Dimensional, 3 Level Version (EQ-5D-3L) From Baseline to Month 6 | The EQ-5D-3L is a generic measure of health status consisting in the EQ-5D-3L descriptive system and the EQ visual analogue scale (EQ VAS). The EQ-5D-3L descriptive system is characterized on five dimensions: mobility, self-care, ability to undertake usual activities, pain and anxiety/depression. Patients were asked to indicate their level of health on each dimension using one of three levels: "no health problems", "moderate health problems", and "severe health problems". Responses from the questionnaire were converted to a single health index utility score; this ranges from -0.595 to 1. EQ VAS records the patient's self-rated health on a vertical visual analogue scale from 0 to 100 where the endpoints are labelled 'Best imaginable health state' (100) and 'Worst imaginable health state' (0). Change in EQ-5D-3L utility score and VAS score from baseline to month 6 between ITB and BMT arm were assessed. Change=EQ-5D-3L utility or VAS score at month 6 - EQ-5D-3L utility or VAS score. | Intent to treat analysis. Last Observation Carried Forward (LOCF) imputation method. | Posted | Mean | Standard Deviation | units on a scale | Baseline and month 6 |
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| Secondary | Change in SF-12 (12-item Short Form) From Baseline to Month 6 | The SF-12 is generic assessment of health-related quality of life, which evaluates 8 health dimensions (physical functioning, role physical, bodily pain, vitality, social functioning, role emotional, mental health, and general health). Subscale scores for each dimension were aggregated into summary scores for physical (PCS) and mental health (MCS) components (ranging from 0 to 100, with higher scores indicating better health). Changes in the PCS and MCS from baseline to Month 6 were both compared between the BMT and ITB arms. Change=SF-12 score at month 6 - SF-12 score at baseline. | Intent to treat analysis. Last Observation Carried Forward (LOCF) imputation method. SF-12 assessment has been introduced later in a second version of the protocol, hence the lower number of patients. | Posted | Mean | Standard Deviation | units on a scale | Baseline and month 6 |
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| Secondary | Change in Stroke Specific Quality of Life (SS-QoL ) From Baseline to Month 6 | SS-QoL questionnaire is a self-assessed quality of life questionnaire specifically designed for post-stroke patients. It evaluates 49 items across 12-domains: personality, energy, language, mobility, vision, upper extremity function, thinking, mood, work/productivity, self-care, and family and social roles. Each item is rated on a 5-point Likert Scale, measuring either positive or negative response to a statement. Summary score is composed of an unweighted average of the 12 domain scores, with higher scores indicating better QoL. Total score ranges from 1 to 5. Change in SS-QoL summary score from baseline to month 6 between ITB and BMT arm was assessed. Change=SS-QoL score at month 6 - SS-QoL score at baseline. | Intent to treat analysis. Last Observation Carried Forward (LOCF) imputation method. | Posted | Mean | Standard Deviation | units on a scale | Baseline and month 6 |
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| Secondary | Therapy Satisfaction | Patients were presented with two statements ("I am satisfied with the reduction in spasticity provided by my treatment", and "I would recommend this therapy to a friend"). They agreed, disagreed or were neutral with the statements. | Intent to treat analysis. | Posted | Count of Participants | Participants | month 6 |
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| Secondary | Healthcare Resource Utilization | Number of patients with healthcare professional contacts outside of study visits in the ITB and BMT between baseline and months 6 | Intent to treat analysis. | Posted | Count of Participants | Participants | baseline, ITB test (only ITB arm), second assessment (only BMT arm), week 6 (only ITB arm), month 3, month 6 |
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From ITB test (for ITB arm) and randomization (for BMT arm) untill month 6 follow-up visit
Safety analyses were performed on a modified ITT (intent to treat) patient set: all patients were analyzed as treated; ITB-I included only implated patients. BMT+ITB-NI included also patients randomized to ITB, but not implanted.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ITB-I | Patients implanted with intrathecal baclofen pump | 1 | 25 | 12 | 25 | 23 | 25 |
| EG001 | BMT+ITB-NI | Patients randomized to BMT plus patients randomized to ITB but not implanted (treated with one or a combination oral antispastic medication) | 0 | 35 | 10 | 35 | 21 | 35 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Urinary tract infection | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Implant site infection | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Cystitis | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Pneumonia bacterial | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Cerebrovascular accident | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Hemiparesis | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Intracranial hypotension | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Muscle spasticity | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Normal pressure hydrocephalus | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Transient ischaemic attack | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Nephrolithiasis | Renal and urinary disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Hydronephrosis | Renal and urinary disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Device dislocation | General disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Device occlusion | General disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Implant site effusion | General disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Pain | General disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Alcohol poisoning | Injury, poisoning and procedural complications | MedDRA (13.0) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (13.0) | Systematic Assessment |
| |
| Post-traumatic pain | Injury, poisoning and procedural complications | MedDRA (13.0) | Systematic Assessment |
| |
| Suture related complication | Injury, poisoning and procedural complications | MedDRA (13.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Mobility decreased | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Plantar fasciitis | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Diastolic dysfunction | Cardiac disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Mitral valve stenosis | Cardiac disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Mental disorder | Psychiatric disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Faecaloma | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Diabetic retinopathy | Eye disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) | Systematic Assessment |
| |
| Osteochondroma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.0) | Systematic Assessment |
| |
| Ingrowing nail | Skin and subcutaneous tissue disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cerumen impaction | Ear and labyrinth disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Conjunctivitis | Eye disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Eyelid oedema | Eye disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Vision blurred | Eye disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Faecaloma | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Gastritis | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Hypoaesthesia oral | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Implant site pain | General disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Pain | General disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Adverse drug reaction | General disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Asthenia | General disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Chronic fatigue syndrome | General disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Gait disturbance | General disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Implant site reaction | General disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Drug hypersensitivity | Immune system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Bronchopneumonia | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Nail infection | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA (13.0) | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA (13.0) | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA (13.0) | Systematic Assessment |
| |
| Head injury | Injury, poisoning and procedural complications | MedDRA (13.0) | Systematic Assessment |
| |
| Incision site erythema | Injury, poisoning and procedural complications | MedDRA (13.0) | Systematic Assessment |
| |
| Incision site pain | Injury, poisoning and procedural complications | MedDRA (13.0) | Systematic Assessment |
| |
| Limb injury | Injury, poisoning and procedural complications | MedDRA (13.0) | Systematic Assessment |
| |
| Postoperative ileus | Injury, poisoning and procedural complications | MedDRA (13.0) | Systematic Assessment |
| |
| Procedural headache | Injury, poisoning and procedural complications | MedDRA (13.0) | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA (13.0) | Systematic Assessment |
| |
| Skin laceration | Injury, poisoning and procedural complications | MedDRA (13.0) | Systematic Assessment |
| |
| Blood pressure increased | Investigations | MedDRA (13.0) | Systematic Assessment |
| |
| Residual urine volume increased | Investigations | MedDRA (13.0) | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Vitamin D deficiency | Metabolism and nutrition disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Bursitis | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Plantar fasciitis | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Complex regional pain syndrome | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Epilepsy | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Hemiparesis | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Hypotonia | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Muscle spasticity | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Myoclonus | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Sedation | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Aggression | Psychiatric disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Depressed mood | Psychiatric disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Listless | Psychiatric disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Dysuria | Renal and urinary disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Erectile dysfunction | Reproductive system and breast disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Pelvic pain | Reproductive system and breast disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Postnasal drip | Respiratory, thoracic and mediastinal disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Blister | Skin and subcutaneous tissue disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Ingrowing nail | Skin and subcutaneous tissue disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Decubitus ulcer | Skin and subcutaneous tissue disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Alcohol use | Social circumstances | MedDRA (13.0) | Systematic Assessment |
| |
| Cataract operation | Surgical and medical procedures | MedDRA (13.0) | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Hypertensive crisis | Vascular disorders | MedDRA (13.0) | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MedDRA (13.0) | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alessandra Calabrese, PhD | Medtronic Clinical Neuromodulation | alessandra.calabrese@medtronic.com |
| ID | Term |
|---|---|
| D009128 | Muscle Spasticity |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D009122 | Muscle Hypertonia |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
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