E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Nervous System Diseases [C10] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 17.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10028335 |
E.1.2 | Term | Muscle spasticity |
E.1.2 | System Organ Class | 10029205 - Nervous system disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To demonstrate that ITB therapy, compared to BMT, has superior efficacy in the treatment of spasticity in adult post-stroke patients with generalised spastic hypertonia who have not reached their therapy goal with other treatment interventions assessed by the Ashworth Scale (AS) |
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E.2.2 | Secondary objectives of the trial |
To evaluate whether ITB therapy is superior to BMT on:
- Function assessed by Fuctional Independence Measure (FIM), 10 meter timed walking test
- Safety (Adverse Events (AE))
- Pain assessed by Numeric Pain Rating Scale (NPRS)
- Primary therapy goal achievement assessed by Goal Attainment Scale (GAS)
- Quality of Life (QoL) assessed by QoL questionnaires: EuroQol group - 5 dimensional (EQ-5D) and Stroke Specific - Quality of Life (SS-QoL)
- Satisfaction withthe therapy assessed by Likert Scale (patient and caregiver)
- Healthcare resource utilisation. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
To be eligible for inclusion into this study, patients must fulfil all of the following criteria prior to study enrolment:
1. Patient (or legal guardian) has been informed of the study procedures and has given written informed consent.
2. 18 - 75 years of age
3. Patieint experienced last stroke > 6 months prior to enrolment
4. Patient presents spasticity in at least two extremities
5. Patient presents an Ashworth score of at least 3 in a minimum of two of the affected muscle groups in the lower extremities
6. Patient is eligible to receive ITB therapy following the Adult Spasticity Algorithm
a. Patient does not reach his/her therapy goal with other treatment interventions
7. Patient is medically stable:
a. stable blood pressure:
i. no change in hypertensive medication in the last month
NOTE: ventriculo-peritoneal shunts and valves can be present
8. If female, she must either:
a. be post-menopausal or surgically sterilised; or
b. use a hormonal contraceptive, intra-uterine device, diaphragm with spermicide,
or condom with spermicide, for the duration of the study
9. Patient/family is willing to comply with the study protocol including attending the study visits |
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E.4 | Principal exclusion criteria |
To be eligible for inclusion in this study the patients must NOT meet any of the following criteria:
1. Patient/family is considered by the physician to be unable or unwilling to participate in long-term ITB therapy management
2. Patient has known hypersensitivity to baclofen
3. Active systemic infection
NOTE: pressure sores are not a contraindication unless they are present near the
implant sites
4. Presence of a cardiac pacemaker, ICD, implantable neurostimulator or drug delivery device
5. Uncontrolled refractory epilepsy
6. Use of oral vitamin K anatagonists e.g. warfarin or coumadin; unless the patient can switch to another accepted anticoagulant (e.g. heparin) for the period of ITB test and implant
7. Patient is pregnant or breast feeding
8. Patient received a Botulinum toxin injectin less than 4 months ago
9. According to the investigator's opinion, the patient is not capable to comprehend the nature of the study and to give his/her informed consent him/herself |
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary Endpoints:
The average AS will be calculated as an average of the S value on following lower extremities muscles: hip flexors, hip adductors, knee extensors, knee flexors and ankle dorsal flexors.
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Timepoint of evaluation of this endpoint:
Change inthe average AS from baseline to 6 months visit.
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E.5.2 | Secondary end point(s) |
Secondary Endpoint:
Secondary endpoints will be evaluated to assess improvements in function, pain, satisfaction with the therapy, primary therapy goal achievement, resource utilisation and quality of life in the ITB therapy arm compared to the BMT arm.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Timepoint of evaluation of this endpoint:
Secondary endpoints will be evaluated at 6 months visit |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 18 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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Last visit of the last patient |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 7 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 7 |