E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Upper limb spasticity following stroke |
|
MedDRA Classification |
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 compare the upper limb (UL) function of patients with spasticity due to stroke who receive botulinum toxin injection(s) to the upper arm and/or forearm flexors/hand/shoulder girdle plus a four week evidence based UL therapy programme (intervention group) with subjects who receive the UL therapy programme alone (control group) one month after study entry. |
|
E.2.2 | Secondary objectives of the trial |
• To compare the upper limb (UL) function and impairment of patients with spasticity due to stroke who receive botulinum toxin injection(s) to the upper arm and/or forearm flexors/hand/shoulder girdle plus a four week evidence based UL therapy programme (intervention group) with subjects who receive the UL therapy programme (control group) 3 and 12 months after study entry. • To compare attainment of patient-selected UL goals, disability and stroke related quality of life between intervention and control groups at 1, 3 and 12 months. • To seek the experience and views of patients about UL botulinum toxin treatment and the UL therapy programme • To compare the health and social services resources used by control and intervention groups • To report adverse events and compare the use of other antispasticity treatments between intervention and control groups. • To investigate the influence of severity of UL impairment, time since stroke, and baseline muscle activity. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Aged over 18 years • At least 1 month since stroke • Upper limb spasticity ( MAS >2 at the elbow and/or spasticity at wrist or shoulder (no validated measure of spasticity at these sites.) • Reduced UL function (ARAT score 0-56). • Willing and able to participate in UL therapy programme. • Patient must be able and willing to understand and comply with the requirements of the protocol and the UL therapy programme. •Written informed consent before completing any study-related procedure (any assessment or evaluation that would not have formed par of their normal care). Patient must be able and willing to understand and comply with the requirements of the protocol and the UL therapy programme.
|
|
E.4 | Principal exclusion criteria |
•Significant speech or cognitive impairment which will impede assessment •Other significant upper limb impairment e.g. fracture or frozen shoulder within 6 months, severe arthritis, amputation. •Evidence of contracture •Pregnancy or lactation (female patients who are at risk of pregnancy must have a negative pregnancy test on the day of randomisation and prior to any subsequent botulinum injection). •Female patients at risk of pregnancy who are not willing to take adequate precautions against pregnancy for the duration of the study. •Diagnosis likely to interfere with rehabilitation or outcome assessments e.g. registered blind, malignancy. •Other diagnosis which may contribute to upper limb spasticity e.g. multiple sclerosis, cerebral palsy. •Contraindications to intramuscular injection. •Religious objections to blood products(botulinum toxin contains human albumin) •Contraindications to botulinum toxin which include bleeding disorders, myasthenia gravis and concurrent use of aminoglycosides. •Use of botulinum toxin to the upper limb in the previous three months. •Known allergy or hypersensivity to any of the test compounds
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
Comparison of the difference in the Action Research Arm Test (ARAT) score between the 2 treatment groups 4 weeks after study entry. |
|
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 | Yes |
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 | Yes |
E.6.13.1 | Other scope of the trial description |
Cost effectiveness (health and social services resources) |
|
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) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Upper limb therapy programme. |
|
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 | 11 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
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
|
This is the last visit of the last subject undergoing the trial. |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |