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 | 15.1 |
E.1.2 | Level | HLT |
E.1.2 | Classification code | 10052785 |
E.1.2 | Term | Multiple sclerosis acute and progressive |
E.1.2 | System Organ Class | 100000004852 |
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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 |
The aim of this study is to examine whether prolonged release fampridine Fampyra can enhance the beneficial effect of physical exercise in patients with MS and to examine whether the combined beneficial effect can increase activity and thereby possibly social participation and Quality of Life in an ICF context (the International Classification of Functioning, Disability and Health) [33].
Furthermore it is the aim to examine whether the potential beneficial effect persists three months after ended intervention and to estimate the influence of both the neural and the muscular component.
In addition we will propose evidence-based guidelines for the selection of patients in whom treatment with prolonged release fampridine will be beneficial.
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
-Patients with relapsing remitting multiple sclerosis (RRMS), secondary progressive multiple sclerosis (SPMS) or primary progressive multiple sclerosis (PPMS) fulfilling the McDonald criteria [34]
-age 18-60 years
-EDSS 3-6.5
-Pyramidal FS ≥ 2
-Participants must be able to transport self to gym and to the University of Southern Denmark
-Participants must be able to complete Timed 25 Foot Walk (T25FW) and Six Spot Step Test (SSST)
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E.4 | Principal exclusion criteria |
-History of epileptic seizures
-MS relapse or change in disease modifying treatment (DMT) within 60 days
-Cancer within five years
-Blood pressure ≥ 160/100
-Severe arrhythmia or ischaemic heart disease or unexplained abnormal cardiac auscultation
- ALAT ≥ 90 U/l, BASP ≥ 210 U/l, γ-GT ≥ 230 U/l
-GFR < 80 ml/min.
-History of severe pulmonary disease or unexplained abnormal pulmonary auscultation
-Pregnancy
-Concomitant treatment with carvedilol, propranolol or metformine.
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E.5 End points |
E.5.1 | Primary end point(s) |
1: Improved muscular strength in the lower extremities measured by dynamometry.
2: Primary endpoint: Self evaluated walking capacity measured by MSWS-12.
3: Walking capacity measured by SSST. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
1: 20 weeks
2: 32 weeks
2: 34 weeks |
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E.5.2 | Secondary end point(s) |
1: Activity measured by accelerometer, walking capacity measured by SSST, walking speed measured by T25FW and 6MWT, functional capacity in the lower extremities measured by CST and self evaluated walking capacity measured by MSWS-12.
2: : Quality of Life measured by SF-36, depression measured by MDI and fatigue measured by FSMC.
3: Walking speed measured by T25FW and 6MWT, functional capacity in the lower extremities measured by CST and self evaluated walking capacity measured by MSWS-12.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1: 20 weeks.
2: 32 weeks.
3: 34 weeks. |
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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 | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
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 | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | Yes |
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 | Yes |
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 | 4 |
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 | No |
E.8.7 | Trial has a data monitoring committee | No |
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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 4 |
E.8.9.1 | In the Member State concerned days | |