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| Name | Class |
|---|---|
| The Danish Multiple Sclerosis Society | UNKNOWN |
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The purpose of this study is to investigate fatigue in patients with multiple sclerosis (MS) and to determine the correlation between the symptom and cerebral changes.
Only recruiting from:
Department of Neurology, Aarhus University Hospital, Denmark
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 3.4 diaminopyridine | Active Comparator | Single dose 3,4 diaminopyridine |
|
| Placebo | Placebo Comparator | Two tablets identical to active treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3,4-diaminopyridine | Drug | Single dose 3,4 diaminopyridine |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Subjective fatigue (FSS) | Weeks | |
| Maximal voluntary isometric contraction, central activation before and after exercise | at the time of investigation | |
| Digit Symbol-Coding scores | Weeks | |
| Changes in normal appearing white matter and normal appearing gray matter (MRS-, MTI- and DTI- parameters) | at the time of MRI | |
| Cortical atrophy | at the time of MRI | |
| Intracortical inhibition/facilitation determined by transcranial magnetic stimulation (+/- 3,4-diaminopyridine) | at the time of investigation |
| Measure | Description | Time Frame |
|---|---|---|
| Subjective fatigue (MFI-20, Danish version) | Weeks | |
| Rapid voluntary twitches | at the time of investigation | |
| 6 minute walk test |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Henning Andersen, MD, DMSc | Aarhus University Hospital | Principal Investigator |
| Johannes Jacobsen, Professor | Aarhus University Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aarhus University Hospital, Department of Neurology | Aarhus | 8000 | Denmark |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D005221 | Fatigue |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| ID | Term |
|---|---|
| D000077770 | Amifampridine |
| ID | Term |
|---|---|
| D015761 | 4-Aminopyridine |
| D000631 | Aminopyridines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
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| Placebo |
| Drug |
Single dose placebo treatment |
|
|
| at the time of investigation |
| 9-hole peg test | at the time of investigation |
| WAIS/WMS tests | at the time of investigation |
| WHO-5 Questionnaire | at the time of investigation |
| Major Depression Inventory | at the time of investigation |
| Lesion load | at the time of MRI |
| Whole brain atrophy | at the time of MRI |
| Subjective fatigue (VAS) | at the time of investigation |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011725 |
| Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |