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Study was not approved by Health Surveillance Agency
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This protocol aims to assess of L-carnitine and piracetam to relieve weakness, muscle fatigue and muscle pain in patients with Postpoliomyelitis Syndrome.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| L-carnitine and piracetam | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| L-carnitine and piracetam | Drug | L-carnitine/piracetam (990mg/810mg) PO BID |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Muscle Weakness | 26 weeks | |
| Changes in fatigue | 26 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in muscle pain | 26 weeks | |
| Changes in daytime sleepiness | 26 weeks | |
| Changes in quality of life |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Acary Souza Bulle Oliveira, MD, PhD | Federal University of São Paulo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UNIFESP | São Paulo | São Paulo | Brazil |
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| Placebo |
| Drug |
Placebo PO BID |
|
| 26 weeks |
| Changes in daily function | 26 weeks |
| Changes in depressive mood | 26 weeks |
| Changes in oxidative capacity in skeletal muscle | 26 weeks |
| Occurrence of adverse events | 26 weeks |
| ID | Term |
|---|---|
| D016262 | Postpoliomyelitis Syndrome |
| ID | Term |
|---|---|
| D011051 | Poliomyelitis |
| D009187 | Myelitis |
| D002494 | Central Nervous System Infections |
| D007239 | Infections |
| D004769 | Enterovirus Infections |
| D010850 | Picornaviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D020966 | Muscular Disorders, Atrophic |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D013118 | Spinal Cord Diseases |
| D019636 | Neurodegenerative Diseases |
| D000090862 | Neuroinflammatory Diseases |
| D009468 | Neuromuscular Diseases |
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| ID | Term |
|---|---|
| D002331 | Carnitine |
| D010889 | Piracetam |
| ID | Term |
|---|---|
| D050337 | Trimethyl Ammonium Compounds |
| D000644 | Quaternary Ammonium Compounds |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D000081 | Acetamides |
| D000577 | Amides |
| D000085 | Acetates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D011760 | Pyrrolidinones |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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