A Randomized, Double Blind, Placebo Controlled Trial L-carnitine and Piracetam in the Treatment of Weakness, Muscle Fatigue and Muscle Pain in the Postpoliomyelitis Syndrome

NCT ID: NCT01549847

Last Updated: 2015-11-17

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL

Brief Summary

This protocol aims to assess of L-carnitine and piracetam to relieve weakness, muscle fatigue and muscle pain in patients with Postpoliomyelitis Syndrome.

Conditions

Postpoliomyelitis Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

L-carnitine and piracetam

Group Type: EXPERIMENTAL

L-carnitine and piracetam

Intervention Type: DRUG

L-carnitine/piracetam (990mg/810mg) PO BID

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo PO BID

Interventions

L-carnitine and piracetam

L-carnitine/piracetam (990mg/810mg) PO BID

Intervention Type: DRUG

Placebo

Placebo PO BID

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patients with Postpoliomyelitis Syndrome diagnosis confirmed over a year;
• Electromyography test compatible with poliomyelitis;
• Preserved ability to swallow medication;
• Oral communication ability preserved;
• Preserved ability to perform pedaling test in at least one lower limb affected by Postpoliomyelitis Syndrome;
• Ability to understand information about the study and to document the decision about participating in the trial by signing the Informed Consent Form.

Exclusion Criteria

• History of intolerance to L-carnitine or piracetam;
• Treatment with L-carnitine during the past 3 months;
• Treatment with piracetam or any other nootropics pyrrolidone derivatives, during the past three months;
• Anemia (hemoglobin reference range - men 13 to 17 g/dL and women 12 to 15 g/dL);
• High level of glycated hemoglobin (> 7.0%);
• Electrolyte imbalance (hypokalaemia - reference potassium concentration range: 3.5 to 5.6 mmol / L);
• Renal failure (creatinine reference range: 0.70 to 1.50 mg/dL);
• Urinary tract infection;
• Thyroid dysfunction (reference range: free T4: 0.54 to 0.67 mg/dL and TSH reference range: 0.5 to 5.5 μUI/mL) or usual treatment with thyroid hormone supplementation;
• Cardiomyopathy;
• Uncontrolled hypertension;
• Known or suspected autoimmune disease;
• Confirmed pregnancy, or plans to get pregnant during the trial;
• Depression or bipolar affective disorders with moderate to severe episodes within the last twelve months;
• Insulin-dependent diabetes mellitus;
• Treatment with anticoagulant drugs over two weeks (including non-steroidal anti-inflammatory drugs (NSAIDs), warfarin, phenprocoumon, heparin);
• Usual cocaine or alcohol use;
• Any other condition judged by the investigator as a possibility to interfere on the participant's decision to be part of the study or to accomplish investigation procedures.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biolab Sanus Farmaceutica

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Acary Souza Bulle Oliveira, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Federal University of São Paulo

Locations

UNIFESP

São Paulo, São Paulo, Brazil

Countries

Brazil

Other Identifiers

CAR-PIR.11.01

Identifier Type: -

Identifier Source: org_study_id