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

Postpoliomyelitis Syndrome Clinical Trial

Official title:

A Phase III, Randomized, Double Blind, Placebo Controlled Trial to Evaluate the Therapeutic Effect of the Association of L-carnitine and Piracetam as an Adjuvant Therapy in the Treatment of Weakness, Muscle Fatigue and Muscle Pain in the Postpoliomyelitis Syndrome

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01549847
• Other study ID #: CAR-PIR.11.01
• Status: Withdrawn
• Phase: Phase 3
• First received: March 7, 2012
• Last updated: November 16, 2015

Study information

• Verified date: November 2015
• Source: Biolab Sanus Farmaceutica
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Health Surveillance Agency
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Muscle Weakness
• Postpoliomyelitis Syndrome
• Syndrome

Intervention

Drug:
• L-carnitine and piracetam
L-carnitine/piracetam (990mg/810mg) PO BID
• Placebo
Placebo PO BID

Locations

Country	Name	City	State
Brazil	UNIFESP	São Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
Biolab Sanus Farmaceutica

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Muscle Weakness		26 weeks	No
Primary	Changes in fatigue		26 weeks	No
Secondary	Changes in muscle pain		26 weeks	No
Secondary	Changes in daytime sleepiness		26 weeks	No
Secondary	Changes in quality of life		26 weeks	No
Secondary	Changes in daily function		26 weeks	No
Secondary	Changes in depressive mood		26 weeks	No
Secondary	Changes in oxidative capacity in skeletal muscle		26 weeks	No
Secondary	Occurrence of adverse events		26 weeks	Yes