Trial record 4 of 13 for:    "Post Polio syndrome"

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Biolab Sanus Farmaceutica.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Biolab Sanus Farmaceutica
ClinicalTrials.gov Identifier:
NCT01549847
First received: March 7, 2012
Last updated: March 8, 2012
Last verified: March 2012
  Purpose

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


Condition Intervention Phase
Postpoliomyelitis Syndrome
Drug: L-carnitine and piracetam
Drug: Placebo
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Biolab Sanus Farmaceutica:

Primary Outcome Measures:
  • Changes in Muscle Weakness [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
  • Changes in fatigue [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in muscle pain [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
  • Changes in daytime sleepiness [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
  • Changes in quality of life [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
  • Changes in daily function [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
  • Changes in depressive mood [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
  • Changes in oxidative capacity in skeletal muscle [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
  • Occurrence of adverse events [ Time Frame: 26 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 120
Study Start Date: April 2012
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: L-carnitine and piracetam Drug: L-carnitine and piracetam
L-carnitine/piracetam (990mg/810mg) PO BID
Placebo Comparator: Placebo Drug: Placebo
Placebo PO BID

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01549847

Locations
Brazil
UNIFESP Not yet recruiting
São Paulo, SP, Brazil
Contact: Acary Souza Bulle Oliveira, MD, PhD         
Principal Investigator: Acary Souza Bulle Oliveira, MD, PhD         
Sponsors and Collaborators
Biolab Sanus Farmaceutica
Investigators
Principal Investigator: Acary Souza Bulle Oliveira, MD, PhD Federal University of São Paulo
  More Information

No publications provided

Responsible Party: Biolab Sanus Farmaceutica
ClinicalTrials.gov Identifier: NCT01549847     History of Changes
Other Study ID Numbers: CAR-PIR.11.01
Study First Received: March 7, 2012
Last Updated: March 8, 2012
Health Authority: Brazil: National Health Surveillance Agency

Keywords provided by Biolab Sanus Farmaceutica:
Postpoliomyelitis Syndrome
Piracetam
L-Carnitine

Additional relevant MeSH terms:
Postpoliomyelitis Syndrome
Muscle Weakness
Poliomyelitis
Myelitis
Central Nervous System Viral Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Muscular Disorders, Atrophic
Muscular Diseases
Musculoskeletal Diseases
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
Spinal Cord Diseases
Neurodegenerative Diseases
Neuromuscular Diseases
Neuromuscular Manifestations
Neurologic Manifestations
Pathologic Processes
Signs and Symptoms
Carnitine
Piracetam
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 24, 2014