NCT01549847

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 7, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 9, 2012

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
Last Updated

November 17, 2015

Status Verified

November 1, 2015

First QC Date

March 7, 2012

Last Update Submit

November 16, 2015

Conditions

Postpoliomyelitis Syndrome

Keywords

Postpoliomyelitis SyndromePiracetamL-Carnitine

Outcome Measures

Primary Outcomes (2)

  • Changes in Muscle Weakness

    26 weeks

  • Changes in fatigue

    26 weeks

Secondary Outcomes (7)

  • Changes in muscle pain

    26 weeks

  • Changes in daytime sleepiness

    26 weeks

  • Changes in quality of life

    26 weeks

  • Changes in daily function

    26 weeks

  • Changes in depressive mood

    26 weeks

  • +2 more secondary outcomes

Study Arms (2)

L-carnitine and piracetam

EXPERIMENTAL
Drug: L-carnitine and piracetam

Placebo

PLACEBO COMPARATOR
Drug: Placebo

Interventions

L-carnitine and piracetamDRUG

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

L-carnitine and piracetam
PlaceboDRUG

Placebo PO BID

Placebo

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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;
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UNIFESP

São Paulo, São Paulo, Brazil

Location

MeSH Terms

Conditions

Postpoliomyelitis Syndrome

Interventions

CarnitinePiracetam

Condition Hierarchy (Ancestors)

PoliomyelitisMyelitisCentral Nervous System InfectionsInfectionsEnterovirus InfectionsPicornaviridae InfectionsRNA Virus InfectionsVirus DiseasesMuscular Disorders, AtrophicMuscular DiseasesMusculoskeletal DiseasesCentral Nervous System DiseasesNervous System DiseasesSpinal Cord DiseasesNeurodegenerative DiseasesNeuroinflammatory DiseasesNeuromuscular Diseases

Intervention Hierarchy (Ancestors)

Trimethyl Ammonium CompoundsQuaternary Ammonium CompoundsAminesOrganic ChemicalsAcetamidesAmidesAcetatesAcids, AcyclicCarboxylic AcidsPyrrolidinonesPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Acary Souza Bulle Oliveira, MD, PhD

    Federal University of São Paulo

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 7, 2012

First Posted

March 9, 2012

Primary Completion

February 1, 2013

Last Updated

November 17, 2015

Record last verified: 2015-11

Locations

BR(1)