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Trial record 11 of 37 for:    acorda

A Study to Define the ECG Effects of Tizanidine Compared to Placebo and the Positive Control, Moxifloxacin, in Healthy Men and Women Using a Blinded ECG Evaluator: A Thorough ECG Trial (TQT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Acorda Therapeutics
ClinicalTrials.gov Identifier:
NCT01839279
First received: April 22, 2013
Last updated: May 29, 2014
Last verified: May 2014
  Purpose

This is a single-center, partial-blind, randomized, placebo-controlled, parallel design study with a nested crossover comparison to define the ECG effects of tizanidine compared to placebo and the positive control, moxifloxacin, in healthy men and women. The study will be conducted in a Phase 1 unit with sufficient facilities to house subjects as required by the protocol.


Condition Intervention Phase
Spasticity
Drug: Tizanidine
Drug: Placebo crossover to moxifloxacin
Drug: Moxifloxacin crossover to placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Partial-Blind, Randomized, Parallel Design Study With a Nested Crossover Comparison to Define the ECG Effects of Tizanidine Compared to Placebo and the Positive Control, Moxifloxacin, in Healthy Men and Women Using a Blinded ECG Evaluator: A Thorough ECG Trial

Resource links provided by NLM:


Further study details as provided by Acorda Therapeutics:

Primary Outcome Measures:
  • A single supratherapeutic oral dose of tizanidine 24 mg given with food and its effects on cardiac repolarization (QTc interval) in healthy volunteers [ Time Frame: on Day 14 ] [ Designated as safety issue: No ]
    The primary endpoint will be the baseline-adjusted, placebo-corrected effect on QTc (ΔΔQTc) on Day 14.


Secondary Outcome Measures:
  • Safety of a single therapeutic dose of tizanidine 8 mg given with food and its effects on cardiac repolarization (QTc) interval in healthy volunteers [ Time Frame: Day 5 ] [ Designated as safety issue: No ]
    The baseline-adjusted, placebo-corrected (ΔΔQTc) on QTc method not selected as primary endpoint

  • Assessing the relationship between changes in the QTc interval and plasma levels of tizanidine using concentration-effect modeling [ Time Frame: Days -1, 1, 5, 14, 15 ] [ Designated as safety issue: No ]
    1) Model 1 will be a linear model with an intercept; 2) Model 2 will be a linear model with mean intercept fixed to 0 (with variability); and 3) Model 3 will be a linear model with no intercept.

  • Pharmacokinetic (PK) profile of single doses of 8 and 24 mg tizanidine after reaching steady state [ Time Frame: Days 5 and 14 ] [ Designated as safety issue: No ]
    Area under the plasma concentration-time curve during a dosing interval (AUCt), maximum plasma concentration (Cmax), the lowest plasma concentration (Ctrough), and time to reach maximum plasma concentration (tmax).


Enrollment: 136
Study Start Date: April 2013
Study Completion Date: May 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tizanidine
Oral dose of 2 and 4 milligram (mg) tablets
Drug: Tizanidine
Other Name: Zanaflex
Placebo Comparator: Placebo crossover to moxifloxacin
Placebo followed by a single dose 400 mg moxifloxacin tablets.
Drug: Placebo crossover to moxifloxacin
Active Comparator: Moxifloxacin crossover to placebo
single dose of 400 mg moxifloxacin followed by placebo
Drug: Moxifloxacin crossover to placebo

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Women of childbearing potential should have a negative urine pregnancy test prior to Screening and Day -2 of the trial
  • All subjects of childbearing potential must practice a highly effective method of birth control excluding oral contraceptives for the duration of the trial and up to 3 months after the last dose of investigational product. Oral contraceptives are not allowed, based on the precaution listed in the Zanaflex package insert.
  • Have a body mass index (BMI) ranging between 19 and 30 kg/m2
  • Comprehend and be able to provide written informed consent
  • Be willing and able to comply with all trial requirements

Exclusion Criteria:

  • Female who is either pregnant, breastfeeding or planning to become pregnant
  • History of hypersensitivity or allergic reaction to tizanidine or moxifloxacin or any of the tablet components
  • Any condition possibly affecting drug absorption, metabolism or excretion including previous surgery for removal of parts of stomach, bowel, liver, gall bladder, or pancreas
  • History of Long QT Syndrome or a first-generation relative with this condition
  • Evidence or history of clinically significant allergies except for untreated, asymptomatic, seasonal allergies at time of dosing, hematological, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, renal, psychiatric, or neurological disease. Determination of clinical significance is to be made at the Investigator's discretion
  • History or presence of any malignant or benign neoplasm considered by the investigator to be clinically significant
  • History of drug or alcohol abuse or dependence within the last year
  • Have an active infectious disease
  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: NCT01839279

Locations
United States, Texas
Covance- Dallas
Dallas, Texas, United States, 75247
Sponsors and Collaborators
Acorda Therapeutics
Investigators
Study Director: Mathews Adera, MD Acorda Therapeutics
  More Information

No publications provided

Responsible Party: Acorda Therapeutics
ClinicalTrials.gov Identifier: NCT01839279     History of Changes
Other Study ID Numbers: ZAN-QT-1006
Study First Received: April 22, 2013
Last Updated: May 29, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Moxifloxacin
Norgestimate, ethinyl estradiol drug combination
Tizanidine
Adrenergic Agents
Adrenergic Agonists
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Analgesics
Anti-Bacterial Agents
Anti-Infective Agents
Anticonvulsants
Antineoplastic Agents
Autonomic Agents
Central Nervous System Agents
Contraceptive Agents
Contraceptive Agents, Female
Contraceptives, Oral
Contraceptives, Oral, Combined
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Muscle Relaxants, Central
Neuromuscular Agents
Neurotransmitter Agents
Parasympatholytics
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014