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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)

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ClinicalTrials.gov Identifier: NCT01839279
Recruitment Status : Completed
First Posted : April 24, 2013
Results First Posted : June 1, 2015
Last Update Posted : February 5, 2019
Sponsor:
Information provided by (Responsible Party):
Acorda Therapeutics

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Spasticity Drug: Tizanidine Drug: Placebo Drug: Moxifloxacin Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 136 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : April 2013
Actual Primary Completion Date : February 2014
Actual Study Completion Date : May 2014

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Tizanidine
Oral dose of 2 and 4 milligram (mg) tablets
 Drug: Tizanidine
Other Name: Zanaflex
Placebo Comparator: Placebo
Placebo followed by a single dose 400 mg moxifloxacin tablets.
 Drug: Placebo
Drug: Moxifloxacin
Active Comparator: Moxifloxacin
Single dose of 400 mg moxifloxacin followed by placebo.
 Drug: Placebo
Drug: Moxifloxacin


Outcome Measures
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Primary Outcome Measures :
  1. The Primary Endpoint Will be the Baseline-adjusted, Placebo-corrected Effect on QTc (ΔΔQTc) on Day 14. [ Time Frame: Baseline and Day 14 ]
    Change from baseline in Cardiac Repolarization (QTc Interval) at Day 14 (Tizanidine 24 mg). Moxifloxacin was not investigational drug, it was used to assess the sensitivity of the study.


Secondary Outcome Measures :
  1. The Baseline-adjusted, Placebo-corrected (ΔΔQTc) on QTc Method Not Selected as Primary Endpoint. [ Time Frame: Baseline and Day 5 ]
    Change from baseline in Cardiac Repolarization (QTc Interval) at Day 5 (Tizanidine 8 mg). Moxifloxacin was not investigational drug, it was used to assess the sensitivity of the study.

  2. Assessing the Relationship Between Changes in the QTc Interval and Plasma Levels of Tizanidine Using Concentration-effect Modeling [ Time Frame: Day 5, Day 14 ]
    The relationship will be quantified using a linear mixed effects model with an intercept. Data from Day 5 and Day 14 were fitted into regression model to obtain a slope of change. The measure type 'Number' followed by (90% Confidence Interval) shown in results is the slope from the linear fit.

  3. Maximum Plasma Concentration (Cmax) of Single Doses of 8 and 24 mg Tizanidine After Reaching Steady State. [ Time Frame: 0.5, 1, 1.5, 2, 4, 8, 12 & 24 hours post dose on Days 5 (8 mg) and 14 (24 mg) ]
  4. Time to Reach Maximum Plasma Concentration (Tmax) of Single Doses of 8 and 24 mg Tizanidine After Reaching Steady State. [ Time Frame: 0.5, 1, 1.5, 2, 4, 8, 12 & 24 hours post dose on Days 5 (8 mg) and 14 (24 mg) ]
  5. Area Under the Plasma Concentration-time Curve During a Dosing Interval (AUCt) of Single Doses of 8 and 24 mg Tizanidine After Reaching Steady State. [ Time Frame: 0.5, 1, 1.5, 2, 4, 8, 12 & 24 hours post dose on Days 5 (8 mg) and 14 (24 mg) ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01839279


Locations
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United States, Texas
Covance- Dallas
Dallas, Texas, United States, 75247
Sponsors and Collaborators
Acorda Therapeutics
Investigators
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Study Director: Mathews Adera, MD Acorda Therapeutics
More Information
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Responsible Party: Acorda Therapeutics
ClinicalTrials.gov Identifier: NCT01839279     History of Changes
Other Study ID Numbers: ZAN-QT-1006
First Posted: April 24, 2013    Key Record Dates
Results First Posted: June 1, 2015
Last Update Posted: February 5, 2019
Last Verified: May 2015
Additional relevant MeSH terms:
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Muscle Spasticity
Muscular Diseases
Musculoskeletal Diseases
Muscle Hypertonia
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Moxifloxacin
Clonidine
Tizanidine
Norgestimate, ethinyl estradiol drug combination
Anti-Bacterial Agents
Anti-Infective Agents
Topoisomerase II Inhibitors
 Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Contraceptives, Oral, Combined
Contraceptives, Oral
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Anticonvulsants
Muscle Relaxants, Central