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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

Tracking Information
First Submitted Date  ICMJE April 22, 2013
First Posted Date  ICMJE April 24, 2013
Results First Submitted Date  ICMJE February 27, 2015
Results First Posted Date  ICMJE June 1, 2015
Last Update Posted Date February 5, 2019
Study Start Date  ICMJE April 2013
Actual Primary Completion Date February 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 12, 2015)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: April 23, 2013)
  • 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 ]
    The primary endpoint will be the baseline-adjusted, placebo-corrected effect on QTc (ΔΔQTc) on Day 14.
  • Safety of 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: Up to 26 ± 2 days (end of study follow-up call) ]
    Adverse events will be assessed throughout a subject's participation in the study including a follow-up phone call approximately 1 week after the last dose of investigational drug.
Change History Complete list of historical versions of study NCT01839279 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 12, 2015)
  • 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.
  • 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.
  • 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) ]
  • 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) ]
  • 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) ]
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Spasticity
Intervention  ICMJE
  • Drug: Tizanidine
    Other Name: Zanaflex
  • Drug: Placebo
  • Drug: Moxifloxacin
Study Arms  ICMJE
  • Experimental: Tizanidine
    Oral dose of 2 and 4 milligram (mg) tablets
    Intervention: Drug: Tizanidine
  • Placebo Comparator: Placebo
    Placebo followed by a single dose 400 mg moxifloxacin tablets.
    Interventions:
    • Drug: Placebo
    • Drug: Moxifloxacin
  • Active Comparator: Moxifloxacin
    Single dose of 400 mg moxifloxacin followed by placebo.
    Interventions:
    • Drug: Placebo
    • Drug: Moxifloxacin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 29, 2014)
136
Original Estimated Enrollment  ICMJE
 (submitted: April 23, 2013)
116
Actual Study Completion Date  ICMJE May 2014
Actual Primary Completion Date February 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01839279
Other Study ID Numbers  ICMJE ZAN-QT-1006
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Acorda Therapeutics
Study Sponsor  ICMJE Acorda Therapeutics
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Mathews Adera, MD Acorda Therapeutics
PRS Account Acorda Therapeutics
Verification Date May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP