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Trial record 44 of 509 for:    MOXIFLOXACIN

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 Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Spasticity
Interventions Drug: Tizanidine
Drug: Placebo
Drug: Moxifloxacin
Enrollment 136
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Tizanidine Initial Placebo and Crossover to Moxifloxacin Initial Moxifloxacin and Crossover to Placebo
Hide Arm/Group Description [Not Specified] Dosing of moxifloxacin will only be analyzed for cause (if the effect of moxifloxacin is not as expected). Dosing of moxifloxacin will only be analyzed for cause (if the effect of moxifloxacin is not as expected).
Period Title: Overall Study
Started 72 32 32
QT/QTc Analysis Set 72 32 32
PK Analysis Set 70 0 0
Moxifloxacin/Placebo Analysis Set 0 31 30
PK/QTc Analysis Set 70 0 0
Completed 59 30 30
Not Completed 13 2 2
Reason Not Completed
Adverse Event             4             1             1
Withdrawal by Subject             4             1             1
Classified as 'Other'             5             0             0
Arm/Group Title Tizanidine Initial Placebo and Crossover to Moxifloxacin Initial Moxifloxacin and Crossover to Placebo Total
Hide Arm/Group Description [Not Specified] Dosing of moxifloxacin will only be analyzed for cause (if the effect of moxifloxacin is not as expected). Dosing of moxifloxacin will only be analyzed for cause (if the effect of moxifloxacin is not as expected). Total of all reporting groups
Overall Number of Baseline Participants 72 32 32 136
Hide Baseline Analysis Population Description
Safety Population
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 72 participants 32 participants 32 participants 136 participants
33.4  (6.75) 34.1  (7.51) 35.3  (7.21) 34.0  (7.03)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 72 participants 32 participants 32 participants 136 participants
Female
39
  54.2%
17
  53.1%
17
  53.1%
73
  53.7%
Male
33
  45.8%
15
  46.9%
15
  46.9%
63
  46.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 72 participants 32 participants 32 participants 136 participants
Hispanic or Latino
30
  41.7%
6
  18.8%
12
  37.5%
48
  35.3%
Not Hispanic or Latino
42
  58.3%
26
  81.3%
20
  62.5%
88
  64.7%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1.Primary Outcome
Title The Primary Endpoint Will be the Baseline-adjusted, Placebo-corrected Effect on QTc (ΔΔQTc) on Day 14.
Hide Description 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.
Time Frame Baseline and Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
QT/QTc Analysis set: Received at least 1 dose of study drug (including placebo), had measurements at baseline and on-treatment with at least 1 time point post-dose with at minimum triplicate measures giving rise to a QTc value for primary correction method. Effect of moxifloxacin was as expected. Therefore, no analysis required per Medical Monitor.
Arm/Group Title Tizanidine 24 mg Tizanidine Placebo 24 mg Tizanidine 24 mg Placebo-corrected
Hide Arm/Group Description:
60 subjects Tizanidine 24 mg single dose
61 subjects placebo used for the analysis.
60 subjects Tizanidine 24 mg single dose, 61 subjects placebo used for the analysis.
Overall Number of Participants Analyzed 60 61 121
Least Squares Mean (90% Confidence Interval)
Unit of Measure: milliseconds (msec)
Timepoint (Hour) 0
-4.3
(-6.3 to -2.3)
-0.5
(-2.5 to 1.4)
-3.7
(-6.6 to -0.9)
0.5
-2.0
(-4.0 to 0.1)
1.2
(-0.8 to 3.2)
-3.2
(-6.0 to -0.3)
1
-4.0
(-6.0 to -2.0)
2.6
(0.6 to 4.5)
-6.6
(-9.4 to -3.8)
1.5
-4.7
(-6.9 to -2.6)
2.7
(0.6 to 4.8)
-7.4
(-10.5 to -4.4)
2
-3.6
(-5.6 to -1.6)
2.9
(0.9 to 4.8)
-6.4
(-9.2 to -3.6)
4
1.6
(-0.4 to 3.6)
3.4
(1.4 to 5.4)
-1.8
(-4.6 to 1.0)
8
-2.4
(-4.1 to -0.7)
3.1
(1.4 to 4.8)
-5.5
(-7.9 to -3.1)
12
-2.0
(-3.5 to -0.5)
1.0
(-0.5 to 2.5)
-3.0
(-5.1 to -0.8)
24
0.4
(-1.3 to 2.2)
2.6
(0.9 to 4.4)
-2.2
(-4.6 to 0.2)
2.Secondary Outcome
Title The Baseline-adjusted, Placebo-corrected (ΔΔQTc) on QTc Method Not Selected as Primary Endpoint.
Hide Description 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.
Time Frame Baseline and Day 5
Hide Outcome Measure Data
Hide Analysis Population Description
QT/QTc Analysis set: Received at least 1 dose of study drug (including placebo), had measurements at baseline and on-treatment with at least 1 time point post-dose with at minimum triplicate measures giving rise to a QTc value for primary correction method. Effect of moxifloxacin was as expected. Therefore, no analysis required per Medical Monitor.
Arm/Group Title Tizanidine 8 mg Tizanidine Placebo 8 mg Tizanidine 8 mg Placebo-corrected
Hide Arm/Group Description:
70 subjects Tizanidine 8 mg single dose.
63 subjects placebo used for analysis.
70 subjects Tizanidine 8 mg single dose, 63 subjects placebo used for analysis.
Overall Number of Participants Analyzed 70 63 133
Least Squares Mean (90% Confidence Interval)
Unit of Measure: msec
Timepoint (Hour) 0
-0.8
(-2.5 to 0.8)
-0.9
(-2.7 to 0.8)
0.1
(-2.3 to 2.5)
0.5
-0.4
(-2.3 to 1.4)
0.4
(-1.5 to 2.3)
-0.8
(-3.5 to 1.8)
1
0.0
(-1.9 to 1.9)
2.3
(0.3 to 4.3)
-2.3
(-5.1 to 0.4)
1.5
1.1
(-0.7 to 2.9)
1.3
(-0.6 to 3.1)
-0.1
(-2.7 to 2.4)
2
-0.4
(-2.0 to 1.3)
0.4
(-1.3 to 2.1)
-0.7
(-3.1 to 1.6)
4
2.6
(1.2 to 4.0)
1.0
(-0.5 to 2.5)
1.6
(-0.4 to 3.6)
8
-1.5
(-3.1 to 0.0)
0.6
(-1.0 to 2.3)
-2.2
(-4.4 to 0.1)
12
-0.1
(-1.6 to 1.4)
0.7
(-0.9 to 2.3)
-0.8
(-3.0 to 1.5)
24
-0.5
(-2.0 to 1.0)
1.4
(-0.1 to 3.0)
-1.9
(-4.1 to 0.3)
3.Secondary Outcome
Title Assessing the Relationship Between Changes in the QTc Interval and Plasma Levels of Tizanidine Using Concentration-effect Modeling
Hide Description 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.
Time Frame Day 5, Day 14
Hide Outcome Measure Data
Hide Analysis Population Description
Pk/QTc Analysis set will include all subjects in the QT/QTc analysis set with at least one valid PK assessment. Effect of moxifloxacin was as expected. Therefore, no analysis required per Medical Monitor.
Arm/Group Title Tizanidine
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 70
Measure Type: Number
Number (90% Confidence Interval)
Unit of Measure: msec per ng/mL
-0.1209
(-0.1894 to -0.0524)
4.Secondary Outcome
Title Maximum Plasma Concentration (Cmax) of Single Doses of 8 and 24 mg Tizanidine After Reaching Steady State.
Hide Description [Not Specified]
Time Frame 0.5, 1, 1.5, 2, 4, 8, 12 & 24 hours post dose on Days 5 (8 mg) and 14 (24 mg)
Hide Outcome Measure Data
Hide Analysis Population Description
PK Analysis set: all subjects from Group 1 who received at least one study drug and have at least one valid PK assessment
Arm/Group Title Day 5 (Tizanidine 8 mg) Day 14 (Tizanidine 24 mg)
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 70 60
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng/mL
11.7
(43.9%)
27.4
(42.7%)
5.Secondary Outcome
Title Time to Reach Maximum Plasma Concentration (Tmax) of Single Doses of 8 and 24 mg Tizanidine After Reaching Steady State.
Hide Description [Not Specified]
Time Frame 0.5, 1, 1.5, 2, 4, 8, 12 & 24 hours post dose on Days 5 (8 mg) and 14 (24 mg)
Hide Outcome Measure Data
Hide Analysis Population Description
PK Analysis set: all subjects from Group 1 who received at least one study drug and have at least one valid PK assessment
Arm/Group Title Day 5 (Tizanidine 8 mg) Day 14 (Tizanidine 24 mg)
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 70 60
Median (Full Range)
Unit of Measure: hour
1.35
(0.600 to 4.10)
2.10
(0.600 to 4.10)
6.Secondary Outcome
Title 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.
Hide Description [Not Specified]
Time Frame 0.5, 1, 1.5, 2, 4, 8, 12 & 24 hours post dose on Days 5 (8 mg) and 14 (24 mg)
Hide Outcome Measure Data
Hide Analysis Population Description
PK Analysis set: all subjects from Group 1 who received at least one study drug and have at least one valid PK assessment
Arm/Group Title Day 5 (Tizanidine 8 mg) Day 14 (Tizanidine 24 mg)
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 70 60
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: ng*hr/mL
32.4
(65.1%)
115
(52.8%)
Time Frame Up to 23 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Tizanidine Initial Placebo and Crossover to Moxifloxacin Initial Moxifloxacin and Crossover to Placebo Placebo and Moxifloxacin Groups Combined
Hide Arm/Group Description [Not Specified] [Not Specified] [Not Specified] [Not Specified]
All-Cause Mortality
Tizanidine Initial Placebo and Crossover to Moxifloxacin Initial Moxifloxacin and Crossover to Placebo Placebo and Moxifloxacin Groups Combined
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Tizanidine Initial Placebo and Crossover to Moxifloxacin Initial Moxifloxacin and Crossover to Placebo Placebo and Moxifloxacin Groups Combined
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/72 (0.00%)   0/32 (0.00%)   1/32 (3.13%)   1/64 (1.56%) 
Pregnancy, puerperium and perinatal conditions         
Ectopic Pregnancy  1  0/72 (0.00%)  0/32 (0.00%)  1/32 (3.13%)  1/64 (1.56%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (15.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Tizanidine Initial Placebo and Crossover to Moxifloxacin Initial Moxifloxacin and Crossover to Placebo Placebo and Moxifloxacin Groups Combined
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   44/72 (61.11%)   16/32 (50.00%)   23/32 (71.88%)   39/64 (60.94%) 
Gastrointestinal disorders         
GASTROINTESTINAL DISORDERS  1  21/72 (29.17%)  8/32 (25.00%)  10/32 (31.25%)  18/64 (28.13%) 
NAUSEA  1  9/72 (12.50%)  4/32 (12.50%)  5/32 (15.63%)  9/64 (14.06%) 
DRY MOUTH  1  10/72 (13.89%)  0/32 (0.00%)  3/32 (9.38%)  3/64 (4.69%) 
General disorders         
GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS  1  24/72 (33.33%)  9/32 (28.13%)  9/32 (28.13%)  18/64 (28.13%) 
FATIGUE  1  13/72 (18.06%)  1/32 (3.13%)  1/32 (3.13%)  2/64 (3.13%) 
APPLICATION SITE PRURITUS  1  5/72 (6.94%)  1/32 (3.13%)  4/32 (12.50%)  5/64 (7.81%) 
APPLICATION SITE IRRITATION  1  5/72 (6.94%)  3/32 (9.38%)  1/32 (3.13%)  4/64 (6.25%) 
Musculoskeletal and connective tissue disorders         
MUSCULOSKELETAL AND CONNECTIVE TISSUE DISORDERS  1  10/72 (13.89%)  2/32 (6.25%)  3/32 (9.38%)  5/64 (7.81%) 
BACK PAIN  1  4/72 (5.56%)  2/32 (6.25%)  1/32 (3.13%)  3/64 (4.69%) 
MUSCULOSKELETAL CHEST PAIN  1  4/72 (5.56%)  0/32 (0.00%)  1/32 (3.13%)  1/64 (1.56%) 
Nervous system disorders         
NERVOUS SYSTEM DISORDERS  1  32/72 (44.44%)  8/32 (25.00%)  8/32 (25.00%)  16/64 (25.00%) 
SOMNOLENCE  1  20/72 (27.78%)  4/32 (12.50%)  4/32 (12.50%)  8/64 (12.50%) 
DIZZINESS  1  17/72 (23.61%)  2/32 (6.25%)  4/32 (12.50%)  6/64 (9.38%) 
HEADACHE  1  10/72 (13.89%)  5/32 (15.63%)  3/32 (9.38%)  8/64 (12.50%) 
PARAESTHESIA  1  7/72 (9.72%)  0/32 (0.00%)  1/32 (3.13%)  1/64 (1.56%) 
DIZZINESS POSTURAL  1  4/72 (5.56%)  0/32 (0.00%)  1/32 (3.13%)  1/64 (1.56%) 
Skin and subcutaneous tissue disorders         
SKIN AND SUBCUTANEOUS TISSUE DISORDERS  1  8/72 (11.11%)  4/32 (12.50%)  7/32 (21.88%)  11/64 (17.19%) 
RASH  1  5/72 (6.94%)  1/32 (3.13%)  1/32 (3.13%)  2/64 (3.13%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (15.1)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Sponsor (Acorda) has right to review and comment on proposed publications within a specified time frame, up to 60 days; multi-center trials require joint publication unless specifically permitted otherwise.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Executive Medical Director
Organization: Acorda Therapeutics, Inc.
Phone: 914-437-4300 ext 5263
EMail: paupperle@acorda.com
Layout table for additonal information
Responsible Party: Acorda Therapeutics
ClinicalTrials.gov Identifier: NCT01839279     History of Changes
Other Study ID Numbers: ZAN-QT-1006
First Submitted: April 22, 2013
First Posted: April 24, 2013
Results First Submitted: February 27, 2015
Results First Posted: June 1, 2015
Last Update Posted: February 5, 2019