SpasticityPhase 2TQTNCT01839279

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

A Phase 2 study testing Tizanidine and Moxifloxacin in people with Spasticity, run by Acorda Therapeutics at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for: Spasticity
What is being tested?: Tizanidine and Moxifloxacin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 136 participants
Where: 1 siteUnited States
Study dates: Apr 2013to May 2014
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 45 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Covance- Dallas
Dallas, Texas, 75247

Other trials in United States

About this study

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

Conditions: Spasticity
Being tested: Tizanidine, Placebo, Moxifloxacin
Medical subject headings: Muscle Spasticity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TizanidineDrug
Also called Zanaflex
PlaceboDrug
MoxifloxacinDrug

Study groups in NCT01839279
Study group	Role	What they receive
Tizanidine	Experimental	Oral dose of 2 and 4 milligram (mg) tablets Receives: Drug: Tizanidine
Placebo	Placebo comparator	Placebo followed by a single dose 400 mg moxifloxacin tablets. Receives: Drug: Placebo; Drug: Moxifloxacin
Moxifloxacin	Active comparator	Single dose of 400 mg moxifloxacin followed by placebo. Receives: Drug: Placebo; Drug: Moxifloxacin

What is being measured

The primary outcome is the main question the study is designed to answer.

The Primary Endpoint Will be the Baseline-adjusted, Placebo-corrected Effect on QTc (ΔΔQTc) on 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.
Measured: Baseline and Day 14

Secondary outcomes (5)

The Baseline-adjusted, Placebo-corrected (ΔΔQTc) on QTc Method Not Selected as Primary Endpoint.
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.
Measured: Baseline and Day 5
Assessing the Relationship Between Changes in the QTc Interval and Plasma Levels of Tizanidine Using Concentration-effect Modeling
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.
Measured: Day 5, Day 14
Maximum Plasma Concentration (Cmax) of Single Doses of 8 and 24 mg Tizanidine After Reaching Steady State.
Measured: 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.
Measured: 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.
Measured: 0.5, 1, 1.5, 2, 4, 8, 12 & 24 hours post dose on Days 5 (8 mg) and 14 (24 mg)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2013May 2014

First posted24 Apr 2013 (estimated)
Study startApr 2013
Primary completionFeb 2014
Study completionMay 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for SpasticityStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 136 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01839279
Sponsor's protocol ID: ZAN-QT-1006
Acronym: TQT
Status last verified: Mar 2021
First submitted: 22 Apr 2013
Last updated: 23 Mar 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Spasticity trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01839279
Acronym / sponsor ID: TQT / ZAN-QT-1006
Conditions: Spasticity
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 136 participants (actual)
Lead sponsor: Acorda TherapeuticsIndustry (pharma, biotech, devices)
Study start: Apr 2013
Primary completion: Feb 2014 (actual)
Study completion: May 2014 (actual)
First posted: 24 Apr 2013 (estimated)
Results: Posted 1 Jun 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Tizanidine	Experimental	Drug: TizanidineOral dose of 2 and 4 milligram (mg) tablets
Placebo	Placebo comparator	Drug: Placebo, Drug: MoxifloxacinPlacebo followed by a single dose 400 mg moxifloxacin tablets.
Moxifloxacin	Active comparator	Drug: Placebo, Drug: MoxifloxacinSingle dose of 400 mg moxifloxacin followed by placebo.

Who may qualify

Ages: 18 to 45 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (8 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
TizanidineAlso: Zanaflex	Drug	Tizanidine
Placebo	Drug	Moxifloxacin, Placebo
Moxifloxacin	Drug	Moxifloxacin, Placebo

Primary outcome

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.

5 secondary outcomes

The Baseline-adjusted, Placebo-corrected (ΔΔQTc) on QTc Method Not Selected as Primary Endpoint.
Time frame: Baseline and Day 5
Assessing the Relationship Between Changes in the QTc Interval and Plasma Levels of Tizanidine Using Concentration-effect Modeling
Time frame: Day 5, Day 14
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)

Results and safety

Results posted to the registry on 1 Jun 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Tizanidine	72	59
Initial Placebo and Crossover to Moxifloxacin	32	30
Initial Moxifloxacin and Crossover to Placebo	32	30

Primary outcome: The Primary Endpoint Will be the Baseline-adjusted, Placebo-corrected Effect on QTc (ΔΔQTc) on Day 14.

Time frame: Baseline and Day 14. Least squares mean (90% Confidence Interval). Unit: milliseconds (msec)

Measure	Tizanidine 24 mg n = 60	Tizanidine Placebo 24 mg n = 61	Tizanidine 24 mg Placebo-corrected n = 121
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)

Population analysed: 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.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 23 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Tizanidine	0 of 72 (0%)	44 of 72 (61.1%)	Not reported
Initial Placebo and Crossover to Moxifloxacin	0 of 32 (0%)	16 of 32 (50%)	Not reported
Initial Moxifloxacin and Crossover to Placebo	1 of 32 (3.1%)	23 of 32 (71.9%)	Not reported
Placebo and Moxifloxacin Groups Combined	1 of 64 (1.6%)	39 of 64 (60.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Mathews Adera, MD study director

Acorda Therapeutics

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Tizanidine and Moxifloxacin in people with Spasticity, run by Acorda Therapeutics at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Jun 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Primary Endpoint Will be the Baseline-adjusted, Placebo-corrected Effect on QTc (ΔΔQTc) on Day 14. (time frame: Baseline and Day 14). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01839279.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2021.