Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01839279
Other study ID # ZAN-QT-1006
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date April 2013
Est. completion date May 2014

Study information

Verified date March 2021
Source Acorda Therapeutics
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. The study will be conducted in a Phase 1 unit with sufficient facilities to house subjects as required by the protocol.


Recruitment information / eligibility

Status Completed
Enrollment 136
Est. completion date May 2014
Est. primary completion date February 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 45 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Tizanidine

Placebo

Moxifloxacin


Locations

Country Name City State
United States Covance- Dallas Dallas Texas

Sponsors (1)

Lead Sponsor Collaborator
Acorda Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary The Primary Endpoint Will be the Baseline-adjusted, Placebo-corrected Effect on QTc (??QTc) 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. Baseline and Day 14
Secondary The Baseline-adjusted, Placebo-corrected (??QTc) 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. Baseline and Day 5
Secondary 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. Day 5, Day 14
Secondary Maximum Plasma Concentration (Cmax) of Single Doses of 8 and 24 mg Tizanidine After Reaching Steady State. 0.5, 1, 1.5, 2, 4, 8, 12 & 24 hours post dose on Days 5 (8 mg) and 14 (24 mg)
Secondary Time to Reach Maximum Plasma Concentration (Tmax) of Single Doses of 8 and 24 mg Tizanidine After Reaching Steady State. 0.5, 1, 1.5, 2, 4, 8, 12 & 24 hours post dose on Days 5 (8 mg) and 14 (24 mg)
Secondary 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. 0.5, 1, 1.5, 2, 4, 8, 12 & 24 hours post dose on Days 5 (8 mg) and 14 (24 mg)
See also
  Status Clinical Trial Phase
Recruiting NCT06150729 - Study of Intramuscular Injections of OnabotulinumtoxinA to Assess Change in Disease Activity in Pediatric Participants With Spasticity Associated With Cerebral Palsy
Completed NCT02400619 - Shockwaves Therapy and Botulinum Toxin for the Treatment of Spasticity in Patients With Cerebral Palsy. A Cross Over RCT Phase 1
Completed NCT02261142 - Efficacy and Cost-effectiveness of Spasticity Treatment With Multifocal TENS N/A
Completed NCT01945684 - A Randomized, Double Blind, Multi-center, Active Drug Controlled, Phase III Clinical Trial to Compare the Safety and Efficacy of DWP450 Versus Botox® in Treatment of Post Stroke Upper Limb Spasticity Phase 3
Completed NCT01444794 - Adult Subjects Suffering From Lower Limb Spasticity Following Stroke
Terminated NCT02877836 - Functional MRI and DTI in the Preoperative Assessment of Dystonia N/A
Completed NCT02334683 - Compare Two Guidance Techniques for Botulinum Toxin Injections for the Treatment of Limb Spasticity and Focal Dystonia N/A
Completed NCT02170779 - Developing and Testing a Comprehensive MS Spasticity Management Program Phase 2
Recruiting NCT05674604 - Cryoneurolysis for Knee and Shoulder Pain in an Inpatient Setting
Not yet recruiting NCT05926596 - Leg Stretching Using an Exoskeleton on Demand for People With Spasticity N/A
Terminated NCT01712087 - Long-term Surveillance of the MedStream Programmable Infusion System
Completed NCT03906305 - Dry Needling and Bobath Treatment Clinical Effects Focused on Stroke Patients N/A
Completed NCT03302741 - Imaging of 3D Innervation Zone Distribution in Spastic Muscles From High-density Surface EMG Recordings Phase 4
Completed NCT02291159 - Effects of DNHS Technique in the Treatment of Upper Limb Spasticity and Function in Stroke N/A
Completed NCT01743651 - Efficacy Study of Arbaclofen to Treat Spasticity in Multiple Sclerosis Phase 3
Completed NCT01523210 - DTI Study of the Influence of Physiotherapy on Distribution of BoNT in Spastic Muscle N/A
Completed NCT02073513 - Kinesiotaping the Hand in Cerebral Palsy N/A
Completed NCT00607542 - Oral Baclofen Pharmacokinetics and Pharmacodynamics in Children With Spasticity Phase 1/Phase 2
Completed NCT00702468 - Evaluate the Maintenance of Effect After Long-term Treatment With Sativex® in Subjects With Symptoms of Spasticity Due to Multiple Sclerosis Phase 3
Active, not recruiting NCT04815967 - Efficacy and Safety Study of MYOBLOC® in the Treatment of Adult Upper Limb Spasticity Phase 2/Phase 3