Pilot, Proof-of-Concept Study of Sublingual Tizanidine in Children With Chronic Traumatic Brain Injury (TBI)

NCT00287157 | Completed Phase 1

• 1 other identifier: Protocol C2/5/TZ-TBI-01
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

Nightly administration of a unique, sublingual (under the tongue) formulation of tizanidine, a known anti-spasticity medication, has been shown in a previous study to improve sleep and next-day functioning in CP (cerebral palsy) patients. It is hypothesized that this improvement in sleep efficiency (i.e.,fewer wake episodes, longer time asleep, etc.) with resulting improvement in quality-of-life (i.e.,improvements in next-day functioning, cognition and movement) may also be seen in a similar patient population, i.e., children with traumatic brain injury (TBI).

Conditions

Traumatic Brain Injury

Keywords

Traumatic Brain Injury; Actigraphy; Spasticity, Cognition and Functioning

Outcome Measures

Primary Outcomes (1)

• Improvement in Spasticity, Cognition and Daily Function

  4 weeks

Secondary Outcomes (1)

• Improvement in nighttime actigraphy sleep parameters

  4 weeks

Interventions

Sublingual Tizanidine HCl DRUG

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Males/Females 8-18 years of age with documented history of TBI
• Documented Loss of Consciousness(LOC) for more than 24 H, or initial GCS (Glasgow Coma Score) lower than 8
• Current Spasticity that interferes with task performance
• Patient is able to cooperate and understand general explanations

You may not qualify if:

• History of allergy to tizanidine or any inactive component (including lactose intolerance)
• Use of other hypnotic medication within 3 days of baseline visit and during the study
• Botox therapy within 6 weeks of baseline, or use of Baclofen pump during the trial
• Use of CYP1A2 inhibitors (ex. ciprofloxacin or fluvoxamine) for the duration of the study
• Female patients on oral contraceptives
• Significant abnormalities in clinical screening laboratory parameters (ALT, AST, Bilirubin\>2 x uln; Creatinine\>2 mg/dl;WBC \<2300/mm3, platelets\<80,000/mm3)
• Taking of other medications that may adversely interfere with the actions of the study medication or outcome variables within 2 weeks of 5 half-lives of the baseline visit

Sponsors & Collaborators

• Teva GTC: lead

Study Sites (1)

Alyn Hospital Pediatric and Adolescent Rehabilitation Center

Jerusalem, 01090, Israel

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic; Muscle Spasticity

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Muscular Diseases; Musculoskeletal Diseases; Muscle Hypertonia; Neuromuscular Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ido Yatsiv, MD

  Hadassah Medical Center, Ein Kerem, Jerusalem

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: February 2, 2006
• First Posted: February 6, 2006
• Study Start: December 1, 2006
• Study Completion: May 1, 2007
• Last Updated: January 21, 2009

Record last verified: 2007-09

Locations

IL (1)