Loading clinical trials...

Oral Baclofen Pharmacokinetics and Pharmacodynamics in Children With Spasticity | Clinical Trials | Clareo Health

COMPLETEDPHASE1/PHASE2

Oral Baclofen Pharmacokinetics and Pharmacodynamics in Children With Spasticity

Pediatric Pharmacokinetic and Pharmacodynamic Study of Oral Baclofen for the Treatment of Spasticity Associated With Cerebral Palsy

NCT00607542•Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

View on ClinicalTrials.gov

Summary

Oral baclofen is used commonly to treat spasticity in children with cerebral palsy. Although for adults there is dosing,safety and efficacy information in the package insert, this is not the case for children. The purpose of this study is to determine how fast the drug is cleared from the body, the correct dose, and long-term safety and efficacy for children with spasticity.

Detailed Description

Although oral baclofen has been used for several decades for the treatment of spasticity in adults and in children, there is very little data regarding the pharmacokinetic (PK) or pharmacodynamic (PD) properties of baclofen in children. Therefore, pediatric guidelines, including dose ranges, dosing schedules, dose escalation strategies and anticipated side effects are extrapolated from adult data and require an assumption that safety and efficacy in children is comparable to that in adults. Furthermore, there is wide variability in dosing strategies among practitioners who treat children with cerebral palsy (CP) with respect to starting doses, maximum doses and rates of dose escalation.Establishment of safe and effective dosing strategies for children with CP requires an understanding of the PK and PD properties of baclofen in children and recognition of individual differences that may contribute to divergent clinical responses to baclofen among children with CP.

Eligibility

Age

2 - 16 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Males and females aged 2-16 years, inclusive.
•2. Triceps skinfold thickness between the 5th and 95th percentiles for age (Refer to Appendix 3).
•3. Gross Motor Function Classification Scale (GMFCS) Level II - V (GMFCS classifies children by functional mobility with Level I indicating minimal motor disability and V indicating total body involvement and dependence on others for mobility (Palisano et al, 1997).
•4. Ashworth score of 2 or higher in at least one arm and one leg (knee + elbow flexors and/or extensors).
•5. Cerebral Palsy: Motor disability due to a static, non-progressive brain injury/ malformation occurring prenatally or any time prior to the age of 2 years.
•6. No history of baclofen use within the past 4 months.
•7. Female subject, is premenarchal, or is incapable of pregnancy because of a hysterectomy or tubal ligation; or female subject who is sexually active and capable of pregnancy, has been using an acceptable method of contraception (hormonal contraceptives, intrauterine device, spermicide and barrier) for at least one month prior to study entry and agrees to continue to use one of these for the duration of the study; or female subject who is sexually abstinent and capable of pregnancy, agrees to continued abstinence or to use an acceptable method of birth control (either intrauterine device or spermicide and barrier) should sexual activity commence.
•8. Subject ≥10 years of age has negative urine tests at screening and baseline for alcohol, non-medically prescribed drugs of abuse, and no history of tobacco use.

Exclusion Criteria

•1. Hypersensitivity to baclofen.
•2. Selective dorsal rhizotomy.
•3. Active intrathecal baclofen pump within the past 6 months.
•4. Use of botulinum toxin in past 4 months or use any time during the study.
•5. Use of tone altering medications (e.g. baclofen, benzodiazepines, levodopa, trihexyphenidyl) for \>3 consecutive days duration within the past 4 months.
•6. Start of any drug or product known to be a significant cytochrome P450 enzyme inducer or inhibitor within the past 30 days.
•7. Orthopaedic surgery within the past year or any time during the study.
•8. Abdominal surgery within the past six months or any time during the study.
•9. Uncontrolled seizures (baseline seizure frequency \>1 per month or history of more than 2 prolonged seizures lasting longer than 5 minutes duration within the past year.
•10. Severe behavior difficulties or psychiatric disturbance
+14 more criteria

Locations (11)

Rehabilitation Institute of Chicago

Chicago, Illinois, United States

Children's Hospital of Lousiana

New Orleans, Louisiana, United States

Kennedy Krieger Institute

Baltimore, Maryland, United States

Gillette Children's Speciality Healthcare

Saint Paul, Minnesota, United States

Children's Mercy Hospital and Clinics

Kansas City, Missouri, United States

Washington Univeristy - St. Louis Children's hospital

St Louis, Missouri, United States

SUNY Upstate Medical University

Syracuse, New York, United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Texas Children's Hospital

Houston, Texas, United States

Kluge Children's Rehabilitation Center - University of Virginia

Charlottesville, Virginia, United States

Key Dates

Start Date

November 1, 2008

Primary Completion Date

January 1, 2011

Completion Date

January 1, 2011

Last Updated

December 6, 2011

Enrollment

ACTUAL participants

Conditions

SpasticityCerebral Palsy

Interventions

baclofen

DRUG

Effects of Treadmill Training and Whole-body Vibration in Children With Cerebral Palsy

NCT04630392

Cerebral Palsy

View study

RECRUITING

A Study to Estimate How Often Post-stroke Spasticity Occurs and to Provide a Standard Guideline on the Best Way to Monitor Its Development

NCT06055725

Spasticity as Sequela of Stroke

View study

RECRUITING

The EXOPULSE Study - a Database for Routine Follow-up of Clinical Outcomes

NCT05901259

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 6, 2011Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Oral Baclofen Pharmacokinetics and Pharmacodynamics in Children With Spasticity

Inclusion Criteria

Exclusion Criteria

Effects of Treadmill Training and Whole-body Vibration in Children With Cerebral Palsy

A Study to Estimate How Often Post-stroke Spasticity Occurs and to Provide a Standard Guideline on the Best Way to Monitor Its Development

The EXOPULSE Study - a Database for Routine Follow-up of Clinical Outcomes

Sleep Quality and Caregiver Burden in Children With Cerebral Palsy

Effects of Play Based Neural Mobilisation Activities on Hand Grip Strength and Dexterity in Cerebral Palsy Children

Swiss Cerebral Palsy Registry