Oral Baclofen Pharmacokinetics and Pharmacodynamics in Children With Spasticity
NCT ID: NCT00607542
Last Updated: 2011-12-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
61 participants
INTERVENTIONAL
2008-11-30
2011-01-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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1
starting dose of baclofen 2.5 mg PO TID with dose escalation as tolerated
baclofen
2.5 mg oral baclofen tablets given three times a day; dose gradually escalated as specified in the protocol
Interventions
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baclofen
2.5 mg oral baclofen tablets given three times a day; dose gradually escalated as specified in the protocol
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
11. Proven gastric dysmotility: known history of abnormal gastric emptying study and/or history of vomiting 3 or more times per week.
12. Severe Gastroesophageal Reflux Disease: known history of esophagitis (documented on abnormal endoscopy or biopsy).
13. Malnutrition: defined as triceps skin fold thickness less than 5th or greater than 95th percentile for age.
14. Renal or Liver disease: Elevated bilirubin, LFTs greater than twice the upper limit of normal, reduced BUN/Cr ratio (\<5), or abnormal creatinine clearance that is clinically significant as determined by the investigator.
15. Abnormal CBC: Anemia, polycythemia, neutropenia, leukocytosis, thrombocytopenia, or thrombocytosis clinically significant as determined by the investigator.
16. Pregnancy or lactation.
17. Severe respiratory or cardiac disease: Requirement for prolonged supplemental oxygen (\>7 days), history of clinically significant congenital heart disease, congestive heart failure or cardiomegaly, and/or hospital admission within past 6 months for cardiac symptoms or respiratory distress.
18. Previous baclofen failure: Lack of response to baclofen or presence of unacceptable side effects. If previous baclofen therapy was tried \>4 months prior to study and discontinued, the decision to enroll subject will be at the discretion of the site investigator and reason for discontinuation of oral baclofen will be recorded.
19. Use of medications that interfere with measurements of serum creatinine levels within the past 14 days (e.g., trimethoprim-sulfa, fibric acid derivatives other than gemfibrizol, keto acids, salicylates, some cephalosporins, cimetidine, phenacemide) .
20. Subject tests positive at screening for the hepatitis B surface antigen or hepatitis C antibody, or has a history of a positive result for one of these tests.
21. Subject is known to have tested seropositive for the human immunodeficiency virus (HIV) or subject is concomitantly receiving anti-retroviral therapy.
22. Any serious, unstable medical illness or clinically significant abnormal laboratory assessment that would adversely impact the scientific interpretability or unduly increase the risks of the protocol.
23. Subject has a disorder or history of a condition, other than that related to CP that could interfere with drug absorption, distribution, metabolism, or excretion.
24. Any condition which would make the patient
2 Years
16 Years
ALL
No
Sponsors
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
Responsible Party
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Principal Investigators
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Janice Brunstrom, MD
Role: PRINCIPAL_INVESTIGATOR
Washington University of St. Louis
Richard Stevenson, MD
Role: PRINCIPAL_INVESTIGATOR
University of Virginia
Locations
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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
Seattle Children's Hospital
Seattle, Washington, United States
Countries
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References
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McLaughlin MJ, He Y, Brunstrom-Hernandez J, Thio LL, Carleton BC, Ross CJD, Gaedigk A, Lewandowski A, Dai H, Jusko WJ, Leeder JS. Pharmacogenomic Variability of Oral Baclofen Clearance and Clinical Response in Children With Cerebral Palsy. PM R. 2018 Mar;10(3):235-243. doi: 10.1016/j.pmrj.2017.08.441. Epub 2017 Sep 1.
He Y, Brunstrom-Hernandez JE, Thio LL, Lackey S, Gaebler-Spira D, Kuroda MM, Stashinko E, Hoon AH Jr, Vargus-Adams J, Stevenson RD, Lowenhaupt S, McLaughlin JF, Christensen A, Dosa NP, Butler M, Schwabe A, Lopez C, Roge D, Kennedy D, Tilton A, Krach LE, Lewandowski A, Dai H, Gaedigk A, Leeder JS, Jusko WJ. Population pharmacokinetics of oral baclofen in pediatric patients with cerebral palsy. J Pediatr. 2014 May;164(5):1181-1188.e8. doi: 10.1016/j.jpeds.2014.01.029. Epub 2014 Mar 5.
Other Identifiers
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267200603421
Identifier Type: -
Identifier Source: secondary_id
NICHD-2005-13-2
Identifier Type: -
Identifier Source: org_study_id