Placebo Controlled Study of Baclofen for GERD in Children With Cerebral Palsy

Phase 4

Withdrawn

• Conditions: Cerebral Palsy; GERD
• Interventions: Drug: placebo; Drug: Baclofen

• Registration Number: NCT01386255
• Lead Sponsor: Boston Children's Hospital

Brief Summary

Despite the use of proton pump inhibitors and available prokinetics, medical therapy is ineffective in an important number of children with cerbreal palsy (CP) and gastroesophageal reflux disease (GERD), and failure of medical therapy is associated with a substantial morbidity. Many patients, particularly children with CP and GERD, continue to experience complications despite aggressive therapy because antisecretory medications do not address the primary reflux mechanism (TLESR). Furthermore, in patients with CP, surgical options are fraught with serious complications and long-term morbidity. Because the available treatment options for children with CP and intractable GERD are limited, new therapies are urgently needed. Baclofen, which has been shown in animals and humans to decrease TLESRs, may be a good alternative for the treatment of children with CP with intractable GERD.

Detailed Description

Despite the use of proton pump inhibitors and available prokinetics, medical therapy is ineffective in an important number of children with cerbreal palsy (CP) and gastroesophageal reflux disease (GERD), and failure of medical therapy is associated with a substantial morbidity. Many patients, particularly children with CP and GERD, continue to experience complications despite aggressive therapy because antisecretory medications do not address the primary reflux mechanism (TLESR).

This is a placebo controlled trial of baclofen for the treatment of GERD in children with CP.

Study Timeline

• Study Start: 2009-04
• Study First Submitted: 2011-06-29
• Study First Submitted QC: 2011-06-29
• Study First Posted: 2011-07-01
• Primary Completion: 2012-04
• Study Completion: 2012-04-30
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-26
• Last Update Posted: 2017-08-29

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• 3-18 years old
• Diagnosis of Cerebral Palsy
• Symptoms of GERD for at least 3 months
• At least 8 weeks on BID therapy with a PPI at a therapeutic dose at time of enrollment
• Normal upper gastrointestinal barium contrast study (UGI)
• Have a g-tube that is used for more than 75% of calories and a stable feeding schedule for at least 2 weeks
• If seizures are present, they need to be controlled and on stable medications for 4 weeks

Exclusion Criteria

• Underlying electrolyte disturbance
• History of Nissen fundoplication
• Renal insufficiency
• Currently receiving baclofen
• Baclofen allergy
• Uncontrolled seizure disorder
• Lack of informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	placebo	Identical palcebo suspension
baclofen	Baclofen	Baclofen suspension

Primary Outcome Measures

Name	Time	Method
Symptom control	3 weeks	Symptom frequency during the 2 weeks of placebo and baclofen administration.

Secondary Outcome Measures

Name	Time	Method
GERD control	3 weeks	Frequency and duration of reflux episodes detected by MII during 24 hours of recording after two weeks of maximum dose.; Proportion of full-column and non-acid reflux episodes detected by MII during 24 hours after two weeks of maximum dose.; Frequency of TLESRs and reflux associated with TLESRs at half of the maximum dose, and after two weeks of maximum dose are administered
side effects of baclofen	3 weeks	Incidence of side effects and rate of discontinuation of the study

Trial Locations

Locations (1)

Children's Hospital Boston; 🇺🇸 Boston, Massachusetts, United States