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

Withdrawn before enrolling · Phase 4 · Has a placebo group

Conditions studied: Cerebral Palsy, GERD

In brief

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.

Key facts

Study ID

NCT01386255

Run by

Boston Children's Hospital

People needed

0

Starts

2009-04-01

Expected to finish

2012-04-30

Last updated by the study team

2017-08-29

Who can join

Age: 3 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

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

Where it is running

• Children's Hospital Boston — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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