Placebo Controlled Study of Baclofen for GERD in Children With Cerebral Palsy
| Status: | Recruiting |
|---|---|
| Conditions: | Gastroesophageal Reflux Disease , Neurology |
| Therapuetic Areas: | Gastroenterology, Neurology |
| Healthy: | No |
| Age Range: | 3 - 18 |
| Updated: | 4/2/2016 |
| Start Date: | April 2009 |
| Contact: | Samuel Nurko, MD |
| Email: | Samuel.Nurko@childrens.harvard.edu |
| Phone: | 617-355-6055 |
Despite the use of proton pump inhibitors and available prokinetics, medical therapy is
ineffective in an important number of children with CP and 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.
ineffective in an important number of children with CP and 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.
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
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