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

Cerebral Palsy research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Cerebral Palsy

GERD

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:BaclofenThe final baclofen dose will be 0.7 mg/kg (to a maximum of 40 mg/day) divided in three doses.

Drug:placeboplacebo. No other names

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

baclofenBaclofen suspension

placeboIdentical palcebo suspension

Study Status

Withdrawn

Start Date: April 2009

Completed Date: April 30, 2012

Phase: Phase 4

Type: Interventional

Design:

Primary Outcome: Symptom control

Secondary Outcome: GERD control

Study sponsors, principal investigator, and references

Principal Investigator: Samuel Nurko, MD

Lead Sponsor: Boston Children’s Hospital

Collaborator: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

More information:https://clinicaltrials.gov/show/NCT01386255

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