Clinical Trials

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Pediatric Neurology and Neurosurgery

At Cleveland Clinic, we are currently running the following pediatric neurology clinical studies. If your child is eligible for any of these pediatric neurology studies and you are interested in participating, please contact us to assess your eligibility.

Pediatric Headache

A Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Four-Armed Parallel Group Study to Evaluate the Efficacy of Zolmitriptan 0.5, 2.5 and 5 mg Nasal Spray in the Treatment of Acute Migraine Headache in Adolescents

Purpose: To compare the efficacy of zolmitriptan nasal spray 0.5, 2.5 and 5 mg with placebo in the treatment of migraine headache in adolescents.

Eligibility: Participants must be ages 12 to 17.

Principal Investigator: David Rothner, MD

Research Coordinator: Diane Davies, 216.444.0173

 

TXA107979: A Randomized, Multicenter, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of a Combination Product Containing Sumatriptan and Naproxen Sodium for the Acute Treatment of Migraine in Adolescents

Principal Investigator: David Rothner, MD 216.444.5514

Trial Description: Adolescents suffering from migraine attacks may not be able to participate in their normal activities. In an effort to reduce the burden of migraine headaches in this population, many clinical trials have evaluated the use of triptan therapy in adolescent migraine. To date, these studies to evaluate the use of triptans have failed to provide sufficient evidence to secure regulatory approval in the US for treatment of adolescents. Several factors may account for the failure of triptan treatment to achieve statistical significance in this population, as compared to adults. Differences include the symptom patterns and duration of migraine attacks in this population and study design issues (for example high placebo response rates, or selection of primary endpoint). As a consequence, there are no FDA-approved treatment options available for adolescents who have migraine.

This phase IIIB study will evaluate the efficacy, and safety of a range of doses of a combination product, sumatriptan and naproxen sodium (10 mg/60 mg, 30 mg/180 mg, 85 mg/500 mg), for the acute treatment of migraine (with moderate or severe pain) in adolescents ages 12 to 17 years old.

Entry Requirements: Subjects must meet IHS criteria for migraine with or without aura and all other inclusion and exclusion criteria. Attacks should last a minimum of three hours and be associated with moderate to severe headache pain.

For more information, contact Diane Davies, Research Nurse, at 216.444.0173.

Cerebrovascular

Vascular Effects of Infection in Pediatric Stroke

Purpose: A multi-centered, NIH funded study on the Vascular Effects of Infection in Pediatric Stroke (VIPS).

Eligibility: Children — age one month to 18 years within two weeks of new onset arterial ischemic stroke.

Principal Investigator: Neil Friedman, MBChB

Research Coordinator: Diane Davies, 216.444.0173

Epilepsy

Study Name: 09-555: ASK CHILDREN (ASSESS SPECIFIC KINDS OF CHILDRN CHALLENGES IN NEUROLOGY DEVICES

Primary Investigator: Neil Friedman, MBChB

Trial Description: Assessing children’s perception of the impact that certain devices on their life. A questionnaire done in conjunction with the FDA. The FDA is looking for a more effective way to evaluate devices in children.

Inclusion Criteria: Children ages 7 to 15 with VP Shunt, Spinal Cord Stimulator post spinal cord injury, DBS for Dystonia, VNS for epilepsy, Cochlear implant


Treatment of children with spasticity: differences in intrathecal baclofen (ITB) deliver
Description: Clinical study to assess optimal delivery location of ITB in children with spasticity secondary to Cerebral Palsy
Study Design: Internal study. Corporate sponsor, Codman, Johnson & Johnson
Eligibility: Children who are candidates for ITB treatment Age 4 (30 lbs) to 16 years
Contact: Mark Luciano, MD, PhD, 216.444.5747

In-patient study for Patients with partial seizures

Description: A double-blind, randomized, multicenter, placebo-controlled, in-patient, maximum 34 day study of study drug in oral solution (20-50 mg/kg/day as adjunctive treatment of refractory partial onset seizures in pediatric epileptic subjects ranging in age from 1 month to less than 4 years of age.
Eligibility: Patients must be between 1 month and less than 4 years of age, using 1 or 2 other anti-epileptic medicines and who are willing to spend 7 days in our pediatric monitoring unit. All study related costs are being paid for by the sponsor company. Patients participating in N01009 may be eligible to participate in a one year long-term follow-up study.
Contact: Diane Davies 216.444.0173 or toll-free 800.223.2273 ext. 4-0173.

In-patient study for Patients with partial seizures

Description: Evaluating Cognitive and neuropsychological effects of a study drug in children with partial seizures. A 19-week, randomized, double-blind, multicenter, placebo-controlled safety study to evaluate the cognitive and neuropsychological effects of a study drug 20-60 mg/kg/day, divided in twice daily dosing as adjunctive treatment in children 4-16 years old, inclusive with refractory partial onset seizures.
Eligibility: Patients must be between 4 and 16 years of age, have partial epilepsy and on 1 or 2 other anti-epileptic medications that are not working optimally to control the seizures.
Contact: Diane Davies 216.444.0173 or toll-free 800.223.2273 ext. 4-0173.

Pediatric Neurology

Study Name: ACE BUSPIRONE STUDY

Primary Investigator: Sumit Parikh, MD

Trial Description: The primary objective for the study is to evaluate the effects of twice-daily oral buspirone on core features of autism in autistic children aged 2-6 years as measured by the change from baseline in the Autism Diagnostic Observation Schedule (ADOS) Composite Total scores compared to placebo at 6 months.

Inclusion Criteria: Children with Autism ages 2 to 6


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