Topiramate for the Prophylactic Treatment of Cyclic Vomiting Syndrome in Children

NCT00286988 | Terminated Phase 4

• 1 other identifier: TOPMAT-EME-4001
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the effectiveness, tolerability and safety of oral topiramate for the preventative management of Cyclic Vomiting Syndrome. It is believed that topiramate will decrease the frequency, duration and severity of attacks experienced by children and adolescents with Cyclic Vomiting Syndrome.

Conditions

Vomiting

Keywords

Preventative; Open-Label; Safety/Efficacy

Outcome Measures

Primary Outcomes (1)

• Reduction of cycle frequency as measured by number of days between cycles.

Secondary Outcomes (13)

• Decreased duration of attacks (measured in hours)

• Decreased intensity of attacks (0-4 point scale; none, mild, moderate, severe, excruciating)

• Decreased associated symptoms (0-4 point scales; none, mild, moderate, severe, excruciating)

• Nausea

• Vomiting

Interventions

Topiramate DRUG

Eligibility Criteria

• Age: 4 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Meet the2004 ICHD Criteria for Cyclical Vomiting.
• vomiting attack lasting \> 24 hours duration for 3 consecutive months
• years of age.
• If female, subjects must:
• be premenarchal or otherwise incapable of pregnancy, or
• have practiced one of the following methods of contraception for at least one month prior to study entry: hormonal contraceptives, spermicide and barrier, intrauterine device, partner sterility, or
• be practicing abstinence and agree to continue abstinence or to use an acceptable method of contraception (as listed above) should sexual activity commence.
• Able to take oral medication in tablet form or sprinkle form
• Subjects or their guardians must be willing and able to: a) read and comprehend written instructions, b) complete the assessment forms, c) return for regular visits, and d) adhere to medication regimens.
• Subjects (or their legally acceptable representative) must have signed an informed consent document

You may not qualify if:

• Have taken topiramate within 14 days prior to the start of the prospective baseline period.
• Have taken certain medications for cyclical vomiting prophylaxis
• Have progressive neurological disorder or a structural disorder of the brain from birth, trauma or past infection.
• Subjects who have taken any medications for migraine prophylaxis, within 2 weeks of the start of the prospective baseline period.
• Subjects starting non-pharmacologic prophylactic approaches (e.g., acupuncture, biofeedback, chiropractic methods) within 1 month prior to Visit 1.
• Require continuing treatment with anticonvulsant therapy for a non-migraine condition.
• Significant major psychiatric disorder (e.g., major depression) or subjects receiving anti-psychotic medication.
• History of attempted suicide or suicidal tendencies.
• History of substance abuse.
• Pregnant or lactating females.
• Have clinically unstable neurological, cardiovascular, gastrointestinal, musculoskeletal, pulmonary or other disease.
• Have any disease or condition that could compromise the function of those body systems that could result in altered absorption, excess accumulation, or impaired metabolism or excretion of the test medications (e.g., abnormal renal and/or hepatic function).
• Have active liver disease.
• Have received an investigational drug or used an investigational device within 30 days of study entry.
• Employees of the investigator, study center, or sponsor (i.e., principal investigator, sub-investigator(s), study coordinators, other study staff, employees, or contractors of each), with direct involvement in the proposed study or other studies under the direction of that investigator, study center or sponsor, as well as family members of the employees or the investigator.

Sponsors & Collaborators

• Monarch Medical Research: lead
• Ortho-McNeil Neurologics, Inc.: collaborator

Study Sites (1)

Monarch Medical Research - Child and Adolescent Neurology

Norfolk, Virginia, 23510, United States

Location

Related Publications (2)

• CULLEN KJ, MA CDONALD WB. The periodic syndrome: its nature and prevalence. Med J Aust. 1963 Aug 3;50(2):167-73. No abstract available.

  PMID: 14024194 BACKGROUND

• Abu-Arafeh I, Russell G. Prevalence and clinical features of abdominal migraine compared with those of migraine headache. Arch Dis Child. 1995 May;72(5):413-7. doi: 10.1136/adc.72.5.413.

  PMID: 7618907 BACKGROUND

Related Links

• Click here for more information on Cyclic Vomiting Syndrome

MeSH Terms

Conditions

Vomiting

Interventions

Topiramate

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fructose; Hexoses; Monosaccharides; Sugars; Carbohydrates; Ketoses

Study Officials

• Donald W Lewis, MD

  Monarch Medical Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 1, 2006
• First Posted: February 6, 2006
• Study Start: March 1, 2006
• Primary Completion: May 1, 2007
• Study Completion: June 1, 2007
• Last Updated: January 6, 2011

Record last verified: 2007-04

Locations

US (1)