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VomitingPhase 4NCT00286988

Topiramate for the Prophylactic Treatment of Cyclic Vomiting Syndrome in Children

A Phase 4 study testing Topiramate in people with Vomiting, run by Monarch Medical Research at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 4 to 12 years
Conditions the study is for
Vomiting
What is being tested?
Topiramate
How many people
12 participants
Where
1 siteUnited States
Study dates
Mar 2006to Jun 2007
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 4 to 12 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Meet the2004 ICHD Criteria for Cyclical Vomiting.
  • 1 vomiting attack lasting > 24 hours duration for 3 consecutive months
  • 4-12 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
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  • 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

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Monarch Medical Research - Child and Adolescent Neurology

    Norfolk, Virginia, 23510

Other trials in United States

About this study

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.

Read the detailed description

There is very little controlled data on the preventative treatment for Cyclic Vomiting Syndrome. The existing evidence consists of small, retrospective clinical series that evaluate symptomatic responses to five medications including cyproheptadine, propranolol, amitriptyline, phenobarbital and pizotifen (n >10). These published data consist of uncontrolled or retrospective reports. In addition, varying inclusion criteria and outcomes (i.e. obtained by family recall) were used in these studies limiting the basis upon which to compare relative effectiveness.

During the prospective baseline period, the subject will maintain cyclical vomiting records in which all headache occurrences will be recorded and characterized. (Cyclical vomiting records will be maintained throughout the study). The purpose of this study is to assess the effectiveness, tolerability and safety of oral topiramate for the preventative management of Cyclic Vomiting Syndrome using a prospective design, established diagnostic criteria (ICHD 2004), and defined, objective primary and secondary endpoints.

Conditions
Vomiting
Being tested
Topiramate
Keywords
Preventative, Open-Label, Safety/Efficacy
Medical subject headings
Vomiting

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TopiramateDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (13)

  1. Decreased duration of attacks (measured in hours)

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

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

  4. Nausea

  5. Vomiting

  6. Headache

  7. Abdominal pain

  8. Decreased disability

  9. PedMidas

  10. Missed school (days per attack)

  11. Missed work (parent(s)) (days per attack)

  12. Decreased use of acute therapies (e.g. anti-emetics)

  13. Decreased emergency department visits.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Feb 2006 (estimated)
  2. Study startMar 2006
  3. Primary completionMay 2007
  4. Study completionJun 2007

Why it stopped: Insufficient potential subjects

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
12 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00286988
Sponsor's protocol ID
TOPMAT-EME-4001
Status last verified
Apr 2007
First submitted
1 Feb 2006
Last updated
6 Jan 2011
Results posted
No

Publications

  • 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.

    PubMed 14024194

  • 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.

    PubMed 7618907

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Topiramate in people with Vomiting, run by Monarch Medical Research at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 6 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Insufficient potential subjects). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Reduction of cycle frequency as measured by number of days between cycles.. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00286988, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2011.

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