NCT06581185

Brief Summary

Telephone interview on patient who suffered from PTC ten years ago regarding their headache status

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 27, 2024

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 3, 2024

Completed
Last Updated

September 3, 2024

Status Verified

August 1, 2024

Enrollment Period

2 months

First QC Date

August 27, 2024

Last Update Submit

August 29, 2024

Conditions

Keywords

Headacheoutcome

Outcome Measures

Primary Outcomes (1)

  • headache outcome HIT-6

    How many patients will suffer from headache after recovery from PTC measured by HIT 6 questionnaire

    5-10 years

Secondary Outcomes (1)

  • Quality of life (QOL)

    5-10 years

Study Arms (1)

Research

Patients who were diagnosed with PTC as children

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Adults who were diagnosed with Ptc at their childhood .

You may qualify if:

  • Patients who were diagnosed with PTC as children

You may not qualify if:

  • Patients has other headache types other than PTC

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bani Zion

Haifa, Israel

Location

Related Publications (7)

  • Smith JL. Whence pseudotumor cerebri? J Clin Neuroophthalmol. 1985 Mar;5(1):55-6. No abstract available.

  • Kesler A, Bassan H. Pseudotumor cerebri - idiopathic intracranial hypertension in the pediatric population. Pediatr Endocrinol Rev. 2006 Jun;3(4):387-92.

  • Buchheit WA, Burton C, Haag B, Shaw D. Papilledema and idiopathic intracranial hypertension. N Engl J Med. 1969 Apr 24;280(17):938-42. doi: 10.1056/NEJM196904242801707. No abstract available.

  • Friedman DI, Jacobson DM. Diagnostic criteria for idiopathic intracranial hypertension. Neurology. 2002 Nov 26;59(10):1492-5. doi: 10.1212/01.wnl.0000029570.69134.1b.

  • Baker RS, Baumann RJ, Buncic JR. Idiopathic intracranial hypertension (pseudotumor cerebri) in pediatric patients. Pediatr Neurol. 1989 Jan-Feb;5(1):5-11. doi: 10.1016/0887-8994(89)90002-7.

  • Couch R, Camfield PR, Tibbles JA. The changing picture of pseudotumor cerebri in children. Can J Neurol Sci. 1985 Feb;12(1):48-50. doi: 10.1017/s0317167100046588.

  • Dhiravibulya K, Ouvrier R, Johnston I, Procopis P, Antony J. Benign intracranial hypertension in childhood: a review of 23 patients. J Paediatr Child Health. 1991 Oct;27(5):304-7. doi: 10.1111/j.1440-1754.1991.tb02544.x.

MeSH Terms

Conditions

Pseudotumor CerebriHeadache

Condition Hierarchy (Ancestors)

Intracranial HypertensionBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • jacob Genizi

    Bnai Zion Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 27, 2024

First Posted

September 3, 2024

Study Start

July 1, 2024

Primary Completion

August 31, 2024

Study Completion

August 31, 2024

Last Updated

September 3, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations