Pituitary Function and Spontaneous Intracranial Hypotension | NCT02603549

Studies
Pituitary Function and Spontaneous Intracranial Hypotension

NCT02603549

Sponsor

Cedars-Sinai Medical Center

Status

Suspended

Last Update Posted

Jan 31, 2019Actual

Enrollment

100Estimated

Phase

Not provided

Conditions

Hyperprolactinemia
Spontaneous Intracranial Hypotension

Interventions

Pituitary panel will be drawn pre-op and post-op for all patients.

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2019

Overall Recruitment Status or Expanded Access Status

Suspended

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Study protocol needs to be amended. Recruitment is halted until amendment is completed and approved by IRB.

Expanded Access Info

Start Date

Jul 2015

Primary Completion Date

Dec 2020Estimated

Completion Date

Dec 2020Estimated

First Submitted Date

Nov 10, 2015

First Submission Date that Met QC Criteria

Nov 10, 2015

First Posted Date

Nov 13, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 29, 2019

Last Update Posted Date

Jan 31, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Vivien Bonert, MD, Clinical Director, Pituitary Center, Cedars-Sinai Medical CenterPrincipal Investigator

Lead Sponsor

Cedars-Sinai Medical CenterOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Previous research has identified spontaneous cerebral spinal fluid leakage as a cause for spontaneous intracranial hypotension, leading to positional headache patterns. Typical magnetic resonance imaging findings include subdural fluid collections, enhancement of pachymenginges, engorgement of venous structures, pituitary hyperemia, and sagging of the brain (SEEPS). Because pituitary hyperemia has been documented in cases of spontaneous cerebral spinal fluid leakage and is known to mimic a pituitary tumor or hyperplasia, the investigators would like to like to assess the clinical manifestations and neuroimaging abnormalities of SIH patients with regard to the pituitary gland. Specifically, the investigators are looking to analyze the compression of the pituitary stalk and conduct a systemic evaluation of pituitary function in SIH patients.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Surgery or Blood Patch			Other: Pituitary panel will be drawn pre-op and post-op for all patients.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pituitary panel will be drawn pre-op and post-op for all patients.	Other		Surgery or Blood Patch

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Comparing the levels of prolactin pre and post treatment		90 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male or female patients
Age 18 years and older
Diagnosis of SIH:
LP
Brain MRI (SEEPS)

Exclusion Criteria:

Pregnant and post-partum females
Nursing mothers
Patients with potential hyperprolactinemia due to:
Hypothyroidism,
Chronic renal disorder
Liver disease (including cirrhosis)
Primary or secondary amenorrhea
Polycystic Ovary Syndrome
Seizure disorder
Illicit drug use

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with Spontaneous intracranial hypotension (SIH)

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Vivien Bonert, MD	Cedars-Sinai Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Cedars-Sinai Medical Center		Los Angeles	California	90048	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
16705110	Background	Schievink WI. Spontaneous spinal cerebrospinal fluid leaks and intracranial hypotension. JAMA. 2006 May 17;295(19):2286-96. doi: 10.1001/jama.295.19.2286.
13036182	Background	SCHALTENBRAND G. Normal and pathological physiology of the cerebrospinal fluid circulation. Lancet. 1953 Apr 25;1(6765):805-8. doi: 10.1016/s0140-6736(53)91948-5. No abstract available.

ID	Term
D006964	Hyperpituitarism
D010900	Pituitary Diseases
D007027	Hypothalamic Diseases
D001927	Brain Diseases

ID	Term
D006966	Hyperprolactinemia
D019585	Intracranial Hypotension