Pathophysiology and Treatment of Cerebrospinal Hypotensio... | NCT06805591

Studies
Pathophysiology and Treatment of Cerebrospinal Hypotension Exploration Study

NCT06805591

Sponsor

Danish Headache Center

Status

Enrolling by invitation

Last Update Posted

Feb 6, 2025Actual

Enrollment

400Estimated

Phase

Not provided

Conditions

Spontaneous Intracranial Hypotension
Intracranial Hypotension
Post-Lumbar Puncture Headache

Interventions

Not provided

Countries

Denmark

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

ID	Type	Description	Link
NNF24OC0087919	Other Grant/Funding Number	Novo Nordisk Foundation

Status Module

Record Verification Date

Feb 2025

Overall Recruitment Status or Expanded Access Status

Enrolling by invitation

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 10, 2024Actual

Primary Completion Date

Sep 30, 2029Estimated

Completion Date

Sep 30, 2029Estimated

First Submitted Date

Jan 28, 2025

First Submission Date that Met QC Criteria

Jan 28, 2025

First Posted Date

Feb 3, 2025Actual

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

Feb 3, 2025

Last Update Posted Date

Feb 6, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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

The goal of this observational study is to learn about the effects of a low-pressure environment on the brain in patients with intracranial hypotension and to potentially improve diagnostics and treatment of this condition.

The primary objective will be:

To investigate the change in clinical biomarkers measured before and after successful treatment.

The secondary objectives will be:

To investigate if clinical biomarkers can predict the outcome of treatment. Participants undergoing standard treatment for intracranial hypotension will undergo additional examinations and surveys and will be followed up for a year for the study.

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

Yes

Target Follow-Up Duration

1 Year

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

400Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients with suspected Intracranial Hypotension		Patients will be included in the cohort if suspected of intracranial hypotension. The group will therefore be subgrouped into patients with spontaneous intracranial Hypotension, post-lumbar puncture headache, and patients suspected but not demonstrated with intracranial hypotension.
Control Group		Group consisting of healthy control participants.

Interventions

Not provided

Measure	Description	Time Frame
To investigate the change in clinical biomarkers measured before and after successful treatment.		From enrollment to 1 year post-treatment.

Eligibility Module

Eligibility Criteria

Inclusion Criteria (patients):

Age 18-80.
Patients with a suspected intracranial hypotension diagnosis.
Participants must read and understand the Danish language or have an official interpreter present to be able to understand the work-up and sign the participation consent for the study.

Inclusion Criteria (Control):

Age 18-80.
Healthy people who do not suffer from any form of primary headache except infrequent tension-type headache.
Participants must read and understand the Danish language or have an official interpreter present to be able to sign the participation consent for the study.

Exclusion Criteria (patients):

Pregnant or breastfeeding females
Patients in whom the examination cannot be performed due to anatomical reasons such as severe head dysmorphia or severe ophthalmological diseases.
The patient has a disease, takes medication, or abuses alcohol or drugs that could, in the investigator´s opinion interfere with the assessments of safety, tolerability, or efficacy, or interfere with the conduct or interpretation of the study.
The patient is, in the investigator´s opinion, unlikely to comply with the protocol or is unsuitable for any reason.

Exclusion Criteria (Control):

Pregnant or breastfeeding females
Participants in whom the examination cannot be performed due to anatomical reasons such as severe head dysmorphia or severe ophthalmological diseases.
The participant has a disease, takes medication, or abuses alcohol or drugs that could, in the investigator´s opinion interfere with the interpretation of the study.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Patients at the Danish Headache Center with suspected intracranial hypotension

Sampling Method

Non-Probability Sample

ID	Term
D019585	Intracranial Hypotension
D051299	Post-Dural Puncture Headache

ID	Term
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D051271	Headache Disorders, Secondary