HyperprolactinemiaNCT02603549
Pituitary Function and Spontaneous Intracranial Hypotension
An observational study of Hyperprolactinemia and Spontaneous Intracranial Hypotension, run by Cedars-Sinai Medical Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyperprolactinemia, Spontaneous Intracranial Hypotension
- What is being tested?
- Pituitary panel will be drawn pre-op and post-op for all patients.
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to Dec 2020
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with Spontaneous intracranial hypotension (SIH)
Who may be able to join
- Male or female patients
- Age 18 years and older
- Diagnosis of SIH:
- LP
- Brain MRI (SEEPS)
Who cannot join
- Pregnant and post-partum females
- Nursing mothers
- Patients with potential hyperprolactinemia due to:
- Hypothyroidism,
- Chronic renal disorder
- Liver disease (including cirrhosis)
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- Primary or secondary amenorrhea
- Polycystic Ovary Syndrome
- Seizure disorder
- Illicit drug use
Trial locations and contacts
1 site in 1 country.
United States1 site
Cedars-Sinai Medical Center
Los Angeles, California, 90048
About this study
Official title: Spontaneous Spinal Cerebrospinal Fluid Leaks and Intracranial Hypotension
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.
- Being tested
- Pituitary panel will be drawn pre-op and post-op for all patients.
- Medical subject headings
- Hyperprolactinemia, Intracranial Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pituitary panel will be drawn pre-op and post-op for all patients.Other
| Study group | Role | What they receive |
|---|---|---|
| Surgery or Blood Patch | Not described Receives: Other: Pituitary panel will be drawn pre-op and post-op for all patients. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparing the levels of prolactin pre and post treatment
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2015 (estimated)
- Study startJul 2015
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Why it stopped: Study protocol needs to be amended. Recruitment is halted until amendment is completed and approved by IRB.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HyperprolactinemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vivien Bonert, MD, Cedars-Sinai Medical Center
- Investigators
- Vivien Bonert, MD, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02603549
- Sponsor's protocol ID
- Pro39357
- Status last verified
- Jan 2019
- First submitted
- 10 Nov 2015
- Last updated
- 31 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 16705110SCHALTENBRAND 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.
PubMed 13036182Mokri B. Cerebrospinal fluid volume depletion and its emerging clinical/imaging syndromes. Neurosurg Focus. 2000 Jul 15;9(1):e6. doi: 10.3171/foc.2000.9.1.6.
PubMed 16859267
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spontaneous Spinal Cerebrospinal Fluid Leaks and Intracranial Hypotension
- ClinicalTrials.gov ID
- NCT02603549
- Acronym / sponsor ID
- Pro39357
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: Study protocol needs to be amended. Recruitment is halted until amendment is completed and approved by IRB.
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 13 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgery or Blood Patch | – | Other: Pituitary panel will be drawn pre-op and post-op for all patients. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Spontaneous intracranial hypotension (SIH)
Key inclusion criteria (5 listed)
- Male or female patients
- Age 18 years and older
- Diagnosis of SIH:
- LP
- Brain MRI (SEEPS)
Key exclusion criteria (10 listed)
- Pregnant and post-partum females
- Nursing mothers
- Patients with potential hyperprolactinemia due to:
- Hypothyroidism,
- Chronic renal disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pituitary panel will be drawn pre-op and post-op for all patients. | Other | Surgery or Blood Patch |
Primary outcome
Comparing the levels of prolactin pre and post treatment
Time frame: 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2019.
- Background: PubMed 16705110Schievink WI. Spontaneous spinal cerebrospinal fluid leaks and intracranial hypotension. JAMA. 2006 May 17;295(19):2286-96. doi: 10.1001/jama.295.19.2286.
- Background: PubMed 13036182SCHALTENBRAND 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.
- Background: PubMed 16859267Mokri B. Cerebrospinal fluid volume depletion and its emerging clinical/imaging syndromes. Neurosurg Focus. 2000 Jul 15;9(1):e6. doi: 10.3171/foc.2000.9.1.6.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vivien Bonert, MD principal investigator
Cedars-Sinai Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hyperprolactinemia and Spontaneous Intracranial Hypotension, run by Cedars-Sinai Medical Center 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 5 inclusion and 10 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: paused, as of the sponsor's last update on 31 Jan 2019. 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.
Are results available for this study?
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?
Comparing the levels of prolactin pre and post treatment (time frame: 90 days). 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 NCT02603549, which also lists 3 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 31 Jan 2019.