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Withdrawn study on plasma patches for rare headaches leaves questions unanswered

NCT ID NCT07283536

Disease control Sponsor: Beijing Tiantan Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled This study
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study planned to compare two methods of delivering a platelet-rich plasma patch to treat headaches caused by low spinal fluid pressure. The trial was withdrawn before any participants were enrolled, so no data was collected. The goal was to see if a simpler blind approach could work as well as a targeted one guided by imaging.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
platelet-rich plasma (PRP)
What this could lead to
If successful, this could show that a simpler blind patch works as well as a targeted one for treating SIH headaches.
What could go wrong
The trial was withdrawn before enrolling anyone, so no results are available. The approach is still experimental and unproven.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Expected to start

Dec 2025

An estimate. Start dates often move.

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Informed consent to participate the research obtained from the patient. 2. Age 18-65 years. 3. Satisfies the criteria for SIH according to the International Classification of Headache Disorders criteria for headaches attributed to spontaneous (or idiopathic) low CSF pressure. 4. Failed conservative management (bed rest oral or intravenous hydration, and analgesics) lasting at least 2 weeks. Exclusion Criteria: 1. There was concern for other causes of intracranial hypotension, such as postdural puncture, postsurgical and post-traumatic CSF leaks. 2. Prior treatment with EBP at any time previously. 3. Any contraindication to epidural puncture, such as space-occupying intracranial or intraspinal lesions, spinal defect, suspected infection over the puncture site, bleeding disorder and current anticoagulation therapy. History of drug and alcohol abuse, cognitive dysfunction, or mental illness. 4. Unable to comprehend the pain NRS. 5. Unable to cooperate with postoperative treatment, rehabilitation, and follow-up visits.

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Conditions

The condition(s) this trial relates to.

intracranial hypotension spontaneous intracranial hypotension

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Spontaneous intracranial hypotension

More trials for these conditions

Other studies related to the condition(s) this trial covers.