Old drug, new hope: thalidomide tested for Kids' fever disorder
NCT ID NCT07476625
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether thalidomide can reduce or stop fever episodes in children with PFAPA syndrome, a condition causing repeated fevers and sore throats. About 106 children aged 3 to 18 will take either thalidomide or colchicine daily for 6 months. Researchers will track how many children have no fevers during treatment and monitor for side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- thalidomide
- What this could lead to
- If it works, this could offer a new treatment option to control fever episodes in children with PFAPA syndrome.
- What could go wrong
- This is an early-stage trial with only 106 participants, so results may not apply to all children. Thalidomide has known side effects, including drowsiness and nerve damage.
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
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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.
- Participants
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About 106 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Apr 2026
An estimate. Start dates often move.
- Expected to finish
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Mar 2028
An estimate. End dates often move.
- Lead sponsor
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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
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3 to 18 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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. Meet the 2019 Eurofever or 2020 CARRA diagnostic criteria for PFAPA syndrome. 2. Aged 3 to 18 years (inclusive) at the time of screening. 3. Have experienced at least 3 febrile episodes within the past six months. 4. History of responsiveness to glucocorticoid treatment during at least 3 previous episodes, but with continued recurrence. (Responsiveness is defined as normalization of body temperature within 24 hours after a maximum dose of 2 mg/kg \[up to 60 mg\] administered as a single or two divided doses). Exclusion Criteria: 1.Diagnosis of monogenic or other polygenic periodic fever syndromes. 2.Presence of immunodeficiency or neoplastic diseases. 3.Active bacterial, fungal, or viral infection during the screening period. 4.Prior treatment with immunosuppressive agents. 5.Prior use of thalidomide or colchicine. 6.Laboratory parameters at screening that meet any of the following (based on the most recent test result at the study hospital prior to the first dose): 1. White Blood Cell (WBC) count \< 4 × 10⁹/L, Hemoglobin (HGB) \< 100 g/L, or Platelet (PLT) count \< 100 × 10⁹/L. 2. Serum Alanine Aminotransferase (ALT) \> 2 times the Upper Limit of Normal (ULN). 3. Glomerular Filtration Rate (GFR/CCR) \< 60 mL/min/1.73m².
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.