A Phase 4 interventional study of Lugols Strong Iodine in Hyperthyroidism, Autoimmune, sponsored by Jesús María Villar del Moral. Completed at 21 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-06.
Sponsored by Jesús María Villar del Moral · Phase 4, Interventional, and Treatment
Among 12 studies in Graves Disease with a site in Spain — 6 open to participants now, 7 under way, 1 of them phase 3. Graves Disease · Spain.
Among the 12 studies in Graves Disease with a site in Spain, this one is the 6th largest by enrollment of the 11 interventional ones that give a count, is the only one that started in 2019, is the only one in phase 4, and was the 1st registered.
162 studies on the registry are indexed under Graves Disease; 53 are open to participants now.
Browse Graves Disease studies →6 of the 12 studies in Graves Disease with a site in Spain are open now. Recruiting first, the newest first:
argenx · Sites in Spain, Belgium, Bulgaria and 11 more countries
Ages 18+
Merida Biosciences · Sites in Spain, United States
Ages 18–65
Sanofi · Sites in Spain, Argentina, Canada and 6 more countries
Ages 18–75
Andrea Goldmann · Sites in Spain, Belgium, France and 2 more countries
Ages 18+
Immunovant Sciences GmbH · Sites in Spain, United States, Australia and 15 more countries
Ages 18–75
A study can be open while its sites in Spain have not opened yet or have stopped. Only those recruiting at a site in Spain →
Of the 39 Graves Disease studies recruiting now, 17 (44%) set no upper age limit and 20 (51%) stop at 75 or younger; 3 take children under 18; 7 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
12 studies; the count open now beside each. This study's row is marked.
First in 2019; this study’s year is marked. 1 started in 2019.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 184 is above the median of 60 across 104 interventional studies indexed under Graves Disease.
Median enrollment 184 across the 11 interventional studies, 486 across the 1 observational. Of the 5 that completed or were terminated, 4 (80%) have results posted.
This tab as a report to print or save as PDF → With an account.
10 of 12 have an industry lead sponsor. The 8 most frequent:
This is the only study on the registry with Jesús María Villar del Moral as lead sponsor.
Jesús María Villar del Moral has 1 study filed under Graves Disease — fewer than ten, so there is no comparison to draw.
3 of the studies in Graves Disease with a site in Spain that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06984627SanofiA Study to Investigate the Efficacy and Safety of Rilzabrutinib in Adult Participants With Graves' Disease | 2027-02-11 |
| NCT07018323Immunovant Sciences GmbHA Study to Assess the Efficacy, Safety, and Tolerability of IMVT-1402 as Treatment for Adult Participants With Graves' Disease | 2027-05 |
| NCT06963203Andrea GoldmannThyroidectomy for Graves' Disease or Amiodarone-induced Thyrotoxicosis | 2027-06 |
Add all 3 to your calendar (.ics) → With an account.
Among the 12 studies in Graves Disease with a site in Spain, from their registry updates:
This tab as a report to print or save as PDF → With an account.
Currently, both the American Thyroid Association and the European Thyroid Association recommend the use of Lugol Solution (LS) in the preparation of patients undergoing thyroidectomy for Graves' disease (GD), but their recommendations are based on a low level of evidence. This means that its use is not generalized among the different endocrine surgery units.
Methods:
Study population: 270 patients (135 patients in each arms) undergoing total thyroidectomy (TT) due to GD in Spanish hospitals, which perform a minimum of 100 thyroidectomies a year, at least 10 of them for GD.
Variables:
Preoperative variables
Intraoperative variables
Postoperative variables
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patients who meet all of the following criteria will be eligible:
Exclusion Criteria:
The participant can not participate in the study if he / she presents any of the following circumstances:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients will receive Lugol Solution preparation for 10 days before thyroidectomy
Drug: Lugols Strong Iodine
Patients will not receive preparation before thyroidectomy
5 L.I. drops / 8 hours for 10 days before surgery
Postoperative complications
To analyze whether, in euthyroid patients undergoing TT due to GD, preoperative non-preparation with LS increases the appearance of postoperative complications compared to the use of LS preparation. The main variable will be the rate of postoperative complication: hypoparathyroidism, recurrent laryngeal nerve injury, hematoma, surgical site infection or death.
Time frame: 30 days after surgery
Surgical difficulty
Score of the difficulty of the surgery by the surgeon through the Thyroidectomy Difficulty Scale.
Time frame: Intraoperatively
Intraoperative hemorrhage
Amount of blood lost during the thyroidectomy in dL.
Time frame: Intraoperatively
Surgical time.
Time from surgical incision to skin closure in minutes.
Time frame: Intraoperatively.
Intraoperative neuromonitoring.
Rate of patients with loss of electromyographic signal during intraoperative neuromonitoring.
Time frame: Intraoperatively.
Postoperative Long of Stay
Days to hospital discharge after surgery.
Time frame: 30 days after surgery
Readmissions
Rate of readmissions.
Time frame: 30 days after surgery.
Permanent complications
Rate of patients with permanent complications, including hypoparathyroidism or recurrent laryngeal nerve injury.
Time frame: 180 days after surgery
Adverse events
Number of patients with an adverse event after administration of Lugol solution.
Time frame: 180 days after surgery
Plan to share: No
Ran from Nov 2019 to primary completion in Nov 2023, 48 months.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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