Effectiveness of oral corticosteroids in unilateral recurrent laryngeal nerve palsy after thyroidectomy

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-001231-48-FR

Enrollment

400

Registered

2018-03-26

Start date

2019-05-14

Completion date

Unknown

Last updated

2025-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

MedDRA version: 20.0 Level: LLT Classification code 10038130 Term: Recurrent laryngeal nerve palsy System Organ Class: 100000004852

Interventions

Trade Name: Solupred Product Name: solupred Pharmaceutical Form: Orodispersible tablet Pharmaceutical form of the placebo: Capsule Route of administration of the placebo: Oral use

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients undergoing total or partial thyroidectomy (no lymphe node dissection) Age = 18 yo Informed consent, and signed Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 300 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 100

Exclusion criteria

Exclusion criteria: Patients undergoing thyroid cancer surgery (with lymphe node dissection) Patients with pre operative recurrent laryngeal nerve palsy Patients with bilateral recurrent laryngeal nerve palsy Patients with allergy to Prednisolone Patients with ongoing infection

Design outcomes

Primary

Measure	Time frame
Main Objective: Study the effectiveness of oral corticosteroids in vocal fold remobilization (at Day 7) for patients with unilateral recurrent laryngeal nerve palsy after thyroidectomy;Secondary Objective: Study the incidence of unilateral recurrent laryngeal nerve palsy Study the rate of complete remobilization at M1 and M3 between placebo and corticosteroids group Study the rate of partial remobilization between at D7, M1 and M3 between placebo and corticosteroids group Observance and tolerance of oral corticosteroids ;Primary end point(s): Complete remobilization of laryngeal palsy, evaluated by naso fibroscope inspection at Day 7 after thyroidectomy Complete response is definied by optimal contact of paralysed vocal fold with controlateral vocal fold ;Timepoint(s) of evaluation of this end point: day 7	—

Measure

Time frame

Main Objective: Study the effectiveness of oral corticosteroids in vocal fold remobilization (at Day 7) for patients with unilateral recurrent laryngeal nerve palsy after thyroidectomy;Secondary Objective: Study the incidence of unilateral recurrent laryngeal nerve palsy Study the rate of complete remobilization at M1 and M3 between placebo and corticosteroids group Study the rate of partial remobilization between at D7, M1 and M3 between placebo and corticosteroids group Observance and tolerance of oral corticosteroids ;Primary end point(s): Complete remobilization of laryngeal palsy, evaluated by naso fibroscope inspection at Day 7 after thyroidectomy Complete response is definied by optimal contact of paralysed vocal fold with controlateral vocal fold ;Timepoint(s) of evaluation of this end point: day 7

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Secondary

Measure	Time frame
Secondary end point(s): Percentage of recurrent laryngeal nerve palsy in studied population Complete remobilization of laryngeal palsy at M1 and M3 between placebo and corticosteroids group Partial remobilization of laryngeal palsy at D7, M1 and M3 between placebo and corticosteroids group (partial remobilization is definied by non optimal vocal fold movement) Observance and tolerance of oral corticosteroids evaluated by interrogation ;Timepoint(s) of evaluation of this end point: Day 7, Month 1 and 3	—

Measure

Time frame

Secondary end point(s): Percentage of recurrent laryngeal nerve palsy in studied population Complete remobilization of laryngeal palsy at M1 and M3 between placebo and corticosteroids group Partial remobilization of laryngeal palsy at D7, M1 and M3 between placebo and corticosteroids group (partial remobilization is definied by non optimal vocal fold movement) Observance and tolerance of oral corticosteroids evaluated by interrogation ;Timepoint(s) of evaluation of this end point: Day 7, Month 1 and 3

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Countries

France

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026