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Efficacy and safety of Levetiracetam treatment in patients suffering from Restless Legs Syndrome Eficacia y seguridad de un tratamiento con levetiracetam en pacientes con síndrome idiopático de piernas inquietas

Efficacy and safety of Levetiracetam treatment in patients suffering from Restless Legs Syndrome Eficacia y seguridad de un tratamiento con levetiracetam en pacientes con síndrome idiopático de piernas inquietas

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2005-001516-41-ES
Enrollment
12
Registered
2005-10-10
Start date
2005-09-07
Completion date
Unknown
Last updated
2012-03-19

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

Conditions

Restless legs syndrome (RLS)

Interventions

Trade Name: Keppra 250 Product Name: Levetiracetam Pharmaceutical Form: Film-coated tablet INN or Proposed INN: levetiracetam CAS Number: 102767-28-2 Current Sponsor code: ucb-L059 Concentration unit

Sponsors

Clínica Plató Fundació Privada
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Male and female older than 30 years old. 2. Patients with idiopathic RLS. 3. RLS diagnostic according to protocol of center. 4. Score scale according International Restless Study Group. 3. Patients must give their written consent to participate in the study. 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. Patients with secondary RLS. 2. Pregnant or breast-feeding. 3. Renal impairment.

Design outcomes

Primary

MeasureTime frame
Secondary Objective: To assess the safety of Levetiracetam in patients suffering from RLS.;Primary end point(s): Severity of RLS symptoms.;Main Objective: To assess the efficacy of Levetiracetam in patients suffering from RLS.—

Countries

Spain

Outcome results

None listed

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