Lyrica Dose Response Study With Restless Legs Syndrome (RLS) Patients

Viatris

Status and phase: Completed; Phase 2

Conditions: Restless Legs Syndrome

Treatments: Drug: Pregabalin; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00676403

A0081183

Details and patient eligibility

About

To test the effectiveness and tolerability of Lyrica at various dose levels in RLS patients

Enrollment: 137 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Moderate to severe idiopathic RLS
• symptoms occur predominantly in the evening
• symptoms interfere with sleep onset or maintenance

Exclusion criteria

• Any secondary RLS
• require treatment for daytime RLS symptoms
• symptomatic neuropathies

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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137 participants in 6 patient groups, including a placebo group

1

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: placebo

2

Experimental group

Description:

investigational treatment

Treatment:

Drug: Pregabalin

Drug: Pregabalin

Drug: Pregabalin

Drug: Pregabalin

Drug: Pregabalin

3

Experimental group

Description:

investigational treatment

Treatment:

Drug: Pregabalin

Drug: Pregabalin

Drug: Pregabalin

Drug: Pregabalin

Drug: Pregabalin

4

Experimental group

Description:

investigational treatment

Treatment:

Drug: Pregabalin

Drug: Pregabalin

Drug: Pregabalin

Drug: Pregabalin

Drug: Pregabalin

5

Experimental group

Description:

investigational treatment

Treatment:

Drug: Pregabalin

Drug: Pregabalin

Drug: Pregabalin

Drug: Pregabalin

Drug: Pregabalin

6

Experimental group

Description:

investigational treatment

Treatment:

Drug: Pregabalin

Drug: Pregabalin

Drug: Pregabalin

Drug: Pregabalin

Drug: Pregabalin