A Study to Evaluate the Efficacy and Safety of Cabergoline Compared With Placebo for the Treatment of RLS

Restless Legs Syndrome Clinical Trial

Official title:

A Double-blind, Randomized, Placebo-controlled Multicenter Efficacy Study for the Treatment of Patients With Restless Legs Syndrome (RLS)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00627003
• Other study ID #: CABAS-0067-033
• Status: Completed
• Phase: Phase 3
• First received: February 19, 2008
• Last updated: April 22, 2011
• Start date: November 2002
• Est. completion date: May 2003

Study information

• Verified date: April 2011
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Bundesinstitute fur Arzneimittel und Medicinprodukte
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy and safety of cabergoline compared with placebo on periodic leg movements (PLMS) arousl index and sleep efficiency in patients with RLS. Also, additional objective and subjective sleep parameters and quality of life will be assessed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: May 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Idiopathic RLS

• Moderate to severe symptoms as indicated by an IRLS total score greater than or equal to 10 and a severity at night score of greater than or equal to 4

• In a baseline polysomnography, patients had to have periodic leg movements during sleep arousal index greater than 5/hour of total sleep time

Exclusion Criteria:

• Patients suffering from seconadry RLS, due to causes such as iron deficiency or renal disease, or suffering from secondary RLS while taking drugs suspected of causing secondary forms of RLS

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Psychomotor Agitation
• Restless Legs Syndrome

Intervention

Drug:
• Cabergoline
Cabergoline oral tablets administered once daily in the evening: 0.5 mg daily on Days 1 to 3, 1.0 mg daily on Days 4 to 7, 1.5 mg daily on Days 8 to 10, and 2.0 mg daily on Days 11 to 14, followed by a stable dose for an additional 3 weeks

Other:
• Placebo
Placebo oral tablets administered daily for 5 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sleep efficiency		Week 5	No
Primary	PLMS-arousal index (PLMS-AI)		Week 5	No
Secondary	Sleep Questionnaire Form A		Weeks 2 and 5	No
Secondary	Quality of Life for RLS questionnaire		Weeks 2 and 5	No
Secondary	Clinical Global Impressions		Weeks 2 and 5	No
Secondary	Safety including type and frequency of adverse events, changes in laboratory data and abnormalities observed in electrocardiography		Weeks 2 and 5	No
Secondary	Total score of the severity rating scale of the International RLS (IRLS) Study Group		Weeks 2 and 5	No
Secondary	RLS-6 severity scales		Weeks 2 and 5	No

External Links

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