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

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00627003
• Collaborator: (none)
• Enrollment: 43
• Arms: 2
• Duration (Months): 5.9

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Restless Legs Syndrome	Drug: Cabergoline; Other: Placebo	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 43 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Care Provider)
• Primary Purpose: Treatment
• Official Title: A Double-blind, Randomized, Placebo-controlled Multicenter Efficacy Study for the Treatment of Patients With Restless Legs Syndrome (RLS)
• Study Start Date: Nov 1, 2002
• Actual Study Completion Date: May 1, 2003

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	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
Experimental: 2	Other: Placebo; Placebo oral tablets administered daily for 5 weeks

Outcome Measures

Primary Outcome Measures

1. Sleep efficiency [Week 5]

2. PLMS-arousal index (PLMS-AI) [Week 5]

Secondary Outcome Measures

1. Sleep Questionnaire Form A [Weeks 2 and 5]

2. Quality of Life for RLS questionnaire [Weeks 2 and 5]

3. Clinical Global Impressions [Weeks 2 and 5]

4. Safety including type and frequency of adverse events, changes in laboratory data and abnormalities observed in electrocardiography [Weeks 2 and 5]

5. Total score of the severity rating scale of the International RLS (IRLS) Study Group [Weeks 2 and 5]

6. RLS-6 severity scales [Weeks 2 and 5]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• To obtain contact information for a study center near you, click here.

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00627003
• Other Study ID Numbers: CABAS-0067-033
• First Posted: Feb 29, 2008
• Last Update Posted: Apr 25, 2011
• Last Verified: Apr 1, 2011

• Additional relevant MeSH terms: Psychomotor Agitation; Restless Legs Syndrome; Syndrome; Cabergoline

Study Results

No Results Posted as of Apr 25, 2011