NCT00627003

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Nov 2002

Shorter than P25 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2002

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2003

Completed
4.8 years until next milestone

First Submitted

Initial submission to the registry

February 19, 2008

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 29, 2008

Completed
Last Updated

April 25, 2011

Status Verified

April 1, 2011

First QC Date

February 19, 2008

Last Update Submit

April 22, 2011

Conditions

Restless Legs Syndrome

Outcome Measures

Primary Outcomes (2)

  • Sleep efficiency

    Week 5

  • PLMS-arousal index (PLMS-AI)

    Week 5

Secondary Outcomes (6)

  • Sleep Questionnaire Form A

    Weeks 2 and 5

  • Quality of Life for RLS questionnaire

    Weeks 2 and 5

  • Clinical Global Impressions

    Weeks 2 and 5

  • Safety including type and frequency of adverse events, changes in laboratory data and abnormalities observed in electrocardiography

    Weeks 2 and 5

  • Total score of the severity rating scale of the International RLS (IRLS) Study Group

    Weeks 2 and 5

  • +1 more secondary outcomes

Study Arms (2)

1

EXPERIMENTAL
Drug: Cabergoline

2

EXPERIMENTAL
Other: Placebo

Interventions

CabergolineDRUG

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

1
PlaceboOTHER

Placebo oral tablets administered daily for 5 weeks

2

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Restless Legs Syndrome

Interventions

Cabergoline

Condition Hierarchy (Ancestors)

Nervous System DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersParasomniasMental Disorders

Intervention Hierarchy (Ancestors)

ErgolinesErgot AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-Ring

Study Officials

  • Pfizer CT.gov Call Center

    Pfizer

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

February 19, 2008

First Posted

February 29, 2008

Study Start

November 1, 2002

Study Completion

May 1, 2003

Last Updated

April 25, 2011

Record last verified: 2011-04