NCT00200941

Brief Summary

This study is intended to determine whether topiramate is an efficacious and safe treatment for restless legs syndrome.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Aug 2001

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

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

August 1, 2001

Completed
3.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2005

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
Last Updated

December 16, 2005

Status Verified

September 1, 2005

First QC Date

September 12, 2005

Last Update Submit

December 15, 2005

Conditions

Restless Legs Syndrome

Keywords

Restless Legs SyndromeTopiramateActigraphyPolysomnography

Outcome Measures

Primary Outcomes (1)

  • The average number of periodic leg movements during three consecutive nights of actigraphy beginning at the end of the double blind phase

Secondary Outcomes (7)

  • Proportion of time in bed without leg movements during the three consecutive nights of actigraphy beginning at the end of the double blind phase

  • SF-36 at the last visit of the double blind phase

  • Score on the RLS Rating Scale (modified) questionnaire at the last visit of the double blind phase

  • Periodic leg movements during sleep and wakefulness during the PSG recorded at the end of the double blind phase

  • PSG measures including periodic leg movement arousal index, latency until sustained sleep, sleep efficacy, and wake after sleep onset

  • +2 more secondary outcomes

Interventions

TopiramateDRUG

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The symptoms of each subject must meet the diagnostic criteria of the International RLS Study Group
  • More than five periodic leg movements per hour recorded during baseline polysomnography (PSG)
  • Each subject must discontinue all treatments for RLS and agreed not to take other RLS treatments during the study

You may not qualify if:

  • Clinically unstable medical problems
  • History of nephrolithiasis
  • Progressive neurologic disease
  • Inadequate therapeutic response from two previous treatment regimens for RLS
  • Subjects unable to discontinue medications known to cause or suppress RLS
  • Subjects with sleep apnea syndrome
  • Subjects consuming daily more than three beverages containing caffeine

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Neurocare

Newton, Massachusetts, 02459, United States

Location

MeSH Terms

Conditions

Restless Legs Syndrome

Interventions

Topiramate

Condition Hierarchy (Ancestors)

Nervous System DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersParasomniasMental Disorders

Intervention Hierarchy (Ancestors)

FructoseHexosesMonosaccharidesSugarsCarbohydratesKetoses

Study Officials

  • Michael P Biber, MD

    Neurocare

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
ECT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 20, 2005

Study Start

August 1, 2001

Study Completion

April 1, 2005

Last Updated

December 16, 2005

Record last verified: 2005-09

Locations

US(1)