NCT00530530

Brief Summary

To demonstrate the superiority of ASP8825 over placebo and the dose response in patients with restless legs syndrome

Trial Health

87
On Track

Trial Health Score

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

Enrollment
474

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 2007

Shorter than P25 for phase_2

Geographic Reach
1 country

6 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

September 13, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 17, 2007

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
Last Updated

October 29, 2014

Status Verified

October 1, 2014

Enrollment Period

1.3 years

First QC Date

September 13, 2007

Last Update Submit

October 28, 2014

Conditions

Restless Legs Syndrome

Keywords

ASP8825Restless legs SyndromeXP13512

Outcome Measures

Primary Outcomes (1)

  • The change of the International Restless Legs Syndrome rating scale score

    12 weeks

Secondary Outcomes (6)

  • Investigator-related Clinical Global Impression of Improvement

    12 weeks

  • Patient- related Clinical Global Impression of Improvement

    12 weeks

  • The Pittsburgh sleep quality index

    12 weeks

  • The SF-36 Health Survey

    12 weeks

  • The Restless Legs Syndrome QOL Questionnaire

    12 weeks

  • +1 more secondary outcomes

Study Arms (4)

1

EXPERIMENTAL

Dose 1

Drug: ASP8825

2

EXPERIMENTAL

Dose 2

Drug: ASP8825

3

EXPERIMENTAL

Dose 3

Drug: ASP8825

4

PLACEBO COMPARATOR
Drug: Placebo

Interventions

ASP8825DRUG

oral

Also known as: XP13512
123
PlaceboDRUG

oral

4

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with RLS, based on the International RSL Study Group Diagnostic Criteria
  • History of RLS symptoms at least 15 nights in the prior month or, if on treatment, this frequency of symptoms before treatment was started
  • Documented RLS symptoms for at least 4 of the 7 consecutive evenings/ nights during the baseline study period

You may not qualify if:

  • A sleep disorder (e.g., sleep apnea) that may significantly affect the assessment of RLS
  • A history of RLS symptom augmentation or end-of-dose rebound with previous dopamine agonist treatment
  • Neurologic disease or movement disorder (e.g., diabetic neuropathy, Parkinson's Disease, Multiple Sclerosis, dyskinesias and dystonias

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Unknown Facility

Chugoku, Japan

Location

Unknown Facility

Hokkaido, Japan

Location

Unknown Facility

Kansai, Japan

Location

Unknown Facility

Kanto, Japan

Location

Unknown Facility

Kyusyu, Japan

Location

Unknown Facility

Tōhoku, Japan

Location

Related Publications (1)

  • Inoue Y, Hirata K, Uchimura N, Kuroda K, Hattori N, Takeuchi M. Gabapentin enacarbil in Japanese patients with restless legs syndrome: a 12-week, randomized, double-blind, placebo-controlled, parallel-group study. Curr Med Res Opin. 2013 Jan;29(1):13-21. doi: 10.1185/03007995.2012.746217. Epub 2012 Nov 30.

    PMID: 23121149DERIVED

MeSH Terms

Conditions

Restless Legs Syndrome

Interventions

1-(((alpha-isobutanoyloxyethoxy)carbonyl)aminomethyl)-1-cyclohexaneacetic acid

Condition Hierarchy (Ancestors)

Nervous System DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersParasomniasMental Disorders

Study Officials

  • Central Contact

    Astellas Pharma Inc

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2007

First Posted

September 17, 2007

Study Start

September 1, 2007

Primary Completion

January 1, 2009

Study Completion

January 1, 2009

Last Updated

October 29, 2014

Record last verified: 2014-10

Locations

JP(6)