Study Details

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A study of Oral Dosing of Gabapentin enacarbil in Japanese Restless Legs Syndrome Patients

This trial is complete
The study has ended normally, and participants are no longer being examined or treated (that is, the last participant's last visit has occurred).

Clinicaltrials.gov ID

The unique identification code given to each clinical study upon registration at ClinicalTrials.gov.
NCT03053427

Astellas Study ID

The unique identification code given by the study sponsor.

8825-CL-0101

EudraCT ID

The unique identification code given to each clinical study upon registration at EudraCT (European Union Drug Regulating Authorities Clinical Trials Database).

N/A

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Condition

Restless Legs Syndrome

Phase

These clinical trials happen after a drug or treatment has been approved for patients to take. Clinical trials in phase 4 usually take place over many years because researchers want to learn about long term use and safety of a drug or treatment.

Phase 4

Age

20 years - 80 years

Sex

Female & Male

Product

N/A

Type

A type of clinical study in which participants are assigned to groups that receive one or more intervention/treatment (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

Interventional

Trial Dates

Mar 2017 - Jun 2018

Masking

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Enrollment number

375

Gabapentin enacarbil Post-marketing Clinical Study A Randomized, double-blind, placebo-controlled, parallel-group study in subjects with Restless Legs Syndrome.

Study summary

Study documents

Study Documents, including study results, are available after a study is completed or terminated, according to Astellas Transparency policy.

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Locations

Site JP00031

Chiba, Japan

Site JP00025

Nagoya, Japan

Site JP00014

Shinjuku, Japan

Site JP00043

Tokorozawa, Japan

Site JP00003

Sapporo, Japan

Site JP00051

Fukuoka, Japan

Site JP00016

Shinagawa, Japan

Site JP00035

Kyoto, Japan

Site JP00020

Kyoto, Japan

Site JP00042

Kyoto, Japan

Site JP00018

Chuo, Japan

Site JP00010

Osaka, Japan

Site JP00033

Hirakata, Japan

Site JP00026

Osaka, Japan

Site JP00029

Nagoya, Japan

Site JP00006

Kitakyushu, Japan

Site JP00039

Osaka, Japan

Site JP00037

Osaka, Japan

Site JP00002

Sapporo, Japan

Site JP00038

Kawasaki, Japan

Site JP00004

Sapporo, Japan

Site JP00019

Ota, Japan

Site JP00023

Sapporo, Japan

Site JP00049

Yokohama, Japan

Site JP00040

Nagoya, Japan

Site JP00028

Chofu, Japan

Site JP00048

Meguro, Japan

Site JP00012

Arakawa, Japan

Site JP00024

Chuo, Japan

Site JP00001

Chofu, Japan

Site JP00046

Nakano, Japan

Site JP00041

Kawanishi, Japan

Site JP00011

Shibuya, Japan

Site JP00009

Yokosuka, Japan

Site JP00030

Saitama, Japan

Site JP00032

Sakai, Japan

Site JP00045

Otaru, Japan

Site JP00015

Shinagawa, Japan

Site JP00022

Kitakyushu, Japan

Site JP00005

Kobe, Japan

Site JP00013

Shinagawa, Japan

Site JP00017

Yokohama, Japan

Site JP00008

Shinjuku, Japan

Site JP00021

Shinjuku, Japan

Site JP00047

Osaka, Japan

Site JP00034

Musashino, Japan

Site JP00050

Yokohama, Japan

Site JP00044

Saitama, Japan

Site JP00036

Fukuoka, Japan

Site JP00007

Yokohama, Japan

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