NCT01981941 is a Phase 4 clinical trial of Gabapentin enacarbil in Restless Legs Syndrome (RLS), sponsored by Astellas Pharma Inc.

Who is sponsoring NCT01981941?

NCT01981941 is sponsored by Astellas Pharma Inc.

What drugs are being tested in NCT01981941?

Interventions in NCT01981941: Gabapentin enacarbil.

What condition does NCT01981941 study?

NCT01981941 studies Restless Legs Syndrome (RLS).

Is NCT01981941 still recruiting?

NCT01981941 is currently completed. Last updated 8 November 2024.

Last reviewed 2024-11-08 · How we verify

NCT01981941

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Post-marketing Study of Gabapentin Enacarbil to Evaluate the Effect in Restless Leg Syndrome (RLS) Patients With Moderate Renal Impairment

Completed Phase 4 Last updated 8 November 2024

What this trial tests

Phase 4 trial testing Gabapentin enacarbil in Restless Legs Syndrome (RLS) in 19 participants. Completed in 13 May 2015.

Timeline

5 November 2013

Primary endpoint
13 May 2015

13 May 2015

Quick facts

Lead sponsor	Astellas Pharma Inc
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	19
Start date	5 November 2013
Primary completion	13 May 2015
Estimated completion	13 May 2015
Sites	5 locations across Japan

Drugs / interventions tested

Gabapentin enacarbil (GABAPENTIN ENACARBIL) — full drug profile →

Conditions studied

Restless Legs Syndrome (RLS) — all drugs for Restless Legs Syndrome (RLS) →

Sponsor

Astellas Pharma Inc — full company profile →

Who can join

Adults 20 to 80, any sex, with Restless Legs Syndrome (RLS). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

To evaluate the safety, efficacy and pharmacokinetics of gabapentin enacarbil in moderate to severe primary RLS patients with moderate renal impairment and to confirm dosage and administration in such population.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of Gabapentin enacarbil

Trials testing the same drug.

NCT03053427 — A Study of Oral Dosing of Gabapentin Enacarbil in Japanese Restless Legs Syndrome Patients · Phase 4 · completed

Other Astellas Pharma Inc trials

Trials by the same sponsor.

NCT07318714 — A Study of ASP2246 for People Who Have Movement Problems Caused by Brain Injury After a Stroke · Phase 1, PHASE2 · recruiting
NCT07094204 — A Study to Find a Suitable Dose of ASP5834 in Adults With Solid Tumors · Phase 1 · recruiting
NCT06970665 — A Study About the Safety of ASP3021 Eye Injections and if They Help People in Japan With Vision Loss From Age-related Ma · Phase 4 · recruiting
NCT06364696 — A Study to Find a Suitable Dose of ASP4396 in Adults With Solid Tumors · Phase 1 · active not recruiting
NCT06206421 — A Study to Assess Long-term Safety of Fezolinetant Given to Japanese Women Going Through Menopause · Phase 3 · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01981941 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Astellas Pharma Inc
Last refreshed: 8 November 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01981941.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing