NCT01112644

Brief Summary

The primary objective for the 12-week Titration-/Maintenance Period is: To demonstrate superior efficacy of OXN PR compared to PLA in the improvement of symptom severity of RLS.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
205

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Apr 2010

Shorter than P25 for phase_3

Geographic Reach
3 countries

3 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

April 1, 2010

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

April 23, 2010

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 28, 2010

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

October 23, 2018

Status Verified

October 1, 2018

Enrollment Period

1.2 years

First QC Date

April 23, 2010

Last Update Submit

October 19, 2018

Conditions

Moderate to Severe Idiopathic RLS With Daytime Symptoms

Outcome Measures

Primary Outcomes (1)

  • Changes in the IRLS score between the two treatment arms will be compared

    The primary objective for the 12-week Titration-/Maintenance Period is: IRLS: International Restless Legs Syndrome Study Group Rating Scale Assessment Period baseline (visit 3) to final Maintenance Period.

    12 weeks and a 6 month extension

Study Arms (2)

OXN PR

EXPERIMENTAL

Different daily doses; intake every 12 hours

Drug: Oxycodone naloxone prolonged release tablets (OXN PR)

PLA

PLACEBO COMPARATOR

Different daily doses; intake every 12 hours

Drug: Oxycodone naloxone prolonged release tablets (OXN PR)Other: Placebo (PLA)

Interventions

Oxycodone naloxone prolonged release tablets (OXN PR)DRUG

Different daily doses; intake every 12 hours

OXN PRPLA
Placebo (PLA)OTHER

Different daily doses; intake every 12 hours

PLA

Eligibility Criteria

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

You may qualify if:

  • Moderate to severe idiopathic RLS with daytime symptoms

You may not qualify if:

  • Females who are pregnant or lactating.
  • Subjects with evidence of significant structural abnormalities of the gastrointestinal tract.
  • Subjects with evidence of impaired liver/kidney function upon entry into the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Paracelsus Elena Klinik

Kassel, Germany

Location

Unknown Facility

Barcelona, Spain

Location

Unknown Facility

Gothenburg, Sweden

Location

Related Publications (2)

  • Oertel WH, Hallstrom Y, Saletu-Zyhlarz GM, Hopp M, Bosse B, Trenkwalder C; RELOXYN Study Group. Sleep and Quality of Life Under Prolonged Release Oxycodone/Naloxone for Severe Restless Legs Syndrome: An Analysis of Secondary Efficacy Variables of a Double-Blind, Randomized, Placebo-Controlled Study with an Open-Label Extension. CNS Drugs. 2016 Aug;30(8):749-60. doi: 10.1007/s40263-016-0372-1.

    PMID: 27401882DERIVED

  • Trenkwalder C, Benes H, Grote L, Garcia-Borreguero D, Hogl B, Hopp M, Bosse B, Oksche A, Reimer K, Winkelmann J, Allen RP, Kohnen R; RELOXYN Study Group. Prolonged release oxycodone-naloxone for treatment of severe restless legs syndrome after failure of previous treatment: a double-blind, randomised, placebo-controlled trial with an open-label extension. Lancet Neurol. 2013 Dec;12(12):1141-50. doi: 10.1016/S1474-4422(13)70239-4. Epub 2013 Oct 18.

    PMID: 24140442DERIVED

Related Links

Study Design

Study Type
interventional
Phase
phase 3
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

April 23, 2010

First Posted

April 28, 2010

Study Start

April 1, 2010

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

October 23, 2018

Record last verified: 2018-10

Locations

SE(1)DE(1)ES(1)