Restless Legs SyndromePhase 2NCT02231918

Study to Investigate Pharmacokinetics (PK) of Pramipexole in Pediatric Patients Who Are Individually Optimized to Stable Pramipexole Doses for the Treatment of Idiopathic Restless Legs Syndrome (RLS)

A Phase 2 study testing MIRAPEX® - low, MIRAPEX® - medium and MIRAPEX® - high in people with Restless Legs Syndrome, run by Boehringer Ingelheim.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Study to determine the pharmacokinetics (PK) of pramipexole (PPX) after administration of a single dose orally (p.o.) in pediatric patients with the diagnosis of RLS Read more about this study

Who is it for?: Ages 6 to 16 years
Conditions the study is for: Restless Legs Syndrome
What is being tested?: MIRAPEX® - low, MIRAPEX® - medium and MIRAPEX® - high
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 26 participants
Where: No sites listed yet
Study dates: May 2006to Jul 2007
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 6 to 16 years
All sexes
No healthy volunteers
Child

Who may be able to join

Male or female patients ages 6 years to 16 years (two age groups, 6 to 11 years and 12 to 16 years, with the same number of patients if possible)
Diagnosis of idiopathic Restless Legs Syndrome (RLS) according to the Clinical RLS criteria of the International Restless Legs Syndrome Study Group (IRLSSG)
All 4 of the following criteria must be present:
An urge to move the legs, usually accompanied or caused by uncomfortable and unpleasant sensations in the legs. (Sometimes the urge to move is present without the uncomfortable sensations and sometimes the arms or other body parts are involved in addition to the legs.)
The urge to move or unpleasant sensations begin or worsen during periods of rest or inactivity such as lying or sitting
The urge to move or unpleasant sensations are partially or totally relieved by movement, such as walking or stretching, at least as long as the activity continues

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The urge to move or unpleasant sensations are worse in the evening or night than during the day or only occur in the evening or night. (When symptoms are very severe, the worsening at night may not be noticeable but must have been previously present.)
Must meet all 4 of the diagnostic criteria for adult RLS (see inclusion criterion No. 2 above) and either:
The child must be able to describe the leg discomfort in their own words or
The child must have 2 or 3 of the following:
Sleep disturbance
Periodic Limb Movements During Sleep (PLMS) index >5 per hour of sleep, or
A biological parent or sibling with definite RLS
Written informed consent consistent with International Conference on Harmonisation (ICH)/ Good Clinical Practice (GCP) and Local Institutional Review Board requirements for children obtained prior to any study procedures being performed
Ability and willingness to comply with the study treatment regimen and to attend study assessments
Must be on PPX treatment at the same evening maintenance dose for a minimum of 7 days prior to entry into this study as determined by the investigator
A patient who is taking PPX but not as an evening maintenance dose may return for a repeat screening if the patient can be successfully switched and re-stabilized to an evening PPX maintenance dose

Who cannot join

Any women of childbearing potential having a positive serum pregnancy test at screening
Any women of childbearing potential not using a medically accepted method of contraceptive (Intra-Uterine Device, oral, implantable, injectable contraceptives and estrogen patch, double barrier method [spermicide + diaphragm], or abstinence at the discretion of the investigator)
Patients who have a clinically significant renal disease or serum creatinine level greater than 1.0 mg/dL at screening
Any of the following lab results at screening:
Hemoglobin (Hgb) below the lower limit of normal (LLN), which is determined to be clinically significant
Basal thyroid stimulating hormone (TSH), triiodothyronine (T3) or thyroxine (T4) clinically significantly (at the investigator's discretion) out of the normal range at screening (if not caused by substitution therapy according to the investigator's opinion)

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Patients with any clinically significant abnormalities in laboratory parameters at screening at the investigator's discretion
Other clinically significant metabolic-endocrine, hematological, gastrointestinal disease, pulmonary disease (such as severe asthma) which in the opinion of the investigator would preclude the patient from participating in this study
History or clinical signs of any neurological disease with potential to secondarily cause RLS symptoms
Presence of any other sleep disorder such as Rapid Eye Movement (REM) sleep behavior disorder, narcolepsy, or sleep apnea syndrome
History of schizophrenia or any psychotic disorder, history of mental disorders, or any present Axis I psychiatric disorder according to the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) requiring any medical therapy
History of/or clinical signs of epilepsy or seizures other than fever-related seizures in early childhood
History of/or clinical signs of any malignant neoplasm including suspicious undiagnosed skin lesions (which may be melanoma), melanoma, or a history of melanoma
Any other conditions that, in the opinion of the investigator, would interfere with the evaluation of the results or constitute a health hazard for the patient
Allergic response to PPX or the inactive ingredients in its tablet formulation
Had previous treatment with dopamine agonists other than PPX within 14 days prior to the baseline visit
Had any other medical treatment for RLS besides the study medication within 14 days prior to the baseline visit
Had withdrawal symptoms of any medication at screening or at the baseline visit

About this study

Official title: An Open-label Clinical Study to Investigate Pharmacokinetics (PK) of Different Doses (0.125 mg, 0.25 mg, 0.5 mg) of Pramipexole Administered Once Daily Orally in Pediatric Patients Who Are Individually Optimized to Stable Pramipexole Doses for the Treatment of Idiopathic Restless Legs Syndrome (RLS)

Study to determine the pharmacokinetics (PK) of pramipexole (PPX) after administration of a single dose orally (p.o.) in pediatric patients with the diagnosis of RLS

Conditions: Restless Legs Syndrome
Being tested: MIRAPEX® - low, MIRAPEX® - medium, MIRAPEX® - high
Medical subject headings: Restless Legs Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MIRAPEX® - lowDrug
MIRAPEX® - mediumDrug
MIRAPEX® - highDrug

Study groups in NCT02231918
Study group	Role	What they receive
MIRAPEX® - low	Experimental	Not described Receives: Drug: MIRAPEX® - low
MIRAPEX® - medium	Experimental	Not described Receives: Drug: MIRAPEX® - medium
MIRAPEX® - high	Experimental	Not described Receives: Drug: MIRAPEX® - high

What is being measured

The primary outcome is the main question the study is designed to answer.

Cmax,ss
Maximum concentration of the Pramipexole (PPX) in plasma at steady state over a uniform dosing interval (Cmax,ss).
Measured: 0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.
Cmin,ss
Minimum measured concentration of the analyte in plasma at steady state over a uniform dosing interval (Cmin,ss).
Measured: 0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.
Cpre,N
Predose concentration of the analyte in plasma at steady state immediately before administration of the next dose N (Cpre,N).
Measured: 0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.
Cavg
Average concentration of the analyte in plasma at steady state (Cavg).
Measured: 0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.
Tmax,ss
Time from dosing to maximum concentration at steady state (Tmax,ss).
Measured: 0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.
Tmin,ss
Time from dosing to minimum concentration at steady state (Tmin,ss ).
Measured: 0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.
AUCτ,ss
Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval (AUCτ,ss ).
Measured: 0.25h before the drug administration on day 1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on Day 1.
λz,ss
Terminal rate constant in plasma at steady state (λz,ss ).
Measured: 0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.
t1/2,ss
Terminal half-life of the analyte in plasma at steady state (t1/2,ss ).
Measured: 0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.
MRTpo,ss
Mean residence time of the analyte in the body at steady state (MRTpo,ss).
Measured: 0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.
CL/F,ss
Apparent clearance of the analyte in the plasma after extravascular administration at steady state; F = absolute bioavailability factor (CL/F,ss ).
Measured: 0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.
Vz/F,ss
Apparent volume of distribution during the terminal phase λz following an extravascular dose at steady state (Vz/F,ss ).
Measured: 0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.
Ae 0-12,ss
Amount of analyte that is eliminated in urine at steady state over a time interval t1to t2 (0-12h).
Measured: 12 hours after last study drug administration on day 1
fe 0-12,ss
Fraction of administered drug excreted unchanged in urine at steady state over a time interval t1 to t2 (fe 0-12,ss ).
Measured: 12 hours after last study drug administration on day 1.
CLR,ss
Renal clearance of the analyte at steady state (CLR(0-12),ss ).
Measured: 12h after last study drug administration on day 1
PTF
Peak-trough fluctuation (PTF) is defined as the difference between Cmax and Cmin divided by Cavg and multiplied with 100% at steady-state.
Measured: 0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.

Secondary outcomes (3)

Number of Patients With Drug Related Adverse Events
Number of patients with adverse events due to study drug.
Measured: From first drug administration until 24 hours after last study drug administration, upto 48 days
Vital Signs (Systolic and Diastolic Blood Pressure)
Vital signs (Systolic and diastolic blood pressure (both supine and after standing for 1 minute)).
Measured: -0:15h(hours) pre-dose, and 0:30h, 1:00h, 2:00h, 3:00h, 5:00h, 7:00h, 12:00h, 24:00h post-dose.
Vital Signs (Pulse Rate)
Vital signs (Pulse rate (both supine and after standing for 1 minute)).
Measured: -0:15h(hours) pre-dose, and 0:30h, 1:00h, 2:00h, 3:00h, 5:00h, 7:00h, 12:00h, 24:00h

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

May 2006Jul 2007

First posted4 Sep 2014 (estimated)
Study startMay 2006
Primary completionJul 2007

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Restless Legs SyndromeStudies of the same condition, open and under way.
More trials run by Boehringer IngelheimThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 26 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02231918
Sponsor's protocol ID: 248.600
Status last verified: Sep 2015
First submitted: 3 Sep 2014
Last updated: 6 Oct 2015
Results posted: Yes, on ClinicalTrials.gov

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Restless Legs Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-label Clinical Study to Investigate Pharmacokinetics (PK) of Different Doses (0.125 mg, 0.25 mg, 0.5 mg) of Pramipexole Administered Once Daily Orally in Pediatric Patients Who Are Individually Optimized to Stable Pramipexole Doses for the Treatment of Idiopathic Restless Legs Syndrome (RLS)
ClinicalTrials.gov ID: NCT02231918
Acronym / sponsor ID: 248.600
Conditions: Restless Legs Syndrome
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 26 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: May 2006
Primary completion: Jul 2007 (actual)
First posted: 4 Sep 2014 (estimated)
Results: Posted 6 Oct 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study to determine the pharmacokinetics (PK) of pramipexole (PPX) after administration of a single dose orally (p.o.) in pediatric patients with the diagnosis of RLS

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
MIRAPEX® - low	Experimental	Drug: MIRAPEX® - low
MIRAPEX® - medium	Experimental	Drug: MIRAPEX® - medium
MIRAPEX® - high	Experimental	Drug: MIRAPEX® - high

Who may qualify

Ages: 6 to 16 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (17 listed)

Male or female patients ages 6 years to 16 years (two age groups, 6 to 11 years and 12 to 16 years, with the same number of patients if possible)
Diagnosis of idiopathic Restless Legs Syndrome (RLS) according to the Clinical RLS criteria of the International Restless Legs Syndrome Study Group (IRLSSG)
Must meet all 4 of the diagnostic criteria for adult RLS (see inclusion criterion No. 2 above) and either:
Written informed consent consistent with International Conference on Harmonisation (ICH)/ Good Clinical Practice (GCP) and Local Institutional Review Board requirements for children obtained prior to any study procedures being performed
Ability and willingness to comply with the study treatment regimen and to attend study assessments

Key exclusion criteria (18 listed)

Any women of childbearing potential having a positive serum pregnancy test at screening
Any women of childbearing potential not using a medically accepted method of contraceptive (Intra-Uterine Device, oral, implantable, injectable contraceptives and estrogen patch, double barrier method [spermicide + diaphragm], or abstinence at the discretion of the investigator)
Patients who have a clinically significant renal disease or serum creatinine level greater than 1.0 mg/dL at screening
Any of the following lab results at screening:
Other clinically significant metabolic-endocrine, hematological, gastrointestinal disease, pulmonary disease (such as severe asthma) which in the opinion of the investigator would preclude the patient from participating in this study

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
MIRAPEX® - low	Drug	MIRAPEX® - low
MIRAPEX® - medium	Drug	MIRAPEX® - medium
MIRAPEX® - high	Drug	MIRAPEX® - high

Primary outcome

Cmax,ss
Time frame: 0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.
Maximum concentration of the Pramipexole (PPX) in plasma at steady state over a uniform dosing interval (Cmax,ss).
Cmin,ss
Time frame: 0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.
Minimum measured concentration of the analyte in plasma at steady state over a uniform dosing interval (Cmin,ss).
Cpre,N
Time frame: 0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.
Predose concentration of the analyte in plasma at steady state immediately before administration of the next dose N (Cpre,N).
Cavg
Time frame: 0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.
Average concentration of the analyte in plasma at steady state (Cavg).
Tmax,ss
Time frame: 0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.
Time from dosing to maximum concentration at steady state (Tmax,ss).
Tmin,ss
Time frame: 0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.
Time from dosing to minimum concentration at steady state (Tmin,ss ).
AUCτ,ss
Time frame: 0.25h before the drug administration on day 1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on Day 1.
Area under the concentration-time curve of the analyte in plasma at steady state over a uniform dosing interval (AUCτ,ss ).
λz,ss
Time frame: 0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.
Terminal rate constant in plasma at steady state (λz,ss ).
t1/2,ss
Time frame: 0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.
Terminal half-life of the analyte in plasma at steady state (t1/2,ss ).
MRTpo,ss
Time frame: 0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.
Mean residence time of the analyte in the body at steady state (MRTpo,ss).
CL/F,ss
Time frame: 0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.
Apparent clearance of the analyte in the plasma after extravascular administration at steady state; F = absolute bioavailability factor (CL/F,ss ).
Vz/F,ss
Time frame: 0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.
Apparent volume of distribution during the terminal phase λz following an extravascular dose at steady state (Vz/F,ss ).
Ae 0-12,ss
Time frame: 12 hours after last study drug administration on day 1
Amount of analyte that is eliminated in urine at steady state over a time interval t1to t2 (0-12h).
fe 0-12,ss
Time frame: 12 hours after last study drug administration on day 1.
Fraction of administered drug excreted unchanged in urine at steady state over a time interval t1 to t2 (fe 0-12,ss ).
CLR,ss
Time frame: 12h after last study drug administration on day 1
Renal clearance of the analyte at steady state (CLR(0-12),ss ).
PTF
Time frame: 0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.
Peak-trough fluctuation (PTF) is defined as the difference between Cmax and Cmin divided by Cavg and multiplied with 100% at steady-state.

3 secondary outcomes

Number of Patients With Drug Related Adverse Events
Time frame: From first drug administration until 24 hours after last study drug administration, upto 48 days
Vital Signs (Systolic and Diastolic Blood Pressure)
Time frame: -0:15h(hours) pre-dose, and 0:30h, 1:00h, 2:00h, 3:00h, 5:00h, 7:00h, 12:00h, 24:00h post-dose.
Vital Signs (Pulse Rate)
Time frame: -0:15h(hours) pre-dose, and 0:30h, 1:00h, 2:00h, 3:00h, 5:00h, 7:00h, 12:00h, 24:00h

Results and safety

Results posted to the registry on 6 Oct 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
PPX (MIRAPEX®, 0.125 mg)	9	9
PPX (MIRAPEX®, 0.25 mg)	15	14
PPX (MIRAPEX®, 0.5 mg)	2	1

Primary outcome: Cmax,ss

Time frame: 0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.. Geometric mean (Geometric Coefficient of Variation). Unit: ng/mL

Measure	PPX (MIRAPEX®, 0.125 mg) n = 9	PPX (MIRAPEX®, 0.25 mg) n = 15	PPX (MIRAPEX®, 0.5 mg) n = 2
6 to <12 years (N=5, 9, 0)	0.633 (26.2)	1.13 (35.3)	NA (NA)
12 to <18 years(N=4, 6, 2))	0.396 (30.0)	0.677 (40.3)	NA (NA)

Population analysed: Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.

Primary outcome: Cmin,ss

Time frame: 0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.. Geometric mean (Standard Deviation). Unit: ng/mL

Measure	PPX (MIRAPEX®, 0.125 mg) n = 9	PPX (MIRAPEX®, 0.25 mg) n = 15	PPX (MIRAPEX®, 0.5 mg) n = 2
6 to <12 years (N=5, 9, 0)	0.0872 (35.5)	0.136 (99.5)	NA (NA)
12 to <18 years(N=4, 6, 2)	0.0972 (37.5)	0.122 (53.8)	NA (NA)

Population analysed: Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.

Primary outcome: Cpre,N

Measure	PPX (MIRAPEX®, 0.125 mg) n = 9	PPX (MIRAPEX®, 0.25 mg) n = 15	PPX (MIRAPEX®, 0.5 mg) n = 2
6 to <12 years (N=4, 8, 0)	0.074 (17.3)	0.147 (75.3)	NA (NA)
12 to <18 years (N=1, 5, 1)	NA (NA)	0.112 (60.7)	NA (NA)

Population analysed: Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.

Primary outcome: Cavg

Measure	PPX (MIRAPEX®, 0.125 mg) n = 9	PPX (MIRAPEX®, 0.25 mg) n = 15	PPX (MIRAPEX®, 0.5 mg) n = 2
6 to <12 years (N=5, 8, 0)	0.213 (27.4)	0.458 (42.8)	NA (NA)
12 to <18 years (N=4, 6, 1)	0.137 (21.3)	0.309 (35.2)	NA (NA)

Population analysed: Pharmacokinetic Set (PK): All evaluable patients who received at least one dose of Pramipexole (PPX) between 0.125 and 0.5 mg were included in the PK analysis.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: From first drug administration until 24 hours after last study drug administration, upto 48 days. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
MIRAPEX® (0.125 mg)	0 of 9 (0%)	2 of 9 (22.2%)	Not reported
MIRAPEX® (0.25 mg)	0 of 15 (0%)	3 of 15 (20%)	Not reported
MIRAPEX® (0.5 mg)	0 of 2 (0%)	1 of 2 (50%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing MIRAPEX® - low, MIRAPEX® - medium and MIRAPEX® - high in people with Restless Legs Syndrome, run by Boehringer Ingelheim.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Oct 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cmax,ss (time frame: 0.25h before the drug administration on day1 and 0.5 h, 1 h, 2 h, 3 h, 5 h, 7h, 12h and 24h after the last drug administration on day 1.). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02231918.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2015.