Sifrol (Pramipexole) Onset of Action and Impact: a 12-wee... | NCT00721279

Status Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Name	Type	Description	Arm Group Labels	Other Names
Sifrol® (pramipexole dihydrochloride)	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Frequency Analysis for Baseline Pattern of RLS Symptoms	Severity of RLS was rated using the International RLS Severity Scale. This scale measures the severity of RLS symptoms and comprises of 10 questions with 5 possible answers, each answer scored from 0-4 points and is classified into 5 RLS severity groups: 0 points = no symptoms, 1-10 points = mild, 11-20 points = moderate, 21-30 points = severe, 31-40 points = very severe.	Baseline
Change in Total Scores of IRLS (International Restless Legs Rating Scale)	The International Restless Legs Syndrome Rating Scale (IRLS) is a rating scale used to assess the severity of RLS symptoms. The IRLS consists of 10 items, each of which is rated from 0 to 4 points, higher values denoting an increased severity of symptoms. Maximum total score is 40. Score totals are grouped into four levels of severity: 1-10 points = mild RLS, 11-20 points = moderate RLS, 21-30 points = severe RLS, and 31-40 = very severe RLS. The change from baseline was calculated as baseline minus the week 12 value.	Baseline and final visit (week12)
Change in Global Clinical Impression - Improvement (CGI-I) Scale	The Clinical Global Impression Improvement scale (CGI-I) requires the clinician to rate how much the patient's illness has improved or worsened relative to a baseline state. A patient's illness is compared to change over time and rated as: very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse	baseline and final visit (week 12)
Frequency of Adverse Events	Frequency of patients with any adverse event, causally related adverse events and serious adverse events	Up to 16 weeks
Correlation of the Change in IRLS at End of Titration and at Final Visit

Eligibility Module

Name	Affiliation	Role
Boehringer Ingelheim	Boehringer Ingelheim	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
Boehringer Ingelheim Investigational Site		Absam			Austria
Boehringer Ingelheim Investigational Site

Results Section

Participant Flow Module

ID	Title	Description
FG000	De-novo Patients	Patients that had not been treated for RLS at baseline
FG001	Pre-treated Patients	Patients that had been treated for RLS at baseline

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

N= 432 - De-novo, 85 - Pre-treated, 517- Total

Mean

Standard Deviation

years

Title

Denominators

Categories

Mild

Title	Measurements
	OG0000.7 OG0012.4

Moderate

Title	Measurements
	OG000

Primary

Change in Total Scores of IRLS (International Restless Legs Rating Scale)

The International Restless Legs Syndrome Rating Scale (IRLS) is a rating scale used to assess the severity of RLS symptoms. The IRLS consists of 10 items, each of which is rated from 0 to 4 points, higher values denoting an increased severity of symptoms. Maximum total score is 40. Score totals are grouped into four levels of severity: 1-10 points = mild RLS, 11-20 points = moderate RLS, 21-30 points = severe RLS, and 31-40 = very severe RLS.

The change from baseline was calculated as baseline minus the week 12 value.

Only those patients of the full analysis set with an evaluation of the IRLS at visit 3 were included

Posted

Median

Inter-Quartile Range

scores on a scale

Baseline and final visit (week12)

ID	Title	Description
OG000	De-novo Patients	Patients that had not been treated for RLS at baseline
OG001	Pre-treated Patients	Patients that had been treated for RLS at baseline

Units	Counts
Participants

Primary

Change in Global Clinical Impression - Improvement (CGI-I) Scale

The Clinical Global Impression Improvement scale (CGI-I) requires the clinician to rate how much the patient's illness has improved or worsened relative to a baseline state. A patient's illness is compared to change over time and rated as: very much improved, much improved, minimally improved, no change, minimally worse, much worse, or very much worse

Full analysis set

Posted

Number

percentage of participants

baseline and final visit (week 12)

ID	Title	Description
OG000	De-novo Patients	Patients that had not been treated for RLS at baseline
OG001	Pre-treated Patients	Patients that had been treated for RLS at baseline

Units	Counts
Participants	OG000

Primary

Frequency of Adverse Events

Frequency of patients with any adverse event, causally related adverse events and serious adverse events

Safety Analysis Set (SAF)

Posted

Number

participants

Up to 16 weeks

ID	Title	Description
OG000	Overall	All Patients

Units	Counts
Participants	OG000549

Title	Denominators	Categories

Primary

Correlation of the Change in IRLS at End of Titration and at Final Visit

Correlation of the change in IRLS at end of titration and at final visit

Full Analysis Set (FAS)

Posted

Number

percentage of patients

Up to 12 weeks

ID	Title	Description
OG000	Overall	All Patients

Units	Counts
Participants	OG000523

Title	Denominators

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Epilepsy	Nervous system disorders	MedDRA 9.0	Systematic Assessment	EG0000 affected452 at risk EG0011 affected97 at risk
Confusion	Psychiatric disorders	MedDRA 9.0	Systematic Assessment	EG0000 affected452 at risk EG0011 affected97 at risk
Suicidal Tendency	Psychiatric disorders	MedDRA 9.0	Systematic Assessment	EG0000 affected452 at risk EG0011 affected97 at risk
Depression	Psychiatric disorders	MedDRA 9.0	Systematic Assessment	EG0000 affected452 at risk EG0011 affected97 at risk

ID	Term
D009422	Nervous System Diseases
D020919	Sleep Disorders, Intrinsic
D020920	Dyssomnias
D012893	Sleep Wake Disorders
D020447	Parasomnias
D001523	Mental Disorders

ID	Term
D052160	Benzothiazoles
D013844	Thiazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring

ID	Title	Description
BG000	De-novo Patients	Patients that had not been treated for RLS at baseline
BG001	Pre-treated Patients	Patients that had been treated for RLS at baseline
BG002	Total	Total of all reporting groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	De-novo Patients	Patients that had not been treated for RLS at baseline			0	452	0	452
EG001	Pre-treated Patients	Patients that had been treated for RLS at baseline			2	97	0	97