Trial Outcomes & Findings for Sifrol (Pramipexole) Onset of Action and Impact: a 12-weeks Observational Study in Patients With Primary Restless Legs Syndrome (NCT NCT00721279)

NCT ID: NCT00721279

Last Updated: 2014-06-04

Results Overview

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.

• Recruitment status: COMPLETED
• Target enrollment: 549 participants
• Primary outcome timeframe: Baseline
• Results posted on: 2014-06-04

Participant Flow

Participant milestones

Measure	De-novo Patients Patients that had not been treated for RLS at baseline	Pre-treated Patients Patients that had been treated for RLS at baseline
Overall Study STARTED	452	97
Overall Study COMPLETED	416	73
Overall Study NOT COMPLETED	36	24

Reasons for withdrawal

Measure	De-novo Patients Patients that had not been treated for RLS at baseline	Pre-treated Patients Patients that had been treated for RLS at baseline
Overall Study Lack of Efficacy	6	3
Overall Study Tolerability insufficient	5	2
Overall Study Withdrawal by Subject	13	3
Overall Study Other	12	16

Baseline Characteristics

Sifrol (Pramipexole) Onset of Action and Impact: a 12-weeks Observational Study in Patients With Primary Restless Legs Syndrome

Baseline characteristics by cohort

Measure	De-novo Patients n=452 Participants Patients that had not been treated for RLS at baseline	Pre-treated Patients n=97 Participants Patients that had been treated for RLS at baseline	Total n=549 Participants Total of all reporting groups
Age, Continuous	66.48 years STANDARD_DEVIATION 12.87 • n=5 Participants	67.81 years STANDARD_DEVIATION 12.61 • n=7 Participants	66.69 years STANDARD_DEVIATION 12.82 • n=5 Participants
Sex/Gender, Customized Female	317 participants n=5 Participants	66 participants n=7 Participants	383 participants n=5 Participants
Sex/Gender, Customized Male	131 participants n=5 Participants	23 participants n=7 Participants	154 participants n=5 Participants
Sex/Gender, Customized missing	4 participants n=5 Participants	8 participants n=7 Participants	12 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline

Population: Full analysis set (FAS)

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.

Outcome measures

Measure	De-novo Patients n=440 Participants Patients that had not been treated for RLS at baseline	Pre-treated Patients n=83 Participants Patients that had been treated for RLS at baseline
Frequency Analysis for Baseline Pattern of RLS Symptoms Mild	0.7 percentage of participants	2.4 percentage of participants
Frequency Analysis for Baseline Pattern of RLS Symptoms Moderate	19.3 percentage of participants	18.1 percentage of participants
Frequency Analysis for Baseline Pattern of RLS Symptoms Severe	62.0 percentage of participants	55.4 percentage of participants
Frequency Analysis for Baseline Pattern of RLS Symptoms Very Severe	18.0 percentage of participants	24.1 percentage of participants

PRIMARY outcome

Timeframe: Baseline and final visit (week12)

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

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.

Outcome measures

Measure	De-novo Patients n=428 Participants Patients that had not been treated for RLS at baseline	Pre-treated Patients n=80 Participants Patients that had been treated for RLS at baseline
Change in Total Scores of IRLS (International Restless Legs Rating Scale)	17 scores on a scale Interval 13.0 to 22.0	16 scores on a scale Interval 11.0 to 22.75

PRIMARY outcome

Timeframe: baseline and final visit (week 12)

Population: Full analysis set

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

Outcome measures

Measure	De-novo Patients n=440 Participants Patients that had not been treated for RLS at baseline	Pre-treated Patients n=83 Participants Patients that had been treated for RLS at baseline
Change in Global Clinical Impression - Improvement (CGI-I) Scale Very much improved	47.0 percentage of participants	44.6 percentage of participants
Change in Global Clinical Impression - Improvement (CGI-I) Scale Much improved	45.5 percentage of participants	42.2 percentage of participants
Change in Global Clinical Impression - Improvement (CGI-I) Scale Minimally improved	3.0 percentage of participants	8.4 percentage of participants
Change in Global Clinical Impression - Improvement (CGI-I) Scale Minimally worse	0.0 percentage of participants	0.0 percentage of participants
Change in Global Clinical Impression - Improvement (CGI-I) Scale Much worse	0.2 percentage of participants	0.0 percentage of participants
Change in Global Clinical Impression - Improvement (CGI-I) Scale Very much worse	0.0 percentage of participants	0.0 percentage of participants
Change in Global Clinical Impression - Improvement (CGI-I) Scale missing	2.5 percentage of participants	2.4 percentage of participants
Change in Global Clinical Impression - Improvement (CGI-I) Scale No change	1.8 percentage of participants	2.4 percentage of participants

PRIMARY outcome

Timeframe: Up to 16 weeks

Population: Safety Analysis Set (SAF)

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

Outcome measures

Measure	De-novo Patients n=549 Participants Patients that had not been treated for RLS at baseline	Pre-treated Patients Patients that had been treated for RLS at baseline
Frequency of Adverse Events serious adverse events	2 participants	—
Frequency of Adverse Events Any adverse event	25 participants	—
Frequency of Adverse Events Causally related adverse event	7 participants	—

PRIMARY outcome

Timeframe: Up to 12 weeks

Population: Full Analysis Set (FAS)

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

Outcome measures

Measure	De-novo Patients n=523 Participants Patients that had not been treated for RLS at baseline	Pre-treated Patients Patients that had been treated for RLS at baseline
Correlation of the Change in IRLS at End of Titration and at Final Visit End of titration - Deterioration (n=517)	0.0 percentage of patients	—
Correlation of the Change in IRLS at End of Titration and at Final Visit End of titration - No change (n=517)	19.7 percentage of patients	—
Correlation of the Change in IRLS at End of Titration and at Final Visit End of titration - Improvement (n=517)	80.3 percentage of patients	—
Correlation of the Change in IRLS at End of Titration and at Final Visit Final Visit - Deterioration	0.2 percentage of patients	—
Correlation of the Change in IRLS at End of Titration and at Final Visit Final Visit - No change	5.4 percentage of patients	—
Correlation of the Change in IRLS at End of Titration and at Final Visit Final Visit - Improvement	94.5 percentage of patients	—

Adverse Events

De-novo Patients

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Pre-treated Patients

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	De-novo Patients n=452 participants at risk Patients that had not been treated for RLS at baseline	Pre-treated Patients n=97 participants at risk Patients that had been treated for RLS at baseline
Nervous system disorders Epilepsy	0.00% 0/452 • Up to 12 weeks The Safety Analysis Set (SAF) including the data of all 549 patients reported to have received at least one dose of pramipexole.	1.0% 1/97 • Up to 12 weeks The Safety Analysis Set (SAF) including the data of all 549 patients reported to have received at least one dose of pramipexole.
Psychiatric disorders Confusion	0.00% 0/452 • Up to 12 weeks The Safety Analysis Set (SAF) including the data of all 549 patients reported to have received at least one dose of pramipexole.	1.0% 1/97 • Up to 12 weeks The Safety Analysis Set (SAF) including the data of all 549 patients reported to have received at least one dose of pramipexole.
Psychiatric disorders Suicidal Tendency	0.00% 0/452 • Up to 12 weeks The Safety Analysis Set (SAF) including the data of all 549 patients reported to have received at least one dose of pramipexole.	1.0% 1/97 • Up to 12 weeks The Safety Analysis Set (SAF) including the data of all 549 patients reported to have received at least one dose of pramipexole.
Psychiatric disorders Depression	0.00% 0/452 • Up to 12 weeks The Safety Analysis Set (SAF) including the data of all 549 patients reported to have received at least one dose of pramipexole.	1.0% 1/97 • Up to 12 weeks The Safety Analysis Set (SAF) including the data of all 549 patients reported to have received at least one dose of pramipexole.

Other adverse events

Adverse event data not reported

Additional Information

Boehringer Ingelheim Call Center

Boehringer Ingelheim Pharmaceuticals

Phone: 1-800-243-0127

Email: clintriage.rdg@boehringer-ingelheim.com

Results disclosure agreements

• Principal investigator is a sponsor employee Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.
• Publication restrictions are in place

Restriction type: OTHER