Trial Outcomes & Findings for Non-interventional Observational Study on the Influence of Pramipexole on Sensory Symptoms of Restless Legs Syndrome (RLS) (NCT NCT00887289)

NCT ID: NCT00887289

Last Updated: 2014-06-27

Results Overview

Change in Total Sum Score of McGill Pain Questionnaire at Visit 3 to baseline. The sum scores can have values in the range from 0 (no pain) to 20 (worst pain). A negative change is an improvement of pain, a positive change a worsening of pain.

• Recruitment status: COMPLETED
• Target enrollment: 1504 participants
• Primary outcome timeframe: Baseline to Visit 3
• Results posted on: 2014-06-27

Participant Flow

Participant milestones

Measure	Pramipexole 0.088 mg every day (qd), titration up to 0.54 mg qd possible
Overall Study STARTED	1504
Overall Study COMPLETED	1409
Overall Study NOT COMPLETED	95

Reasons for withdrawal

Measure	Pramipexole 0.088 mg every day (qd), titration up to 0.54 mg qd possible
Overall Study Lack of Efficacy	14
Overall Study Adverse Event	27
Overall Study Withdrawal by Subject	26
Overall Study Lost to Follow-up	8
Overall Study Other	20

Baseline Characteristics

Non-interventional Observational Study on the Influence of Pramipexole on Sensory Symptoms of Restless Legs Syndrome (RLS)

Baseline characteristics by cohort

Measure	Pramipexole n=1504 Participants 0.088 mg every day (qd), titration up to 0.54 mg qd possible
Age, Continuous	65.0 Years STANDARD_DEVIATION 13.0 • n=5 Participants
Gender Female	1008 participants n=5 Participants
Gender Male	490 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline to Visit 3

Population: Full analysis set, no imputation technique was applied

Change in Total Sum Score of McGill Pain Questionnaire at Visit 3 to baseline. The sum scores can have values in the range from 0 (no pain) to 20 (worst pain). A negative change is an improvement of pain, a positive change a worsening of pain.

Outcome measures

Measure	Pramipexole n=1320 Participants 0.088 mg every day (qd), titration up to 0.54 mg qd possible
Summary of Change From Baseline in Total Sum of McGill Pain Questionnaire to Visit 3	-14.48 Scores on scale Standard Deviation 9.69

PRIMARY outcome

Timeframe: Baseline to Visit 3

Population: All patients of the full analysis set treated by a general practitioner, no imputation technique was applied

Change in Total Sum Score of McGill Pain Questionnaire at Visit 3 to baseline. The sum scores can have values in the range from 0 (no pain) to 20 (worst pain). A negative change is an improvement of pain, a positive change a worsening of pain.

Outcome measures

Measure	Pramipexole n=830 Participants 0.088 mg every day (qd), titration up to 0.54 mg qd possible
Summary of Change From Baseline in Total Sum of McGill Pain Questionnaire to Visit 3 for Patients Treated by General Practitioner	-15.87 Scores on scale Standard Deviation 9.39

PRIMARY outcome

Timeframe: Baseline to Visit 3

Population: All patients of the full analysis set treated by a neurologist, no imputation technique was applied

Change in Total Sum Score of McGill Pain Questionnaire at Visit 3 to baseline. The sum scores can have values in the range from 0 (no pain) to 20 (worst pain). A negative change is an improvement of pain, a positive change a worsening of pain.

Outcome measures

Measure	Pramipexole n=490 Participants 0.088 mg every day (qd), titration up to 0.54 mg qd possible
Summary of Change From Baseline in Total Sum of McGill Pain Questionnaire to Visit 3 for Patients Treated by Neurologist	-12.13 Scores on scale Standard Deviation 9.73

SECONDARY outcome

Timeframe: Baseline to Visit 3

Population: Full analysis set (FAS)

Change in RLS-6 at Visit 3 to baseline. The sum scores can have values in the range from 0 (best) to 20 (worst) A negative change is an improvement of RLS-6, a positive change a worsening of RLS-6.

Outcome measures

Measure	Pramipexole n=1391 Participants 0.088 mg every day (qd), titration up to 0.54 mg qd possible
Summary of Change From Baseline in Restless Legs Syndrome Severity Scale With 6 Questions to Visit 3	-1.63 Scores on scale Standard Deviation 0.98

SECONDARY outcome

Timeframe: Baseline to Visit 3

Population: Full analysis set, no imputation technique was applied

Change in IRLS at Visit 3 to baseline. The sum scores can have values in the range from 0 (best) to 40 (worst) A negative change is an improvement of IRLS, a positive change a worsening of IRLS.

Outcome measures

Measure	Pramipexole n=1364 Participants 0.088 mg every day (qd), titration up to 0.54 mg qd possible
Summary of Change From Baseline in International Restless Legs Syndrome Scale for Severity to Visit 3	-17.71 Scores on scale Standard Deviation 8.86

SECONDARY outcome

Timeframe: Baseline to Visit 3

Population: Full analysis set, no imputation technique was applied

Number of patients with occurence of behavioural changes in terms of impulse control disorders

Outcome measures

Measure	Pramipexole n=1492 Participants 0.088 mg every day (qd), titration up to 0.54 mg qd possible
Behavioural Changes During Treatment	8 participants

Adverse Events

Pramipexole

Serious events: 6 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Pramipexole n=1504 participants at risk 0.088 mg every day (qd), titration up to 0.54 mg qd possible
General disorders Death	0.13% 2/1504 • 14 Weeks
Musculoskeletal and connective tissue disorders Muscoloskeletal chest pain	0.07% 1/1504 • 14 Weeks
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Hepatic neoplasm malignant	0.07% 1/1504 • 14 Weeks
Surgical and medical procedures Gallbladder operation	0.07% 1/1504 • 14 Weeks
Surgical and medical procedures Hospitalization	0.07% 1/1504 • 14 Weeks

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