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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00887289

Enrollment

1504

Registered

2009-04-23

Start date

2009-04-30

Completion date

2009-10-31

Last updated

2014-06-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Restless Legs Syndrome

Brief summary

The main goal of this open-label, prospective, non-controlled, non-interventional post marketing surveillance study is to evaluate how pramipexole treatment works when applied in actual practice. In actual practice patients who would have been excluded in the clinical registration studies of pramipexole in moderate to severe primary Restless Legs Syndrome (i.e. those with certain disease histories, co-morbidities and/or demographic characteristics) will also be treated with pramipexole. Thus, during this post marketing surveillance study additional information on the efficacy and safety of pramipexole in those patients will be obtained. The objectives of this post marketing surveillance study are: * To investigate the influence of Sifrol® (pramipexole) treatment on unpleasant sensory symptoms of Restless Legs Syndrome as measured with the short form of the McGill Pain Questionnaire. * To assess if improvement of sensory symptoms correlates with overall Restless Legs Syndrome severity (International Restless Legs Syndrome Scale for Severity) and with secondary symptoms like sleeping problems and daytime tiredness (items 1 & 6 from Restless Legs Syndrome-6). * To evaluate if the treatment effect of Sifrol on overall Restless Legs Syndrome severity (International Restless Legs Syndrome Scale for Severity) differs between patients with high pain scores and patients with lower pain scores. * To compare General Practitioner and neurologist sites patient populations in terms of demographics, Restless Legs Syndrome severity at Visit 1 and treatment outcomes at Visit 3. * To evaluate the development of behavioural changes under pramipexole treatment.

Detailed description

Study Design:

Interventions

None listed

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Diagnosis of primary moderate to severe Restless Legs Syndrome. 2. Patients who are planned to be treated with Sifrol® (pramipexole) and where the decision of treatment is made independent of the patients' inclusion into this post marketing surveillance study. 3. Male or female patients aged at least 18 years. 4. Written informed consent by the patient for study participation.

Exclusion criteria

1. Any contraindications according to the Summary of Product Characteristics: hypersensitivity to pramipexole or to any of the excipients. 2. Previous or ongoing treatment with Sifrol® (pramipexole). 3. Previous or ongoing treatment with dopamine receptor agonists.

Design outcomes

Primary

Measure	Time frame	Description
Summary of Change From Baseline in Total Sum of McGill Pain Questionnaire to Visit 3	Baseline to Visit 3	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.
Summary of Change From Baseline in Total Sum of McGill Pain Questionnaire to Visit 3 for Patients Treated by General Practitioner	Baseline to Visit 3	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.
Summary of Change From Baseline in Total Sum of McGill Pain Questionnaire to Visit 3 for Patients Treated by Neurologist	Baseline to Visit 3	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.

Secondary

Measure	Time frame	Description
Summary of Change From Baseline in Restless Legs Syndrome Severity Scale With 6 Questions to Visit 3	Baseline to Visit 3	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.
Summary of Change From Baseline in International Restless Legs Syndrome Scale for Severity to Visit 3	Baseline to Visit 3	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.
Behavioural Changes During Treatment	Baseline to Visit 3	Number of patients with occurence of behavioural changes in terms of impulse control disorders

Countries

Germany

Participant flow

Participants by arm

Arm	Count
Pramipexole 0.088 mg every day (qd), titration up to 0.54 mg qd possible	1,504
Total	1,504

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Adverse Event	27
Overall Study	Lack of Efficacy	14
Overall Study	Lost to Follow-up	8
Overall Study	Other	20
Overall Study	Withdrawal by Subject	26

Baseline characteristics

Characteristic	Pramipexole
Age, Continuous	65.0 Years STANDARD_DEVIATION 13
Gender Female	1008 participants
Gender Male	490 participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	0 / 1,504
serious Total, serious adverse events	6 / 1,504

Outcome results

Primary

Summary of Change From Baseline in Total Sum of McGill Pain Questionnaire to Visit 3

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.