Long-term Efficacy, Safety and Tolerability of Pramipexole in Patients With Idiopathic Moderate to Severe Restless Legs Syndrome (RLS)

This study has been completed.

Sponsor:

Information provided by:

Boehringer Ingelheim Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT00472199

First received: May 10, 2007

Last updated: May 18, 2012

Last verified: May 2012

History of Changes

Results First Received: July 2, 2009

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Primary Purpose: Treatment
Condition:	Restless Legs Syndrome
Interventions:	Drug: Pramipexole Drug: Placebo

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Of 331 patients enrolled, 329 were treated with study drug. Two patients were randomized, but before their first intake of trial medication they decided to not participate in the study.

Reporting Groups

	Description
Pramipexole	4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
Placebo	4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets

Participant Flow: Overall Study

	Pramipexole	Placebo
STARTED	166	163
COMPLETED	131	103
NOT COMPLETED	35	60
Adverse Event	19	23
Lack of Efficacy	4	25
Lost to Follow-up	2	4
Protocol Violation	3	2
Withdrawal by Subject	6	5
personal reason	0	1
patient was asymptomatic	1	0

Baseline Characteristics

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Reporting Groups

	Description
Pramipexole	4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
Placebo	4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
Total	Total of all reporting groups

Baseline Measures

	Pramipexole	Placebo	Total
Number of Participants [units: participants]	166	163	329
Age [units: years] Mean ± Standard Deviation	57.9 ± 12.7	55.8 ± 11.4	56.8 ± 12.1
Gender [units: participants]
Female	102	94	196
Male	64	69	133

Outcome Measures

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1. Primary:

Change From Baseline in International Restless Legs Syndrome Study Group Rating Scale (IRLS) Total Score After 26 Weeks [ Time Frame: Baseline and 26 weeks ]

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2. Secondary:

Clinical Global Impression - Global Improvement (CGI-I) Responder Rate [ Time Frame: after 26 weeks of treatment ]

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3. Secondary:

International Restless Legs Syndrome (IRLS) Study Group Rating Scale Responder Rate [ Time Frame: after 26 weeks of treatment ]

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4. Secondary:

Patient Global Impression (PGI) Responder Rate [ Time Frame: after 26 weeks of treatment ]

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5. Secondary:

Change From Baseline in Restless Legs Syndrome-6 (RLS-6) Score "Satisfaction With Sleep" After 26 Weeks [ Time Frame: baseline and 26 weeks of treatment ]

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6. Secondary:

Change From Baseline in RLS-6 Score "Severity Falling Asleep" After 26 Weeks [ Time Frame: Baseline and 26 weeks of treatment ]

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7. Secondary:

Change From Baseline in RLS-6 Score "Severity During the Night" After 26 Weeks [ Time Frame: baseline and 26 weeks of treatment ]

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8. Secondary:

Change From Baseline in RLS-6 Score "Severity During the Day When at Rest" After 26 Weeks [ Time Frame: Baseline and 26 weeks of treatment ]

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9. Secondary:

Change From Baseline RLS-6 Score "Severity During the Day Engaged in Activities" After 26 Weeks [ Time Frame: Baseline and 26 weeks of treatment ]

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10. Secondary:

Change From Baseline in RLS-6 Score "Tired or Sleepy During the Day" After 26 Weeks [ Time Frame: Baseline and 26 weeks of treatment ]

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11. Secondary:

Change From Baseline in IRLS Mood Disturbance Score (Item 10) After 26 Weeks [ Time Frame: Baseline and 26 weeks of treatment ]

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12. Secondary:

Change From Baseline in Visual Analogue Scale (VAS) Score for Pain in Limbs After 26 Weeks [ Time Frame: Baseline and 26 weeks of treatment ]

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13. Secondary:

Change From Baseline in Quality of Life in RLS (RLS QoL) Score After 26 Weeks [ Time Frame: Baseline and 26 weeks of treatment ]

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14. Secondary:

Change From Baseline in Short Form-36 (SF-36) Dimension Bodily Pain After 26 Weeks [ Time Frame: Baseline and 26 weeks ]

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15. Secondary:

Change From Baseline in SF-36 Dimension General Health After 26 Weeks [ Time Frame: Baseline and 26 weeks ]

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16. Secondary:

Change From Baseline in SF-36 Dimension Mental Health After 26 Weeks [ Time Frame: Baseline and 26 weeks ]

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Measure Type	Secondary
Measure Title	Change From Baseline in SF-36 Dimension Mental Health After 26 Weeks
Measure Description	Score ranging from 0 to 100 with higher scores indicating better mental health
Time Frame	Baseline and 26 weeks
Safety Issue

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intent to treat analysis. Number of randomized patients with a baseline and at least one non-missing post-baseline measure. Imputation by last observation carried forward (LOCF) for post-baseline values

Reporting Groups

	Description
Pramipexole	4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
Placebo	4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets

Measured Values

	Pramipexole	Placebo
Number of Participants Analyzed [units: participants]	155	152
Change From Baseline in SF-36 Dimension Mental Health After 26 Weeks [units: Scores on a scale] Median ( Inter-Quartile Range )	5 ( -5.0 to 15.0 )	5 ( -5.0 to 10.0 )

No statistical analysis provided for Change From Baseline in SF-36 Dimension Mental Health After 26 Weeks

17. Secondary:

Change From Baseline in SF-36 Dimension Physical Functioning After 26 Weeks [ Time Frame: Baseline and 26 weeks ]

Show Outcome Measure 17

18. Secondary:

Change From Baseline in SF-36 Dimension Role Limitations Due to Emotional Problems After 26 Weeks [ Time Frame: Baseline and 26 weeks ]

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19. Secondary:

Change From Baseline in SF-36 Dimension Role Limitations Due to Physical Problems After 26 Weeks [ Time Frame: Baseline and 26 weeks ]

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20. Secondary:

Change From Baseline in SF-36 Dimension Social Functioning After 26 Weeks [ Time Frame: Baseline and 26 weeks ]

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21. Secondary:

Change From Baseline in SF-36 Dimension Vitality After 26 Weeks [ Time Frame: Baseline and 26 weeks ]

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22. Secondary:

Change From Baseline in SF-36 Dimension Mental Component Summary After 26 Weeks [ Time Frame: Baseline and 26 weeks ]

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23. Secondary:

Change From Baseline in SF-36 Dimension Physical Component Summary After 26 Weeks [ Time Frame: Baseline and 26 weeks ]

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24. Secondary:

Diagnosis of Classified Augmentation According to Independent Expert Panel [ Time Frame: after at least 4 weeks of treatment ]

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25. Secondary:

Worsening of RLS Symptoms (by at Least 4 Points in the IRLS Total Score Compared to Baseline) After Treatment Discontinuation [ Time Frame: after at least 1 week of treatment discontinuation ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: 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.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.

Results Point of Contact:

Name/Title: Boehringer Ingelheim Call Center
Organization: Boehringer Ingelheim Pharmaceuticals
phone: 1-800-243-0127
e-mail: clintriage.rdg@boehringer-ingelheim.com

No publications provided

Responsible Party:	Boehringer Ingelheim, Study Chair, Boehringer Ingelheim
ClinicalTrials.gov Identifier:	NCT00472199 History of Changes
Other Study ID Numbers:	248.629, EUDRACT2006-006431-42
Study First Received:	May 10, 2007
Results First Received:	July 2, 2009
Last Updated:	May 18, 2012
Health Authority:	Austria: Federal Office for Safety in Health Care Belgium: Federal Agency for Medicines and Health Products, FAMHP Finland: Finnish Medicines Agency Germany: Federal Institute for Drugs and Medical Devices Great Britain: MHRA Ireland: Irish Medicines Board Netherlands: Central Committee on Research involving Human Subjects (CCMO) Slovakia: State Institute for Drug Control Spain: Spanish Agency for Medicines and Health Products

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