A Randomised, Comparing Fixed Doses of Pramipexole to Investigate the Efficacy and Safety in Patients With RLS.

Browse trials for

• Psychomotor Agitation 500
• Restless Legs Syndrome 248
• Syndrome 9,217

Psychomotor Agitation

500 studies on the registry are indexed under Psychomotor Agitation; 55 are open to participants now.

This study's enrollment of 154 is above the median of 90 across 413 interventional studies indexed under Psychomotor Agitation.

Lead sponsor

Boehringer Ingelheim is the lead sponsor of 2,245 studies on the registry; 58 are open to participants now.

Of its 162 completed or terminated interventional studies of FDA-regulated products, 116 (72%) have results posted.

Study arms

• Experimental
  Pramipexole 0.25 mg once daily

  Pramipexole 0.25 mg given once daily

  Drug: Pramipexole 0.125 mg tablet

• Experimental
  Pramipexole 0.5 mg once daily

  Pramipexole 0.5 mg given once daily

  Drug: Pramipexole 0.5 mg tablet

• Experimental
  Pramipexole 0.75 mg once daily

  Pramipexole 0.75 mg given once daily

  Drug: Pramipexole 0.125 mg tablet · Drug: Pramipexole 0.5 mg tablet

Interventions

• DrugPramipexole 0.125 mg tablet
• DrugPramipexole 0.5 mg tablet

Primary outcomes

1. Change From Baseline in International Restless Legs Syndrome (IRLS) Total Score at 6 Weeks

   The International Restless Legs Syndrome Study Group (IRLSSG) proposes classification of severity based on the total score on the IRLS (0-10, mild; 11-20, moderate; 21-30, severe; 31-40, very severe). A decrease in the score of the IRLS by 10 or more points corresponds to the improvement of severity by one rank and has clinical importance. Therefore, the primary endpoint in the double-blind period was set as a decrease by 10 or more points in the mean change on the total score of the IRLS from the baseline to Visit 5 (last observation day in the double-blind period) at all doses of 0.25 mg, 0.5 mg, and 0.75 mg/day of pramipexole.

   Time frame: Week 6 - change from baseline

Secondary outcomes

1. IRLS Responder

   The percentage of patients with 50 % or more reduction of IRLS (The measure means the percentage of high responder on the trial medications)

   Time frame: baseline to week 6

2. Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) Total Score at 6 Weeks

   PSQI developed to evaluate the quality of sleep is a self-recording questionnaire consisting of 18 questions focused on 7 factors such as sleep quality, sleep period time, sleep latency, sleep efficiency, sleep difficulty, use of hypnotics, and hindrance to activities of daily living due to daytime sleepiness. Each score (0-3 points) in the respective factors was added to calculate the total score (0-21 points). Rating scale scored from 0 (best sleep) to 21 (worst sleep).

   Time frame: Week 6 - change from baseline

3. Change From Baseline in Japanese Version of the Epworth Sleepiness Scale (JESS) Total Score at 6 Weeks

   ESS is a self-recording scale used to evaluate sleepiness experienced in daily activities and it consists of 8 items focused on specific situations such as reading books and watching television. Each score (0-3 points) to 8 questions was added simply to calculate the total ESS score. A Japanese translation of the ESS (a provisional version provided by the Japanese Respiratory Society) used so far had not been prepared through the international scale development and validation process, but the version prepared through this process was published at the 31st meeting of the Japanese Society of Sleep Research. The questions in JESS had been discussed with the original author of the ESS and their measurement concepts had been confirmed. The JESS is the Japanese version of ESS prepared through the international scale development and validation process. Rating scale scored from 0 (no daytime sleep) to 24 (worst daytime sleep)

   Time frame: Week 6 - change from baseline

4. Clinical Global Impression Global Improvement (CGI-I) Responder

   CGI is extensively used for risk-benefit evaluation (efficacy) of drug therapies. The CGI evaluates the severity and improvement in 7 ranks. It also evaluates the therapeutic effect and side effects in 4 ranks, separately. Rating scale from 1 (very much improved) to 7 (very much worse). The percentage of patients who were evaluated as 1(very much improved) or 2(much improved) by the investigator were considered responders.

   Time frame: baseline to week 6

5. Patient Global Impression (PGI) Responder

   PGI is used to evaluate a global impression by patients themselves in 7 ranks. Rating scale from 1 (very much better) to 7 (very much worse). The percentage of patients where the patient evaluated himself/herself as 1(very much better) or 2(much better)were considered responders.

   Time frame: baseline to week 6

6. Clinically Significant Abnormalities in Vital Signs (Blood Pressure and Pulse Rate in Both Supine and Standing Positions), ECG, Laboratory Tests - Double Blind Period.

   Time frame: baseline to 6 weeks

7. Change From Baseline in International Restless Legs Syndrome (IRLS) Total Score at 52 Weeks for Open-Label Period

   The International Restless Legs Syndrome Study Group (IRLSSG) proposes classification of severity based on the total score on the IRLS (0-10, mild; 11-20, moderate; 21-30, severe; 31-40, very severe).

   Time frame: Week 52 - change from baseline

8. IRLS Responder for Open-label Period

   The percentage of patients with 50 % or more reduction of IRLS (The measure means the percentage of high responder on the trial medications)

   Time frame: baseline to week 52

9. Change From Baseline in Pittsburgh Sleep Quality Index (PSQI) Total Score at 52 Weeks for Open-Label Period

   PSQI developed to evaluate the quality of sleep is a self-recording questionnaire consisting of 18 questions focused on 7 factors such as sleep quality, sleep period time, sleep latency, sleep efficiency, sleep difficulty, use of hypnotics, and hindrance to activities of daily living due to daytime sleepiness. Each score (0-3 points) in the respective factors was added to calculate the total score (0-21 points). Rating scale scored from 0 (best sleep) to 21 (worst sleep).

   Time frame: Week 52 - change from baseline

10. Change From Baseline in Japanese Version of the Epworth Sleepiness Scale (JESS) Total Score at 52 Weeks for Open-Label Period

    ESS is a self-recording scale used to evaluate sleepiness experienced in daily activities and it consists of 8 items focused on specific situations such as reading books and watching television. Each score (0-3 points) to 8 questions was added simply to calculate the total ESS score. A Japanese translation of the ESS (a provisional version provided by the Japanese Respiratory Society) used so far had not been prepared through the international scale development and validation process, but the version prepared through this process was published at the 31st meeting of the Japanese Society of Sleep Research. The questions in JESS had been discussed with the original author of the ESS and their measurement concepts had been confirmed. The JESS is the Japanese version of ESS prepared through the international scale development and validation process. Rating scale scored from 0 (no daytime sleep) to 24 (worst daytime sleep)

    Time frame: Week 52 - change from baseline

11. Clinical Global Impression Global Improvement (CGI-I) Responder at 52 Weeks for Open-label Period

    CGI is extensively used for risk-benefit evaluation (efficacy) of drug therapies. The CGI evaluates the severity and improvement in 7 ranks. It also evaluates the therapeutic effect and side effects in 4 ranks, separately. Rating scale from 1 (very much improved) to 7 (very much worse). The percentage of patients who were evaluated as 1(very much improved) or 2(much improved) by the investigator were considered responders.

    Time frame: baseline to week 52

12. Patient Global Impression (PGI) Responder at 52 Weeks for Open-Label Period

    PGI is used to evaluate a global impression by patients themselves in 7 ranks. Rating scale from 1 (very much better) to 7 (very much worse). The percentage of patients where the patient evaluated himself/herself as 1(very much better) or 2(much better)were considered responders.

    Time frame: baseline to week 52

13. Possible Augmentation in RLS Symptoms at 52 Weeks for Open-Label Period

    Possible augmentation defined as persistence of a state in which RLS symptoms begin to occur 2 hours earlier than the usual time zone for 5 days or more a week

    Time frame: baseline to week 52

Baseline characteristics