RANDOMIZED, DOUBLE-BLIND, 6-WEEK STUDY OF PREGABALIN IN SUBJECTS WITH RESTLESS LEG SYNDROME - N/A

• Register: EUCTR
• Last refreshed on: 4 January 2022
• Main ID: EUCTR2008-000025-19-DE
• Date of registration: 06/05/2008
• Prospective Registration: Yes
• Primary sponsor: Pfizer Inc. 235 East 42nd Street, New York, NY 10017
• Public title: RANDOMIZED, DOUBLE-BLIND, 6-WEEK STUDY OF PREGABALIN IN SUBJECTS WITH RESTLESS LEG SYNDROME - N/A
• Scientific title: RANDOMIZED, DOUBLE-BLIND, 6-WEEK STUDY OF PREGABALIN IN SUBJECTS WITH RESTLESS LEG SYNDROME - N/A
• Date of first enrolment: 03/07/2008
• Target sample size: 120
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-000025-19
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: no; Single blind: no; Double blind: yes; Parallel group: yes; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: yes; Other: no
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Austria, Germany, Spain

Key inclusion & exclusion criteria

Inclusion criteria:
4.1. Inclusion Criteria

Subjects must meet the following criteria to be eligible to participate in the study:

1. Initial diagnosis of RLS should be made by a physician with experience and/or training in RLS. Idiopathic RLS with the presence of all four clinical manifestations of RLS:
• Urge to move the legs usually with dysesthesias: An urge to move the legs usually accompanied or caused by uncomfortable and unpleasant sensations in the legs. (Sometimes the urge to move is present without the uncomfortable sensations and sometimes the arms or other body parts are involved in addition to the legs);
• Onset or exacerbation with rest: The urge to move or unpleasant sensations begin or worsen during periods of rest or inactivity such as lying or sitting;
• Relief with movement: The urge to move or unpleasant sensations are partially or totally relieved by movements, such as walking or stretching, at least as long as the activity continues;
• Circadian pattern: The urge to move or unpleasant sensations are worse in the evening or night than during the day or only occur in the evening or night (when symptoms are very severe, the worsening at night may not be noticeable but must have been previously present);
Final diagnosis of RLS for acceptance into the study is to be confirmed by a RLS Diagnostic Confirmation Panel member using the RLS Telephone Diagnostic Interview (RLS-TDI), a structured patient interview.

2. RLS symptoms occur predominantly in the evening (between the hours of 17:00 to 7:00);

3. A history or the presence of RLS symptoms interfering with sleep onset or maintenance on 15 or more nights per month for at least 6 months;

4. An International Restless Leg Scale (IRLS) total score at beginning of placebo run-in and at the baseline to be = 15;

5. Have =15 nights with RLS symptoms in the month prior to screening. Subjects receiving RLS therapy at the time of screening are to have had =15 nights per month with RLS symptoms prior to initiation of this treatment. Have =2 nights per week with RLS symptoms at the baseline visit;

6. Both genders. Age range between 18 to 65 years;

7. Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the trial;

8. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
Subjects may not participate in the study if they meet any of the following criteria:

1. Any form of secondary RLS;

2. Requiring treatment for daytime RLS symptoms (between the hours of 7:00 to 17:00);

3. Placebo responders as defined by >50% improvement in IRLS Scale between begining of placebo run-in and Baseline visits;

4. Any symptomatic neuropathies or any current diagnosis of (clinically relevant) concomitant conditions that may confound assessments as to the judgment of the investigator, for example, painful leg and moving toes syndrome;

5. Clinically significant lumbar radiculopathy or central spinal stenosis by history or examination;

6. Presence of other severe central nervous degenerative diseases such as Parkinson’s disease, dementia, progressive supranuclear paresthesia, multisystem atrophy, Huntington Chorea, amyotrophic lateral sclerosis, or Alzheimer’s disease;

7. Failure to respond to gabapentin in past medical history;

8. Known hypersensitivity to any components of the trial medication or similar drugs;

9. Serum ferritin below 10µg/L;

10. History or presence at the screening or baseline visits, of a severe sleep disorder (especialy those with difficulty falling and/or staying asleep) that may confound assessments (ie, if a sleep study has been previously performed: Apnea/Hypopnea Index greater than 20);

11. Use of medications likely to influence sleep architecture or motor manifestations during sleep prior to the baseline visit (BL) without an appropriate washout period. Note: See Appendix 1. These include neuroleptics, hypnotics, sedatives, antidepressants, anxiolytics, anticonvulsants, psychostimulant medications, barbiturates and opioids;

12. Employed in shift work (for example, employment hours disruptive to the normal circadian sleep-wake cycle such as nighttime or variable rotating shifts);

13. Requiring prescription medication for concurrent conditions which could interfere with efficacy assessments;

14. Clinically significant liver disease, or an elevation in either bilirubin, aspartate aminotransferase (AST), or alanine aminotransferase (ALT) levels >3 times the upper limit of normal value (ULN);

15. Clinically significant renal disease, or creatinine clearance level <60 mL/min (estimated by Cockroft-Gault method);

16. Any other clinically significant condition (eg, cardiac dysfunction, active neoplasm) or laboratory assay abnormality, which would interfere with the subject’s ability to participate the study;

17. Pregnant or lactating women, or women with child-bearing potential who are not surgically sterile, two years postmenopausal, or do not practice two combined methods of medically acceptable forms of contraception;

18. Participating in other investigational drug studies or having received other investigational drugs within the previous 30 days of the screen visit;

19. Other clinically significant acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration or may interfere with the interpretation of study results and, at the discretion of the investigator;

20. Current or history of chronic alcohol or drug abuse within the past 12 months.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Restless legs syndrome (RLS)
MedDRA version: 9.1 Level: LLT Classification code 10058920 Term: Restless legs syndrome

Intervention(s)

Trade Name: Lyrica 25 mg Hartkapseln
Pharmaceutical Form: Capsule*
INN or Proposed INN: Pregabalin
CAS Number: 148553-50-8
Current Sponsor code: Lyrica
Other descriptive name: (s)-2-(aminomethyl)-5-methylhexanoic acid
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 25-
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use

Trade Name: Lyrica 50 mg Hartkapseln
Pharmaceutical Form: Capsule*
INN or Proposed INN: Pregabalin
CAS Number: 148553-50-8
Current Sponsor code: Lyrica
Other descriptive name: (s)-2-(aminomethyl)-5-methylhexanoic acid
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 50-
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use

Trade Name: Lyrica 75 mg Hartkapseln
Pharmaceutical Form: Capsule*
INN or Proposed INN: Pregabalin
CAS Number: 148553-50-8
Current Sponsor code: Lyrica
Other descriptive name: (s)-2-(aminomethyl)-5-methylhexanoic acid
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 75-
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use

Trade Name: Lyrica 150 mg Hartkapseln
Pharmaceutical Form: Capsule*
INN or Proposed INN: Pregabalin
CAS Number: 148553-50-8
Current Sponsor code: Lyrica
Other descriptive name: (s)-2-(aminomethyl)-5-methylhexanoic acid
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Pharmaceutical form of the placebo: Capsule*
Route of administration of the placebo: Oral use

Trade Name: Lyrica 225 mg Hartkapseln
Pharmaceutical Form: Capsule*
INN or Proposed INN: Pregabalin
CAS Number: 148553-50-8
Current Sponsor code: Lyrica
Other descriptive name: (s)-2-(aminometh

Primary Outcome(s)

Secondary Objective: • To assess the tolerability and safety of pregabalin in RLS subjects as with respect to dose level.
• To assess the pregabalin dose response of the following endpoints:
-CGI-I Responders;
-Subjective perception of sleep;
-Quality of Life in RLS;
-Early study discontinuation due to Adverse Events.

Main Objective: To characterize the dose-response relationship for pregabalin in the treatment of RLS
symptoms in subjects with idiopathic RLS using the IRLS scale.

Primary end point(s): Change from baseline to endpoint in the RLS symptom severity using the International Restless Leg Group Symptom Severity Rating Scale (IRLS) total score at Week 6 with regard to dose level.

Secondary ID(s)

2008-000025-19-ES

A0081183

Ethics review

Status: Approved
Approval date: 03/07/2008
Contact:

Results

• Results available: Yes
• Date Posted: 13/02/2015
• Date Completed: 17/01/2009
• URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2008-000025-19/results