Pramipexole in Out-patients With Idiopathic Restless Legs Syndrome (IRLS)

NCT00654498 | Completed Phase 3 Results

• 1 other identifier: 248.630
• Study Type: interventional
• Target: 306
• Locations: 1 country
• Sites: 16

Brief Summary

To determine efficacy and safety of Pramipexole 0.125mg to 0.75mg daily for 6 weeks compared to placebo in the treatment of idiopathic Restless Legs Syndrome (RLS)

Conditions

Restless Legs Syndrome

Outcome Measures

Primary Outcomes (2)

• The Change From Baseline to Week 6 in the Total Score of Restless Legs Syndrome Rating Scale for Severity of the International Restless Legs Syndrome Study Group (IRLS).

  The IRLS was a 10-item self patient's rating scale for assessing severity of restless legs syndrome symptoms with each item ranging from 0 (no symptoms) to 4 (very severe symptoms). The total IRLS score ranges from 0 (no symptoms) to 40 (worst possible symptoms).

  Baseline and 6 weeks of treatment

• The Proportion of Patients With Clinical Global Impressions -Improvement Scale (CGI-I) Assessment of "Much Improved" and "Very Much Improved"

  CGI-I: 7-point clinician rated scale ranging from 1 (very much improved) to 7 (very much worse). Improvement is defined as a score of 1 (very much improved)and 2 (much improved.

  6 weeks of treatment

Secondary Outcomes (10)

• The Proportion of IRLS Responders

  6 weeks of treatment

• The Proportion of Patient Global Impression(PGI) Responders

  6 weeks of treatment

• The Proportion of Patients With Epworth Sleepiness Scale (ESS) Categorised >10

  week 6 of treatment

• the Mean Change From Baseline to Week 6 in Satisfaction of Sleep at Night of RLS-6 Rating Scales

  Baseline and 6 weeks of treatment

• The Mean Change From Baseline in the Severity of RLS at Time of Falling Sleep of RLS-6 Rating Scales.

  Baseline and 6 weeks of treatment

Study Arms (2)

Pramipexole

OTHER

4 weeks of individual dose titration starting with Pramipexole 0.125 mg, next dose steps 0.25 mg, 0.5 mg and 0.75 mg, fixed dose for 2 weeks, once daily

Drug: Pramipexole

Placebo

OTHER

4 weeks of individual dose titration as for the investigational product, once daily

Drug: Placebo

Interventions

Pramipexole DRUG

Pramipexole

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent consistent with International Conference on Harmonisation (ICH) / Good Clinical Practice (GCP) and local legislation given prior to any study procedures.
• Ability and willingness to comply with study treatment regimen and to attend study assessments.
• Male or female out-patients aged 18-80 years.
• Diagnosis of idiopathic Restless Legs Syndrome (IRLS) according to the clinical Restless Legs Syndrome (RLS) criteria of the International Restless Legs Syndrome Study Group (IRLSSG)
• All four criteria must be present to fulfil the diagnosis of RLS:
• 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).
• The urge to move or unpleasant sensations begin or worsen during periods of rest or inactivity such as lying or sitting.
• The urge to move or unpleasant sensations are partially or totally relieved by movement, such as walking or stretching, at least as long as the activity continues.
• 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).
• Restless Legs Syndrome (RLS)rating scale for severity total score \>15.
• Restless Legs Syndrome (RLS) symptoms present at least 2 to 3 days per week during the last 3 months.

You may not qualify if:

• Women of child-bearing potential (i.e. premenopausal women, or postmenopausal women less than 2 years after last menses) who do not use during the clinical trial an adequate method of contraception such as: hormonal therapy (combined oral contraceptives, injectables, or subcutaneous implants), hormonal intrauterine devices, sexual abstinence, surgical sterilization of patient and/or partner, hysterectomy, bilateral ovariectomy or partners vasectomy
• Any woman of child-bearing potential not having a negative pregnancy test at screening
• Patients who are breastfeeding
• Concomitant or previous pharmacologically therapy of RLS as follows:
• Any intake of levodopa within 5 days prior to baseline visit (V2)
• Any intake of dopamine agonists within 14 days prior to baseline visit (V2)
• Current (less than 14 days before treatment with trial medication or concomitant) treatment with medication or dietary supplements, which could significantly influence RLS symptoms, e.g. dopaminergic (other than levodopa or dopamine agonists) or anti-dopaminergic drugs, non-selective Monoamine Oxidase (MAO) inhibitors, sympathomimetics, neuroleptics, anti-depressants, hypnotics, any benzodiazepines, antiepileptics, opioids, clonidine, magnesium, ferrous salts, Folic acid, vitamin B12, antihistaminics, lithium, metoclopramide or Withdrawal symptoms caused by stopping any of the drugs above
• Confirmed diagnose of diabetic nephropathy or clinically significant renal disease
• Creatinine higher than upper limit of normal (ULN) at screening
• Clinical significant hepatic disease or Alanine aminotransferase (ALT) \>2 times the upper limit of normal range at screening
• Clinical or laboratory signs of microcytic anaemia, or ferritin in serum below the lower bound of the reference range
• Any of the following lab results at screening:
• Basal Thyroid Stimulating Hormone (TSH), T3 or T4 clinically significantly (at the investigators discretion) out of normal range at screening (if not caused by substitution therapy according the investigators opinion)
• Patients with any clinically significant abnormalities in laboratory parameters at screening at the investigators discretion
• Other clinically significant metabolic-endocrine, haematological, gastro-intestinal disease or pulmonary disease (such as severe COPD). Poorly controlled cardiovascular disease (including hypotension and severe coronary artery disease)

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (16)

248.630.04 Boehringer Ingelheim Investigational Site

Beijing, China

Location

248.630.05 Boehringer Ingelheim Investigational Site

Beijing, China

Location

248.630.06 Boehringer Ingelheim Investigational Site

Beijing, China

Location

248.630.07 Boehringer Ingelheim Investigational Site

Beijing, China

Location

248.630.08 Boehringer Ingelheim Investigational Site

Beijing, China

Location

248.630.15 Boehringer Ingelheim Investigational Site

Guangzhou, China

Location

248.630.14 Boehringer Ingelheim Investigational Site

Haerbin, China

Location

248.630.10 Boehringer Ingelheim Investigational Site

Hangzhou, China

Location

248.630.09 Boehringer Ingelheim Investigational Site

Nanjing, China

Location

248.630.12 Boehringer Ingelheim Investigational Site

Qingdao, China

Location

248.630.01 Boehringer Ingelheim Investigational Site

Shanghai, China

Location

248.630.02 Boehringer Ingelheim Investigational Site

Shanghai, China

Location

248.630.03 Boehringer Ingelheim Investigational Site

Shanghai, China

Location

248.630.16 Boehringer Ingelheim Investigational Site

Suzhou, China

Location

248.630.13 Boehringer Ingelheim Investigational Site

Wuhan, China

Location

248.630.11 Boehringer Ingelheim Investigational Site

Xian, Shanxi Province, China

Location

Related Links

• Related Info

MeSH Terms

Conditions

Restless Legs Syndrome

Interventions

Pramipexole

Condition Hierarchy (Ancestors)

Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Parasomnias; Mental Disorders

Intervention Hierarchy (Ancestors)

Benzothiazoles; Thiazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim Pharmaceuticals

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2008
• First Posted: April 8, 2008
• Study Start: April 1, 2008
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: June 9, 2014
• Results First Posted: March 3, 2010

Record last verified: 2014-03

Locations

CN (16)