RLS
Conditions
Interventions
Trade Name: Horizant
Product Name: HORIZANT
Product Code: HORIZANT
Pharmaceutical Form: Tablet
INN or Proposed INN: Gabapentin enacarbil
CAS Number: 478296-72-9
Current Sponsor code: Horizant
Other de
Sponsors
Instituto de Investigaciones del Sueño
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Idiopathic RLS, according to diagnostic criteria established by the International RLS Study Group (Allen et al., 2003). 2. A history (if currently controlled on medication) or the presence of RLS symptoms on 3 or more days per week for at least 12 months. 3. For Group A: An IRLS score ?20 at baseline assessment For Group B: An IRLS score ?15 both during dopaminergic treatment and an IRLS score ? 20 following wash-out, during the baseline visit. 4. Aged 18 - 80 years. 5. Creatinine clearance >60 ml/min 6. Women of childbearing potential must have a negative pregnancy test at screen and must agree to use medically accepted methods not to become pregnant. 7. Prior to any study-specific procedures, a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the trial. 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 46 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 46
Exclusion criteria
Exclusion criteria: 1. Any secondary forms of RLS. 2. Current or previous augmentation according to the MPI diagnostic criteria for augmentation (particularly important for Group B) 3. History or current diagnosis of other clinically relevant diseases that may confound assessments or RLS symptoms. 4. Serum ferritin <18 mcg/ml 5. If the patient is currently being treated with drugs likely to influence sleep architecture or motor manifestations during sleep (such as neuroleptics, hypnotics, sedatives, antidepressants, anxiolytics, anticonvulsants, psychoactive medications, steroids, barbiturates and opiates), a wash-out period of at least five half-lives will be undertaken. The washout period for previous intake of L-DOPA or dopamine agonists will be two weeks. 7. Employed in shift work (for example, employment hours disruptive to the normal circadian sleep-wake cycle such as nighttime or variable rotating shifts) or irregular sleep-wake schedules. 8. Patients who require prescription medication for concurrent conditions which could interfere with efficacy assessments. 9. Surgery within 180 days of baseline visit, which in the opinion of the investigator would negatively impact the patient?s participation in the study. 10. A significant medical or psychiatric disorder (see below 7.4.) 11. Any other clinically significant condition or laboratory assay abnormality, which would interfere with the patient?s ability to participate in the study. 12. Other severe acute or chronic medical or psychiatric condition or laboratory assay abnormality that may increase the risk associated with study participation or study drug administration or may interfere with the interpretation of study results and would make the patient inappropriate for entry into this study. 13. Breastfeeding.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the IRLS response to a two-week treatment with gabapentin enacarbil (600 mg/d) in treatment-naïve RLS patients vs. a similar group of patients previously treated with dopaminergics for at least 90% of the time during the last five years, as judged by the clinical impression of the investigator.;Secondary Objective: -To compare the response on the RLS-6 to a two-week treatment with gabapentin enacarbil in treatment-naïve RLS patients vs. a similar group of patients previously treated with dopaminergics for at least 90% of the time during the last five years. - tocompare the response on sleep to a two-week treatment with gabapentin enacarbil in treatment-naïve RLS patients vs. a similar group of patients previously treated with dopaminergics for at least 90% of the time during the last five years. -To compare the response on pain to a two-week treatment with gabapentin enacarbil in treatment-naïve RLS patients vs. a similar group of patients previously treated with dopaminergics for at least 90% of the time during the last five years.? To compare general toxicity between both groups to two-weeks treatment with gabapentin enacarbil (600 mg/d) in treatment-naïve RLS patients vs. a similar group of patients previously treated with dopaminergics for at least 90% of the time during the last five years.;Primary end point(s): 1. Comparison between both patient groups of: Placebo-corrected change in IRLS total score (Walters et al., 2003) This scale will be completed on every visit. This subject-based scale has been validated in a large-scaled multi-national multi-center trial17. The IRLS, has been shown to be a valid measure of RLS symptom severity in both clinical and self-referred subject samples.;Timepoint(s) of evaluation of this end point: 5 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Comparison between both patient groups of: a. Clinical Global Impressions (CGI)-Severity (Guy, 1976) Will be performed at every visit. At visits Screening and BL where no treatment is administered to the subjects, only item 1 has to be completed. The CGI-S Scale had been initially developed for a risk-benefit estimation within the treatment of mentally ill subjects. Nowadays, the four global scales (severity of illness, change in severity from baseline, therapeutic efficacy and tolerability of treatment) are used as different measures of treatment outcome in different kinds of pharmacological studies. The CGI-S is considered also as a highly valid (?gold standard?) outcome measure for evaluation of treatments in RLS subjects. b. RLS-6 scale The RLS-6 scale49 has been increasingly used in clinical trials, particularly in Europe. Six 11-point scales with ranges between 0=not at all to 10=maximum are used to assess the severity of RLS in the course of treatment, they were include in diaries. These scales proved to be sensitive both for description of changes in severity during the study as well as for the demonstration of differences between active treatment and placebo. The following four scales of the RLS-6 are designed to assess severity of RLS and be used at every visit: ? Severity of RLS at time falling asleep ? Severity of RLS during the night ? Severity of RLS during the day at rest ? Severity of RLS during the day when engaged in daytime activities. Two further scales are added which cover sleep and daytime tiredness: ? Satisfaction with sleep ? Severity of daytime tiredness/sleepiness. c. Medical Outcomes Study (MOS) Scale (Hays, 2005) The MOS scale includes questions on subjective perception of sleep initiation, sleep maintenance, perceived sleep quality, daytime somnolence and sleep breathing disorders (REF). As RLS affects sleep, this rating scale will have the opportunity to measure any improvements in sleep and thereby | — |
Countries
Spain
Contacts
Public ContactJAVIER SORIANO VENTURA
FUNDACION TEOFILO HERNANDO
Outcome results
None listed