SLEEP MAINTENANCE IN SUBJECTS WITH FIBROMYALGIA SYNDROME AND SLEEP MAINTENANCE DISTURBANCE MedDRA version: 9.1 Level: LLT Classification code 10016631 Term: Fibromyalgia syndrome
Conditions
Interventions
Trade Name: LYRICA 75 mg Capsules
Product Name: Pregabalin
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Pregabalin
CAS Number: 148-553-50-8
Other descriptive name: (S)-3-(aminomethyl)-5-met
Sponsors
Pfizer Inc., 235 East 42nd Street, New York, NY 10017, US
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. 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 study. 2. Men or women of any race, at least 18 years of age. 3. Women of childbearing potential must be non-pregnant and non-lactating, must have a negative pregnancy test at screening and must agree to utilize a medically acceptable form of contraception. Non-vasectomized men must either abstain from sexual activity or use an acceptable form of contraception. 4. Understand and be willing to cooperate with study procedures, including scheduled visits, daily IVRS diary completion and PSG. 5. Meet the American College of Rheumatology (ACR) criteria for fibromyalgia at Screening (Visit 1). 6. Customary bedtime between 9 PM and midnight and rise between 5 and 9 AM. 7. Maintain a normal daytime-awake, nighttime–asleep schedule, including approximately 6.5-8.5 hours each night in bed, and less than 3 hours variation in night-to-night bedtime for the past month prior to Screening (Visit 1). 8. Have clinically disturbed sleep on interview, reflected by difficulty in maintaining sleep at least 3 times per week for at least one month and meet Research Diagnosis Criteria (RDC) for insomnia disorder. Self Report Sleep Inclusion Criteria (to be confirmed by Visit 3): A minimum of 5 daily IVRS diary data points are required from Visit 2. 9. Self report Total Sleep Time (sTST) =6.0 hours for at least 3 nights/week during the screening period (IVRS diary). 10. Self-report wake time after sleep onset (sWASO) totaling at least 60 minutes for at least 3 three nights/ week during the screening period (IVRS diary). PSG Sleep Inclusion Criteria (Visit 3): 11. Mean WASO >45 minutes calculated on each of the 2 PSG nights with neither night WASO =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1.History of any active sleep disorder other than RDC insomnia disorder. 2.History of any sleep or circadian rhythm sleep disorder incl. RLS, narcolepsy, sleep apnea, phase advance or delay syndromes within the past 5 years. 3.Taking CNS active medication known to affect sleep wake function (within 5 half lives), or unable to wash out of prohibited medications by Visit2. (Note: stable SSRI antidepressant usage, in cases where sleep disturbance preceded and is not secondary to antidepressant use is permitted per allowed/prohibited medication list.) 4.Currently on or planning to be involved in night/rotating shift work or traveling across more than 4 time zones in 14 days prior to screening, plan to travel across time zones during the study, regular napping (or any after 6PM), or regular disruptions during the night (such as care for dependents). 5.Clinically significant depression or other DSM-IV Axis I disorder (as determined by psychiatric exam and/or Mini International Neuropsychiatric Interview, version 6.0; [MINI]) that would confound assessment of sleep or make the subject inappropriate for a clinical trial. 6.Imminent risk for self-injurious/suicidal or violent/homicidal behavior, as deemed by the investigator. 7.Any clinically unstable hematological, autoimmune, endocrine, cardiovascular, renal, hepatic, gastrointestinal, or neurological disorder. 8.Substance abuse in the last 6 months and dependence in the last year (other than nicotine). 9.Current or within the last 6 months, white blood cell count of 2000 mg/day gabapentin, per medical history; pregabalin within 60 days prior to Screening. 15.Use of alcohol as a sleep aid, or more than 2 standard drinks consumed per day, or more than 14 consumed per week, except for isolated instances. 16.Excessive caffeine use over the last 3 months, except for isolated instances. 17.Excessive cigarette or cigar smoking over the last 3 months. 18.Positive urine drug screen for any of the following substances or classes of compounds: amphetamines, barbiturates, opiates, benzodiazepines, sedatives and hypnotics, cocaine, phencyclidine (PCP), cannabinoids, or other drugs of abuse. As the protocol allows for a seven-day washout period prior to Visit2 for current sleep medications (benzodiazepines, sedatives and hypnotics), positive results for these sleep aid medications will be allowed for Visi
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: • To demonstrate the effect of pregabalin compared to placebo on sleep maintenance as measured by WASO obtained by PSG in patients with fibromyalgia and sleep maintenance disturbance.;Secondary Objective: • To characterize the effect of pregabalin on other measures of sleep maintenance in patients with fibromyalgia using PSG, including: TST, SE, NAASO, WTDS, WTAS, LPS, and SWS • To investigate the effect of pregabalin on overall sleep problem index and sleep disturbance (as measured by specific MOS-SS subscales and NRS sleep quality score) • To characterize the effect of pregabalin on sleep maintenance as determined by subject- rated assessments of WASO (sWASO) and total sleep time (sTST), latency to sleep onset (LSO); and pain, as determined by NRS pain score • To investigate the safety and tolerability of pregabalin in patients with fibromyalgia and sleep disturbance.;Primary end point(s): The primary endpoint in this study is the mean WASO (as determined by PSG assessment) from two consecutive nights in the last visit of each treatment period. The primary endpoint will be analyzed using a linear mixed effects model including sequence, period, and treatment as fixed factors and subject within sequence and within-subject error as random factors. The point estimate for mean treatment difference (pregabalin-placebo) and 95% confidence intervals (CIs) for the true mean treatment difference will be reported. Descriptive statistics will also be reported for the primary efficacy endpoint by visit and treatment group. The primary analysis will be performed on the per-protocol population of subjects reaching the approved treatment dose of 300-450 mg/day. Subjects not able to tolerate those doses will be included in the safety population, and in a full analysis set. | — |
Countries
Germany
Outcome results
None listed