Patients with diabetic polyneuropathy (DPN)
Conditions
Interventions
Trade Name: Lyrica 75 mg capsulas duras
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Pregabalina
CAS Number: 148553-50-8
Current Sponsor code: Lyrica
Other descriptive name: PREGABALIN
Conc
Sponsors
Instituto de Investigaciones del Sueño
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.History of signs and symptoms of bilateral painful DPN (confirmed by means of a nerve conduction study). 2.Beginning of the sensory symptoms symmetrically in both feet. 3.If symptoms of DPN are in remission because of being currently controlled with medication, history of signs and symptoms of diabetic neuropathy. 4.If the patient presents symptoms at the moment of the study inclusion, these symptoms must interfere with sleep onset or sleep maintenance during an average of at least four nights per week for the last three months. 5.Type II diabetes with HbA1c?10 6.Duration of DPN ?6 months. 7.A score of >40 mm on the Short-Form McGill Pain Questionnaire (SF-MPQ) visual analogue scale (VAS). 8.A score ?4 on a VAS pain rating scale, based on at least 4 daily pain entries during the week before randomization. 9.WASO =65 years) yes F.1.3.1 Number of subjects for this age range 4
Exclusion criteria
Exclusion criteria: 1.History of diseases (pernicious anemia, hypothyroidism, etc.) that occur with sensory neuropathy. 2.History or current diagnosis of other clinically relevant diseases that may confound assessments of DPN symptoms. 3.Patients who require current prescription medication for concomitant diseases which could interfere with efficacy assessments. 4.Diagnosis of significant physical or psychiatric disorder (such as symptomatic peripheral vascular disease). 5.History of exposition to substances known to cause neuropathy or that are potential retinotoxins. 6.Sleep apnea with an index of apneas and/or hypoapneas per hour of sleep > 20. 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.Surgery within the previous 180 days of baseline visit, which in the opinion of the investigator would negatively impact the patient?s participation in the study. 9.Any other clinically significant condition or laboratory assay abnormality, which could interfere with the patient?s ability to participate in the study. 10.Pregnant or lactating women. 11.Patients with known hypersensitivity and/or intolerance to any component of the study drug or similar drugs. 12.Clinically significant renal disease which could cause that the patient might not complete the study, or an increase of serum creatinine 1.5 times higher than the upper limit of normal laboratory ranges. Abnormal results of analysis implying that a patient can not be included in the study can be repeated once, before the basal visit, with the aim to confirm or reject patient inclusion. 13.Patients who had participated in other investigational drug studies or who had received other investigational drugs within the previous 30 days of the selection visit. 14.History of chronic alcoholism or drug abuse during the last 12 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: ?To investigate a potential increase of the slow wave activity (delta bands) in patients with DPN during treatment with pregabalin, by means of a quantitative analysis of the sleep EEG (Fast Fourier Transformations).;Primary end point(s): The principal objective is to assess changes in slow wave activity in the delta band (delta power) through spectral analysis of EEG during sleep in patients with DPN after undergoing a four-week treatment with pregabalin and placebo;Timepoint(s) of evaluation of this end point: 4th week of the tratment;Secondary Objective: ?To investigate if the treatment with pregabalin in patients with DPN causes changes in the other wavebands different form delta bandsduring the analysis of the sleep EEG?To investigate if these possible changes in the wavebands of the EEG spectra are related to the drug dose and/or the treatment duration?To investigate possible changes in the sleep architecture by means of visual analysis during the treatment with pregabalin in patients with DPN. ?To investigate the possible therapeutic effects of pregabalin in other neurological anomalies or respiratory anomalies occurring during sleep in the DPN?To investigate if the treatment with pregabalin causes a subjective improvement of sleep, measured by evaluation scales?To investigate if the treatment with pregabalin during sleep in DPN causes an improvement of the nocturnal pain?To investigate if the possible improvement of sleep architecture is related with the possible improvement of neuropathic pain. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Polysomnographic Studies of polysomnography (PSG) will be conducted in the baseline and S4 visits by some variables;Timepoint(s) of evaluation of this end point: no | — |
Countries
Spain
Contacts
Public ContactDr. Diego Garcia-Borreguero
Instituto de Investigación delSueño
Outcome results
None listed