Effects of pregabalin on slow wave sleep and glucose tolerance in patients with diabetic polyneuropathy. An exploratory study.

• Conditions: Patients with diabetic polyneuropathy (DPN); Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2011-004371-36-ES
• Lead Sponsor: Instituto de Investigaciones del Sueño

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11-17
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 0

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 <60% as completed on a sleep diary.
10.If the patient is taking anti-diabetic medication at the moment of study inclusion, the patient must have been on a stable regimen for 30 days previous to randomization.
11.Patients who are willing and able to comply with the patient sleep diary, scheduled visits, treatment plan, laboratory tests, and other study procedures.
12.Patients who accept that they might be treated with placebo during the first study phase.
13.Patients aged between 18 and 80 years.
14.Women of childbearing potential must have a negative pregnancy test at screen and must agree not to become pregnant.
15.Prior to any study specific procedures, the patient must personally sign and date the 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 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 4

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified