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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00980746
Other study ID # BIA-2093-206
Secondary ID EudraCT 2007-002
Status Completed
Phase Phase 2
First received September 18, 2009
Last updated March 26, 2013
Start date November 2007
Est. completion date November 2008

Study information

Verified date March 2013
Source Bial - Portela C S.A.
Contact n/a
Is FDA regulated No
Health authority Austria: Ethikkommission
Study type Interventional

Clinical Trial Summary

The primary objective of the study is to assess the efficacy of eslicarbazepine acetate (ESL) as therapy for patients with painful diabetic neuropathy.


Recruitment information / eligibility

Status Completed
Enrollment 557
Est. completion date November 2008
Est. primary completion date November 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Written informed consent to participate in the study

- Men and women aged 18 years or older

- Diagnosis of diabetes mellitus Type 1 or 2

- Diagnosis of pain attributed to diabetic neuropathy for more than 1 year prior to enrolment

- Stable glycemic control: (total glycated haemoglobin [HbA1c] level = 11% at screening)

- Cooperation and willingness to complete all aspects of the study

- Completion of at least 4 daily diaries during the week preceding randomisation

- A minimum average daily pain score of 4 on the NRPS in the last 4 diary entries before randomisation.

Exclusion Criteria:

- Pain of other origin that might confound the assessment of neuropathic pain of diabetic origin

- Significant or unstable medical or psychiatric disorders

- Drug or alcohol abuse in the preceding 2 years

- Peripheral vascular disease with a history of amputation, except amputation of toes

- Severe renal function impairment, as shown by calculated creatinine clearance values < 30 mL/min at screening

- Relevant clinical laboratory abnormalities (e.g., Na+ <130 mmol/L, alanine (ALT) or aspartate (AST) transaminases >2.0 times the upper limit of normal, white blood cell count (WBC) <2,500 cells/mm3)

- Previous participation in any study with eslicarbazepine acetate

- Pregnancy or breast feeding

- History of hypersensitivity to the investigational products or to drugs with a similar chemical structure

- History of non-compliance

- Likelihood of requiring treatment during the study period with drugs or other interventions not permitted by the clinical study protocol.

- Participation in a clinical study within 3 months prior to screening

- Any clinically significant concomitant condition, which might influence the assessments or conduct of the trial

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Eslicarbazepine acetate
Eslicarbazepine acetate tablets, scored to allow dose titration during the titration period.
Placebo
oral route

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Bial - Portela C S.A.

Outcome

Type Measure Description Time frame Safety issue
Primary Change From Baseline to Endpoint in Mean Pain, Scored Daily on a on an 11-point (0-10) Numeric Rating Pain Scale (NRPS), Where 0 = no Pain and 10 = Worst Possible Pain ?Endpoint mean pain was defined as the mean of the last 4 available pain scores in the last 7 days of the treatment period. Likewise, baseline mean pain was defined as the mean of the last 4 available pain scores in the last 7 days of the baseline period. 17 weeks No
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