Efficacy and Safety of Eslicarbazepine Acetate as Therapy in Subjects With Fibromyalgia

NCT01820585 | Completed Phase 2 Results

• 1 other identifier: BIA-2093-210
• Study Type: interventional
• Target: 528
• Locations: 0 countries
• Sites: N/A

Brief Summary

This was a double-blind, randomised, placebo-controlled, parallel-group, multicentre, multinational, Phase II study in 528 subjects with pain due to Fibromyalgia syndrome(FMS). Subjects were randomised in a 1:1:1:1 ratio to receive placebo, Eslicarbazepine acetate (ESL) 400 mg once daily (QD), ESL 800 mg QD or ESL 1200 mg QD. The study was carried out as follows.

Conditions

Fibromyalgia

Keywords

fibromyalgia; Eslicarbazepine acetate (BIA 2-093); ESL

Outcome Measures

Primary Outcomes (1)

• Absolute Change From Baseline to Endpoint in Mean Pain

  The primary efficacy variable was the absolute change from baseline to endpoint in mean pain. Pain intensity was assessed on an 11-point (0-10) Numeric pain rating scale (NPRS), where 0 = no pain and 10 = worst possible pain and was recorded in a subject's diary. The subject was instructed to complete the assessment daily on awakening.Primary analyses were conducted on the full analysis set (FAS) which consisted of all randomised subjects who received at least 1 dose of study medication and with at least 1 post-randomisation rating of 24-h-average pain. The primary efficacy variable was the absolute change from baseline to endpoint in mean pain recorded in a subject's diary upon awakening each morning. An ANCOVA on the FAS revealed no statistically significant differences between the 3 ESL groups and the placebo group after 13 weeks of treatment.

  Baseline and 13 Weeks

Study Arms (4)

Placebo

PLACEBO COMPARATOR

Tablets

Drug: Placebo

ESL 400 mg

ACTIVE COMPARATOR

Eslicarbazepine acetate (BIA 2-093) tablets

Drug: ESL 400 mg

ESL 800 mg

ACTIVE COMPARATOR

Eslicarbazepine acetate (BIA 2-093) tablets

Drug: ESL 800 mg

ESL 1200 mg

ACTIVE COMPARATOR

Eslicarbazepine acetate (BIA 2-093) tablets

Drug: ESL 1200 mg

Interventions

Placebo DRUG

Tablets

Also known as: Sugar pills

Placebo

ESL 400 mg DRUG

tablets

Also known as: Eslicarbazepine acetate (BIA 2-093)

ESL 400 mg

ESL 800 mg DRUG

tablets

Also known as: Eslicarbazepine acetate (BIA 2-093)

ESL 800 mg

ESL 1200 mg DRUG

tablets

Also known as: Eslicarbazepine acetate (BIA 2-093)

ESL 1200 mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject was male or female, 18 years of age or older (according to Amendment #1 for Czech Republic \[24 MARCH 2009\]: 18 to 65 years of age).
• Subject was able and willing to provide written informed consent to participate in the study after having the opportunity to review the Subject Information Sheet and Informed Consent Form.
• Subject met the American College of Rheumatology (ACR) 1990 diagnostic criteria for FMS (widespread pain for at least 3 months and pain in at least 11 of 18 tender points) (according to Amendment #1 for Czech Republic \[24 MARCH 2009\]: and the subject's current FMS treatment was either inefficacious or had intolerable side effects).
• Subject was willing and able to understand and comply with all study requirements, in the judgment of the investigator.
• Subject had negative results on the urine test for drugs of abuse at V1 (Screening Visit), except for medications/drugs reported by the subject at the Screening Visit.
• Subject use of allowable non-pharmacological therapies was stable for at least 4 weeks prior to V1 (Screening Visit) and would be maintained at the stable regimen throughout the study.
• Female subject was surgically sterile (i.e. bilateral tubal ligation, bilateral oophorectomy or hysterectomy) or at least 2 years post-menopausal or, if of childbearing potential, she was sexually abstinent or agreed to use a medically acceptable non-hormonal method of contraception
• Addendum according to Amendment #1 for Czech Republic \[24 MARCH 2009\]: Hormonal contraceptives were not acceptable as a contraceptive method in this study. However, their intake was not forbidden throughout the study.
• Addendum according to Amendment #1 for Spain \[19 JANUARY 2009\] and for United Kingdom \[24 MARCH 2009\]: Male subject was sexually abstinent or agreed to use reliable contraceptive methods (i.e. double-barrier method: 1 male barrier \[male condom\] plus 1 female barrier method \[female condom, spermicide or intrauterine device\]. This was mandatory even for sexually active men who had been sterilised.
• Subject had a negative urine test for drugs of abuse.
• The subject had completed at least 4 subject diary pain assessments satisfactorily within the past 7 days prior to V2 and the average pain score was ≥4 and ≤9.

You may not qualify if:

• Subject had a known hypersensitivity to ESL or to other carboxamide derivatives (e.g. oxcarbazepine, carbamazepine) or to any of the excipients.
• Subject had a history of or current active malignancy except for the following: basal cell carcinoma which had been treated; and malignancies that were successfully treated and had no recurrence within 5 years before V1 (Screening Visit).
• Subject had a severe hepatic, renal, respiratory, hematologic or immunologic illness, unstable cardiovascular disease or any other medical or psychiatric condition that, in the judgment of the investigator, made the subject inappropriate for entry into this study.
• Subject had a second or third-degree atrioventricular blockade not corrected with a pacemaker or any other clinically significant abnormality in the 12-lead ECG as determined by the investigator.
• Subject had a history of illicit drug or alcohol abuse within 2 years before V1 (Screening Visit).
• Subject had received an investigational drug (or a medical device) within 3 months of Screening or was currently participating in another study of an investigational drug (or a medical device).
• Subject was pregnant or nursing.
• Subject was an employee of the investigator or study centre, with direct involvement in the proposed study or other studies under the direction of that investigator or study centre or was a family member of the employees or the investigator.
• Subject had any of the following: an inflammatory muscle or rheumatologic disease other than FMS; multiple sclerosis; active infections; untreated endocrine disorders; uncontrolled hypo- or hyper-thyroidism of any type.
• Subjects whose pain was not due primarily to FMS.
• Subject underwent tender point injection within 30 days before V1 (Screening Visit) and/or subject was unwilling to refrain from tender point injection throughout the study.
• Subject had a white blood cell (WBC) count \<2.5 × 109/L, neutrophil count \<1.5 × 109/L, Na+ \<125 mmol/L or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥2 × the upper limit of normal at V1 (Screening Visit) or any other clinically relevant laboratory abnormality that, in the investigator's opinion, could compromise the subject's safety.
• Subject had abnormal values for antinuclear antibody (ANA \>1/160) or rheumatoid factor (RF \>15 IU/mL) at V1 (Screening Visit). After approval of the global amendment in respective countries, the limit for ANA was changed to ≥1/160.
• Subject had abnormal Westergren erythrocyte sedimentation rate (ESR) at V1 (Screening Visit) (ESR \>40 mm/h).
• Subject had creatinine clearance (CLCr) lower than 60 mL/min at Screening.

Sponsors & Collaborators

• Bial - Portela C S.A.: lead

MeSH Terms

Conditions

Fibromyalgia

Interventions

eslicarbazepine acetate

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases

Results Point of Contact

• Title: Head of Clinical Research Section
• Organization: Bial - Portela & Cª, S.A.

clinical.trials@bial.com

+ 351 22 986 61 00

Study Officials

• Patricio Soares-da-Silva, MD, PhD

  BIAL - Portela & Cª, S.A.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2013
• First Posted: March 29, 2013
• Study Start: April 1, 2009
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: July 19, 2013
• Results First Posted: July 19, 2013

Record last verified: 2013-06