Trial to Assess Efficacy and Safety of Lacosamide in Subjects With Osteoarthritis of the Knee

NCT00485472 | Terminated Phase 2 Results

• 2 other identifiers: SP09052006-005048-97
• Study Type: interventional
• Target: 194
• Locations: 7 countries
• Sites: 26

Brief Summary

The purpose of this trial is to evaluate the effectiveness, safety and tolerability of lacosamide (LCM) 400mg/day in treating the signs and symptoms of osteoarthritis of the knee.

Conditions

Osteoarthritis

Keywords

Osteoarthritis; lacosamide; VIMPAT

Outcome Measures

Primary Outcomes (1)

• Change of the Western Ontario and McMaster Universities (WOMAC) Pain Subscale Score (Visual Analogue Scale Version) From Baseline to the End of the 8 Week Maintenance Period

  The Visual Analogue Scale (VAS) version of the WOMAC pain subscale ranges from 0 to 100, high values describe high grade of pain.

  Baseline, end of 8 week Maintenance Period

Secondary Outcomes (8)

• Change From Baseline to End of 8 Week Maintenance Period in WOMAC Physical Function Subscale Score.

  Baseline, end of 8 week Maintenance Period

• Change From Baseline to End of 8 Week Maintenance Period in WOMAC Stiffness Subscale Score.

  Baseline, end of 8 week Maintenance Period

• Change From Baseline to End of 8 Week Maintenance Period in Total WOMAC Score.

  Baseline, end of 8 week Maintenance Period

• Patient's Global Impression of Change From Baseline at the End of 8 Week Maintenance Period.

  at the end of 8 week Maintenance Period

• Response at the End of 8 Week Maintenance Period Versus Baseline Based on the (Slightly Modified)Criteria of the Osteoarthritis Research Society International (OARSI) and the Outcome Measures in Rheumatology Initiative (OMERACT).

  Baseline, end of 8 week Maintenance Period

Study Arms (2)

Lacosamide

EXPERIMENTAL

lacosamide (LCM)

Drug: lacosamide

Placebo

PLACEBO COMPARATOR

Placebo

Other: Placebo

Interventions

lacosamide DRUG

50 or 100mg tablet, 400mg daily, for 12 weeks

Also known as: VIMPAT

Lacosamide

Placebo OTHER

50 or 100mg tablet, 400mg daily, for 12 weeks, matched to Lacosamide

Placebo

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject has symptomatic osteoarthritis of the knee diagnosed using clinical and radiographic evidence as well as ACR criteria with symptom duration of at least 6 months.
• Subject requires therapeutic dose of an NSAID, COX-2 NSAID, and/or paracetamol/acetaminophen for osteoarthritis pain of the index knee and has taken that medication at least 5 days per week for the last 4 weeks prior to the screening visit (Visit 1).

You may not qualify if:

• Subject is not able to withdraw NSAIDs, COX-2 NSAIDs and/or paracetamol
• Subject is taking analgesic other than NSAIDs COX-2 NSAIDs and/or paracetamol
• Subject is planning to begin or stop treatment with glucosamine and/or chondroitin during the trial

Sponsors & Collaborators

• UCB Pharma: lead

Study Sites (26)

Unknown Facility

Kladno, Czechia

Location

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Prague, Czechia

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Bad Hersfeld, Germany

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Berlin, Germany

Location

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Hamburg, Germany

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Leipzig, Germany

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München, Germany

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Debrecen, Hungary

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Esztegom, Hungary

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Győr, Hungary

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Gyula, Hungary

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Verseghy, Hungary

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Veszprém, Hungary

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Bialystok, Poland

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Krakow, Poland

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Torun, Poland

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Warsaw, Poland

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Brăila, Romania

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Lasi, Romania

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Târgovişte, Romania

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Timișoara, Romania

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Stockholm, Sweden

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Morriston, United Kingdom

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Newcastle, United Kingdom

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Oxford, United Kingdom

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Stanmore, United Kingdom

Location

Related Links

• FDA Safety Alerts and Recalls

MeSH Terms

Conditions

Osteoarthritis

Interventions

Lacosamide

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Acetamides; Amides; Organic Chemicals; Acetates; Acids, Acyclic; Carboxylic Acids

Results Point of Contact

• Title: UCB Clinical Trial Call Center
• Organization: UCB Pharma

+1 877 822 9493

Study Officials

• UCB Clinical Trial Call Center

  +1 877 822 9493 (UCB)

  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: June 12, 2007
• First Posted: June 13, 2007
• Study Start: March 1, 2007
• Primary Completion: November 1, 2007
• Study Completion: January 1, 2008
• Last Updated: August 28, 2017
• Results First Posted: September 22, 2009

Record last verified: 2017-07

Locations

CZ (2); GB (4); DE (5); HU (6); PL (4); SE (1); RO (4)