A Trial to Assess the Efficacy and Safety of 400mg/Day Lacosamide in Subjects With Painful Diabetic Neuropathy

NCT00350103 | Completed Phase 3 Results

• 2 other identifiers: SP08742005-005788-27
• Study Type: interventional
• Target: 551
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this trial is to assess whether 400mg/day of lacosamide is effective in reducing pain caused by distal diabetic neuropathy. Two dose-escalation schemes for lacosamide will be used to further determine the efficacy of the "standard" scheme and to evaluate the efficacy and safety of a more rapid titration scheme. Subjects will be randomly assigned to one of three treatment groups. Subjects in two of the groups will receive lacosamide at a dose of 400mg/day, but different dose-escalation schemes will be used to reach this final dose. The third group of subjects will receive a placebo. Subjects will have a 2 in 3 (66 %) chance of getting lacosamide. The maximum lacosamide dose in this trial will be 400mg/day. The maximum treatment duration will be 18 weeks, including a two-week Pre-Treatment Phase and a 12 weeks period on a stable dose of lacosamide or placebo.

Conditions

Painful Diabetic Neuropathy

Keywords

Painful Diabetic Neuropathy; Lacosamide

Outcome Measures

Primary Outcomes (1)

• Change in Average Daily Pain Score From Baseline Week to the Last 4 Weeks of the Maintenance Phase

  An 11-point Likert scale is used to assess the subject's average daily pain. This scale is completed by the subject twice daily (once in the morning and once in the evening). The subject rates his/her average pain over the last 12 hours, from 0 (no pain) to 10 (worst pain ever experienced). The daily pain score is defined as the average score of those collected in the morning and evening. The value reported below is calculated as a difference between the average of the last available 28 days of maintenance for participants completing the maintenance phase (or the last 28 days prior to discontinuation for participants who discontinued in the titration or maintenance phase) and the average of the Baseline week.

  Last 4 weeks of Maintenance Phase, compared to the Baseline Week

Secondary Outcomes (37)

• Time to Sustainable Pain Relief

  From start of trial medication intake (Week 0) up to the last 4 weeks of the Maintenance Phase

• Percentage of Subjects With >= 30% or >= 2-point Reduction of with-in Subject Change in Average Daily Pain Score From the Baseline Week to the Last 4 Weeks of the Maintenance Phase

  Baseline week, last 4 weeks of the Maintenance Phase

• Within-subject Change in Average Daily Pain Score From the Baseline Week to Visit 3

  Baseline week, Visit 3

• Within-subject Change in Average Daily Pain Score From the Baseline Week to Visit 4

  Baseline week, Visit 4

• Within-subject Change in Average Daily Pain Score From the Baseline Week to Visit 5

  Baseline week, Visit 5

Study Arms (3)

Lacosamide Standard Titration (ST)

EXPERIMENTAL

Subjects had their dose titrated from 100 mg/day to 400 mg/day at weekly intervals of 100 mg. Subjects in this treatment group reach their target dose of 400 mg/day 3 weeks after Visit 2. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.

Drug: SPM 929

Lacosamide Fast Titration (FT)

EXPERIMENTAL

Subjects receive 200 mg/day LCM for the first 3 days, 300 mg/day for the next 4 days, and reach their target dose of 400 mg/day after 1 week. They undergo sham titration for the remaining 3 weeks of the Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase.

Drug: SPM 929

Placebo

PLACEBO COMPARATOR

Subjects underwent sham titration for the entire Titration Phase. All subjects completing the Titration Phase enter a 12-week Maintenance Phase

Drug: Placebo

Interventions

SPM 929 DRUG

* Pharmaceutical form: Immediate release film-coated tablets * Concentration: 50mg/ 100mg * Route of administration: Oral use

Also known as: Lacosamide

Lacosamide Fast Titration (FT); Lacosamide Standard Titration (ST)

Placebo DRUG

* Pharmaceutical form: Immediate release film-coated tablets * Route of administration: Oral use

Placebo

Eligibility Criteria

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

You may qualify if:

• Subject has had symptoms of painful diabetic neuropathy for at least 6 months and has a diagnosis of diabetes mellitus (Type I or Type II).

You may not qualify if:

• Subject has previously participated in this trial or subject has previously been assigned to treatment in a trial of the drug under investigation in this trial

Sponsors & Collaborators

• UCB Pharma: lead
• SCHWARZ BIOSCIENCES GmbH - Part of UCB Group: collaborator

Study Sites (1)

Unknown Facility

Monheim, Germany

Location

Related Publications (1)

• Bainbridge J, De Backer M, Eckhardt K, Tennigkeit F, Bongardt S, Sen D, Werhahn KJ, Shaibani A, Faught E. Safety and tolerability of lacosamide monotherapy in the elderly: A subgroup analysis from lacosamide trials in diabetic neuropathic pain. Epilepsia Open. 2017 Sep 11;2(4):415-423. doi: 10.1002/epi4.12079. eCollection 2017 Dec.

  PMID: 29588972 RESULT

Related Links

• Clinical Study Summary on UCB.com
• FDA Safety Alerts and Recalls

MeSH Terms

Conditions

Diabetic Neuropathies

Interventions

Lacosamide

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: UCB
• Organization: Cares

UCBCares@ucb.com

001 844 599 2273

Study Officials

• UCB Cares

  001 844 599 2273 (UCB)

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2006
• First Posted: July 10, 2006
• Study Start: June 30, 2006
• Primary Completion: June 29, 2007
• Study Completion: June 29, 2007
• Last Updated: March 22, 2024
• Results First Posted: March 22, 2024

Record last verified: 2023-09

Locations

DE (1)