Clinical trial NCT00350103: A Trial to Assess the Efficacy and Safety of 400mg/Day Lacosamide in Subjects With Painful Diabetic Neuropathy
Official title: A Multi-center, Randomized, Double-blind, Placebo-controlled Trial to Assess the Efficacy and Safety of 400mg/Day Lacosamide in Subjects With Painful Distal Diabetic Neuropathy Using Two Different Titration Schemes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Painful Diabetic Neuropathy
Keywords: Painful Diabetic Neuropathy
Lacosamide
Lead sponsor: UCB Pharma
Sponsor class: INDUSTRY
Collaborators: name: SCHWARZ BIOSCIENCES GmbH - Part of UCB Group
First posted: 2006-07-10
Enrollment: 551
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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).

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in Average Daily Pain Score From Baseline Week to the Last 4 Weeks of the Maintenance Phase
timeFrame: Last 4 weeks of Maintenance Phase, compared to the Baseline Week
Secondary outcomes:
measure: Time to Sustainable Pain Relief
timeFrame: From start of trial medication intake (Week 0) up to the last 4 weeks of the Maintenance Phase
measure: 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
timeFrame: Baseline week, last 4 weeks of the Maintenance Phase
measure: Within-subject Change in Average Daily Pain Score From the Baseline Week to Visit 3
timeFrame: Baseline week, Visit 3
measure: Within-subject Change in Average Daily Pain Score From the Baseline Week to Visit 4
timeFrame: Baseline week, Visit 4
measure: Within-subject Change in Average Daily Pain Score From the Baseline Week to Visit 5
timeFrame: Baseline week, Visit 5
measure: Within-subject Change in Average Daily Pain Score From the Baseline Week to Visit 6
timeFrame: Baseline week, Visit 6
measure: Within-subject Change in Average Daily Pain Score From the Baseline Week to Visit 7
timeFrame: Baseline week, Visit 7
measure: Within-subject Change in Average Daily Pain Score From the Baseline Week to Visit 8
timeFrame: Baseline week, Visit 8
measure: Within-subject Change in Average Daily Pain Score From the Baseline Week to the Titration Phase
timeFrame: Titration Phase (4 weeks), compared to the Baseline Week
measure: Within-subject Change in Average Daily Pain Score From the Baseline Week to the Maintenance Phase
timeFrame: Maintenance Phase (12 weeks), compared to the Baseline Week
measure: Within-subject Change in Average Daily Pain Score From the Baseline Week to the Treatment Phase
timeFrame: Treatment Phase (16 weeks), compared to the Baseline Week
measure: Within-subject Change in Average Daily Pain Score From the Baseline Week to the Last 4 Weeks of Maintenance Phase
timeFrame: Last 4 weeks of Maintenance Phase, compared to the Baseline Week
measure: Within-subject Change From the Baseline Week to Visit 3 in Daily Perception of Pain Interference With Subject's Sleep
timeFrame: Baseline Week, Visit 3
measure: Within-subject Change From the Baseline Week to Visit 4 in Daily Perception of Pain Interference With Subject's Sleep
timeFrame: Baseline Week, Visit 4
measure: Within-subject Change From the Baseline Week to Visit 5 in Daily Perception of Pain Interference With Subject's Sleep
timeFrame: Baseline Week, Visit 5
measure: Within-subject Change From the Baseline Week to Visit 6 in Daily Perception of Pain Interference With Subject's Sleep
timeFrame: Baseline Week, Visit 6
measure: Within-subject Change From the Baseline Week to Visit 7 in Daily Perception of Pain Interference With Subject's Sleep
timeFrame: Baseline Week, Visit 7
measure: Within-subject Change From the Baseline Week to Visit 8 in Daily Perception of Pain Interference With Subject's Sleep
timeFrame: Baseline Week, Visit 8
measure: Within-subject Change From the Baseline Week to the Titration Phase in Daily Perception of Pain Interference With Subject's Sleep
timeFrame: Titration Phase (4 weeks), compared to the Baseline Week
measure: Within-subject Change From the Baseline Week to the Maintenance Phase in Daily Perception of Pain Interference With Subject's Sleep
timeFrame: Maintenance Phase (12 weeks), compared to the Baseline Week
measure: Within-subject Change From the Baseline Week to the Treatment Phase in Daily Perception of Pain Interference With Subject's Sleep
timeFrame: Treatment Phase (16 weeks), compared to the Baseline Week
measure: Within-subject Change From the Baseline Week to the Last 4 Weeks of Maintenance Phase in Daily Perception of Pain Interference With Subject's Sleep
timeFrame: Last 4 weeks of Maintenance Phase, compared to the Baseline Week
measure: Within-subject Change From the Baseline Week to Visit 3 in Daily Perception of Pain Interference With Subject's General Activity
timeFrame: Baseline Week, Visit 3
measure: Within-subject Change From the Baseline Week to Visit 4 in Daily Perception of Pain Interference With Subject's General Activity
timeFrame: Baseline Week, Visit 4
measure: Within-subject Change From the Baseline Week to Visit 5 in Daily Perception of Pain Interference With Subject's General Activity
timeFrame: Baseline Week, Visit 5
measure: Within-subject Change From the Baseline Week to Visit 6 in Daily Perception of Pain Interference With Subject's General Activity
timeFrame: Baseline Week, Visit 6
measure: Within-subject Change From the Baseline Week to Visit 7 in Daily Perception of Pain Interference With Subject's General Activity
timeFrame: Baseline Week, Visit 7
measure: Within-subject Change From the Baseline Week to Visit 8 in Daily Perception of Pain Interference With Subject's General Activity
timeFrame: Baseline Week, Visit 8
measure: Within-subject Change From the Baseline Week to the Titration Phase in Daily Perception of Pain Interference With Subject's General Activity
timeFrame: Titration Phase (4 weeks), compared to the Baseline Week
measure: Within-subject Change From the Baseline Week to the Maintenance Phase in Daily Perception of Pain Interference With Subject's General Activity
timeFrame: Maintenance Phase (12 weeks), compared to the Baseline Week
measure: Within-subject Change From the Baseline Week to the Treatment Phase in Daily Perception of Pain Interference With Subject's General Activity
timeFrame: Treatment Phase (16 weeks), compared to the Baseline Week
measure: Within-subject Change From the Baseline Week to the Last 4 Weeks of the Maintenance Phase in Daily Perception of Pain Interference With Subject's General Activity
timeFrame: Last 4 weeks of Maintenance Phase, compared to the Baseline Week
measure: Percentage of Days of Rescue Medication Use During the Treatment Phase
timeFrame: During the Treatment Phase (up to 16 weeks)
measure: Within-subject Change From Baseline to Visit 8 in Subject's Quality of Life
timeFrame: Baseline, Visit 8
measure: Percentage of Patients With Categorized Patient's Global Impression of Change in Pain (PGIC) at Visit 8
timeFrame: Visit 8
measure: Percentage of Patients With Categorized Satisfaction With Medications at Visit 8
timeFrame: Visit 8
measure: Change From Baseline in Medical Outcomes Study (MOS) Sleep Scale Scores at Visit 8
timeFrame: Baseline, Visit 8
Other outcomes:
Locations:
city: Monheim
country: Germany
Study officials:
affiliation: 001 844 599 2273 (UCB)
name: UCB Cares
role: STUDY_DIRECTOR
References:
citation: 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.