Back to resultsA Multi-Centre, Randomized, Double-Blind, Placebo Controlled Pilot Trial to Assess the Efficacy, Safety, and Tolerability of SPM 927 in Subjects With Postherpetic Neuralgia (PHN).
Primary Purpose
Postherpetic Neuralgia
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
SPM927/Lacosamide
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Postherpetic Neuralgia focused on measuring Lacosamide, Vimpat®
Eligibility Criteria
Inclusion Criteria:
- Subject has clinically diagnosed painful postherpetic neuralgia present at least six months after healing of a herpes zoster skin rash and has at least one form of allodynia
- Subject must have at least moderate pain (mean pain intensity ≥ 4 out of 10 during the baseline week on Likert scale).
Exclusion Criteria:
- Subject has other conditions that cause pain at least as severe as the postherpetic neuralgia.
- Subject has had any surgical treatment or any neurolytic injections for PHN
- Subject has clinically significant ECG and laboratory abnormalities.
- Subject is receiving treatment with anti-epileptic drugs (AEDs), muscle relaxants, mexiletine, topical analgesics, antidepressants, opioids, non-steroidal anti-inflammatory drugs (NSAIDs), paracetamol, benzodiazepines, and antiviral agents.
- Subject has liver function tests (AST, ALT, alkaline phosphatase, total bilirubin and GGT out of the reference range) > 1,5 x ULN (upper limit of normal) at visit 1
- Subject has serum creatinine ≥ 2 times the upper limit of reference range at Visit 1.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
Outcomes
Primary Outcome Measures
Within-subject change in average daily pain score (Likert categorical scale) from the baseline week to the maintenance phase
Secondary Outcome Measures
Different qualities of pain due to PHN, sleep and activity (daily assessment during entire trial participation)
Investigate the tolerability and safety of SPM927 (assessments and reporting during entire trial participation).
To examine the pharmacokinetics of SPM927 (assessment at all site visits during entire trial participation)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00861068
Brief Title
A Multi-Centre, Randomized, Double-Blind, Placebo Controlled Pilot Trial to Assess the Efficacy, Safety, and Tolerability of SPM 927 in Subjects With Postherpetic Neuralgia (PHN).
Official Title
A Multi-Centre, Randomized, Double-Blind, Placebo Controlled Pilot Trial to Assess the Efficacy, Safety, and Tolerability of SPM 927 in Subjects With Postherpetic Neuralgia (PHN).
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
February 2002 (undefined)
Primary Completion Date
December 2002 (Actual)
Study Completion Date
January 2003 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
UCB Pharma
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The objective of the trial is to investigate the analgesic efficacy of SPM 927 in subjects with moderate to severe neuropathic pain due to Postherpetic Neuralgia (PHN)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postherpetic Neuralgia
Keywords
Lacosamide, Vimpat®
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
SPM927/Lacosamide
Intervention Description
SPM927 (film-coated tablets, 25/50/100mg per tablet), dosage up to 600mg/day, intake in the morning and in the evening, intake for 11 weeks
Intervention Type
Other
Intervention Name(s)
Placebo
Other Intervention Name(s)
SPM927, Lacosamide, Vimpat®
Intervention Description
Placebo tablets two times a day for 10 weeks
Primary Outcome Measure Information:
Title
Within-subject change in average daily pain score (Likert categorical scale) from the baseline week to the maintenance phase
Time Frame
Daily Assessments via patient diary and during patient's visit at the site
Secondary Outcome Measure Information:
Title
Different qualities of pain due to PHN, sleep and activity (daily assessment during entire trial participation)
Time Frame
Daily assessment during entire trial participation including visits at the site
Title
Investigate the tolerability and safety of SPM927 (assessments and reporting during entire trial participation).
Time Frame
Daily assessment during entire trial participation including visits at the site
Title
To examine the pharmacokinetics of SPM927 (assessment at all site visits during entire trial participation)
Time Frame
Daily assessment during entire trial participation including visits at the site
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subject has clinically diagnosed painful postherpetic neuralgia present at least six months after healing of a herpes zoster skin rash and has at least one form of allodynia
Subject must have at least moderate pain (mean pain intensity ≥ 4 out of 10 during the baseline week on Likert scale).
Exclusion Criteria:
Subject has other conditions that cause pain at least as severe as the postherpetic neuralgia.
Subject has had any surgical treatment or any neurolytic injections for PHN
Subject has clinically significant ECG and laboratory abnormalities.
Subject is receiving treatment with anti-epileptic drugs (AEDs), muscle relaxants, mexiletine, topical analgesics, antidepressants, opioids, non-steroidal anti-inflammatory drugs (NSAIDs), paracetamol, benzodiazepines, and antiviral agents.
Subject has liver function tests (AST, ALT, alkaline phosphatase, total bilirubin and GGT out of the reference range) > 1,5 x ULN (upper limit of normal) at visit 1
Subject has serum creatinine ≥ 2 times the upper limit of reference range at Visit 1.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
UCB Clinical Trial Call Center
Organizational Affiliation
+1 877 822 9493 (UCB)
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
A Multi-Centre, Randomized, Double-Blind, Placebo Controlled Pilot Trial to Assess the Efficacy, Safety, and Tolerability of SPM 927 in Subjects With Postherpetic Neuralgia (PHN).
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