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).

Postherpetic Neuralgia Clinical Trial

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).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00861068
• Other study ID #: SP0655
• Status: Completed
• Phase: Phase 2
• Start date: February 2002
• Est. completion date: January 2003

Study information

• Verified date: April 2024
• Source: UCB Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: January 2003
• Est. primary completion date: December 2002
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Neuralgia
• Neuralgia, Postherpetic
• Postherpetic Neuralgia

Intervention

Drug:
• SPM927/Lacosamide
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

Other:
• Placebo
Placebo tablets two times a day for 10 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
UCB Pharma

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Within-subject change in average daily pain score (Likert categorical scale) from the baseline week to the maintenance phase		Daily Assessments via patient diary and during patient's visit at the site
Secondary	Different qualities of pain due to PHN, sleep and activity (daily assessment during entire trial participation)		Daily assessment during entire trial participation including visits at the site
Secondary	Investigate the tolerability and safety of SPM927 (assessments and reporting during entire trial participation).		Daily assessment during entire trial participation including visits at the site
Secondary	To examine the pharmacokinetics of SPM927 (assessment at all site visits during entire trial participation)		Daily assessment during entire trial participation including visits at the site