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).

NCT00861068 | Completed Phase 2

• 1 other identifier: SP0655
• Study Type: interventional
• Target: 44
• Locations: 0 countries
• Sites: N/A

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)

Conditions

Postherpetic Neuralgia

Keywords

Lacosamide, Vimpat®

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

• 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

• 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

Study Arms (2)

1

EXPERIMENTAL

Drug: SPM927/Lacosamide

2

PLACEBO COMPARATOR

Other: Placebo

Interventions

SPM927/Lacosamide DRUG

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

1

Placebo OTHER

Placebo tablets two times a day for 10 weeks

Also known as: SPM927, Lacosamide, Vimpat®

2

Eligibility Criteria

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

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• UCB Pharma: lead

MeSH Terms

Conditions

Neuralgia, Postherpetic

Interventions

2-(acetylamino)-3-methoxy-N-(phenylmethyl)-, (2R)-; Lacosamide

Condition Hierarchy (Ancestors)

Neuralgia; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Study Officials

• UCB Clinical Trial Call Center

  +1 877 822 9493 (UCB)

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 12, 2009
• First Posted: March 13, 2009
• Study Start: February 1, 2002
• Primary Completion: December 1, 2002
• Study Completion: January 1, 2003
• Last Updated: April 19, 2024

Record last verified: 2024-04