Efficacy and Safety of CNV2197944 Versus Placebo in Patients With Post-herpetic Neuralgia

Post-herpetic Neuralgia Clinical Trial

Official title:

A Randomised Double-blind Crossover Study to Compare the Efficacy and Safety of CNV2197944 75 mg Tid Versus Placebo in Patients With Post-herpetic Neuralgia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01848730
• Other study ID #: CNV2197944/201
• Status: Completed
• Phase: Phase 2
• First received: May 3, 2013
• Last updated: October 29, 2014
• Start date: April 2013
• Est. completion date: May 2014

Study information

• Verified date: January 2014
• Source: Convergence Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Africa: Medicines Control CouncilBulgaria: Bulgarian Drug AgencyGeorgia: Ministry of HealthUkraine: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

To investigate the effect of repeat oral dosing of CNV2197944 75 mg tid on the pain experienced in post-herpetic neuralgia (PHN) as measured by changes in PI-NRS after three weeks of treatment compared to the baseline period.

Description:

A 3 week randomised crossover study to investigate the effect of repeat oral dosing of CNV2197944 75 mg tid versus placebo for on the pain experienced in post-herpetic neuralgia (PHN. Each 3 week treatment period is seperated by a 2 week washout period. The primary outcome measure is the change from baseline in the PI-NRS after three weeks of treatment. Secondary outcome measures include pain responder rates, clinical and patient global impressions of pain, and the Neuropathic Pain Symptom Inventory.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: May 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

Male or female between 18 and 85 years of age inclusive, at the time of signing the informed consent.

Patients with post-herpetic neuralgia (PHN) with pain at screening present for more than 3 months after healing of the herpes zoster skin rash. The maximum duration of PHN will be no longer than 5 years.

Exclusion Criteria:

Patients having other severe pain, which may impair the self-assessment of the pain due to PHN.

Patients who have received nerve blocks for neuropathic pain within 4 weeks prior to the start of the single-blind placebo run-in Certain medications used to relieve the pain of PHN, specifically gabapentinoids (gabapentin and pregabalin), carbamazepine and topical agents (eg capsaicin, lidocaine) Patients with a documented failure to respond to a maximally tolerated dose regimen of gabapentin or pregabalin.

Patients taking more than one medication to treat the PHN pain

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neuralgia
• Neuralgia, Postherpetic
• Post-herpetic Neuralgia

Intervention

Drug:
• CNV2197944

• Placebo

Locations

Country	Name	City	State
South Africa	Christiaan Barnard Memorial Hospital	Cape Town

Sponsors (1)

Lead Sponsor	Collaborator
Convergence Pharmaceuticals

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain Intensity Numerical Rating Scale		21 days	No
Secondary	Pain responder rates		21 days	No
Secondary	Neuropathic Pain Symptom Inventory		21 days	No