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

This study has been completed.
Information provided by (Responsible Party):
Convergence Pharmaceuticals
ClinicalTrials.gov Identifier:
First received: May 3, 2013
Last updated: October 29, 2014
Last verified: January 2014
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.

Condition Intervention Phase
Post-herpetic Neuralgia
Drug: CNV2197944
Drug: Placebo
Phase 2

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

Resource links provided by NLM:

Further study details as provided by Convergence Pharmaceuticals:

Primary Outcome Measures:
  • Pain Intensity Numerical Rating Scale [ Time Frame: 21 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pain responder rates [ Time Frame: 21 days ] [ Designated as safety issue: No ]
  • Neuropathic Pain Symptom Inventory [ Time Frame: 21 days ] [ Designated as safety issue: No ]

Enrollment: 103
Study Start Date: April 2013
Study Completion Date: May 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CNV2197944
CNV2197944 75mg tid 21 days
Drug: CNV2197944
Placebo Comparator: Placebo
Placebo tid 21 days
Drug: Placebo

Detailed 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.

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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

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Please refer to this study by its ClinicalTrials.gov identifier: NCT01848730

South Africa
Christiaan Barnard Memorial Hospital
Cape Town, South Africa
Sponsors and Collaborators
Convergence Pharmaceuticals
Principal Investigator: Milton Raff, MD Christiaan Barnard Memorial Hospital, Cape Town, South Africa
  More Information

Responsible Party: Convergence Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01848730     History of Changes
Other Study ID Numbers: CNV2197944/201 
Study First Received: May 3, 2013
Last Updated: October 29, 2014
Health Authority: South Africa: Medicines Control Council
Bulgaria: Bulgarian Drug Agency
Georgia: Ministry of Health
Ukraine: Ministry of Health

Additional relevant MeSH terms:
Neuralgia, Postherpetic
Nervous System Diseases
Neurologic Manifestations
Neuromuscular Diseases
Peripheral Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on May 26, 2016