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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Convergence Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01848730
First received: May 3, 2013
Last updated: January 7, 2014
Last verified: January 2014
  Purpose

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 ]

Estimated Enrollment: 90
Study Start Date: April 2013
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: March 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.

  Eligibility

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

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

No publications provided

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: January 7, 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
Neuralgia, Postherpetic
Pain
Neurologic Manifestations
Nervous System Diseases
Peripheral Nervous System Diseases
Neuromuscular Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on August 18, 2014