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

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ClinicalTrials.gov Identifier: NCT01848730
Recruitment Status : Completed
First Posted : May 7, 2013
Last Update Posted : October 30, 2014
Sponsor:
Information provided by (Responsible Party):
Convergence Pharmaceuticals

Brief 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.

Condition or disease Intervention/treatment Phase
Post-herpetic Neuralgia Drug: CNV2197944 Drug: Placebo Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 103 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : April 2013
Actual Primary Completion Date : February 2014
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shingles

Arm Intervention/treatment
Experimental: CNV2197944
CNV2197944 75mg tid 21 days
Drug: CNV2197944
Placebo Comparator: Placebo
Placebo tid 21 days
Drug: Placebo



Primary Outcome Measures :
  1. Pain Intensity Numerical Rating Scale [ Time Frame: 21 days ]

Secondary Outcome Measures :
  1. Pain responder rates [ Time Frame: 21 days ]
  2. Neuropathic Pain Symptom Inventory [ Time Frame: 21 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Convergence Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01848730     History of Changes
Other Study ID Numbers: CNV2197944/201
First Posted: May 7, 2013    Key Record Dates
Last Update Posted: October 30, 2014
Last Verified: January 2014

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