NCT01848730

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
103

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Apr 2013

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 3, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 7, 2013

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

October 30, 2014

Status Verified

January 1, 2014

Enrollment Period

10 months

First QC Date

May 3, 2013

Last Update Submit

October 29, 2014

Conditions

Post-herpetic Neuralgia

Outcome Measures

Primary Outcomes (1)

  • Pain Intensity Numerical Rating Scale

    21 days

Secondary Outcomes (2)

  • Pain responder rates

    21 days

  • Neuropathic Pain Symptom Inventory

    21 days

Study Arms (2)

CNV2197944

EXPERIMENTAL

CNV2197944 75mg tid 21 days

Drug: CNV2197944

Placebo

PLACEBO COMPARATOR

Placebo tid 21 days

Drug: Placebo

Interventions

CNV2197944DRUG
CNV2197944
PlaceboDRUG
Placebo

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Christiaan Barnard Memorial Hospital

Cape Town, South Africa

Location

MeSH Terms

Conditions

Neuralgia, Postherpetic

Condition Hierarchy (Ancestors)

NeuralgiaPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Milton Raff, MD

    Christiaan Barnard Memorial Hospital, Cape Town, South Africa

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 3, 2013

First Posted

May 7, 2013

Study Start

April 1, 2013

Primary Completion

February 1, 2014

Study Completion

May 1, 2014

Last Updated

October 30, 2014

Record last verified: 2014-01

Locations

ZA(1)