Safety & Efficacy of CNV1014802 in patients with Trigeminal Neuralgia

• Research type

  Research Study

• Full title

  A Phase IIa Placebo-Controlled, Double-Blind Randomized Withdrawal Study to Evaluate the Safety and Efficacy of CNV1014802 in Patients with Trigeminal Neuralgia

• IRAS ID

  90718

• Contact name

  Joanna Zakrzewska

• Sponsor organisation

  Convergence Pharmaceuticals

• Eudract number

  2010-023963-16

• ISRCTN Number

  n.a

• Clinicaltrials.gov Identifier

  n.a

• Research summary

  Safety & Efficacy of CNV1014802 in patients with Trigeminal Neuralgia This research study is evaluating a new investigational drug, called CNV1014802, as a possible treatment for patients suffering from trigeminal neuralgia (TN). TN is an extremely severe facial pain that tends to come and go unpredictably in sudden shock-like attacks. The pain is often described as stabbing, shooting, excruciating, burning, and extremely strong. The pain usually last for a few seconds, but there can be many bursts of pain in quick succession. It is a chronic disorder of the trigeminal nerve (5th head nerve) where the pain is caused by damage or disease to this nerve. CNV1014802 is expected to work in a similar way to carbamazepine and oxcarbazepine, (anti-epileptics which work by decreasing the nerve impulses that cause fits and pain such as the pain caused in TN) - two marketed drugs currently used for the treatment of TN. However, it is hoped that CNV1014802 will be more effective with improved tolerability, thereby, improving the medical care of patients suffering from the disease. The purpose of this study is to provide more information about whether CNV1014802 is safe and effective for treating people with TN. This research is being funded by Convergence Pharmaceuticals Ltd. Patients may be eligible to take part in this study if they between the age of 18 and 70 and have been diagnosed with TN. The study will last for about 9-12 weeks. During this time patients will be expected to visit the study doctor in the unit at various scheduled times, inform the doctor of any changes in their health and how they are feeling during the duration of the study and, have various test and procedures performed. Approximately 40 patients will be randomised into the study at centres across the EU, Switzerland and South Africa.

• REC name

  East of England - Cambridge East Research Ethics Committee

• REC reference

  11/EE/0466

• Date of REC Opinion

  5 Jan 2012

• REC opinion

  Further Information Favourable Opinion