Efficacy and Safety of CNV2197944 Versus Placebo in Patients With Diabetic Peripheral Neuropathy

Convergence Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Diabetic Peripheral Neuropathy

Treatments: Drug: CNV2197944; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01893125

CNV2197944/202

Details and patient eligibility

About

To investigate the effect of repeat oral dosing of CNV2197944 75 mg tid on the pain experienced in diabetic peripheral neuropathy (DPN) as measured by changes in PI-NRS after three weeks of treatment compared to the baseline period.

Full 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 diabetic peripheral neuropathy (DPN). 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.

Enrollment: 126 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female between 18 and 85 years of age inclusive, at the time of signing the informed consent
• Diabetes Mellitus (Type I or II)with HbA1c <9%
• Evidence of symmetrical bilateral pain in lower limbs with evidence of decreased sensation or impaired reflexes and a Michigan Neuropathy Screening -Instrument score of >3 on physical examination
• Patients with diabetic peripheral neuropathy (DPN) with pain at screening present for more than 6 months. The maximum duration of DPN 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 DPN
• Patients who have received nerve blocks for neuropathic pain within 4 weeks -Patients on other concomitant medications used to relieve the pain of DPN
• Patients with a documented failure to respond to a maximally tolerated dose regimen of gabapentin or pregabalin

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

---

126 participants in 2 patient groups, including a placebo group

CNV2197944

Experimental group

Description:

CNV2197944 75mg tid 21 days

Treatment:

Drug: CNV2197944

Placebo

Placebo Comparator group

Description:

Placebo 1 cap tid 21 days

Treatment:

Drug: Placebo