mononeuropathic pain due to post-herpetic neuralgia, post-operative neuropathic pain, or traumatic nerve injury MedDRA version: 14.0 Level: LLT Classification code 10054095 Term: Neuropathic pain System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Product Name: GRT6010 concentrate and solvent for oral solution
Pharmaceutical Form: Concentrate for oral solution
INN or Proposed INN: GRT6010
Current Sponsor code: GRT6010
Concentration unit: mg/ml
Sponsors
Grünenthal GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age 18 years to 65 years 2. Presence of of persistent neuropathic pain for at least 6 months at the time of the Enrollment Visit. Allowed reasons for neuropathic pain are modified radical mastectomy or breast conserving surgery, lateral and postero-lateral thoracotomy, traumatic nerve lesions of upper or lower limb, and post herpetic neuralgia. 3. Presence of “probable” or “definite” neuropathic pain. 4. Presence of dynamic mechanical allodynia on the affected side, or alternatively, the mechanical pain sensitivity for any of the pinprick stimuli is higher on the affected compared to the contralateral side. 5. At either Visit 5 or Visit 6: Presence of an average evoked pain intensity score of >20 on the 0 100 point numeric rating scale (NRS) for at least 1 of the 3 clinical sub-tests for dynamic mechanical allodynia (i.e., standardized brush [Somedic, Sweden], cotton wool tip or cotton wisp). The average will be calculated as the arithmetic mean of all measurements per sub test. Alternatively, the arithmetic mean of the 5 test replicates for any of the pinprick stimuli for mechanical pain sensitivity is at least 3 times higher for the affected side compared to the contralateral side. 6. Presence of an average ongoing pain intensity score of >4 to =65 years) yes F.1.3.1 Number of subjects for this age range 5
Exclusion criteria
Exclusion criteria: 1. Any kind of hepatic impairment at Visit 1 or at Visit 3. 2. Either active hepatitis within the past 3 months or presence of chronic hepatitis irrespective of its activity status. 3. Estimated creatinine clearance of less than 60 mL/minute x 1.73 m2 (Modification of Diet in Renal Disease [MDRD]-formula with correction by body surface [Levey et al. 1999]) at either Visit 1 or at Visit 3. 4. Clinically relevant cardiac disease (e.g., unstable angina pectoris, angina pectoris Canadian Cardiovascular Society [CCS] Grade III to IV, acute myocardial infarction within the last 3 months, cardiac insufficiency New York Heart Association [NYHA] Class III to IV). 5. Electrocardiogram (ECG) with clinically relevant findings at either Visit 1 or at Visit 3, including but not limited to repeated prolongation of QTc > 450 ms (Fredericia correction), or a history of additional risk factors for torsade de pointes (e.g., family history of Long QT Syndrome). 6. Clinically relevant pulmonary disease (e.g., Medical Research Council breathlessness scale of 2 or above). 7. Specific antitumor therapy within the last 6 months, e.g., adjuvant radiotherapy or chemotherapy, biologics, or angiogenesis inhibitors. 8. CYP2D6 poor metabolizer phenotype as predicted by CYP2D6 genotyping. 9. Presence of confounding pain conditions (e.g., ulnar nerve entrapment, radial nerve injury associated with major soft-tissue or bone damage, cervico-thoracic radiculopathy, carpal tunnel syndrome, chemotherapy-induced peripheral neuropathy, or complex regional pain syndrome type I or type II). 10. Phantom breast or phantom limb pain. 11. Presence of exclusively negative symptoms of neuropathic pain (e.g., hypoesthesia or total anesthesia) in the affected area.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To explore the efficacy of GRT010 oral solution on spontaneous and evoked pain in subjects with persistent moderate to severe peripheral neuropathic pain due to post-herpetic neuralgia, post-operative neuropathic pain, or post-traumatic nerve injury;Secondary Objective: To determine the assay sensitivity of the chosen design, the adequacy of assessment tools, and choice of subject population;Primary end point(s): 1. The difference between baseline and end-of-double-blind treatment ongoing pain intensity scores compared to placebo on a 0-10 point NRS. 2. The difference between baseline and end-of-double-blind treatment brush-evoked pain intensity scores compared to placebo on a 0-.1000 point NRS (measured as part of the dynamic mechanical allodynia assessments). ;Timepoint(s) of evaluation of this end point: day 7 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. The difference between baseline and end-of-double-blind treatment of the current pain intensity scores compared to placebo on a 0-10 point NRS 2. The difference between baseline and end-of-double-blind treatment scores for dynamic mechanical allodynia and mechanical pain sensitivity compared separately to placebo on a 0-100 point NRS. 3. The difference between the average ongoing pain intensity scores during baseline and over the entire treatment period compared to placebo on a 0-10 point NRS 4. The assessment of responder rates (rates of 10% to 90% improvement of pain intensity score).;Timepoint(s) of evaluation of this end point: day 7 | — |
Countries
Germany, Hungary, Poland, United Kingdom
Contacts
Public ContactClinical Development Operations
Grünenthal GmbH
Outcome results
None listed