Trial · NCT07596485
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Incidence and severity of adverse events, abnormal clinical laboratory values, abnormal physical examinations, abnormal vital signs, abnormal electrocardiograms (ECGs), and suicidal ideation | 12 months | Safety of RP-008 with varenicline |
| Secondary | Number of responders, defined as participants with reduced TN pain score, attacks, and severity, to RP-008 with varenicline treatment | 3 and 12 months | Efficacy of RP-008 with varenicline |
| Secondary | Change in pain as assessed by the 11-point Numerical Pain Rating Scale (NRS), where 0 corresponds to "no pain" and 10 corresponds to "pain as bad as you can imagine" | 3 and 12 months | Efficacy of RP-008 with varenicline |
| Secondary | Change in pain as assessed by the Brief Pain Inventory (BPI) Pain Interference (PI) sub-scale, where 0 corresponds to pain having no interference with daily activities and 10 corresponds to pain interfering completely with daily activities | 3 and 12 months | Efficacy of RP-008 with varenicline |
| Secondary | Change from baseline in Pittsburgh Sleep Quality Index (PSQI), where scores range from 0-21 and higher score indicates worse sleep quality | 3 and 12 months | Efficacy of RP-008 with varenicline |
| Secondary | Change from baseline in Hospital Anxiety and Depression Scale (HADS), where sub-scale scores range from 0-21 and higher score indicates greater symptom severity | 3 and 12 months | Efficacy of RP-008 with varenicline |
| Secondary | Change from baseline in Work Productivity and Activity Impairment (WPAI): Neuropathic Pain v2.0, where scores are expressed as 0-100% and higher percentage indicates greater impairment | 3 and 12 months | Efficacy of RP-008 with varenicline |
| Secondary | Change from baseline in Penn Facial Pain Scale Revised (Penn-FPS-R), where scores range from 0-120 and higher score indicates greater pain-related disability | 3 and 12 months | Efficacy of RP-008 with varenicline |
| Secondary | Change from baseline in 5-level EuroQual-5D (EQ-5D-5L), where scores range from 0-100 and higher scores indicate better health status | 3 and 12 months | Efficacy of RP-008 with varenicline |
| Secondary | Change from baseline in Patient Global Assessment of TN (PGA-TN), where scores range from 1 to 5 and higher score indicates higher severity of symptoms and inability to carry out normal activities | 3 and 12 months | Efficacy of RP-008 with varenicline |
| Secondary | Change from baseline in Modified Barrow Neurological Institute Pain Intensity Score (BNI), where scores range from I to V and higher score indicates higher pain and need for medication | 3 and 12 months | Efficacy of RP-008 with varenicline |
| Secondary | Improvement in Patient Global Impression of Change (PGIC) and Clinician Global Impression of Change (CGIC) scale, where scores range from 1 to 7 and higher score indicates worsening of status | 3 and 12 months | Efficacy of RP-008 with varenicline |
| Secondary | AAV5 anti-capsid and anti-transgene antibody titer | 12 months | Immune response to RP-008 |
| Secondary | Vector shedding profile of RP-008 | 12 months | Vector shedding in plasma, urine, tears, saliva, and mucus |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT07596485/registered