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Vitamin C as add-on Therapy in Patients With Acute Herpes Zoster

Primary Purpose

Neuropathic Pain

Status
Suspended
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Vitamin C
Sponsored by
Pascoe Pharmazeutische Praeparate GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neuropathic Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Male and female patients older than 18 years
  2. Diagnosis of acute herpes zoster
  3. Presence of at least one efflorescence
  4. Peak NRS pain score ≥ 5 within the last 24h
  5. Based on the appraisal of the investigator: adequate educational as well as intelligence level and communicative capacity in order to comply with the requirements of the trial
  6. Written informed consent of the patient
  7. Negative urine pregnancy test at the baseline visit (prior to the first infusion of study medication) for female patients of childbearing potential.
  8. Women of child-bearing potential must apply during the entire duration of the trial a highly effective method of birth control, which is defined as those which result in a low failure rate (i.e., less than 1 % per year) when used constantly and correctly such as implants, injectables, combined oral contraceptive method (oestrogen and progestogen), or some intrauterine devices (IUDs) or sexual abstinence (true abstinence, only if in line with the preferred and usual lifestyle) or vasectomy of partner. Women of non-childbearing potential may be included if surgically sterile (tubal ligation or hysterectomy) or post-menopausal with at least 1 year without spontaneous menses.
  9. Patients are suitable for study participation according to their general medical situation

Exclusion Criteria:

  1. History of oxalate-urolithiasis or nephrolithiasis
  2. Current active zoster episode for more than 10 days
  3. Known severe renal function impairment consistent with Kidney Disease Improving Global Outcome (KDIGO) Glomerular Filtration Rate (GFR) stages G4 and 5 (< 30 ml/min/1.73m2)
  4. Known iron storage disease (e.g., thalassemia, hemochromatosis, sideroblastic anemia)
  5. Known erythrocytic glucose-6-phosphate dehydrogenase deficiency (at least class 3 = 10-60% rest activity = moderate deficiency)
  6. Prior vaccination with Zostavax®
  7. Signs or symptoms or diagnosed complications of herpes zoster such as zoster disseminatus, zoster generalisatus, zoster meningitis, zoster encephalitis, zoster myelitis, zoster pneumonitis, acute retinal necrosis (ARN)
  8. Contraindication to aciclovir treatment according to the current Summary of Product Characteristics (SmPC).
  9. Any disease that may interfere with the assessment of the course of the acute varicella zoster virus reactivation e.g.

    1. dermatological diseases such as psoriasis/eczema in the area of affected dermatomes
    2. painful local or systemic diseases such as wound infection or inflammation
  10. Immunodeficiency diseases, including but not limited to Human Immunodeficiency Virus (HIV)
  11. Known active malignancies other than non-melanoma skin cancer (NMSC)
  12. Severe uncontrolled diabetes mellitus, implanted insulin pump and severe respiratory obstructive diseases
  13. Other severe concomitant diseases with severe impairment of the patient's general condition
  14. History of additional herpes zoster in the last 3 months prior to baseline
  15. Any of the following medication, that might interact with the study medication or interfere with its effect

    1. Intravenous virostatics like aciclovir or brivudin within 4 weeks prior to baseline
    2. Oral virostatics like aciclovir or brivudin longer than 48 hours
    3. Any supplementary ascorbic acid (vitamin C) within 4 weeks prior to baseline
    4. Long-term analgesics (including local and transdermal) for non-Herpes pain (e.g. headache, rheumatism)
    5. Intake of any analgesics longer than 3 days for treatment of the current zoster symptoms
    6. Anticonvulsive drugs (gabapentin, pregabaline) within 4 weeks prior to baseline
    7. Antiepileptic drugs (carbamazepine) within 4 weeks prior to baseline
    8. Antidepressant drugs such as tricyclic antidepressants, serotonin-norepinephrine reuptake inhibitors (SSRI/SNRI) within 4 weeks prior to baseline
    9. Neuroleptics within 2 days prior to baseline
    10. Use of topical analgesics e.g., lidocaine or capsaicin patches on the site of the current herpes zoster efflorescence within 2 days prior to baseline
  16. Current therapy with immunosuppressive drugs, including but not limited to:

    1. Any systemic chemotherapeutics/cytostatic drugs
    2. Corticosteroids (> 5 mg/d prednisolone or equivalent)
    3. Methotrexate, ciclosporin, azathioprine
  17. Other drugs and interventions that may cause interactions with Vitamin C, including

    1. Fluphenazine
    2. Cumarine derivates
    3. Radiation therapy
  18. Nephrotoxic drugs, that may, according to the investigator's discretion, impair renal function
  19. Any other non-drug treatment of the acute herpes zoster
  20. Known hypersensitivity to the pharmacologic active constituents or any other ingredient of the study medication
  21. Participation in another clinical trial within the last 30 days prior to inclusion, simultaneous participation in another clinical trial or previous participation in this trial.
  22. Mental or physical disability or imprisonment

Sites / Locations

  • Universitätsklinikum Frankfurt am Main

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Arm Label

Group 1 (control group)

Group 2 (750 mg Vitamin C)

Group 3 (7.5 g Vitamin C)

Group 4 (15 g Vitamin C)

Arm Description

300 ml NaCl infusion

295 ml NaCl + 5 ml (750 mg) Vitamin C

250 ml NaCl + 1 x 50 ml (7.5 g) Vitamin C

200 ml NaCl + 2 x 50 ml (2 x 7.5 g) Vitamin C

Outcomes

Primary Outcome Measures

Mean neuropathic pain
Area under the curve (AUC) of mean neuropathic pain measured by numeric rating scale (NRS) from baseline to V5

Secondary Outcome Measures

Number of standard doses of permitted concomitant analgesic medication
Number of standard doses of permitted concomitant analgesic medication (step 1 of analgesic potency according to WHO) from baseline to V5 Step 1 (non-opioids: Paracetamol 500 mg, Ibuprofen 400 mg)
AUC of equianalgesic doses of permitted concomitant analgesic medication
Area under the curve of equianalgesic doses of permitted concomitant analgesic medication (step 2 of analgesic potency according to WHO) from baseline to V5 Step 2 (weak opioids: Metamizole 500 mg, Tramadol 50 mg, Tilidine/Naloxone 50 mg/4 mg)
Presence of a Post-herpetic neuralgia
Proportion of patient who developed a post-herpetic neuralgia at V7

Full Information

First Posted
September 27, 2022
Last Updated
October 4, 2022
Sponsor
Pascoe Pharmazeutische Praeparate GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT05561257
Brief Title
Vitamin C as add-on Therapy in Patients With Acute Herpes Zoster
Official Title
A Double-blind, Placebo-controlled, 4-arm Pilot Study on the Use of Vitamin C as Add on Therapy in Patients With Acute Herpes Zoster
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Suspended
Why Stopped
due to the Corona pandemic
Study Start Date
July 20, 2020 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pascoe Pharmazeutische Praeparate GmbH

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
To compare the efficacy and tolerability of three different doses of Pascorbin® besides standard medication with placebo and the reduction of herpes zoster-associated clinical symptoms as an add-on therapy for patients suffering from acute herpes zoster in primary care

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuropathic Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
76 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group 1 (control group)
Arm Type
Placebo Comparator
Arm Description
300 ml NaCl infusion
Arm Title
Group 2 (750 mg Vitamin C)
Arm Type
Experimental
Arm Description
295 ml NaCl + 5 ml (750 mg) Vitamin C
Arm Title
Group 3 (7.5 g Vitamin C)
Arm Type
Experimental
Arm Description
250 ml NaCl + 1 x 50 ml (7.5 g) Vitamin C
Arm Title
Group 4 (15 g Vitamin C)
Arm Type
Experimental
Arm Description
200 ml NaCl + 2 x 50 ml (2 x 7.5 g) Vitamin C
Intervention Type
Drug
Intervention Name(s)
Vitamin C
Intervention Description
Vitamin C
Primary Outcome Measure Information:
Title
Mean neuropathic pain
Description
Area under the curve (AUC) of mean neuropathic pain measured by numeric rating scale (NRS) from baseline to V5
Time Frame
from Baseline to V5 (day 11-13 after baseline)
Secondary Outcome Measure Information:
Title
Number of standard doses of permitted concomitant analgesic medication
Description
Number of standard doses of permitted concomitant analgesic medication (step 1 of analgesic potency according to WHO) from baseline to V5 Step 1 (non-opioids: Paracetamol 500 mg, Ibuprofen 400 mg)
Time Frame
from Baseline to V5 (day 11-13 after baseline)
Title
AUC of equianalgesic doses of permitted concomitant analgesic medication
Description
Area under the curve of equianalgesic doses of permitted concomitant analgesic medication (step 2 of analgesic potency according to WHO) from baseline to V5 Step 2 (weak opioids: Metamizole 500 mg, Tramadol 50 mg, Tilidine/Naloxone 50 mg/4 mg)
Time Frame
from Baseline to V5 (day 11-13 after baseline)
Title
Presence of a Post-herpetic neuralgia
Description
Proportion of patient who developed a post-herpetic neuralgia at V7
Time Frame
at V7 (day 90 (+/- 2 days))

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male and female patients older than 18 years Diagnosis of acute herpes zoster Presence of at least one efflorescence Peak NRS pain score ≥ 5 within the last 24h Based on the appraisal of the investigator: adequate educational as well as intelligence level and communicative capacity in order to comply with the requirements of the trial Written informed consent of the patient Negative urine pregnancy test at the baseline visit (prior to the first infusion of study medication) for female patients of childbearing potential. Women of child-bearing potential must apply during the entire duration of the trial a highly effective method of birth control, which is defined as those which result in a low failure rate (i.e., less than 1 % per year) when used constantly and correctly such as implants, injectables, combined oral contraceptive method (oestrogen and progestogen), or some intrauterine devices (IUDs) or sexual abstinence (true abstinence, only if in line with the preferred and usual lifestyle) or vasectomy of partner. Women of non-childbearing potential may be included if surgically sterile (tubal ligation or hysterectomy) or post-menopausal with at least 1 year without spontaneous menses. Patients are suitable for study participation according to their general medical situation Exclusion Criteria: History of oxalate-urolithiasis or nephrolithiasis Current active zoster episode for more than 10 days Known severe renal function impairment consistent with Kidney Disease Improving Global Outcome (KDIGO) Glomerular Filtration Rate (GFR) stages G4 and 5 (< 30 ml/min/1.73m2) Known iron storage disease (e.g., thalassemia, hemochromatosis, sideroblastic anemia) Known erythrocytic glucose-6-phosphate dehydrogenase deficiency (at least class 3 = 10-60% rest activity = moderate deficiency) Prior vaccination with Zostavax® Signs or symptoms or diagnosed complications of herpes zoster such as zoster disseminatus, zoster generalisatus, zoster meningitis, zoster encephalitis, zoster myelitis, zoster pneumonitis, acute retinal necrosis (ARN) Contraindication to aciclovir treatment according to the current Summary of Product Characteristics (SmPC). Any disease that may interfere with the assessment of the course of the acute varicella zoster virus reactivation e.g. dermatological diseases such as psoriasis/eczema in the area of affected dermatomes painful local or systemic diseases such as wound infection or inflammation Immunodeficiency diseases, including but not limited to Human Immunodeficiency Virus (HIV) Known active malignancies other than non-melanoma skin cancer (NMSC) Severe uncontrolled diabetes mellitus, implanted insulin pump and severe respiratory obstructive diseases Other severe concomitant diseases with severe impairment of the patient's general condition History of additional herpes zoster in the last 3 months prior to baseline Any of the following medication, that might interact with the study medication or interfere with its effect Intravenous virostatics like aciclovir or brivudin within 4 weeks prior to baseline Oral virostatics like aciclovir or brivudin longer than 48 hours Any supplementary ascorbic acid (vitamin C) within 4 weeks prior to baseline Long-term analgesics (including local and transdermal) for non-Herpes pain (e.g. headache, rheumatism) Intake of any analgesics longer than 3 days for treatment of the current zoster symptoms Anticonvulsive drugs (gabapentin, pregabaline) within 4 weeks prior to baseline Antiepileptic drugs (carbamazepine) within 4 weeks prior to baseline Antidepressant drugs such as tricyclic antidepressants, serotonin-norepinephrine reuptake inhibitors (SSRI/SNRI) within 4 weeks prior to baseline Neuroleptics within 2 days prior to baseline Use of topical analgesics e.g., lidocaine or capsaicin patches on the site of the current herpes zoster efflorescence within 2 days prior to baseline Current therapy with immunosuppressive drugs, including but not limited to: Any systemic chemotherapeutics/cytostatic drugs Corticosteroids (> 5 mg/d prednisolone or equivalent) Methotrexate, ciclosporin, azathioprine Other drugs and interventions that may cause interactions with Vitamin C, including Fluphenazine Cumarine derivates Radiation therapy Nephrotoxic drugs, that may, according to the investigator's discretion, impair renal function Any other non-drug treatment of the acute herpes zoster Known hypersensitivity to the pharmacologic active constituents or any other ingredient of the study medication Participation in another clinical trial within the last 30 days prior to inclusion, simultaneous participation in another clinical trial or previous participation in this trial. Mental or physical disability or imprisonment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Holger Michels
Organizational Affiliation
Pascoe Pharmazeutische Praeparate GmbH
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Andraes Pinter, Dr.
Organizational Affiliation
Universitätsklinik Frankfurt am Main
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitätsklinikum Frankfurt am Main
City
Frankfurt am Main
State/Province
Hessen
ZIP/Postal Code
60590
Country
Germany

12. IPD Sharing Statement

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Vitamin C as add-on Therapy in Patients With Acute Herpes Zoster

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