Short-term effectiveness of Gabapentin versus Placebo in acute Lumbosacral Radiculalgia by herniation disc: a prospective, multicentric, randomized, controlled, double-blind study

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Groupement Des Hopitaux De L'Institut Catholique De Lille

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nervous System Diseases [C10]

Trial duration

9 Feb 2022 → 9 Dec 2024

Decision date (initial)

2024-10-10

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

DGOS PHRC-I (19.32)

External identifiers

EU CT number

2024-518053-42-00

EudraCT number

2020-002849-42

ClinicalTrials.gov

NCT04865042

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Efficacy

Evaluate the analgesic efficacy of Gabapentin versus Placebo in the short term in acute Lumbosacral Radiculalgia due to disc herniation.

Secondary objectives 8

1. Assessing the tolerance of Gabapentin versus Placebo
2. Assess the short-term analgesic efficacy of Gabapentin versus Placebo on the low back pain component.
3. Evaluate the analgesic efficacy of Gabapentin versus Placebo on the radiculalgia and lower back pain components in the longer term.
4. Compare the neuropathic clinical characteristics of acute lumbosacral radiculalgia under treatment and in the days following cessation of treatment.
5. Evaluate the link between the analgesic efficacy of Gabapentin versus Placebo and the initial presence of clinical features suggesting the existence of neuropathic pain.
6. Evaluate the ability of Gabapentin versus Placebo to reduce the use of interdoses of anti-nociceptive analgesics.
7. Evaluate the capacity of Gabapentin versus Placebo to reduce associated anti-nociceptive analgesic treatment, at a distance from its discontinuation.
8. If distribution allows, within the Gabapentin group, assess the influence of antidepressant and antiepileptic drug use on response to treatment.

Conditions and MedDRA coding

lumbosacral radiculalgia

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

1. Age ≥ 18 years
2. Radiculalgia or lumboradiculalgia less than 3 months (pain of a lower limb systematized to a radicular territory, possibly associated with lumbar pain)
3. Inpatient management for a minimum of 72 hours after inclusion
4. Initial radiculalgia VAS ≥ 4 (moderate to severe pain)
5. Concordant disc herniation between clinical symptomatology and imaging (CT or MRI) less than 3 months,
6. Written consent signed by the patient
7. Affiliation to a social security system
8. For women of childbearing age, use of effective contraception

Exclusion criteria 11

1. Motor neurological deficit (≤ 3/5) or cauda equina syndrome (emergency surgical indications),
2. Chronic neuropathic pain in the lower limb affected by radiculalgia
3. Lumbar infiltration performed within 72 hours prior to inclusion or unable to be performed after 72 hours
4. Patient already on Gabapentin or Pregabalin, or having taken these treatments in the 7 days prior to inclusion
5. Contraindication to Gabapentin (Hypersensitivity to the active substance or to any of the excipients: corn starch, talc, yellow iron oxide, titanium dioxide, sodium lauryl sulfate, gelatin, shellac, propylene glycol, black iron oxide and potassium hydroxide)
6. Creatinine clearance < 30ml/min
7. Hemodialysis patient
8. Body weight < 50kgs
9. Transplant patient
10. Patient under guardianship or curatorship
11. Pregnant or breastfeeding woman

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Change in radiculalgia Visual Analogue Scale (VAS) between D1 and D4, D1 corresponding to the 1st dose of treatment administered (Gabapentin or Placebo). In addition, the responder rate at D4 (= radiculalgia pain VAS < 40/100) will also be calculated, but only the change in radiculalgia VAS will be used to conclude on the efficacy of the 2 treatments (Gabapentin or Placebo).

Secondary endpoints 8

1. Rate of patients presenting at least one adverse event (all types and grades) between D1 and D7: According to National Cancer Institute Common terminology criteria for adverse events (NCI CTCAE) v4.0
2. Change in VAS for low back pain between D1 and D4, and responder rate at D4 (= VAS for low back pain < 40/100)
3. Change in radiculalgia VAS and low back pain VAS between Day 1 and Day 7 (time interval including Day 2, Day 3 and Day 4)
4. Change in NPSI (Neuropathic Pain Symptom Inventory) between Day 1 and Day 4, then between Day 1 and Day 7
5. Change in radiculalgia VAS between Day 1 and Day 4, and again between Day 1 and Day 7, depending on the initial positivity of the dn4 (neuropathic pain screening questionnaire).
6. Number of interdoses of anti-nociceptive analgesics between Day 1 and Day 4 and rate of patients using at least one interdose between Day 1 and Day 4.
7. Rate of patients who reduced the associated anti-nociceptive analgesic treatment (reduction in dosage or step or discontinuation) between Day 4 and Day 7.
8. Links between consumption of antidepressants and antiepileptics (yes/no), and radiculalgia pain VAS at D4, if numbers permit in the Gabapentin group.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Groupement Des Hopitaux De L'Institut Catholique De Lille

Sponsor organisation

Groupement Des Hopitaux De L'Institut Catholique De Lille

Address

115 Rue Du Grand But, Bp 50249 Lille, Lille, Lille Bp 50249 Lille Lille

City

Lomme Cedex

Postcode

59462

Country

France

Scientific contact point

Organisation

Groupement Des Hopitaux De L'Institut Catholique De Lille

Contact name

Cordinating investigator

Public contact point

Organisation

Groupement Des Hopitaux De L'Institut Catholique De Lille

Contact name

Cordinating investigator

Locations

1 EU/EEA country · 7 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Summary of results Art. 37(4) CTR

Layperson summary Annex V

Documents 7 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications