TheophyllineNCT07515456
Theophylline, Versus Sumatriptan and Gabapentin in The Treatment of Post-Dural Puncture Headache
A study testing Theophylline, Sumatriptan and Gabapentin in people with Theophylline and Sumatriptan, run by Tanta University at 1 site in Egypt.
Trial summary
The aim of this study is to compare the safety and efficacy of theophylline, sumatriptan, and gabapentin in the treatment of post-dural puncture headache. Read more about this study
- Who is it for?
- Ages 21 to 50 years
- Conditions the study is for
- Theophylline, Sumatriptan, Gabapentin
- What is being tested?
- Theophylline, Sumatriptan and Gabapentin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2024to 1 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age from 21 to 50 years.
- Both sexes.
- American Society of Anesthesiologists (ASA) physical status ≤ II.
- Patient's selection for this study will be based on clinical diagnosis suggesting post-dural puncture headache (PDPH) based on the International Headache Society criteria.
- Patients with numeric rating scale (NRS) of ≥ 5.
Who cannot join
- Pregnant women.
- History of; chronic headache, cluster headache, migraine, convulsions, cerebrovascular accident, and previous neurological diseases.
- Signs of meningismus.
- Dysrhythmia.
- Hypertension.
- Ischemic heart disease.
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- Hyperthyroidism.
- Peripheral vascular disease (ischemic colitis).
- Liver or renal impairment.
- Use of selective serotonin reuptake inhibitors.
- Use of ergotamine derivatives in the past 24 hours.
- Use of monoamine oxidase inhibitors in the last 2 weeks.
- Use of any kind of opiates.
- Allergy to the study medications and any contraindication of oral intake.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Tanta University
Tanta, El-Gharbia, 31527
Asmaa R Eid, MSc, 00201026382543, asmaaragabeid@gmail.com
Najat S Al Shamaa, MD
About this study
Official title: A Comparison Between Safety and Efficacy of Theophylline, Versus Sumatriptan and Gabapentin in The Treatment of Post-Dural Puncture Headache: A Prospective Randomized Double Blinded Study
The aim of this study is to compare the safety and efficacy of theophylline, sumatriptan, and gabapentin in the treatment of post-dural puncture headache.
Read the detailed description
Post-dural puncture headache (PDPH) is a frequent complication of spinal anaesthesia or dural puncture and is an uncomfortable situation for both the patient and the anesthetist.
Theophylline as a form of methyl xanthine, is an adenosine receptor antagonist and can decrease intracranial blood flow and venous enlargement. Evidence shows that intravenous theophylline infusion is a rapid, effective, non-invasive, practical, and low-cost method to treat post-spinal headache.
Sumatriptan is a selective agonist of 5-hydroxytrytamine-like receptors and is used in the treatment of migraine. It has been used in the treatment of PDPH where it may prevent cerebral vasodilation associated with the cerebrospinal fluid (CSF) leak.
Gabapentin is a structural analogue of gamma amino butyric acid; it was used as an anticonvulsant drug for the first time. This drug is now applied in diabetic neuropathy, neuropathic cancer pain and inflammatory injury.
- Conditions
- Theophylline, Sumatriptan, Gabapentin, Post-Dural Puncture Headache
- Being tested
- Theophylline, Sumatriptan, Gabapentin
- Medical subject headings
- Post-Dural Puncture Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TheophyllineDrug
Patients included in this group will receive oral 150 mg theophylline anhydrous tablet (QuibronT/SR, 300 mg dividose tablet, SmithKline Beecham Egypt L.L.C) every 12 hours.
SumatriptanDrug
Patients included in this group will receive oral 25 mg sumatriptan succinate tablet (Sumigran 25, 25 mg tablet, Sigma pharmaceutical industries, Egypt) every 12 hours.
GabapentinDrug
Patients included in this group will receive 200 mg of gabapentin every 12 hours.
| Study group | Role | What they receive |
|---|---|---|
| Group T | Experimental | Patients included in this group will receive oral 150 mg theophylline anhydrous tablet (QuibronT/SR, 300 mg dividose tablet, SmithKline Beecham Egypt L.L.C) every 12 hours. Receives: Drug: Theophylline |
| Group S | Experimental | Patients included in this group will receive oral 25 mg sumatriptan succinate tablet (Sumigran 25, 25 mg tablet, Sigma pharmaceutical industries, Egypt) every 12 hours. Receives: Drug: Sumatriptan |
| Group G | Experimental | Patients included in this group will receive 200 mg of gabapentin every 12 hours. Receives: Drug: Gabapentin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of headache
Severity of headache will be assessed using numeric rating scale (NRS) score where 0 = no pain, and 10 = worst possible pain.
Measured: 24 hours after drug treatment.
Secondary outcomes (5)
Post-Dural Puncture Headache duration
Post-Dural Puncture Headache (PDPH) duration will be recorded from the occurrence of PDPH till numeric rating scale (NRS) score ≤3.
Measured: 24 hours after drug treatment.
Length of hospital stay
Length of hospital stay will be recorded from the hospital admission till discharge.
Measured: Till the discharge from the hospital (Up to 2 weeks)
Treatment-related side effects
Treatment-related side effects such as palpitation, dizziness, gastric irritation, nausea/vomiting, diarrhea, warm sensations in the body, tingling sensation, and tightness in the chest, throat, neck, or jaws will be recorded.
Measured: 24 hours after drug treatment.
Total amount of rescue analgesia consumption
Total amount of rescue analgesia consumption will be measured.
Measured: 24 hours after drug treatment.
Degree of patient satisfaction
Degree of patient satisfaction will be assessed on a 5-point Likert scale patient satisfaction (1, extremely dissatisfied; 2, unsatisfied; 3, neutral; 4, satisfied; 5, extremely satisfied)
Measured: 24 hours after drug treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2026
- Study start1 Dec 2024
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TheophyllineStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asmaa Ragab Mohamed, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07515456
- Sponsor's protocol ID
- 36265MD314/11/24
- Status last verified
- Mar 2026
- First submitted
- 31 Mar 2026
- Last updated
- 7 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison Between Safety and Efficacy of Theophylline, Versus Sumatriptan and Gabapentin in The Treatment of Post-Dural Puncture Headache: A Prospective Randomized Double Blinded Study
- ClinicalTrials.gov ID
- NCT07515456
- Acronym / sponsor ID
- 36265MD314/11/24
- Conditions
- Theophylline, Sumatriptan, Gabapentin, Post-Dural Puncture Headache
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 7 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to compare the safety and efficacy of theophylline, sumatriptan, and gabapentin in the treatment of post-dural puncture headache.
Detailed description
Post-dural puncture headache (PDPH) is a frequent complication of spinal anaesthesia or dural puncture and is an uncomfortable situation for both the patient and the anesthetist.
Theophylline as a form of methyl xanthine, is an adenosine receptor antagonist and can decrease intracranial blood flow and venous enlargement. Evidence shows that intravenous theophylline infusion is a rapid, effective, non-invasive, practical, and low-cost method to treat post-spinal headache.
Sumatriptan is a selective agonist of 5-hydroxytrytamine-like receptors and is used in the treatment of migraine. It has been used in the treatment of PDPH where it may prevent cerebral vasodilation associated with the cerebrospinal fluid (CSF) leak.
Gabapentin is a structural analogue of gamma amino butyric acid; it was used as an anticonvulsant drug for the first time. This drug is now applied in diabetic neuropathy, neuropathic cancer pain and inflammatory injury.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group T | Experimental | Drug: TheophyllinePatients included in this group will receive oral 150 mg theophylline anhydrous tablet (QuibronT/SR, 300 mg dividose tablet, SmithKline Beecham Egypt L.L.C) every 12 hours. |
| Group S | Experimental | Drug: SumatriptanPatients included in this group will receive oral 25 mg sumatriptan succinate tablet (Sumigran 25, 25 mg tablet, Sigma pharmaceutical industries, Egypt) every 12 hours. |
| Group G | Experimental | Drug: GabapentinPatients included in this group will receive 200 mg of gabapentin every 12 hours. |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age from 21 to 50 years.
- Both sexes.
- American Society of Anesthesiologists (ASA) physical status ≤ II.
- Patient's selection for this study will be based on clinical diagnosis suggesting post-dural puncture headache (PDPH) based on the International Headache Society criteria.
- Patients with numeric rating scale (NRS) of ≥ 5.
Key exclusion criteria (14 listed)
- Pregnant women.
- History of; chronic headache, cluster headache, migraine, convulsions, cerebrovascular accident, and previous neurological diseases.
- Signs of meningismus.
- Dysrhythmia.
- Hypertension.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TheophyllinePatients included in this group will receive oral 150 mg theophylline anhydrous tablet (QuibronT/SR, 300 mg dividose tablet, SmithKline Beecham Egypt L.L.C) every 12 hours. | Drug | Group T |
| SumatriptanPatients included in this group will receive oral 25 mg sumatriptan succinate tablet (Sumigran 25, 25 mg tablet, Sigma pharmaceutical industries, Egypt) every 12 hours. | Drug | Group S |
| GabapentinPatients included in this group will receive 200 mg of gabapentin every 12 hours. | Drug | Group G |
Primary outcome
Severity of headache
Time frame: 24 hours after drug treatment.
Severity of headache will be assessed using numeric rating scale (NRS) score where 0 = no pain, and 10 = worst possible pain.
5 secondary outcomes
Post-Dural Puncture Headache duration
Time frame: 24 hours after drug treatment.
Length of hospital stay
Time frame: Till the discharge from the hospital (Up to 2 weeks)
Treatment-related side effects
Time frame: 24 hours after drug treatment.
Total amount of rescue analgesia consumption
Time frame: 24 hours after drug treatment.
Degree of patient satisfaction
Time frame: 24 hours after drug treatment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Theophylline, Sumatriptan and Gabapentin in people with Theophylline and Sumatriptan, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Asmaa R Eid, MSc (00201026382543, asmaaragabeid@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severity of headache (time frame: 24 hours after drug treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2026.