Idiopathic Intracranial HypertensionEarly Phase 1NCT03963336
Quantitative D-dimer Level and Anticoagulant Therapy in Idiopathic Intracranial Hypertension
A Early Phase 1 study testing LMWH and acetazolamide in people with Idiopathic Intracranial Hypertension, run by Fayoum University at 1 site in Egypt.
Trial summary
Idiopathic intracranial hypertension (IIH) is a syndrome characterized by elevated intracranial pressure (ICP) of unknown etiology. The investigators aim to study the quantitative D-dimer level and the role of anticoagulant therapy in the absence of occlusive sinus thrombosis in IIH patients. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Idiopathic Intracranial Hypertension
- What is being tested?
- LMWH and acetazolamide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteEgypt
- Study dates
- 22 Jul 2017to 2 Aug 2018
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- IIH patients of both sexes fulfilling the modified Dandy criteria
Who cannot join
- disturbed conscious level, focal neurological signs, seizures, cerebral venous sinus thrombosis or stenosis, deep venous thrombosis or pulmonary embolism, malignancy, and acute nephritic syndrome.
- Patients with signs of disseminated intravascular coagulopathy and septic sinus thrombosis
- patients with a history of cerebral granuloma or infection, cerebrovascular stroke, head trauma or surgery.
- pregnant females or those who terminated their pregnancy in the last four weeks were also excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: D-dimer and the Use of Anticoagulation in IIH
Idiopathic intracranial hypertension (IIH) is a syndrome characterized by elevated intracranial pressure (ICP) of unknown etiology.
The investigators aim to study the quantitative D-dimer level and the role of anticoagulant therapy in the absence of occlusive sinus thrombosis in IIH patients.
Read the detailed description
24 patients with IIH according to the modified Dandy criteria were enrolled. Headache impact test (HIT6), ophthalmological assessment including Frisen classification for papilledema, visual acuity, visual field by perimetry, and visual evoked potentials were performed to the patients.
Serum quantitative D-dimer level was measured using the enzyme-linked immunosorbent assay (ELISA) technique for the patients and for 24 healthy matched controls.
Patients were divided into two groups: group (A) received acetazolamide and low molecular weight heparin (LMWH) in a prophylactic dose for 2 weeks while group (B) received acetazolamide only. Both groups continued the acetazolamide 1-2g/day for 6 months.
The investigators followed-up the patients after one and six months later through the HIT6 test and the ophthalmological assessment.
- Conditions
- Idiopathic Intracranial Hypertension
- Being tested
- LMWH, acetazolamide
- Keywords
- IIH, D-dimer, microthrombi, anticoagulation
- Medical subject headings
- Pseudotumor Cerebri
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LMWHDrug
Also called Clexan
Subcutaneous LMWH 1mg/kg/day for 2 weeks
acetazolamideDrug
Also called Diamox
Carbonic anhydrase inhibitor 1-2g/day for 6 months
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | 12 IIH patients for whom serum D-dimer was assessed by ELISA.They received acetazolamide and anticoagulant LMWH in the prophylactic dose for 2 weeks then continued on acetazolamide. Follow up after 1 and 6 months through HIT6 test and ophthalmological assessment (visual acuity, Frisen classification for papilledema, visual field, and visual evoked potentials) Receives: Drug: LMWH; Drug: acetazolamide |
| Group B | Active comparator | 12 IIH patients for whom serum D-dimer was assessed by ELISA. They received acetazolamide only. Follow up after 1 and 6 months through HIT6 test and ophthalmological assessment (visual acuity, Frisen classification for papilledema, visual field, and visual evoked potentials) Receives: Drug: acetazolamide |
| Control group | No intervention | 24 healthy subjects for whom serum D-dimer was assessed by ELISA. |
What is being measured
The primary outcome is the main question the study is designed to answer.
serum quantitative D-dimer
higher serum D-dimer levels will be detected in IIH patients of both groups compared to controls
Measured: Baseline assessment
Secondary outcomes (5)
HIT6 score
The HIT6 score will improve in both groups (A and B) after receiving the treatment (either acetazolamide or LMWH)
Measured: 1 and 6 months
Frisen classification for papilledema
papilledema will improve in both groups (A and B) after receiving the treatment (either acetazolamide or LMWH)
Measured: 6 months
Visual acuity (Log Mar)
Visual acuity will improve in both groups (A and B) after receiving the treatment (either acetazolamide or LMWH)
Measured: 6 months
Visual field (Perimetry)
Visual field will improve in both groups (A and B) after receiving the treatment (either acetazolamide or LMWH)
Measured: 6 months
Visual Evoked Potentials (VEP)
VEP will improve in both groups (A and B) after receiving the treatment (either acetazolamide or LMWH)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2019
- Study start22 Jul 2017
- Primary completion23 Jul 2018
- Study completion2 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Intracranial HypertensionStudies of the same condition, open and under way.
- More trials run by Fayoum 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fayoum University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sherine El Mously, Fayoum University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03963336
- Sponsor's protocol ID
- M201
- Status last verified
- May 2019
- First submitted
- 15 May 2019
- Last updated
- 24 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- D-dimer and the Use of Anticoagulation in IIH
- ClinicalTrials.gov ID
- NCT03963336
- Acronym / sponsor ID
- M201
- Conditions
- Idiopathic Intracranial Hypertension
- Keywords
- IIH, D-dimer, microthrombi, anticoagulation
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Fayoum UniversityUniversity, hospital or other
- Study start
- 22 Jul 2017 (actual)
- Primary completion
- 23 Jul 2018 (actual)
- Study completion
- 2 Aug 2018 (actual)
- First posted
- 24 May 2019 (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.
Idiopathic intracranial hypertension (IIH) is a syndrome characterized by elevated intracranial pressure (ICP) of unknown etiology.
The investigators aim to study the quantitative D-dimer level and the role of anticoagulant therapy in the absence of occlusive sinus thrombosis in IIH patients.
Detailed description
24 patients with IIH according to the modified Dandy criteria were enrolled. Headache impact test (HIT6), ophthalmological assessment including Frisen classification for papilledema, visual acuity, visual field by perimetry, and visual evoked potentials were performed to the patients.
Serum quantitative D-dimer level was measured using the enzyme-linked immunosorbent assay (ELISA) technique for the patients and for 24 healthy matched controls.
Patients were divided into two groups: group (A) received acetazolamide and low molecular weight heparin (LMWH) in a prophylactic dose for 2 weeks while group (B) received acetazolamide only. Both groups continued the acetazolamide 1-2g/day for 6 months.
The investigators followed-up the patients after one and six months later through the HIT6 test and the ophthalmological assessment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Drug: LMWH, Drug: acetazolamide12 IIH patients for whom serum D-dimer was assessed by ELISA.They received acetazolamide and anticoagulant LMWH in the prophylactic dose for 2 weeks then continued on acetazolamide. Follow up after 1 and 6 months through HIT6 test and ophthalmological assessment (visual acuity, Frisen classification for papilledema, visual field, and visual evoked potentials) |
| Group B | Active comparator | Drug: acetazolamide12 IIH patients for whom serum D-dimer was assessed by ELISA. They received acetazolamide only. Follow up after 1 and 6 months through HIT6 test and ophthalmological assessment (visual acuity, Frisen classification for papilledema, visual field, and visual evoked potentials) |
| Control group | No intervention | –24 healthy subjects for whom serum D-dimer was assessed by ELISA. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- IIH patients of both sexes fulfilling the modified Dandy criteria
Key exclusion criteria (4 listed)
- disturbed conscious level, focal neurological signs, seizures, cerebral venous sinus thrombosis or stenosis, deep venous thrombosis or pulmonary embolism, malignancy, and acute nephritic syndrome.
- Patients with signs of disseminated intravascular coagulopathy and septic sinus thrombosis
- patients with a history of cerebral granuloma or infection, cerebrovascular stroke, head trauma or surgery.
- pregnant females or those who terminated their pregnancy in the last four weeks were also excluded.
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 |
|---|---|---|
| LMWHAlso: ClexanSubcutaneous LMWH 1mg/kg/day for 2 weeks | Drug | Group A |
| acetazolamideAlso: DiamoxCarbonic anhydrase inhibitor 1-2g/day for 6 months | Drug | Group A, Group B |
Primary outcome
serum quantitative D-dimer
Time frame: Baseline assessment
higher serum D-dimer levels will be detected in IIH patients of both groups compared to controls
5 secondary outcomes
HIT6 score
Time frame: 1 and 6 months
Frisen classification for papilledema
Time frame: 6 months
Visual acuity (Log Mar)
Time frame: 6 months
Visual field (Perimetry)
Time frame: 6 months
Visual Evoked Potentials (VEP)
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2019.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing LMWH and acetazolamide in people with Idiopathic Intracranial Hypertension, run by Fayoum 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 1 inclusion and 4 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: finished, as of the sponsor's last update on 24 May 2019. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
serum quantitative D-dimer (time frame: Baseline assessment). 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 24 May 2019.