Idiopathic Intracranial Hypertension (IIH) is a disease in which the intracranial pressure is pathologically elevated. This can cause blindness, chronic, severe headache, and cognitive dysfunction. IIH is associated with obesity, and the only treatment which controls the disease is weight loss. MedDRA version: 21.1 Level: LLT Classification code 10004277 Term: Benign intracranial hypertension System Organ Class: 100000004852
Conditions
Interventions
Trade Name: Ozempic
Product Name: Ozempic
Pharmaceutical Form: Injection
INN or Proposed INN: Semaglutide
CAS Number: 910463-68-2
Concentration unit: mg milligram(s)
Concentration type: range
Concentr
Sponsors
Rigshospitalet, Neurologisk afdeling
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Part 1: Suspected, new onset IIH with papilledema. Part 2: Confirmed new onset IIH with papilledema according to Friedmann et al. • Female, 18-65 years • BMI = 27 • Written, informed consent • Use of anticontraceptives with a failure rate of =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Unable to provide written informed consent or participate • Malignant IIH with visual threat that requires VP-shunting, optic nerve sheet fenestration or other surgical CSF diversion • Pregnancy or breastfeeding • Treatment with antidiabetics, blood-thinners or medication that may increase the risk of adverse events or affect appetite (other than topiramate or acetazolamid) • Diabetes, congestive heart failure, severe vascular disease, pancreatitis, severe ophthalmological disorders other than IIH (e.g. retinopathy) • History or family history of thyroid carcinomas or other MEN1/MEN2 carcinomas • History of bariatric surgery • Other severe/uncontrolled mental or physical disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: We wish to investigate whether a dual-action weight loss program combining the benefits of a very low calorie diet (VLCD) at the time of diagnosis with a GLP1R analogue for long term weight maintenance is a better treatment option than our regular calorie restricted diet, which is the current standard of care. First, we want to investigate the use of a weight loss program for the treatment of IIH in which a 10-15 % weight loss is chieved in a very short time. We will use a randomized controlled study design with 2 treatment groups (A and B). We hypothesize that an initial VLCD (group A) would, 1.Reduce opening pressure in new-onset IIH significantly more than our standard of care (Group B). The primary outcome is ICP after 8 weeks and weight loss (% of body weight) compared to baseline values in the two groups A and B respectively. ;Secondary Objective: Second, we want to investigate whether the use of a GLP-1R analogue (Semaglutide®) can sustain a long-term weight loss after an initial VLCD in patients with new-onset IIH. A sustained weight loss of 10-20 % is the only known disease modifying treatment(19). We hypothesize that, 2.8 months follow-up treatment with Semaglutide® after 8 weeks on a VLCD will result in a sustained, total weight loss of 10-20 % of total baseline body weight after 10 months in group A and a significant reduction in opening pressure after 10 months in comparison with group B.;Primary end point(s): The primary end point is ICP after 8 weeks and total weight lost (% of body weight). ;Timepoint(s) of evaluation of this end point: 8 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Neuroophthalmological outcome (8 weeks, 4 and 10 months) o Degree of papilledema (Frisén grade) o Visual field perimetric mean deviation (MD) by automated perimetry o Optical coherence tomography (OCT) changes including enhanced depth imaging (EDI) OCT, confocal scanning laser ophthalmoscopy (cSLO) and OCT angiography (OCTA) • Improvement in optic disc elevation and optic nerve sheath diameter assessed with ultrasonography of the optic nerves. • Headache outcome (8 weeks, 4 and 10 months) • Headache days per month • Headache disability (HURT questionnaire) • Headache intensity (8 weeks, 4 and 10 months) • Use of headache medication • Improvement in non-alcoholic fatty liver disease • Percentage in remission after 10 months (absence of papilledema with or withou ICP < 25 mmH2O) • Reduction in body fat percentage and truncal adiposity (10 months DEXA scan) • Quality of life ( WHO QoL questionnaire (short version), 8 weeks and 10 months) • Feasibility • Drop-out before 8 weeks and 10-month follow-up • Percentage of patients in ketosis (ketones in urine and blood) after 4 weeks and 8 weeks • Difficulty following diet and patient satisfaction (scale of 0-10) at 8 weeks and after 10 months • Use of ICP regulating medication (daily dose and length of treatment) • Biomarkers in CSF, blood and saliva (at baseline, 8 weeks and 10 months) • Change in cardiometabolic parameters (HOMA2IR, HbA1c, glucose, serum lipids, urine sample, etc.), samples collected with patients fasting (at baseline, 8 weeks and 10 months) • Adverse effects including biochemical assessment ;Timepoint(s) of evaluation of this end point: Eight weeks and 10 months after inclusion, respectively | — |
Countries
Denmark
Contacts
Public ContactDansk Hovedpinecenter
Rigshospitalet, Neurologisk afdeling
Outcome results
None listed