Trial Outcomes & Findings for Surgical Idiopathic Intracranial Hypertension Treatment Trial (NCT NCT03501966)

NCT ID: NCT03501966

Last Updated: 2022-06-16

Results Overview

Change from baseline to first of Month 6 (Week 26) or time of treatment failure in PMD (perimetric mean deviation) in eligible eye(s) with the size V stimulus

• Recruitment status: TERMINATED
• Study phase: PHASE3
• Target enrollment: 7 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2022-06-16

Participant Flow

Recruitment began in October 2018 and continued until the study stopped on August 28, 2019.

Participant milestones

Measure	Acetazolamide Including Diet Subjects will use 250 mg tablets of acetazolamide, divided into two doses, taken with meals. Initial dose will be 1,000 mg twice per day and increased per titration schedule (Table 6 in protocol). Dietary consultation will include advising subjects to adopt a low sodium weight reduced diet. Acetazolamide: Medical therapy including diet	Optic Nerve Sheath Fenestration Acetazolamide including Diet plus Optic Nerve Sheath Fenestration (ONSF) Subjects will use 250 mg tablets of acetazolamide, divided into two doses, taken with meals. Initial dose will be 1,000 mg twice per day and increased per titration schedule (Table 6 in protocol). Dietary consultation will include advising subjects to adopt a low sodium weight reduced diet. ONSF performed by qualified, certified orbital surgeon using either a medial or supero-medial lid crease approach. ONSF will be performed in one or both eyes, depending on criteria. Optic Nerve Sheath Fenestration: Medical therapy including diet + optic nerve sheath fenestration	Ventriculoperitoneal CSF Shunting Acetazolamide including Diet plus Ventriculoperitoneal CSF Shunting (VPS) Subjects will use 250 mg tablets of acetazolamide, divided into two doses, taken with meals. Initial dose will be 1,000 mg twice per day and increased per titration schedule (Table 6 in protocol). Dietary consultation will include advising subjects to adopt a low sodium weight reduced diet. VPS performed by qualified, certified neurosurgeon using a frameless image-guided stereotactic system and positioning a shunt catheter in the lateral ventricle of the cerebral hemisphere not associated with speech. The catheter will be connected to an adjustable valve, and a distal shunt system will be placed in the peritoneal cavity. Ventriculoperitoneal CSF Shunting: Medical therapy including diet + ventriculoperitoneal CSF Shunting
Overall Study STARTED	2	2	3
Overall Study COMPLETED	0	0	0
Overall Study NOT COMPLETED	2	2	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Surgical Idiopathic Intracranial Hypertension Treatment Trial

Baseline characteristics by cohort

Baseline data not reported

PRIMARY outcome

Timeframe: 6 months

Population: No data collected, study terminated due to poor enrollment prior to any data collection.

Change from baseline to first of Month 6 (Week 26) or time of treatment failure in PMD (perimetric mean deviation) in eligible eye(s) with the size V stimulus

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 3 years

Population: No data collected, study terminated due to poor enrollment prior to any data collection.

Time from randomization to treatment failure

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Population: No data collected, study terminated due to poor enrollment prior to any data collection.

Change in CSF opening pressure measurement by lumbar puncture

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Population: No data collected, study terminated due to poor enrollment prior to any data collection.

Change in papilledema grade

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Population: No data collected, study terminated due to poor enrollment prior to any data collection.

Change in retinal nerve fiber layer thickness

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Population: No data collected, study terminated due to poor enrollment prior to any data collection.

Change in total retinal thickness

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Population: No data collected, study terminated due to poor enrollment prior to any data collection.

Change in VA scores, determined by baseline VA of better than 20/200 (39 or more letters correct) and worsening indicated by less correct letters

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Population: No data collected, study terminated due to poor enrollment prior to any data collection.

Changes in QoL as measured by responses

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Population: No data collected, study terminated due to poor enrollment prior to any data collection.

Changes in QoL as measured by responses

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Population: No data collected, study terminated due to poor enrollment prior to any data collection.

Changes in QoL as measured by responses

Outcome measures

Outcome data not reported

Adverse Events

Acetazolamide Including Diet

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Optic Nerve Sheath Fenestration

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Ventriculoperitoneal CSF Shunting

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Colleen Bauza

Jaeb Center for Health Research

Phone: 813-975-8690

Email: cbauza@jaeb.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place